May 2026 
© Kalorama Information 
 
 
 
 
The Worldwide Market for IVD 
Tests, 19th Edition 
 
 

 
 
 
Table of Contents 
 
The Worldwide Market for IVD Tests, 19th Edition 
May 2026 © Kalorama Information 
i 
  
CHAPTER 1: EXECUTIVE SUMMARY ............................................................................................................ 1 
ABOUT KALORAMA INFORMATION ......................................................................................................................... 1 
OVERVIEW ........................................................................................................................................................ 2 
Figure 1-1: Worldwide IVD Market Sales, 2020, 2025, and 2030 ($ billion) .......................................................... 4 
Figure 1-2: COVID-19 IVD Market, Share by Segment, 2025 (%)  [Immunoassay Lab-Based, Molecular 
Dx Lab-Based, Point-of-Care] ............................................................................................................................. 5 
SCOPE AND METHODOLOGY ................................................................................................................................. 7 
SIZE AND GROWTH OF THE MARKET ..................................................................................................................... 10 
Table 1-1: Global In Vitro Diagnostic (IVD) Sales, by Product Segment, 2025-2030 ($ million)   [Blood 
Bank Molecular; Blood Bank Screening; Drugs of Abuse; Blood Grouping/Typing; Circulating Tumor 
Cells; Clinical Chemistry; Coagulation; Histology/Cytology; Continuous Glucose; Diabetes HbA1c 
Immunoassays, Lab-Based;  Hematology;  HPV, Molecular; Immunoassays - Infectious Disease;  
Immunoassays - Other; Mass Spectrometry; Microbiology (ID/AST); Molecular Microbiology; 
Nucleic Acid Assays; POC, OTC Diabetes; POC, OTC Other; POC, Professional; Other] .................................... 10 
MARKET HIGHLIGHTS ........................................................................................................................................ 12 
MARKET ASSUMPTIONS ..................................................................................................................................... 14 
Table 1-2: IVD Market Assumptions 2025 Outlook ............................................................................................. 15 
COMPETITIVE PICTURE IN IVD ............................................................................................................................. 16 
FINDING WHAT YOU ARE LOOKING FOR IN THE 19TH EDITION .................................................................................. 17 
Table 1-3: Finding What You Are Looking For in the 19th Edition ....................................................................... 17 
CHAPTER 2: INTRODUCTION .................................................................................................................... 18 
IVD LANDSCAPE ............................................................................................................................................... 18 
SCOPE ............................................................................................................................................................ 18 
Edition-Specific Notes .............................................................................................................................. 19 
Shifting Areas of Concentration .......................................................................................................................... 19 
Report Design .......................................................................................................................................... 20 
PAMA AND CMS ............................................................................................................................................ 22 

 
 
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MARKET ANALYSIS OF IVD MARKET SEGMENTS ..................................................................................................... 26 
Table 2-1: Global In Vitro Diagnostic (IVD) Sales, by Product Segment, 2025-2030 ($ million) (%)  
[Blood Bank Molecular; Blood Bank Screening; Drugs of Abuse; Blood Grouping/Typing; Circulating 
Tumor Cells; Clinical Chemistry; Coagulation; Histology/Cytology; Continuous Glucose; COVID-19 
Dx; Diabetes HbA1c Immunoassays, Lab-Based;  Hematology;  HPV, Molecular; Immunoassays - 
Infectious Disease;  Immunoassays - Other; Mass Spectrometry; Microbiology (ID/AST); Molecular 
Microbiology; POC, OTC Diabetes; POC, OTC Other; POC, Professional; Other] .............................................. 27 
Table 2-2: Additional Global In Vitro Diagnostic (IVD) Markets of Interest (Not in Totals), Sales by 
Product Segment, 2025-2030 ($ million) (%)   [Clinical Sequencing; Drugs of Abuse, Criminal; Drugs 
of Abuse, Employment (non IVD); DTC Genetic Testing; Flow Cytometry; Prenatal Test Services] ................. 28 
TOP SUPPLIERS AND NICHE PLAYERS .................................................................................................................... 29 
Introduction............................................................................................................................................. 29 
Overview of the Top Tier Companies ...................................................................................................... 31 
Table 2-3: Clinical Diagnostic Revenues of Selected Top 20 IVD Companies, 2024 and 2025 ($ million) ............ 31 
Abbott Diagnostics .................................................................................................................................. 32 
Roche Diagnostics ................................................................................................................................... 32 
Danaher Corporation .............................................................................................................................. 33 
Cepheid ................................................................................................................................................... 33 
Radiometer.............................................................................................................................................. 33 
Beckman Coulter ..................................................................................................................................... 33 
Thermo Fisher Scientific .......................................................................................................................... 34 
Dexcom ................................................................................................................................................... 34 
Siemens Healthineers .............................................................................................................................. 34 
bioMérieux .............................................................................................................................................. 34 
Illumina ................................................................................................................................................... 35 
Exact Sciences ......................................................................................................................................... 35 
Sysmex Corporation ................................................................................................................................ 35 
Becton Dickinson & Co ............................................................................................................................ 36 
QuidelOrtho Corporation ........................................................................................................................ 36 
Werfen .................................................................................................................................................... 36 
Natera ..................................................................................................................................................... 36 
Mindray ................................................................................................................................................... 37 
Hologic .................................................................................................................................................... 37 
Agilent ..................................................................................................................................................... 37 
Bio-Rad Laboratories ............................................................................................................................... 37 
QIAGEN N.V. ............................................................................................................................................ 38 

 
 
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Revvity ..................................................................................................................................................... 38 
Overview of Selected Second-Tier Companies ......................................................................................... 38 
Table 2-4: Revenues of Selected Top 20 Niche IVD Players, 2024 and estimated 2025 ($ million) ..................... 39 
Figure 2-1: Top Tier Market Distribution, 2024 and estimated 2025 (%) ............................................................ 40 
Diasorin Group ........................................................................................................................................ 40 
Bruker/CALID Group ................................................................................................................................ 40 
Guardant Health ..................................................................................................................................... 41 
Myriad Genetics ...................................................................................................................................... 41 
Grifols S.A. ............................................................................................................................................... 41 
Diagnostica Stago ................................................................................................................................... 41 
BGI Genomics .......................................................................................................................................... 42 
Sekisui Diagnostics .................................................................................................................................. 42 
ARKAY ...................................................................................................................................................... 42 
GeneDx .................................................................................................................................................... 42 
Fujirebio .................................................................................................................................................. 42 
Fulgent Genetics ...................................................................................................................................... 43 
Seegene ................................................................................................................................................... 43 
Horiba ..................................................................................................................................................... 43 
Randox .................................................................................................................................................... 43 
Eiken Chemical Co ................................................................................................................................... 43 
Nihon Kohden .......................................................................................................................................... 44 
Meridian .................................................................................................................................................. 44 
Menarini Diagnostics .............................................................................................................................. 44 
Haemonetics ........................................................................................................................................... 45 
IVD COMPANIES MERGERS & ACQUISITIONS ......................................................................................................... 46 
Table 2-5: Selected IVD Mergers and Acquisitions, 2023-2026 (first half) .......................................................... 48 
COLLABORATION, PARTNERSHIP, ALLIANCE AGREEMENTS ........................................................................................ 53 
TEST SERVICES ................................................................................................................................................. 62 
Figure 2-2: Clinical Laboratory Test Service Market Forecasted Growth, by Segment, 2024-2029 (%) .............. 62 
Table 2-6: Global Lab Market Segmentation, 2024 ($ billion)  [Hospital and Acute Care Labs, 
Independent Labs, Physician Office Labs] ........................................................................................................ 63 
Table 2-7: Total Revenues for Leading U.S.-based Reference Labs, 2023-2025 ($ million) ................................. 65 
HISTORICAL IVD MARKET VS TODAY .................................................................................................................... 67 
In the Beginning to Now .......................................................................................................................... 68 

 
 
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Figure 2-3: Share of Global IVD Market, by Segment, 2000 and 2025 Compared (%)  [Blood Banking 
(imm & typing); Clinical Chemistry; Coagulation; Hematology; Immunoassays; Microbiology 
[ID/AST]; Molecular; POC – Other; Histology/Cytology; POC Diabetes; Others] .............................................. 68 
Future ...................................................................................................................................................... 69 
Next-Generation Sequencing .................................................................................................................. 69 
Cancer Testing (Liquid Biopsy) ................................................................................................................ 71 
Companion Diagnostics ........................................................................................................................... 72 
CHAPTER 3: THE GLOBAL PICTURE FOR IN VITRO DIAGNOSTIC MARKETS ................................................. 73 
SCOPE ............................................................................................................................................................ 73 
OVERVIEW ...................................................................................................................................................... 74 
Simultaneous Threats: Chronic and Acute .............................................................................................. 74 
Expected World IVD Market Developments ............................................................................................ 74 
GLOBAL POPULATION AND AGING ....................................................................................................................... 77 
Figure 3-1: Global Fertility Rate vs. Population Size, 1950-2050 (billion) ............................................................ 77 
Figure 3-2: Global Population Distribution, 2025 ................................................................................................ 78 
Table 3-1: Elderly Support Ratio in Various Countries, 2010 and 2050  [Australia; Brazil; Canada; 
China; China, Hong Kong SAR; France; Germany; India; Italy; Japan; Mexico; Saudi Arabia; 
Singapore; South Africa; Spain; Turkey; United Kingdom; United States; World]............................................ 79 
Workforce Reduction .............................................................................................................................. 80 
WHO ESSENTIAL IVD LIST ................................................................................................................................. 81 
Table 3-2: WHO Model List of Essential In Vitro Diagnostics (EDL) ..................................................................... 82 
Increase in Chronic Diseases ................................................................................................................... 85 
Figure 3-3: Leading Causes of Death Globally, 2021* (number of deaths in millions) ........................................ 86 
COVID-19 ..................................................................................................................................................... 88 
Table 3-3: Selected Molecular EUA Tests for COVID-19, 2024-July 2025 ............................................................ 89 
Table 3-4: Selected Antigen Immunoassay Tests for SARS-CoV-2, 2024-2025 .................................................... 92 
EMERGING AND EMERGED MARKETS .................................................................................................................... 94 
Table 3-5: Developed/Developing Economies, UN Classification* Table, 2025 .................................................. 95 
Figure 3-4: Developed vs. Developing IVD Market Shares, 2025 and Projected 2030 (%) .................................. 96 
Table 3-6: Countries To Watch for IVD Opportunities, by Total Population and Percent Urban, 2025   
[Australia; Brazil; China; France; Germany; Hungary; India; Mexico; Netherlands; Poland; Romania; 
Saudi Arabia; South Africa; South Korea; Sweden; Switzerland, Turkey; United Kingdom; United 
States] .............................................................................................................................................................. 98 
SIZE AND FORECAST FOR THE GLOBAL IVD MARKET .............................................................................................. 101 
Table 3-7: Global In Vitro Diagnostic Market, Major Country/Region Markets, 2025 and 2030 ($ 
million)   [Australia; Brazil; Canada; China; Eastern Europe; EU 15/W. Europe; India; Japan; Mexico; 

 
 
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Peru; Russia; Saudi Arabia; South Africa; South Korea; Turkey; UAE; United States; Vietnam; Rest of 
World] ............................................................................................................................................................ 102 
Table 3-8: Global In Vitro Diagnostic Market, Regional Markets, 2025 and 2030 ($ million)   [Africa, 
Asia Pacific, Europe, Latin America, Middle East, North America] ................................................................. 103 
Table 3-9: Global In Vitro Diagnostic Market, YOY Growth, by Segment, 2024-2025 (%)  [Blood Bank 
Molecular; Blood Bank Screening – Immunoassays; Blood Grouping/Typing; Clinical Chemistry; 
Coagulation (PT/INR, Molecular); D-dimer; Diabetes HbA1c, Lab; Drugs of Abuse; Hematology - 
Core Lab; Histology/Cytology; Immunoassays - Infectious Disease; Immunoassays - Other Immunos; 
Mass Spectrometry (Micro/Non-Micro); Microbiology (ID/AST); Microbiology (Molecular); NAAT – 
Oncology; NAAT – Genetic/Inherited; POC, OTC Glucose OTC; POC Continuous Glucose; POC, OTC 
Other; POC, Professional/Hospital] ................................................................................................................ 104 
Table 3-10: Global In Vitro Diagnostic Market, Regional Markets, 2024-2025 YOY Change (%)  [Africa, 
Asia Pacific, Europe, Latin America, Middle East, North America] ................................................................. 105 
THE IVD MARKET IN THE UNITED STATES ............................................................................................................ 106 
Table 3-11: United States IVD Market Share, by Segment, 2025 (%)   [Blood Grouping; Clinical 
Chemistry; Coagulation; Hematology; Histology; Immunoassay Infectious Disease; Immunoassay 
Other; Microbiology ID/AST; Microbiology Molecular; Nucleic Acid Assays; POC Diabetes; POC 
Other; Others] ................................................................................................................................................ 107 
PAMA and Reimbursement Changes .................................................................................................... 108 
Impact of CARES Act on PAMA .............................................................................................................. 109 
Table 3-12: Proposed Clinical Diagnostic Laboratory Test (CDLT) Rates, 2020-2027 ........................................ 110 
Saving Access to Laboratory Service Act (SALSA) .................................................................................. 110 
LDT Update ........................................................................................................................................... 111 
Bundled Insurance Payments for ESRD Patients ................................................................................... 112 
Table 3-13: Laboratory Tests Subject to ESRD Consolidated Billing .................................................................. 113 
Advanced Laboratory Tests (ADLT) ....................................................................................................... 115 
Table 3-14: List of Approved ADLTs, March 2026 ............................................................................................. 117 
Precision Medicine and NGS .................................................................................................................. 121 
IVD Market in Europe ............................................................................................................................ 122 
Figure 3-5: International Monetary Fund Inflation Map, Global 2024 .............................................................. 124 
Table 3-15: Western European IVD Market, by Country, 2025 ($ million, estimated)   [Austria; 
Belgium; Denmark; Finland; France; Germany; Greece; Ireland; Italy; Luxembourg; Netherlands; 
Norway; Portugal; Spain; Sweden; Switzerland; UK] ..................................................................................... 125 
EU Regulation ........................................................................................................................................ 126 
Table 3-16: IVD Market Per Capita, Europe, 2025 Estimates   [Bulgaria; Croatia; Czech Republic; 
France; Germany; Greece; Hungary; Italy; Lithuania; Netherlands; Poland; Romania; Russia; Serbia; 
Slovakia; Slovenia; Spain; Sweden; Switzerland; Ukraine; UK] ....................................................................... 129 
Precision Medicine in Europe ................................................................................................................ 130 

 
 
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Brexit ..................................................................................................................................................... 130 
JAPAN .......................................................................................................................................................... 131 
Table 3-17: Japan IVD Market, Share by Segment, 2025 (%)   [Clinical Chemistry; Coagulation; 
Hematology; Histology; Immunoassay Infectious Disease; Immunoassay Other; Microbiology 
ID/AST; Microbiology Molecular; POC Diabetes; POC Other; Others] ........................................................... 133 
EASTERN EUROPE: GROWTH REGION ................................................................................................................. 134 
Table 3-18: Eastern European IVD Market, by Country, 2025 ($ million)   [Bulgaria; Croatia; Czech 
Republic; Hungary; Poland; Romania; Slovakia; Slovenia; Ukraine; Other].................................................... 134 
Figure 3-6: Eastern Europe IVD Market, by Country, 2025 ($ million)   [Bulgaria; Croatia; Czech 
Republic; Hungary; Poland; Romania; Slovakia; Slovenia; Ukraine; Other].................................................... 135 
CHINA: CURRENT IVD MARKET ......................................................................................................................... 136 
Table 3-19: China IVD Market, Share by Segment, 2025 (%)   [Blood Bank Screening; Clinical 
Chemistry; Coagulation; Hematology; Histology; Immunoassay Infectious Disease; Immunoassay 
Other; Microbiology ID/AST; Microbiology Molecular; POC Diabetes; POC Other; Others] .......................... 137 
Table 3-20: Total Midyear Population, by Broad Age Group: China, 2010-2050 (million persons) ................... 138 
Clinical Laboratory Market in China ...................................................................................................... 140 
Volume-Based Procurement in China .................................................................................................... 141 
INDIA: POPULATION AND OPPORTUNITY ............................................................................................................. 143 
Table 3-21: India IVD Market, Share by Segment, 2025 (%)   [Clinical Chemistry, Hematology, 
Coagulation; Histology/Cytology; Immunoassays; Microbiology/Virology; POC Glucose; POC Other; 
Others] ........................................................................................................................................................... 144 
Clinical Laboratory Market in India ....................................................................................................... 146 
IVD Regulation ...................................................................................................................................... 147 
India’s Mukt Bharat Campaign ............................................................................................................. 147 
REST OF ASIA ................................................................................................................................................. 149 
Table 3-22: Asia Pacific Region IVD Market, by Country, 2025 ($ million)   [Australia; China; India; 
Indonesia; Japan; Malaysia; Philippines; Singapore; South Korea; Thailand; Vietnam] ................................. 150 
BRAZIL .......................................................................................................................................................... 151 
Table 3-23: Brazil IVD Market, by Broad Segment, 2025 (%)   [Core Lab; Histology; Immunoassays; 
Microbiology/Virology; Point-of-Care - glucose; Point-of-Care - other] ........................................................ 152 
Disease Trends ...................................................................................................................................... 152 
Clinical Laboratory Market in Brazil ...................................................................................................... 154 
IVD Regulation ...................................................................................................................................... 155 
MEXICO ........................................................................................................................................................ 157 
Table 3-24: Mexico IVD Market, by Broad Segment, 2025 (%)   [Clinical Chemistry, Hematology, 
Coagulation; Histology; Immunoassays; Microbiology; Point-of-Care; Others] ............................................. 157 
THE RUSSIAN FEDERATION ............................................................................................................................... 159 

 
 
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CANADA ....................................................................................................................................................... 161 
EMERGING MARKETS ...................................................................................................................................... 163 
Saudi Arabia IVD Market ....................................................................................................................... 163 
South Africa IVD Market ....................................................................................................................... 164 
South Korea IVD Market ....................................................................................................................... 165 
Turkey IVD Market ................................................................................................................................ 165 
United Arab Emirates (UAE) IVD Market .............................................................................................. 166 
Other Markets to Watch ....................................................................................................................... 167 
Chile ...................................................................................................................................................... 167 
Colombia ............................................................................................................................................... 168 
Indonesia ............................................................................................................................................... 169 
Malaysia ................................................................................................................................................ 170 
Peru ....................................................................................................................................................... 170 
Philippines ............................................................................................................................................. 171 
Poland ................................................................................................................................................... 173 
Romania ................................................................................................................................................ 174 
Thailand ................................................................................................................................................ 174 
Vietnam ................................................................................................................................................. 175 
IVD MARKET OPPORTUNITY BY COUNTRY ........................................................................................................... 176 
Table 3-25: IVD Market Opportunity, by Country (2025 Market Rank, Country CAGR 2025-2030) (%) ............ 176 
CHAPTER 4: COMPANY AND INDUSTRY TRENDS .................................................................................... 179 
SCOPE .......................................................................................................................................................... 179 
EDITION-SPECIFIC NOTES ................................................................................................................................. 180 
Advanced Medicine Without Borders ................................................................................................... 180 
Table 4-1: Key Emerging IVD Markets, 2020-2025 ($ million) ........................................................................... 181 
China Market Update ............................................................................................................................ 182 
Direct to Consumer Genetic Test Services ............................................................................................. 183 
Genetic Testing in Disease .................................................................................................................... 184 
Genomic Testing .................................................................................................................................... 184 
GENE EDITING ............................................................................................................................................... 186 
Table 4-2: Selected Gene Editing / CRISPR Innovations .................................................................................... 187 
CRISPR as a Diagnostic Tool .................................................................................................................. 188 
CRISPR and the Food Industry ............................................................................................................... 189 
MICROBIOME ................................................................................................................................................ 191 

 
 
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Table 4-3: Selected Microbiome Test Innovations ............................................................................................ 193 
NEXT-GENERATION SEQUENCING ...................................................................................................................... 194 
Table 4-4: Selected Clinical NGS Platforms on the Market ................................................................................ 195 
Liquid Biopsy ......................................................................................................................................... 197 
Quality Assurance ................................................................................................................................. 200 
Product News ........................................................................................................................................ 201 
Market Cleared Products ...................................................................................................................... 202 
Liquid Biopsy in Microbiology ............................................................................................................... 203 
Liquid Biopsy Companies in 2022-2025 ................................................................................................. 204 
The Future for Liquid Biopsy .................................................................................................................. 207 
INFORMATION TECHNOLOGY ADVANCES AND ARTIFICIAL INTELLIGENCE .................................................................... 209 
AI in Clinical Practice ............................................................................................................................. 210 
Table 4-5: Selected AI Market Cleared Tests ..................................................................................................... 214 
AI Physician Usage ................................................................................................................................ 215 
The Regulatory Pathway ....................................................................................................................... 216 
Product Initiatives ................................................................................................................................. 216 
Table 4-6: Selected AI Product Initiatives in Development and Collaborations ................................................ 218 
AI in Liquid Biopsy ................................................................................................................................. 219 
Role of AI in Liquid Biopsy Interpretation .............................................................................................. 219 
Industry Leaders and Initiatives ............................................................................................................ 219 
New Liquid Biopsy / AI Products in Development or Recently Launched .............................................. 220 
Table 4-7: Selected AI/Liquid Biopsy Initiatives ................................................................................................. 221 
Future Trends ........................................................................................................................................ 221 
EXOSOME SEQUENCING ................................................................................................................................... 223 
BIOTIN INTERFERENCE IN IMMUNOASSAY DETECTION ERRORS ................................................................................. 224 
Table 4-8: Biotin-free Offerings Currently on the Market ................................................................................. 225 
Table 4-9: Biotin Interference with Troponin Lab Tests – Assays Subject to Biotin Interference ...................... 227 
Clinical Applications and Liquid Biopsy ................................................................................................. 228 
TRAUMATIC BRAIN INJURY AND IVD .................................................................................................................. 230 
PERSONALIZED MEDICINE ................................................................................................................................ 232 
Companion Diagnostics ......................................................................................................................... 233 
Table 4-10: Selected FDA Approved Companion Diagnostics 2025 ................................................................... 234 
TELEHEALTH .................................................................................................................................................. 244 
BLOCKCHAIN .................................................................................................................................................. 245 
SUBSTANCE ABUSE ......................................................................................................................................... 247 

 
 
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Biomarkers and Substance Abuse ......................................................................................................... 247 
Clinical Laboratory Testing for Drugs of Abuse ..................................................................................... 248 
Table 4-11: Global Drug Abuse Statistics ........................................................................................................... 249 
Urine ...................................................................................................................................................... 249 
Blood ..................................................................................................................................................... 251 
Oral ....................................................................................................................................................... 252 
Hair ........................................................................................................................................................ 253 
SALIVA TESTING ............................................................................................................................................. 254 
BREATH TEST ADVANCES .................................................................................................................................. 255 
Table 4-12: Selected Disease Markers in Exhaled Breath .................................................................................. 257 
MICRO-HOSPITAL OPPORTUNITIES ..................................................................................................................... 258 
CLIMATE CHANGE AND INFECTIOUS DISEASE ........................................................................................................ 260 
KICKBACK SCHEMES ........................................................................................................................................ 261 
EARLY SEPSIS DETECTION ................................................................................................................................. 263 
MEDICAL DIAGNOSTICS AND 3D PRINTING .......................................................................................................... 265 
STAFFING SHORTAGES ..................................................................................................................................... 266 
TARGETED TESTING ......................................................................................................................................... 269 
CHAPTER 5: POINT-OF-CARE (POC) TESTS .............................................................................................. 271 
SCOPE .......................................................................................................................................................... 271 
OVERVIEW AND TRENDS .................................................................................................................................. 272 
POC INDUSTRY DRIVERS .................................................................................................................................. 275 
Patient-focused drivers ......................................................................................................................... 275 
Medical/Healthcare-related drivers ...................................................................................................... 275 
Technology drivers ................................................................................................................................ 275 
Economic drivers ................................................................................................................................... 276 
Other drivers ......................................................................................................................................... 276 
POC INDUSTRY CHALLENGES ............................................................................................................................ 277 
REGULATORY CHALLENGES ............................................................................................................................... 278 
PROFESSIONAL POC ....................................................................................................................................... 280 
Table 5-1: Worldwide Professional POC Test Sales, by Category, 2025 -2030 ($ million)   [Cardiac 
Markers; Cholesterol; Coagulation; Critical Care POC; Drugs of Abuse; Fecal Occult Blood; Fertility; 
Glucose; HbA1c POC; Hematology; Infectious Diseases; Urinalysis; Others] ................................................. 281 
Table 5-2: Selected Professional POC Test Innovations (excluding COVID-19 testing) ...................................... 284 
OTC SELF TESTING ......................................................................................................................................... 286 

 
 
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Table 5-3: Worldwide POC Self-Test Sales, by Category, 2025-2030($ million)   [Cholesterol; 
Coagulation; Drugs of Abuse; Fecal Occult Blood; Glucose, Continuous; Glucose, Self;  H. pylori; 
HIV; Other Infectious Disease (inc. COVID-19); Pregnancy; Urinalysis; Other (TSH, Allergy, 
Autoimmune, etc.)] ........................................................................................................................................ 286 
PREGNANCY/FERTILITY TESTS ............................................................................................................................ 288 
Table 5-4: POC Pregnancy and Fertility Test Market Distribution, by End User, 2025 (%)   [OTC, PRO] ........... 288 
Table 5-5: Pregnancy/Fertility POC Test Sales Distribution, by Global Region, 2025 (%)  [Europe; 
Japan; United States; Rest of World] ............................................................................................................. 288 
COLON CANCER SCREENING .............................................................................................................................. 290 
Table 5-6: Selected POC Colon Cancer Tests ..................................................................................................... 292 
Table 5-7: Colon Cancer POC Test Sales Distribution, by Global Region, 2025 (%)  [Europe; Japan; 
United States; Rest of World] ........................................................................................................................ 293 
LIPID TESTING ................................................................................................................................................ 294 
Table 5-8: Lipid POC Test Sales Distribution, by Global Region, 2025 (%)  [Europe; Japan; United 
States; Rest of World] .................................................................................................................................... 294 
DRUGS OF ABUSE TESTING ............................................................................................................................... 296 
Table 5-9: POC Drugs of Abuse Test Sales Distribution, by Setting, 2025 (%)  [Criminal Justice; Critical 
Care - Traditional POC; Employment Screening] ............................................................................................ 296 
Products ................................................................................................................................................ 296 
Table 5-10: Drugs of Abuse Tests on the Market .............................................................................................. 298 
Table 5-11: Drugs of Abuse POC Test Sales Distribution, by Global Region, 2025 (%)  [Europe; Japan; 
United States; Rest of World] ........................................................................................................................ 301 
RAPID AND POC INFECTIOUS DISEASE TESTING .................................................................................................... 302 
Table 5-12: Innovations in Molecular POC Infectious Disease Diagnostics ....................................................... 304 
Products ................................................................................................................................................ 310 
Table 5-13: POC Infectious Disease Test Summary by Disease and Technology ............................................... 311 
HIV and Hepatitis Testing and Monitoring ............................................................................................ 312 
Tuberculosis .......................................................................................................................................... 314 
Tropical and Neglected Diseases ........................................................................................................... 315 
Respiratory Diseases ............................................................................................................................. 317 
Sepsis and Nosocomial Disease ............................................................................................................. 319 
Sexual Health ........................................................................................................................................ 320 
Lyme Disease ......................................................................................................................................... 321 
COVID-19 ............................................................................................................................................... 322 
MARKET SIZE AND GROWTH ............................................................................................................................. 324 
Point-of-Care OTC and Professional Use Immunoassays ...................................................................... 324 

 
 
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Table 5-14: Global POC Immunoassay Sales Distribution, by Region, 2025 (%)  [Europe; Japan; United 
States; Rest of World] .................................................................................................................................... 325 
Table 5-15: Global POC Immunoassay Test Sales, by Test Category, 2025-2030 ($ million)   [OTC/Self 
Tests (Drugs of Abuse; H. pylori; HIV; Infectious Disease/COVID-19; Pregnancy/Ovulation; Other) 
and Professional POC (Cardiac Markers; Drugs of Abuse; HbA1c; Infectious Disease/COVID-19; 
Pregnancy; Other)] ......................................................................................................................................... 328 
Table 5-16: Selected Self-Test Immunoassay Innovations ................................................................................ 330 
Pregnancy Testing ................................................................................................................................. 330 
Cardiovascular Diagnostics ................................................................................................................... 332 
Drugs of Abuse/Therapeutic Drug Monitoring ...................................................................................... 333 
Table 5-17: Infectious Disease POC Test Demand, by Type, 2025 (%)  [C. difficile; COVID-19; E. coli; H. 
pylori; Hepatitis; HIV; Home Test/OTC; Influenza; Malaria; Other respiratory; STD; Others] ........................ 335 
Table 5-18: Infectious Disease POC Test Sales Distribution, by Global Region, 2025 (%)  [Europe; 
Japan; United States; Rest of World] ............................................................................................................. 336 
DIABETES TESTING – BLOOD GLUCOSE MONITORING ............................................................................................ 337 
Table 5-19: Glucose POC Test Sales Distribution, by Global Region, 2025 (%)  [Europe; Japan; United 
States; Rest of World] .................................................................................................................................... 338 
Figure 5-1: POC Glucose Testing Market Growth, by Category, 2025-2030 (%)  [Continuous; HbA1c 
POC, Professional; OTC; Professional] ............................................................................................................ 339 
IT to Aid Diabetes Management ........................................................................................................... 339 
Table 5-20: Selected Apps and Glucose Management IT .................................................................................. 341 
Diabetes Market Analysis ...................................................................................................................... 341 
Table 5-21: Global Diabetes Sales, by Test Category, 2025-2030 ($ million)  [Glucose OTC; Glucose, 
continuous; HbA1c Lab; HbA1c POC] ............................................................................................................. 342 
POC Glucose Competitors ...................................................................................................................... 343 
Table 5-22: Top Three POC Test Vendors, by Glucose Test Revenues, 2025 ($ million) ................................... 343 
Blood Glucose Self-Testing .................................................................................................................... 343 
Table 5-23: Selected Glucose Self-Test Meter Innovations ............................................................................... 344 
Non-invasive Testing Devices ................................................................................................................ 344 
Table 5-24: Selected Noninvasive Glucose Monitoring Devices ........................................................................ 345 
Continuous Glucose Monitoring ............................................................................................................ 345 
Table 5-25: Selected Continuous Blood Glucose System Developments .......................................................... 348 
Blood Glucose Testing by Professionals ................................................................................................ 349 
Table 5-26: Selected Innovations in Hospital-based Glucose Monitoring ......................................................... 350 
Diabetes Testing – Glycated Hemoglobin ............................................................................................. 350 
Table 5-27: Global HbA1c Test Sales Market and Distribution, by Setting, 2025-2030 ($ million)   
[HbA1c Lab; HbA1c POC] ................................................................................................................................ 352 

 
 
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Table 5-28: Selected POC HbA1c Devices .......................................................................................................... 356 
Genes and Other Markers of Diabetes .................................................................................................. 357 
Table 5-29: Selected POC Diabetes Monitoring Tests ....................................................................................... 359 
THE MAJOR POC TEST PLAYERS ........................................................................................................................ 360 
Table 5-30: POC Test Revenues of Selected IVD Companies, 2025 ($ million) .................................................. 360 
CHAPTER 6: THE CORE LAB .................................................................................................................... 365 
SCOPE .......................................................................................................................................................... 365 
CORE LAB OVERVIEW AND TRENDS .................................................................................................................... 366 
Table 6-1: Selected Analytes for the Core Lab................................................................................................... 367 
CONNECTIVITY ............................................................................................................................................... 370 
OVERVIEW OF CHEMISTRY TESTS ....................................................................................................................... 371 
Lab Automation .................................................................................................................................... 372 
MARKET ANALYSIS .......................................................................................................................................... 374 
Table 6-2: Global Lab-based Clinical Chemistry Sales, by Test Category, 2025-2030 ($ million)   [Blood 
Gases; General Chemistries; Urinalysis] ......................................................................................................... 374 
Table 6-3: Global Clinical Chemistry Sales Distribution, by Region, 2025 (%)  [Asia Pacific; Europe; 
North America; Rest of World] ....................................................................................................................... 375 
Table 6-4: Selected Major Clinical Chemistry Companies, by Sales, 2025 ($ million, estimated) ...................... 376 
Table 6-5: Selected Clinical Chemistry Innovations ........................................................................................... 377 
Rapid Response Systems ....................................................................................................................... 377 
Table 6-6: Selected Major Whole Blood Chemistry Analyzers .......................................................................... 378 
Critical Care Analysis ............................................................................................................................. 378 
Table 6-7: Blood Gas, Electrolyte, and Critical Care Instrument Market, by End User, 2025 and 2030 
($ million)  [Lab-based; POC-based] ............................................................................................................... 381 
Table 6-8: Blood Gas, Electrolyte, and Critical Care Market Leaders, 2025 (% distribution of total 
sales, including POC) ...................................................................................................................................... 381 
Urinalysis ............................................................................................................................................... 382 
Table 6-9: Urinalysis Market, by End User, 2025 and 2030 ($ million)   [Lab-based, POC-based] ..................... 382 
Table 6-10: Urinalysis Systems (including POC) Market Leaders, 2025 (% distribution of total sales, 
estimated) ...................................................................................................................................................... 383 
Table 6-11: Selected Urinalysis Innovations ...................................................................................................... 384 
THE COMMERCIAL OUTLOOK FOR CHEMISTRY TESTS ............................................................................................. 385 
 
 

 
 
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CHAPTER 7: IMMUNOASSAYS ................................................................................................................ 386 
SCOPE .......................................................................................................................................................... 386 
OVERVIEW AND TRENDS .................................................................................................................................. 388 
Immunoassay Technology Continues to Evolve .................................................................................... 388 
Table 7-1: Selected Immunoassay Technologies ............................................................................................... 391 
Mass Spectrometry ............................................................................................................................... 392 
Table 7-2: Selected Innovation in Mass Spectrometry for Routine Analyses .................................................... 398 
Radioimmunoassays ............................................................................................................................. 399 
MARKET ANALYSIS .......................................................................................................................................... 401 
Table 7-3: Global Lab-based Immunoassay Sales (excluding infectious disease and blood screening),  
by Analyte Type, 2025-2030 ($ million)   [Allergy; Anemia; Autoimmune; Cardiac Markers; 
Diabetes/HbA1c; Drug of Abuse; Fertility; Proteins; Therapeutic Drugs; Thyroid; Tumor Markers; 
Vitamin D; Others] ......................................................................................................................................... 402 
Table 7-4: Global Immunoassay (excluding infectious disease and blood screening) Sales Distribution,  
by Region, 2025 (%)   [Asia Pacific, Europe, Japan, North America, Rest of World] ....................................... 403 
Table 7-5: IVD Quality Control (immunoassay/molecular) Market, 2025 ($ million, estimated) ...................... 404 
Table 7-6: Selected Immunoassay Quality Control Products ............................................................................ 404 
Table 7-7: Revenues of Leading Lab-based Immunoassay Vendors, 2024-2025 ($ million) .............................. 405 
MATURE ASSAY SEGMENT ................................................................................................................................ 408 
Thyroid Function ................................................................................................................................... 408 
Therapeutic Drug Monitoring ............................................................................................................... 408 
Vitamin D .............................................................................................................................................. 409 
Table 7-8: Selected Vitamin D Immunoassays ................................................................................................... 410 
Anemia .................................................................................................................................................. 411 
Toxicology/DAU .................................................................................................................................... 411 
Allergy ................................................................................................................................................... 413 
GROWTH IMMUNOASSAYS ............................................................................................................................... 416 
Proteins ................................................................................................................................................. 416 
Figure 7-1: Other Proteins, by Percent of Total, 2025 (%) ................................................................................. 417 
Tumor Markers...................................................................................................................................... 417 
Table 7-9: Selected Tumor Marker Innovations ................................................................................................ 420 
Cardiac Markers .................................................................................................................................... 421 
Table 7-10: Regional Cardiac Marker Immunoassay Market Share, by Country, 2025 (%)  [EU 
Countries; Japan; Latin America; Middle East; North America; Rest of Asia Pacific; Rest of Europe; 
Rest of World] ................................................................................................................................................ 423 
Table 7-11: Selected Cardiac Marker Innovations ............................................................................................. 428 

 
 
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Autoimmune ......................................................................................................................................... 429 
Table 7-12: Selected Autoimmune Test Innovations ......................................................................................... 433 
Rheumatoid Arthritis ............................................................................................................................. 434 
Table 7-13: Selected Arthritis Immunoassay Innovations ................................................................................. 437 
Gastrointestinal Disorders ..................................................................................................................... 437 
Table 7-14: Selected Inflammatory Bowel Disease Test Innovations ................................................................ 439 
Transplant Management ...................................................................................................................... 439 
Table 7-15: Selected Immunoassays for Transplant Medicine .......................................................................... 441 
Women’s Health .................................................................................................................................... 441 
Table 7-16: Selected Women’s Health Innovations .......................................................................................... 443 
Alzheimer’s Disease and Multiple Sclerosis ........................................................................................... 444 
Table 7-17: Selected Innovations for Alzheimer’s Disease Immunoassays ....................................................... 448 
Traumatic Brain Injury .......................................................................................................................... 448 
Other Immunoassays ............................................................................................................................ 450 
Figure 7-2: Other Select Immunoassays, by Percent of Total Immunoassays, 2025 (%)  [Bone Marker; 
Endocrine/Adrenal; Radioimmunoassays; Others] ........................................................................................ 450 
Table 7-18: Selected Immunoassay Innovations ............................................................................................... 451 
INNOVATING POC .......................................................................................................................................... 453 
Table 7-19: Selected POC Test Innovations ....................................................................................................... 454 
Table 7-20: Selected POC Immunoassay Test Platforms ................................................................................... 456 
THE COMMERCIAL OUTLOOK FOR IMMUNOASSAYS ............................................................................................... 457 
CHAPTER 8: MOLECULAR ASSAYS .......................................................................................................... 459 
SCOPE .......................................................................................................................................................... 459 
OVERVIEW .................................................................................................................................................... 460 
Table 8-1: Common Next Generation Molecular Test Traits ............................................................................. 463 
SAMPLE PREPARATION AND QUALITY CONTROL .................................................................................................... 465 
Table 8-2: Selected Molecular Test Sample Preparation and QC Innovations .................................................. 469 
MOLECULAR EVOLUTION ................................................................................................................................. 471 
Exosome Sequencing ............................................................................................................................. 471 
Table 8-3: Selected Exosome Test Innovations ................................................................................................. 473 
Liquid Biopsy ......................................................................................................................................... 474 
Table 8-4: Selected Liquid Biopsy Innovations .................................................................................................. 478 
Metabolomic Profiling ........................................................................................................................... 480 
Information Technology ........................................................................................................................ 482 

 
 
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Table 8-5: Selected IT Innovations in Molecular Diagnostics ............................................................................ 484 
Artificial Intelligence (AI) ....................................................................................................................... 488 
Forensic Studies – An Emerging Opportunity ........................................................................................ 489 
Table 8-6: Selected Innovations in Forensic DNA Testing ................................................................................. 491 
Test Platforms ....................................................................................................................................... 492 
Table 8-7: Key Molecular Technologies and Major Players ............................................................................... 492 
Table 8-8: Selected Molecular Test Platform Innovations ................................................................................. 495 
MAJOR PLAYERS ............................................................................................................................................. 498 
Table 8-9: Molecular Test Revenues of Selected IVD Vendors, 2022, 2023, 2024, and estimated 2025 
($ million) ....................................................................................................................................................... 498 
MARKET ANALYSIS .......................................................................................................................................... 501 
Table 8-10: Global Genomic, HLA, NIPT, and Oncology Molecular Test Sales, by Type with NIPT, 2025-
2030  ($ million) ............................................................................................................................................. 501 
Oncology ............................................................................................................................................... 502 
Table 8-11: Global Molecular Cancer Test Sales Distribution, by Region, 2025 (%)  [Asia Pacific; 
Europe; North America; Rest of World] ......................................................................................................... 504 
Table 8-12: Selected Molecular Tumor Marker Test Innovations ..................................................................... 505 
Inherited/Genetic Diseases, Thrombophilia SNPs and Other Disorders ................................................ 507 
Table 8-13: Most Frequently Requested Genetic Tests ..................................................................................... 509 
Table 8-14: Global Molecular Thrombophilia Assay Sales Distribution, by Region, 2025 (%)  [Asia 
Pacific; Europe; North America; Rest of World] ............................................................................................. 511 
Alzheimer’s Disease and Dementia ....................................................................................................... 512 
Cardiovascular Disease ......................................................................................................................... 513 
Table 8-15: Selected Genomic Tests for Inherited Diseases .............................................................................. 514 
Depression and Psychiatric Disorders ................................................................................................... 516 
Prenatal and Newborn Testing ............................................................................................................. 518 
Table 8-16: Global Prenatal Test Sales Distribution, by Region, 2025 (%)   [Asia Pacific; Europe; North 
America; Rest of World] ................................................................................................................................. 519 
Table 8-17: Selected Prenatal Services Provided .............................................................................................. 520 
Table 8-18: Selected Molecular Tests for Prenatal Analysis .............................................................................. 521 
Transplant Diagnostics .......................................................................................................................... 523 
Table 8-19: Global Molecular HLA Testing Sales Distribution, by Region, 2025 (%)  [Asia Pacific; 
Europe; North America; Rest of World] ......................................................................................................... 524 
Figure 8-1: Global Transplant Rate, by Region, 2024 ........................................................................................ 525 
Table 8-20: Selected Innovations of Molecular Transplant Diagnostics ............................................................ 527 
Women’s Health .................................................................................................................................... 527 

 
 
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THE COMMERCIAL OUTLOOK FOR MOLECULAR TESTS ............................................................................................ 529 
CHAPTER 9: HEMATOLOGY .................................................................................................................... 532 
SCOPE .......................................................................................................................................................... 532 
OVERVIEW OF HEMATOLOGY AND TRENDS .......................................................................................................... 533 
Table 9-1: Hematology Analyzer Distribution of Sales, by Menu Capability, 2025 estimated (%) .................... 534 
Table 9-2: Lab-based Hematology Sales, by Analyte Average Annual Distribution, 2025 (%) ........................... 535 
Digital Image Analysis ........................................................................................................................... 535 
Table 9-3: Selected Hematology Image Analysis Innovations ........................................................................... 537 
Digital Evolution .................................................................................................................................... 537 
Quality Control Measurement Programs .............................................................................................. 538 
Table 9-4: Selected Quality Control Hematology FDA Registrations, 2024 ....................................................... 539 
LABORATORY-BASED HEMATOLOGY TESTING ....................................................................................................... 544 
Table 9-5: Selected Hematology Innovations .................................................................................................... 546 
Table 9-6: Global Laboratory-based Hematology Test and Instrument Market, 2025 and 2030 ($ 
million) ........................................................................................................................................................... 547 
Regional Laboratory-based Hematology Test and Instrument Market ................................................ 547 
Table 9-7: Global Laboratory-based Hematology Test and Instrument Market, by Region, 2025 (%)  
[Asia Pacific; Europe; North America; Rest of World] .................................................................................... 547 
DECENTRALIZED HEMATOLOGY TESTING ............................................................................................................. 548 
Hemoglobin/Hematocrit at the POC ..................................................................................................... 549 
Table 9-8: POC Hematology Distribution, by Specialty, 2025 (%)   [Hematocrit/Hemoglobin vs. Other 
Routine Hematology (WBC, Erythrocyte, Platelet)] ....................................................................................... 549 
Table 9-9: Selected POC Hemoglobin and Hematocrit Systems ........................................................................ 550 
Table 9-10: Selected POC Hematology Analyzer Systems ................................................................................. 552 
Table 9-11: Decentralized Hematology Test and Instrument Market, by Type, 2025 and 2030 ($ 
million)   [Instruments, Lab-Style; Handheld Devices] ................................................................................... 553 
MARKET ANALYSIS: LEADING SUPPLIERS ............................................................................................................. 554 
Table 9-12: Top Hematology Company Revenues (Laboratory and POC), 2025 ($ million) .............................. 554 
Figure 9-1: Market Share for Top Hematology Companies (Laboratory and POC), 2025 (%) ............................ 555 
Table 9-13: Global Hematology (Laboratory-based and POC) Sales Distribution, by Region, 2025 (%)  
[Asia Pacific; Europe; North America; Rest of World] .................................................................................... 556 
THE COMMERCIAL OUTLOOK FOR HEMATOLOGY TESTS ......................................................................................... 557 
 
 

 
 
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CHAPTER 10: COAGULATION ................................................................................................................. 558 
SCOPE .......................................................................................................................................................... 558 
OVERVIEW AND TRENDS OF COAGULATION AND IMMUNOHEMATOLOGY TESTS .......................................................... 559 
COVID-19 ............................................................................................................................................... 560 
Direct Oral Anticoagulants (DOACs) ...................................................................................................... 561 
D-dimer ................................................................................................................................................. 562 
Table 10-1: Global D-dimer Sales Distribution, by Region, 2025 (%)  [Asia Pacific; Europe; North 
America; Rest of World] ................................................................................................................................. 563 
MARKET ANALYSIS .......................................................................................................................................... 564 
Table 10-2: Global Coagulation Sales, by Segment, 2025-2030 ($ million)   [D-dimer; Molecular; 
Professional POC; Professional Self; PT/INR Labs] ......................................................................................... 565 
Table 10-3: Global Coagulation Test and Instrument Market, by Region, 2025 (%)  [Asia Pacific; 
Europe; North America; Rest of World] ......................................................................................................... 566 
LAB-BASED TESTING ........................................................................................................................................ 567 
Table 10-4: Selected Lab-based Coagulation Innovations ................................................................................. 568 
Genetic Markers of Hypercoagulopathies ............................................................................................. 569 
Table 10-5: Related CMS Codes for Reimbursement National Limits, Molecular, 2025 ................................... 570 
Table 10-6: Global Molecular - Thrombophilia SNP Sales Distribution, by Region, 2025 (%)  [Asia 
Pacific; Europe; North America; Rest of World] ............................................................................................. 570 
Table 10-7: Selected Molecular Coagulation Test Innovations ......................................................................... 571 
LEADING SUPPLIERS: LABORATORY SYSTEMS ........................................................................................................ 572 
Table 10-8: Top Coagulation Company Market Share Laboratory-based, 2025 (%) .......................................... 572 
DECENTRALIZED COAGULATION TESTING – PROFESSIONAL USE ............................................................................... 573 
Decentralized Coagulation Testing – OTC ............................................................................................. 574 
Table 10-9: Selected POC Coagulation Test Innovations ................................................................................... 575 
Platelet Testing ..................................................................................................................................... 576 
Table 10-10: Selected Platelet Activity Test Innovations .................................................................................. 577 
LEADING SUPPLIERS: POC SYSTEMS ................................................................................................................... 578 
Table 10-11: Top Coagulation Company Revenues, POC, 2025 ($ million, estimated) ..................................... 578 
THE COMMERCIAL MARKET FOR COAGULATION TESTS ........................................................................................... 579 
Table 10-12: Major Anticoagulants Uses and Tests ........................................................................................... 580 
CHAPTER 11: MICROBIOLOGY AND VIROLOGY ....................................................................................... 582 
SCOPE .......................................................................................................................................................... 582 
THE REAL IMPACT OF INFECTIONS ...................................................................................................................... 583 

 
 
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Herpes and Alzheimer’s Disease ........................................................................................................... 583 
Ebola and Cancer .................................................................................................................................. 583 
HIV and Cancer ...................................................................................................................................... 583 
H pylori and Cancer ............................................................................................................................... 584 
Bacteria and Parkinson's ....................................................................................................................... 584 
HPV and Cancer ..................................................................................................................................... 584 
MICROBIAL ANTIBIOTIC RESISTANCE – THE ROLE OF CLINICAL TESTS ........................................................................ 585 
Fast Identification ................................................................................................................................. 585 
Table 11-1: Selected Companies Developing Faster Identification, Some Also with Antimicrobial 
Susceptibility/Resistance Tests ...................................................................................................................... 588 
TRADITIONAL MICROBIOLOGY AND ITS LIMITS ...................................................................................................... 591 
THE NEW MICROBIOLOGY - INNOVATIONS .......................................................................................................... 593 
Liquid Based Microbiology and Automation Innovations ..................................................................... 593 
Post-Blood Culture Microbial ID ............................................................................................................ 596 
PCR and Other NAAT-Based Tests for Infectious Diseases .................................................................... 598 
Table 11-2: Selected Nucleic Acid Amplification Test and Other Molecular Companies in Microbiology ......... 600 
Microbiome-Related Microbiology Tests .............................................................................................. 607 
Illumina ................................................................................................................................................. 607 
Bio-Rad .................................................................................................................................................. 607 
QIAGEN ................................................................................................................................................. 608 
Luminex (Diasorin) ................................................................................................................................ 608 
inBiome BV ............................................................................................................................................ 609 
DNA Genotek ......................................................................................................................................... 609 
Thermo Fisher Scientific ........................................................................................................................ 609 
Others .................................................................................................................................................... 610 
Next-Generation Sequencing-Based Microbiology Approaches ............................................................ 610 
Table 11-3: Selected Companies Applying DNA/RNA Sequencing to Microbiology .......................................... 612 
Syndromic/Multiplex Testing ................................................................................................................ 612 
HIGH-CONSEQUENCE INFECTIOUS DISEASE THREATS ............................................................................................. 615 
Table 11-4: Selected Companies Marketing Products Addressing High-Consequence Infectious 
Disease Threats .............................................................................................................................................. 615 
Tickborne Diseases (TBDs) ..................................................................................................................... 617 
TB and Other Infectious Diseases .......................................................................................................... 618 
Chagas ................................................................................................................................................... 620 
Dengue .................................................................................................................................................. 621 

 
 
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Ebola ..................................................................................................................................................... 623 
Chikungunya ......................................................................................................................................... 624 
Middle East Respiratory Syndrome-Coronavirus (MERS-CoV) .............................................................. 626 
Marburg ................................................................................................................................................ 627 
SARS-CoV-2 (COVID-19) ......................................................................................................................... 627 
Monkeypox ............................................................................................................................................ 628 
MARKET ANALYSIS .......................................................................................................................................... 631 
Table 11-5: Global Microbiology Sales Distribution, by Region, 2025 (%)   [Asia Pacific; Europe; North 
America; Rest of World] ................................................................................................................................. 632 
MARKET ANALYSIS - TRADITIONAL MICROBIOLOGY ID/AST ................................................................................... 633 
Table 11-6: Global Microbiology ID/AST Market, by Segment, 2025-2030 ($ million)   [Blood Culture; 
Chromogenic Media; ID/AST Auto; ID/AST Panels; Rapid Microbiology] ....................................................... 633 
Table 11-7: Global ID/AST Testing Sales Distribution, by Region, 2025 (%)  [Asia Pacific; Europe; North 
America; Rest of World] ................................................................................................................................. 635 
Traditional ID/AST ................................................................................................................................. 636 
Table 11-8: Global ID/AST Testing, Distribution by Systems, (%)   [Auto, Panel] ............................................... 636 
Blood Culture ......................................................................................................................................... 636 
Table 11-9: Selected Advanced Techniques in Positive Blood Culture .............................................................. 639 
Chromogenic Media .............................................................................................................................. 639 
Rapid Tests Performed on Colonies from Culture Media ...................................................................... 640 
Supplies ................................................................................................................................................. 640 
MARKET ANALYSIS - MICROBIOLOGY IMMUNOASSAYS ........................................................................................... 642 
Improvements in Microbiology Immunoassays..................................................................................... 643 
Figure 11-1: Immunoassay Respiratory Testing, by Target Pathogens, 2025 (%)  [Multi-Target, Single-
Target] ............................................................................................................................................................ 644 
Table 11-10: Selected Infectious Disease Immunoassay Innovations ............................................................... 645 
Table 11-11: Global Clinical Laboratory-Based Microbiology/Infectious Disease Immunoassay Market,  
by Pathogen, 2025($ million)   [HAIs/Sepsis; Hepatitis; HIV; Lyme Disease; Mycology; Parasitology; 
Respiratory; STDs; ToRCH; Other] .................................................................................................................. 647 
Table 11-12: Global Laboratory-Based Microbiology/Infectious Disease Immunoassay Market 
Distribution, by Region, 2025 (%)   [Asia Pacific; Europe; North America; Rest of World] ............................. 648 
Hepatitis Testing ................................................................................................................................... 648 
Sepsis ..................................................................................................................................................... 651 
Figure 11-2: Global Lab-based Microbiology Immunoassay Sepsis Market Distribution, by Type, 2025 
(%)  [PCT, Traditional] ..................................................................................................................................... 654 
HIV Immunoassay Testing ..................................................................................................................... 654 
Table 11-13: Selected HIV Assays ...................................................................................................................... 658 

 
 
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Sexually Transmitted Diseases (STDs) ................................................................................................... 658 
ToRCH .................................................................................................................................................... 661 
Lyme Disease ......................................................................................................................................... 661 
MARKET ANALYSIS - MOLECULAR MICROBIOLOGY ................................................................................................ 665 
Table 11-14: Global Molecular Microbiology Sales Distribution by Region, 2025 (%)   [Asia Pacific, 
Europe, North America, RoW]........................................................................................................................ 665 
Table 11-15: Global Molecular Microbiology Market, by Pathogen/Disease Indication, 2025-2030 ($ 
million)   [Blood Bank Screening; GC/Chlamydia; HAI; Hepatitis; HIV; Mycobacteria/TB; Organism 
ID; Respiratory; Others] ................................................................................................................................. 667 
Lab Automation and Molecular Diagnostics ......................................................................................... 668 
Table 11-16: Selected Automated Molecular Test Instrument Platforms ......................................................... 670 
Molecular Respiratory Infection Testing ............................................................................................... 672 
The Respiratory Trio – Flu, Strep, RSV ................................................................................................... 675 
Figure 11-3: Molecular Respiratory Testing, by Target Pathogens, 2025 (%)   [Multi-Target, Single-
Target] ............................................................................................................................................................ 676 
Molecular Testing for Sexually Transmitted Diseases ........................................................................... 677 
Molecular Hepatitis Testing .................................................................................................................. 679 
Molecular HIV Testing ........................................................................................................................... 680 
Table 11-17: Innovations in Molecular POC Diagnostics for HIV ....................................................................... 684 
Molecular Tests for Hospital-Acquired Infections (HAIs) ....................................................................... 684 
Table 11-18: Frequency of the Most Common Nosocomial Infections ............................................................. 685 
Assessing the Problem: Nosocomial Infection Statistics ....................................................................... 685 
Clostridium Difficile ............................................................................................................................... 687 
MRSA ..................................................................................................................................................... 689 
Molecular TB Testing............................................................................................................................. 690 
Limitations of Molecular Microbiology Testing ..................................................................................... 692 
RAPID MICROBIOLOGY TESTS ............................................................................................................................ 693 
Table 11-19: Global Rapid Microbiology Testing Market, Sales Distribution, by Pathogen, 2025 (%)   
[C. Difficile; COVID-19; E. coli; H. pylori; Hepatitis; HIV; Influenza; Malaria; Other respiratory; STD; 
Other] ............................................................................................................................................................. 694 
Figure 11-4: Rapid Infectious Disease Test Sales, by Respiratory/Non-respiratory Segments, 2025 (%) .......... 695 
Figure 11-5: Rapid Respiratory Testing, by Target Pathogens, 2025 (%)   [Multi-Target, Single-Test] .............. 696 
MASS SPECTROMETRY ..................................................................................................................................... 698 
Table 11-20: Selected Companies Marketing Mass Spectrometers and/or Assays for the Clinical 
Laboratory   [CE-Marked and/or 510(k) cleared] ........................................................................................... 699 
THE FUTURE OUTLOOK FOR MICROBIOLOGY ........................................................................................................ 700 

 
 
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CHAPTER 12: BLOOD BANKING SERVICES ............................................................................................... 702 
SCOPE .......................................................................................................................................................... 702 
OVERVIEW .................................................................................................................................................... 703 
The Current Status of Global Blood Collection ...................................................................................... 703 
GLOBAL BLOOD SAFETY ................................................................................................................................... 706 
Table 12-1: Laboratory Screening of Blood Donations for Transfusion-Transmissible Infections, 
Number of Countries  [Chagas; HBV; HCV; HIV; HTLV I/II1; Malaria; Syphilis] ............................................... 706 
Table 12-2: Prevalence of TTIs in Blood Donations [Median (Interquartile range)], by Income Group ............ 707 
Zika Virus ............................................................................................................................................... 707 
Blood and Component Collection .......................................................................................................... 708 
Table 12-3: Blood Component Usage for Selected Conditions .......................................................................... 709 
Reevaluating Blood Transfusions .......................................................................................................... 709 
Table 12-4: Impact of Alloimmunization (% of Patients Screening Positive for One or More 
Antibodies) ..................................................................................................................................................... 710 
BLOOD TYPING AND GROUPING MARKET ............................................................................................................ 712 
Manual Blood Typing Methods ............................................................................................................. 712 
Automated Blood Typing and Screening Methods ................................................................................ 712 
Molecular Methods ............................................................................................................................... 713 
Table 12-5: Selected Blood Typing and Grouping Innovations .......................................................................... 714 
Size and Growth of Typing Markets ...................................................................................................... 717 
Table 12-6: Global Blood Typing Market, 2025-2030 ($ million) ....................................................................... 717 
Blood Typing Market by Geography ..................................................................................................... 717 
Table 12-7: Global Blood Typing Sales Distribution, by Region, 2025 (%)   [Asia Pacific; Europe; North 
America; Rest of World] ................................................................................................................................. 718 
BLOOD TESTING MARKET ................................................................................................................................. 719 
Table 12-8: Selected Blood Testing Innovations ................................................................................................ 719 
Preventing Bacterial Infections ............................................................................................................. 720 
Immunoassays ...................................................................................................................................... 720 
Nucleic Acid Testing (NAT) .................................................................................................................... 722 
Size and Growth of the Market ............................................................................................................. 722 
Table 12-9: Global Blood Banking Diagnostics Market, 2025-2030 ($ million)  [Immunoassay Screen; 
NAT Screens] .................................................................................................................................................. 723 
Blood Testing Market by Geography..................................................................................................... 724 
Table 12-10: Global Blood Testing Market, by Geography, 2025 (%)   [Asia Pacific; Europe; North 
America; Rest of World] ................................................................................................................................. 725 
THE COMMERCIAL OUTLOOK FOR BLOOD BANKING TESTING .................................................................................. 726 

 
 
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CHAPTER 13: HISTOLOGY AND CYTOLOGY ............................................................................................. 728 
SCOPE .......................................................................................................................................................... 728 
OVERVIEW .................................................................................................................................................... 729 
SPECIAL TOPICS .............................................................................................................................................. 731 
Histology Automation ........................................................................................................................... 731 
Table 13-1: Selected Histology Lab Automation ............................................................................................... 734 
Table 13-2: Histology Information Technology Tools ........................................................................................ 735 
Advanced Analysis Solutions ................................................................................................................. 735 
Table 13-3: Selected Advanced Histology Techniques ...................................................................................... 738 
HPV IVD Testing Becomes Main Stream ............................................................................................... 739 
Table 13-4: Global HPV Test Sales Distribution, by Region, 2025 (%)   [Asia Pacific; Europe; North 
America; Rest of World] ................................................................................................................................. 741 
Table 13-5: Selected HPV Test Innovations ....................................................................................................... 743 
MARKET ANALYSIS .......................................................................................................................................... 745 
Total Market ......................................................................................................................................... 745 
Table 13-6: Global Histology/Cytology Sales, by Type, 2025-2030 ($ million)   [HPV; 
Immunohistochemistry; in situ hybridization; Pap Tests; traditional non-Pap stains] ................................... 745 
Regional Market Analysis ...................................................................................................................... 746 
Table 13-7: Global Histology/Cytology Sales Distribution, by Region, 2025 (%)   [Asia Pacific; Europe; 
North America; Rest of World] ....................................................................................................................... 746 
Table 13-8: Revenues of the Major Histology Companies, 2018-2025 ($ million, estimated) .......................... 747 
Traditional Stains .................................................................................................................................. 749 
Table 13-9: Selected Vendors of Traditional Histology Stains ........................................................................... 750 
Pap Testing ............................................................................................................................................ 750 
Table 13-10: Primary and Secondary Prevention of Cervical Cancer, Screening Responses, by Country, 
2021 ............................................................................................................................................................... 752 
Table 13-11: Three approaches to cervical cancer screening and future tests ................................................. 755 
Immunohistochemistry and In Situ Hybridization ................................................................................. 757 
Table 13-12: Selected In Situ Hybridization-based Tests ................................................................................... 759 
Table 13-13: Selected IHC Test Innovations ...................................................................................................... 761 
Pharmacodiagnostic Histology ............................................................................................................. 762 
Table 13-14: Major Pharmacodiagnostic Markers ............................................................................................ 764 
Table 13-15: Selected Pharmacodiagnostic Histology Tests ............................................................................. 766 
Digital Imaging and Computational Pathology ..................................................................................... 767 
Table 13-16: Selected Digital Pathology Image Capture and Viewing Solutions ............................................... 769 
Table 13-17: Selected Digital Imaging Innovations ........................................................................................... 771 

 
 
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Circulating Tumor Cells ......................................................................................................................... 772 
Table 13-18: Innovations in CTC Technology ..................................................................................................... 774 
Flow Cytometry ..................................................................................................................................... 776 
THE COMMERCIAL OUTLOOK FOR HISTOLOGY AND CYTOLOGY TESTS ........................................................................ 780 
CHAPTER 14: COMPANY PROFILES: THE TOP TIER .................................................................................. 782 
SCOPE .......................................................................................................................................................... 782 
ABBOTT DIAGNOSTICS ..................................................................................................................................... 783 
Table 14-1: Abbott Diagnostics Revenue History, 2023-2025 ($ million) .......................................................... 783 
Table 14-2: Abbott Diagnostic Revenues, by Segment, 2023-2025 ($ million, estimated) ............................... 783 
Core Lab ................................................................................................................................................ 784 
Hematology ........................................................................................................................................... 785 
Blood Banking ....................................................................................................................................... 786 
Infectious Diseases – Molecular ............................................................................................................ 787 
Diabetes ................................................................................................................................................ 788 
HIV Point of Care ................................................................................................................................... 790 
i-STAT Business ...................................................................................................................................... 790 
AGILENT TECHNOLOGIES .................................................................................................................................. 793 
Table 14-3: Agilent Revenue History, 2023-2025 ($ million) ............................................................................. 793 
Genomics ............................................................................................................................................... 795 
Cytogenetic Analysis ............................................................................................................................. 797 
Sequencing ............................................................................................................................................ 798 
CRISPR ................................................................................................................................................... 799 
Flow Cytometry ..................................................................................................................................... 799 
Companion Diagnostics - Dako ............................................................................................................. 801 
Digital Pathology ................................................................................................................................... 802 
BECKMAN COULTER / DANAHER ........................................................................................................................ 804 
Hematology ........................................................................................................................................... 804 
Hematology IT ....................................................................................................................................... 805 
Clinical Chemistry .................................................................................................................................. 806 
Immunoassays ...................................................................................................................................... 807 
Microbiology ......................................................................................................................................... 809 
IT Clinical ............................................................................................................................................... 809 
Flow Cytometry ..................................................................................................................................... 810 
Blood Banking ....................................................................................................................................... 811 

 
 
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Beckman Coulter Life Sciences .............................................................................................................. 812 
BECTON, DICKINSON AND COMPANY (BD) .......................................................................................................... 813 
Table 14-4: BD Revenue History, 2023-2025 ($ million, estimated) FYE Sept 30 .............................................. 813 
Cytology ................................................................................................................................................ 814 
Molecular Microbiology ........................................................................................................................ 815 
Traditional Microbiology - ID/AST ......................................................................................................... 816 
Blood Culture ......................................................................................................................................... 817 
Hospital Acquired Infections ................................................................................................................. 819 
Blood Collection .................................................................................................................................... 820 
Mass Spectrometry ............................................................................................................................... 820 
Flow Cytometry ..................................................................................................................................... 821 
Immunoassay ........................................................................................................................................ 822 
BIOMÉRIEUX INC. ........................................................................................................................................... 823 
Table 14-5: bioMérieux Revenue History, 2023-2025 (€ million) ...................................................................... 823 
Traditional Microbiology ....................................................................................................................... 824 
Blood Culture ......................................................................................................................................... 825 
Immunoassays ...................................................................................................................................... 826 
Mass Spectrometry ............................................................................................................................... 827 
BIOFIRE Diagnostics Business ................................................................................................................ 828 
Expansion .............................................................................................................................................. 829 
BIO-RAD LABORATORIES, INC. .......................................................................................................................... 831 
Table 14-6: Bio-Rad Revenue History, 2023-2025 ($ million, estimated) .......................................................... 831 
Quality Control ...................................................................................................................................... 832 
Blood Bank ............................................................................................................................................ 833 
Diabetes ................................................................................................................................................ 835 
Immunoassays ...................................................................................................................................... 836 
Liquid Biopsy ......................................................................................................................................... 837 
Droplet Digital PCR ................................................................................................................................ 838 
Sequencing ............................................................................................................................................ 839 
BRUKER CORPORATION .................................................................................................................................... 841 
Table 14-7: Bruker Revenue History Product Revenue, 2023-2025 ($ million) ................................................. 841 
Acquisitions and Collaborations ............................................................................................................ 843 
Mass Spectrometry ............................................................................................................................... 844 
Microbiology ......................................................................................................................................... 845 
Molecular PCR ....................................................................................................................................... 846 

 
 
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CEPHEID / DANAHER ....................................................................................................................................... 848 
GeneXpert/ Xpress Line ......................................................................................................................... 849 
Tuberculosis .......................................................................................................................................... 850 
Microbiology ......................................................................................................................................... 851 
POC Testing ........................................................................................................................................... 852 
Cancer ................................................................................................................................................... 853 
DANAHER CORPORATION ................................................................................................................................. 854 
Table 14-8: Danaher Revenue History, Diagnostics Segment, 2023-2025 ($ million, estimated) ..................... 854 
DEXCOM ....................................................................................................................................................... 856 
Table 14-9: Dexcom Revenue History, 2023-2025 ($ million) ........................................................................... 856 
EXACT SCIENCES ............................................................................................................................................. 858 
Table 14-10: Exact Sciences Revenue History, 2023-2025 ($ million) ............................................................... 858 
HOLOGIC, INC. ............................................................................................................................................... 860 
Table 14-11: Hologic Revenue History, Diagnostic Product Revenue, 2023-2025 ($ million) ........................... 860 
PANTHER Molecular System ................................................................................................................. 861 
Sexually Transmitted Infections ............................................................................................................ 861 
Infectious Diseases ................................................................................................................................ 861 
PANTHER Fusion .................................................................................................................................... 862 
Cytology ................................................................................................................................................ 864 
ILLUMINA ...................................................................................................................................................... 865 
Table 14-12: Illumina Revenue History, 2023-2025 ($ million, not all revenues are for clinical products 
and services; estimated) ................................................................................................................................ 865 
China ..................................................................................................................................................... 867 
LEICA BIOSYSTEMS/DANAHER ........................................................................................................................... 869 
Digital Pathology ................................................................................................................................... 869 
Tissue Staining ...................................................................................................................................... 869 
Lab Systems ........................................................................................................................................... 870 
NATERA ........................................................................................................................................................ 872 
Table 14-13: Natera Revenue History, 2023-2025 ($ million) ........................................................................... 872 
QIAGEN ...................................................................................................................................................... 875 
Table 14-14: QIAGEN Revenue History, 2023-2025 ($ million) ......................................................................... 875 
Tuberculosis. ......................................................................................................................................... 876 
Molecular Expansion ............................................................................................................................. 877 
Precision Medicine / Companion Diagnostics ....................................................................................... 878 
Molecular Microbiology ........................................................................................................................ 879 

 
 
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Prenatal Testing .................................................................................................................................... 880 
Next-Generation Sequencing ................................................................................................................ 881 
Liquid Biopsy ......................................................................................................................................... 881 
Cervical Cancer ...................................................................................................................................... 882 
Expansion .............................................................................................................................................. 883 
QUIDELORTHO CORPORATION .......................................................................................................................... 885 
Table 14-15: QuidelOrtho Revenue History, 2023-2025 ($ million) .................................................................. 885 
Table 14-16: QuidelOrtho Diagnostic Revenues, by Segment, 2023-2025 ($ million, estimated) ..................... 885 
Immunoassays ...................................................................................................................................... 886 
Rapid Immunoassays ............................................................................................................................ 887 
The Solana Business .............................................................................................................................. 888 
Blood Bank ............................................................................................................................................ 889 
RADIOMETER A/S / DANAHER .......................................................................................................................... 891 
Critical Care ........................................................................................................................................... 892 
Immunoassays ...................................................................................................................................... 893 
HemoCue ............................................................................................................................................... 894 
Transcutaneous Monitoring .................................................................................................................. 895 
REVVITY ........................................................................................................................................................ 896 
Table 14-17: Revvity Revenue History, 2023-2025 ($ million, estimated) ........................................................ 896 
ROCHE DIAGNOSTICS....................................................................................................................................... 898 
Table 14-18: Roche Revenue History, 2023-2025 (CHF million) ........................................................................ 898 
Table 14-19: Roche Diagnostic Revenues, by Segment, 2023-2025 (CHF million) ............................................ 898 
Hematology ........................................................................................................................................... 900 
Immunoassays ...................................................................................................................................... 900 
HIV ......................................................................................................................................................... 902 
Molecular Expansion ............................................................................................................................. 902 
Core Molecular ...................................................................................................................................... 903 
Digital PCR ............................................................................................................................................. 905 
Diabetes Care ........................................................................................................................................ 906 
Coagulation ........................................................................................................................................... 907 
cobas Liat System – POC ....................................................................................................................... 907 
HPV ........................................................................................................................................................ 908 
Blood Bank ............................................................................................................................................ 909 
Transplant Medicine ............................................................................................................................. 910 
Sequencing and Mass Spectrometry ..................................................................................................... 910 

 
 
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Cancer Companion Testing ................................................................................................................... 911 
Information Technology ........................................................................................................................ 912 
ROCHE TISSUE DIAGNOSTICS ............................................................................................................................. 913 
Immunohistochemistry - IHC ................................................................................................................. 914 
Cervical Cancer Screening ..................................................................................................................... 915 
Companion Diagnostics ......................................................................................................................... 916 
SIEMENS HEALTHINEERS (SIEMENS) ................................................................................................................... 918 
Table 14-20: Siemens Healthineers Revenue History, 2023-2025 (€ million) ................................................... 918 
Core Lab ................................................................................................................................................ 919 
Lab Automation .................................................................................................................................... 920 
Immunoassays ...................................................................................................................................... 920 
Hematology ........................................................................................................................................... 921 
Urinalysis ............................................................................................................................................... 922 
Molecular .............................................................................................................................................. 923 
Sequencing with Artificial Intelligence .................................................................................................. 924 
Acute Care – POC .................................................................................................................................. 924 
POC Connectivity ................................................................................................................................... 925 
Business Expansion ............................................................................................................................... 926 
SYSMEX CORPORATION .................................................................................................................................... 928 
Table 14-21: Sysmex Revenue History, 2023-2025 (billions of Yen) FYE March 31 ........................................... 928 
Hematology ........................................................................................................................................... 929 
Coagulation ........................................................................................................................................... 930 
Urinalysis ............................................................................................................................................... 930 
Immunoassays ...................................................................................................................................... 931 
Lab Information System ........................................................................................................................ 932 
Flow Cytometry ..................................................................................................................................... 932 
Precision Medicine / Companion Test Diagnostics ................................................................................ 933 
Liquid Biopsy ......................................................................................................................................... 934 
Sysmex Inostics ..................................................................................................................................... 934 
Forging New Markets ............................................................................................................................ 935 
THERMO FISHER SCIENTIFIC INC. ....................................................................................................................... 937 
Table 14-22: Thermo Fisher Revenue History, Clinical Diagnostics, 2023-2025 ($ million) ............................... 937 
Immunoassays ...................................................................................................................................... 938 
Microbiology ......................................................................................................................................... 939 
Molecular Test Business ........................................................................................................................ 940 

 
 
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Next-Generation Sequencing ................................................................................................................ 941 
qPCR ...................................................................................................................................................... 942 
Oncology Companion Diagnostics ......................................................................................................... 942 
Transplant Medicine ............................................................................................................................. 943 
Mass Spectrometry ............................................................................................................................... 944 
WERFEN ....................................................................................................................................................... 946 
Table 14-23: Werfen Recent Revenue History, 2023-2025 (€ billion) ............................................................... 946 
CHAPTER 15: COMPANY PROFILES: THE SECOND TIER ............................................................................ 948 
SCOPE .......................................................................................................................................................... 948 
ARKRAY ...................................................................................................................................................... 949 
Dry Chemistry / Immunoassays ............................................................................................................. 949 
Urinalysis ............................................................................................................................................... 950 
BGI GENOMICS (FORMERLY BEIJING GENOME INSTITUTE) ...................................................................................... 952 
MGI Tech Co., Limited, China ................................................................................................................ 953 
Prenatal Testing .................................................................................................................................... 953 
Test Services .......................................................................................................................................... 954 
Whole Genome Sequencing (WGS) ....................................................................................................... 955 
NGS Sequencing .................................................................................................................................... 955 
BIOCARTIS ..................................................................................................................................................... 957 
DIAGNOSTICA STAGO S.A.S. ............................................................................................................................. 959 
DIASORIN S.P.A ............................................................................................................................................. 960 
POC ........................................................................................................................................................ 960 
Immunoassays ...................................................................................................................................... 960 
Molecular .............................................................................................................................................. 961 
Molecular Oncology .............................................................................................................................. 961 
EIKEN CHEMICAL CO., LTD ............................................................................................................................... 962 
FUJIREBIO DIAGNOSTICS, INC. ........................................................................................................................... 963 
FULGENT GENETICS, INC .................................................................................................................................. 965 
GENEDX ....................................................................................................................................................... 966 
GRIFOLS S.A. ................................................................................................................................................. 967 
Blood Transfusion Business ................................................................................................................... 967 
ABO Blood Typing .................................................................................................................................. 968 
Molecular ABO Blood Typing ................................................................................................................ 969 
Immunoassays ...................................................................................................................................... 970 

 
 
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GUARDANT HEALTH, INC.................................................................................................................................. 971 
HAEMONETICS ............................................................................................................................................... 973 
HORIBA ........................................................................................................................................................ 974 
MENARINI DIAGNOSTICS .................................................................................................................................. 975 
MERIDIAN BIOSCIENCE, INC. ............................................................................................................................. 976 
MINDRAY - SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. ................................................................... 978 
MYRIAD GENETICS, INC. .................................................................................................................................. 980 
ORASURE TECHNOLOGIES, INC. ......................................................................................................................... 982 
RANDOX LABORATORIES LTD. ........................................................................................................................... 984 
Clinical Chemistries ............................................................................................................................... 985 
POC and Rapid....................................................................................................................................... 985 
Companion Diagnostics ......................................................................................................................... 986 
Controls ................................................................................................................................................. 986 
Evidence Series - Multistat Biochip Analyzers ....................................................................................... 987 
Molecular .............................................................................................................................................. 988 
SEEGENE, INC. ............................................................................................................................................... 990 
SEKISUI DIAGNOSTICS LLC ................................................................................................................................ 992 
VERACYTE, INC. .............................................................................................................................................. 993 
CHAPTER 16: COMPANY PROFILES: BLOOD BANK SPECIALISTS ............................................................... 994 
SCOPE .......................................................................................................................................................... 994 
ALIVEDX ....................................................................................................................................................... 995 
CERUS CORPORATION ...................................................................................................................................... 996 
CHAPTER 17: COMPANY PROFILES: CORE LAB AND OTHER COMPANIES ................................................. 998 
SCOPE .......................................................................................................................................................... 998 
SCIEX PTE LTD. ............................................................................................................................................. 999 
Diabetes .............................................................................................................................................. 1000 
Molecular ............................................................................................................................................ 1001 
EKF DIAGNOSTICS HOLDINGS PLC ................................................................................................................... 1002 
SHIMADZU SCIENTIFIC INSTRUMENTS ............................................................................................................... 1004 
SNIBE CO. LTD. (SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO. LTD.) ................................................. 1006 
TOSOH BIOSCIENCE ....................................................................................................................................... 1008 
TRINITY BIOTECH PLC .................................................................................................................................... 1010 

 
 
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CHAPTER 18: COMPANY PROFILES: CTC & LIQUID BIOPSY TEST PROVIDERS ......................................... 1012 
SCOPE ........................................................................................................................................................ 1012 
EPIC SCIENCES ............................................................................................................................................. 1013 
FOUNDATION MEDICINE, INC. ......................................................................................................................... 1015 
NEOGENOMICS ............................................................................................................................................ 1017 
CHAPTER 19: COMPANY PROFILES: SPECIALISTS .................................................................................. 1019 
SCOPE ........................................................................................................................................................ 1019 
ASCENSIA DIABETES CARE HOLDINGS AG .......................................................................................................... 1020 
INSULET CORPORATION ................................................................................................................................. 1022 
MEDTRONIC PLC ........................................................................................................................................... 1023 
VERILY LIFE SCIENCES LLC .............................................................................................................................. 1025 
CHAPTER 20: COMPANY PROFILES: HEMATOLOGY (CELL ANALYSIS) AND COAGULATION SPECIALISTS .. 1027 
SCOPE ........................................................................................................................................................ 1027 
CELLAVISION AB .......................................................................................................................................... 1028 
MASIMO CORPORATION ................................................................................................................................ 1030 
NOVA BIOMEDICAL CORPORATION (NOVA) ....................................................................................................... 1031 
CHAPTER 21: COMPANY PROFILES: HISTOPATHOLOGY SPECIALISTS ..................................................... 1033 
SCOPE ........................................................................................................................................................ 1033 
AMOY DIAGNOSTICS CO. LTD. ........................................................................................................................ 1034 
APPLIED SPECTRAL IMAGING INC. (ASI) ............................................................................................................ 1036 
VISIOPHARM ................................................................................................................................................ 1038 
CHAPTER 22: COMPANY PROFILES: IMMUNOASSAY SPECIALISTS ......................................................... 1040 
SCOPE ........................................................................................................................................................ 1040 
BIOHIT HEALTHCARE ..................................................................................................................................... 1041 
BIOMERICA INC. ........................................................................................................................................... 1043 
BIO-TECHNE CORPORATION ........................................................................................................................... 1045 
EUROBIO SCIENTIFIC ...................................................................................................................................... 1047 
EUROIMMUN AG (REVVITY) ....................................................................................................................... 1049 
INOVA DIAGNOSTICS, INC. ............................................................................................................................ 1051 
VOLITIONRX LIMITED .................................................................................................................................... 1052 

 
 
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CHAPTER 23: COMPANY PROFILES: MICROBIOLOGY SPECIALISTS ......................................................... 1054 
SCOPE ........................................................................................................................................................ 1054 
ADVANCED BIOLOGICAL LABORATORIES, S.A. (ABL) ........................................................................................... 1055 
ALTONA DIAGNOSTICS ................................................................................................................................... 1057 
ARCDIA INTERNATIONAL OY LTD. .................................................................................................................... 1059 
COPAN ITALIA S.P.A. AND COPAN DIAGNOSTICS, INC. .................................................................................... 1061 
GENETIC ANALYSIS AS ................................................................................................................................... 1063 
Q-LINEA AB ................................................................................................................................................ 1065 
CHAPTER 24: COMPANY PROFILES: MOLECULAR TEST SPECIALISTS ...................................................... 1067 
SCOPE ........................................................................................................................................................ 1067 
PACIFIC BIOSCIENCES OF CALIFORNIA, INC. (PACBIO) .......................................................................................... 1068 
STANDARD BIOTOOLS ................................................................................................................................... 1070 
CHAPTER 25: COMPANY PROFILES: POINT OF CARE TEST SPECIALISTS .................................................. 1072 
SCOPE ........................................................................................................................................................ 1072 
ABINGDON HEALTH LTD. ................................................................................................................................ 1073 
BINX HEALTH ............................................................................................................................................... 1075 
CHEMBIO DIAGNOSTIC SYSTEMS, INC. .............................................................................................................. 1077 
GENEDRIVE PLC (FORMERLY EPISTEM HOLDINGS) ............................................................................................... 1080 
MEDMIRA, INC. ........................................................................................................................................... 1082 
CHAPTER 26: COMPANY PROFILES: PRENATAL TEST SERVICE PROVIDERS ............................................. 1084 
SCOPE ........................................................................................................................................................ 1084 
BERRY GENOMICS CO. LTD. ............................................................................................................................ 1085 
INEX INNOVATE ........................................................................................................................................... 1087 
OXFORD GENE TECHNOLOGY .......................................................................................................................... 1089 
YOURGENE HEALTH....................................................................................................................................... 1091 
CHAPTER 27: COMPANY PROFILES: QUALITY CONTROL & SAMPLE PRETREATMENT SPECIALISTS .......... 1093 
SCOPE ........................................................................................................................................................ 1093 
AGENA BIOSCIENCE, INC. ............................................................................................................................... 1094 
BIOTYPE DIAGNOSTIC GMBH .......................................................................................................................... 1096 
INCELLDX .................................................................................................................................................... 1098 

 
 
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LGC SERACARE LIFE SCIENCES, INC. ................................................................................................................. 1100 
PREANALYTIX GMBH .................................................................................................................................... 1102 
PRECIPIO, INC. ............................................................................................................................................. 1104 
QUANTERIX CORPORATION ............................................................................................................................. 1106 
STRECK INC. ................................................................................................................................................ 1108 
CHAPTER 28: TEST SERVICE PROVIDERS ............................................................................................... 1110 
SCOPE ........................................................................................................................................................ 1110 
AGENDIA BV ............................................................................................................................................... 1111 
AMBRY GENETICS ......................................................................................................................................... 1112 
ARUP LABORATORIES ................................................................................................................................... 1114 
ASPIRA WOMEN’S HEALTH ............................................................................................................................. 1116 
BLUEPRINT GENETICS OY ............................................................................................................................... 1118 
BOSTON HEART DIAGNOSTICS ......................................................................................................................... 1120 
CAREDX, INC. .............................................................................................................................................. 1122 
PREDICTIVE ONCOLOGY ................................................................................................................................. 1124 
LABCORP, LABORATORY CORPORATION OF AMERICA ........................................................................................... 1127 
MAYO CLINIC LABORATORIES .......................................................................................................................... 1129 
MDXHEALTH SA .......................................................................................................................................... 1131 
OPKO DIAGNOSTICS/OPKO HEALTH ................................................................................................................ 1132 
QUEST DIAGNOSTICS ..................................................................................................................................... 1133 
SONIC HEALTHCARE ...................................................................................................................................... 1137 
 
 

 
 
The Worldwide Market for IVD Tests, 19th Edition 
Chapter 1: Executive Summary 
May 2026 © Kalorama Information 
1 
Chapter 1: Executive Summary 
About Kalorama Information 
Kalorama Information, part of Science and Medicine Group Inc., is a trusted publisher of 
market research exclusively focused on the healthcare industry. For over 25 years, Kalorama 
has delivered accurate, timely, and strategic intelligence to leaders in biotechnology, clinical 
diagnostics, in vitro diagnostics (IVD), pharmaceuticals, medical devices, and broader 
healthcare sectors. 
Originally launched in 1998, Kalorama Information quickly established itself as a premier 
source of insight into U.S. and global medical markets. Today, Kalorama remains a leading 
authority on healthcare market dynamics, with a particular emphasis on IVD. 
Kalorama is best known for its flagship title, The Worldwide Market for In Vitro Diagnostic 
Tests, an internationally recognized benchmark in the diagnostics field. Other reports 
published throughout the year cover these and other healthcare topics in greater detail. Our 
innovative approach to research, combined with deep industry expertise, has made Kalorama 
a go-to resource for top healthcare companies, strategic planners, investors, and media 
seeking authoritative market data and trends. 
With a singular focus on healthcare, Kalorama continues to shape informed decision-making 
across the industry through comprehensive, evidence-based analysis. 
Kalorama also works in coordination with other Science and Medicine Group brands, 
including BioInformatics, which focuses on life science markets and marketing, SDi, the 
leading source of information on the laboratory life science and analytical instrumentation 
industry and publisher of IBO, its twice-monthly newsletter, and IMV, which publishes 
reports and data on the medical imaging and clinical markets.  
For more information about Kalorama Information and other services offered by Science and 
Medicine Group, please visit our website. 
 
 

 
 
The Worldwide Market for IVD Tests, 19th Edition 
Chapter 1: Executive Summary 
May 2026 © Kalorama Information 
2 
Overview 
Kalorama Information’s market analysis reveals encouraging news: the in vitro diagnostics 
(IVD) market is poised for positive growth over the forecast period, with incremental gains 
expected in each year. However, growth will not be uniform across all companies or market 
segments. While some routine testing areas may experience flat or modest revenue increases, 
segments leveraging novel technologies such as molecular diagnostics, mass spectrometry, 
genetic testing, and advanced point-of-care (POC) systems are expected to outperform the 
overall market average. 
At the heart of clinical testing growth is the persistent threat to human health. This extends 
beyond individual diseases like diabetes or cancer to the growing prevalence of multiple 
chronic conditions occurring in the same individual. Current estimates indicate that 
approximately 40% of Americans and 33% of the global population suffer from at least one 
chronic condition, with nearly 20% of U.S. adults living with two or more. Conditions such 
as hypertension, chronic lung disease, asthma, heart disease, and cancer rarely exist in 
isolation. Their co-occurrence drives increased healthcare utilization, including more 
provider visits, longer hospital stays, and growing demand for home-based diagnostics, all 
of which fuel IVD test volume growth. 
However, the IVD market faces several limitations. Although advancements in instruments, 
assays, and innovative technologies initially drive higher testing demand, this is often 
tempered by cost-containment efforts from payers and governments worldwide. Healthcare 
budgets are under constant pressure, with many governments actively seeking to curb 
spending growth. 
Key factors shaping the IVD market include: 
• Technological Innovation: Automation, faster turnaround times, real-time alerts, 
enhanced quality control, and integrated software systems are improving laboratory 
efficiency and test reliability. 
• Syndromic and Multiplex Testing: These approaches have gained favor with payors 
in some markets and enjoy increasing adoption by providers for their ability to deliver 
comprehensive diagnostic insights from single samples. 
• Artificial Intelligence (AI) and Robotics: Expected to enhance diagnostic precision 
and workflow efficiency, though AI in IVD still needs to robustly demonstrate 

 
 
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3 
clinical and economic effectiveness comparable to its impact in imaging and other 
medical fields. 
• Novel Biomarkers and Specialty Analyzers: The steady introduction of new 
biomarkers is expanding test menus and enabling more personalized and precise 
diagnostics. 
• Healthcare Delivery Expansion: Increasing focus on smaller clinics and home-based 
testing presents new opportunities targeted by major IVD vendors. 
• Reimbursement Landscape: Favorable reimbursement continues for tests that prove 
clear clinical value, though not all assays benefit equally. 
• Global Market Expansion: Emerging markets are experiencing increased private 
insurance penetration and healthcare access, driving demand for diagnostics. 
Looking ahead over the next five to ten years, moderate and gradual shifts in the IVD product 
markets are anticipated. Manufacturers can expect growth driven primarily by fundamental 
demographic and epidemiological trends, specifically an aging global population, a rising 
disease burden, and expanding international healthcare infrastructure. However, these 
positive trends will be partly offset by fiscal challenges, including government funding cuts 
in the United States, budget constraints in the European Union, and limited hospital spending 
in China. 
Infectious diseases remain a top global priority, particularly in developing countries where 
diagnostic testing is essential and in developed nations facing emerging pathogen threats. 
Additional challenges include geopolitical factors, such as tariffs and trade policies, that may 
disrupt supply chains and affect IVD vendors worldwide. 
AI has the potential to enhance diagnostic accuracy and support higher-value pricing, but its 
long-term impact in the IVD market will depend on its ability to deliver measurable gains in 
clinical outcomes and overall cost efficiency. 
Having weathered the disruption of the pandemic, the IVD market has emerged stronger and 
more growth-oriented, driven by new technologies and expanding opportunities. The 
COVID-19 pandemic led to an unprecedented demand for in-vitro diagnostic expertise. This 
led to a surge in demand for PCR, NGS, and serology-based rapid-test products. As a result, 
the market has opened several new areas of advancement, including microfluidic 
technologies, next-generation sequencing, microarrays, and the growing significance of 

 
 
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4 
precision medicine, including companion diagnostics and multiplex testing, which will drive 
significant growth opportunities.  
This report, The Worldwide Market for In Vitro Diagnostic (IVD) Tests, now in its 19th 
Edition, details this activity on a global scale. The report examines the entirety of the in vitro 
diagnostic market and makes forecasts; assesses trends and scrutinizes vendor activities. The 
worldwide market for in vitro diagnostics in 2025 is $116 billion, as shown in this figure. 
Figure 1-1: Worldwide IVD Market Sales, 2020, 2025, and 2030 ($ billion) 
 
Source: Kalorama Information 
Chapter 5: Point-of-Care, Chapter 7: Immunoassays, and Chapter 11: Microbiology/Virology 
were most affected by demand for COVID-19 tests. These chapters cover multiplex 
respiratory panels, which have been increasingly used to rule out COVID-19. As anticipated, 
the urgency and swift response to COVID-19 testing solutions resulted in a strong uptick in 
the installed base of instruments for both immunoassay and molecular infectious disease 
diagnostic platforms. The capital investment in these systems has expanded overall use and 

 
 
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Chapter 1: Executive Summary 
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5 
extended capabilities beyond the pre-COVID-19 era. This is particularly true of advanced 
molecular, molecular point-of-care and automation systems that may not have been 
purchased without the urgency and funding as a result of the pandemic. 
As reflected in the COVID-19 market value for 2025 ($4.0 billion) compared to 2024 ($5.3 
billion), the market is slowing and becoming more stable, more predictable for future market 
forecasting. 
Figure 1-2: COVID-19 IVD Market, Share by Segment, 2025 (%) 
 
[Immunoassay Lab-Based, Molecular Dx Lab-Based, Point-of-Care] 
 
Source: Kalorama Information 
To some degree, the issues the IVD industry was experiencing before the pandemic have 
worsened.  The opioid crisis has not gone away.  In fact, there is growing evidence that the 
crisis may have worsened as a result of economic woes, high unemployment (which has 

 
 
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Chapter 1: Executive Summary 
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6 
lessened since this report), and rising inflation prompted by the COVID-19 pandemic.  For 
2026, these issues remain a concern but are diminishing.  
New companies entered the IVD market space at a rapid pace throughout 2020, 2021, and 
2022, largely introducing emergency use authorization (EUA) products to detect and guide 
care for COVID-19. Changes by the FDA and other regulatory entities reducing EUA-type 
approvals have resulted in some contraction in vendor participation, but participation has 
remained stable. In some cases, bankruptcy and funding challenges have closed some doors. 
Discontinued COVID-19 product lines and participation have also emerged throughout 2023-
2025, as these segments are less profitable than during the height of the pandemic.  
Top-tier IVD companies accounted for the majority of IVD product sales in 2025.  This has 
been a continuing trend.  Even in COVID-19 testing, consolidation is reflected.  About ten 
companies (Roche, Abbott, Cepheid, bioMérieux among them) were among the labs' favored 
tests, at least in the United States, per an AMP survey.   Top-tier and next-tier companies 
listed in the market tables in Chapter 2 of this report account for the majority of the global 
IVD market.   
That does not mean there are not billions of dollars available for other concerns. The 
remainder of the market is held by 100s of companies, some of which specialize in specific 
test segments and others that serve their local markets. IVD remains dynamic. There are 
constant innovations. This report documents these innovations in each market chapter.  The 
IVD industry is a high-R&D-spend industry, and there is ongoing interest from venture 
capital firms in diagnostic products.  
Kalorama’s report is global, industry-focused, elevating corporate developments and 
financials over academic modeling. This 19th edition of The Worldwide Market for In Vitro 
Diagnostic (IVD) Tests presents the current view of the changes these investments have 
brought in the various market chapters and company profiles in the report.   One cannot look 
at a market without being aware of long-term trends.  Trends such as artificial intelligence, 
next-generation sequencing, gene editing, and microbiome studies are detailed in Chapter 4 
of this report.    

 
 
The Worldwide Market for IVD Tests, 19th Edition 
Chapter 1: Executive Summary 
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7 
Scope and Methodology 
The world market for in vitro diagnostics is provided in U.S. dollars for the years 2025-2030.  
Financial data in foreign currency is translated into US$ using the average annual exchange 
rate as the base. Therefore, previous editions of this report may not align due to the 
readjustment in company revenues.  
Please note that market events change quickly, and vendors release information at different 
times, either publicly or through private channels.  In some cases, the market evaluations 
presented in this edition of the report will differ from those in the 18th edition of this report 
and other reports prepared by the author and Kalorama Information.  This is because the 
market evaluations are based on reported company revenues that were available at the time 
of writing.  They are also based on anticipated market penetration of new tests and an increase 
in the usage of incumbent tests.  This does not always proceed as expected. Thus, information 
changes with time and influences the market estimates.  This methodology, as imperfect as 
it is, is the most rational strategy.  At the same time, this approach results in variations in 
market estimates.  Kalorama makes every effort to maintain transparency in the market 
information contained in this report.   Furthermore, the market data presented in this report 
should be viewed as estimates.  Although Kalorama strives to publish market evaluations and 
projections as close as possible to the market's true value, there is a measure of uncertainty 
involved in the estimation and forecasting process.  
Market analysis in this report covers world markets for in vitro diagnostics; however, the 
reader will find a bias toward the developed areas of the globe in North America, Japan, and 
Western Europe.  All market data are based on manufacturer revenues and not on retail 
pricing or reimbursement payments.  Data for the in vitro diagnostic market are presented in 
U.S. dollar market size by test category and, where possible, by specific analytes.  The dollar 
value of a market segment is directly proportional to the number of tests performed, because 
the cost of the instrumentation is generally buried in the per-test price.    
The report discusses tests and technologies that are currently available and those that are 
expected to take their place. Generally, current products and technologies establish the 
standard of care and their value to payers.   
Kalorama Information based its analysis on currently available information regarding 
international trade policies, trade restrictions, and tariff structures as of the date of this 
report. Rapidly evolving dynamics of global trade regulations, particularly those 

 
 
The Worldwide Market for IVD Tests, 19th Edition 
Chapter 1: Executive Summary 
May 2026 © Kalorama Information 
8 
impacting medical devices, reagents, and diagnostic instrumentation, are considered in 
this analysis and pose significant uncertainty surrounding forecasting and potential 
impact. While reasonable assumptions have been made to account for current 
conditions in trade policy affecting IVD manufacturers and suppliers, there can be no 
assurances that these assumptions will account for future changes in trade policy.                                
Tariff commentary is based on tariff policies in effect as of April 30, 2026.     
The information presented in this report is derived from publicly available information 
sources such as company, government, and medical organization reports.  The analysis is 
based on the author's industry knowledge combined with literature searches and interviews 
with industry professionals and experts in the IVD industry. 
Major information sources include, but are not limited to, the following: 
• Association for  Diagnostic Laboratory Medicine, www.adlm.org (previously 
AACC) 
• American Association of Blood Banks, www.aabb.org 
• Association for Molecular Pathology, www.ampweb.org 
• Centers for Medicare & Medicaid Services 
• CAP Today Online, http://captodayonline.com/ 
• China Cancer Registry 
• Clinical Lab News 
• Croatian Institute of Public Health, Department of Epidemiology 
• EDMA (the European Diagnostic Manufacturers Association), www.edma-ivd.be 
• FDA, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), 
www.fda.gov/cdrh/oivd/index.html 
• The Freedonia Group Economic Data 
• FX Investors, historical currency exchange rates (www.oanda.com) 
• GenomeWeb 
• Interviews and surveys conducted by Kalorama Information 

 
 
The Worldwide Market for IVD Tests, 19th Edition 
Chapter 1: Executive Summary 
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• Institute of Health Information and Statistics of the Czech Republic 
• India Public Sector News 
• IVD company websites, annual reports, financial statements, investor conferences, 
press conferences 
• Japan Analytical Instruments Manufacturers Association, IVD Committee 
• Joint Commission International, Mexico 
• Kalorama Information’s Knowledge Center and previous reports 
• Laboratory Equipment, www.laboratoryequipment.com 
• Medec Canada 
• MDDI Magazine 
• National Bureau of Statistics of China 
• Surveys, Science and Medicine Group/Bioinformatics 
• Strategic Directions International (SDi) 
• The New England Journal of Medicine 
• Oncology KnowledgeBASE, http://oncologyknowledgebase.com 
• World Health Organization databases and fact sheets 
• World Bank 
 
 

 
 
The Worldwide Market for IVD Tests, 19th Edition 
Chapter 1: Executive Summary 
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Size and Growth of the Market 
The worldwide IVD market is valued at $115,559 million ($116 billion) in 2025. The 
following table presents the worldwide IVD market across all segments.   
Table 1-1: Global In Vitro Diagnostic (IVD) Sales, by Product Segment, 2025-2030 ($ million)  
 
[Blood Bank Molecular; Blood Bank Screening; Drugs of Abuse; Blood Grouping/Typing; Circulating Tumor 
Cells; Clinical Chemistry; Coagulation; Histology/Cytology; Continuous Glucose; Diabetes HbA1c 
Immunoassays, Lab-Based;  Hematology;  HPV, Molecular; Immunoassays - Infectious Disease;  
Immunoassays - Other; Mass Spectrometry; Microbiology (ID/AST); Molecular Microbiology; Nucleic Acid 
Assays; POC, OTC Diabetes; POC, OTC Other; POC, Professional; Other] 
Product Segment 
2025 
2030 
CAGR 2025-2030 
POC Professional 
13,537 
16,751 
4% 
Immunoassays - Infectious Disease 
13,165 
15,494 
3% 
Immunoassays - Other 
12,610 
15,267 
4% 
Continuous Glucose 
12,458 
20,600 
11% 
Clinical Chemistry 
10,978 
13,308 
4% 
Molecular Microbiology 
8,672 
10,631 
4% 
POC, OTC Diabetes 
6,693 
7,020 
1% 
Microbiology (ID/AST) 
5,586 
6,314 
2% 
Hematology 
5,495 
7,455 
6% 
Histology/Cytology 
5,017 
6,597 
6% 
Molecular Oncology 
4,705 
9,500 
15% 
POC, OTC Other 
3,642 
4,489 
4% 
Coagulation 
1,794 
2,098 
3% 
D-dimer 
1,475 
1,710 
3% 
HbA1c Immunoassays, Lab-Based 
1,342 
1,700 
5% 
Molecular Genetic/Inherited 
1,332 
1,950 
8% 
Blood Bank Molecular 
1,330 
1,790 
6% 

 
 
The Worldwide Market for IVD Tests, 19th Edition 
Chapter 1: Executive Summary 
May 2026 © Kalorama Information 
11 
Product Segment 
2025 
2030 
CAGR 2025-2030 
HPV, Molecular 
1,270 
2,145 
11% 
Blood Grouping/Typing 
1,045 
1,150 
2% 
Mass Spectrometry 
1,032 
1,580 
9% 
Blood Bank Screening 
834 
885 
1% 
Drugs of Abuse 
333 
353 
1% 
Circulating Tumor Cells 
152 
185 
4% 
Other 
1,062 
1,474 
7% 
 Total 
115,559 
150,446 
5% 
 
 
 
 
Source: Kalorama Information 
 
 
 

 
 
The Worldwide Market for IVD Tests, 19th Edition 
Chapter 1: Executive Summary 
May 2026 © Kalorama Information 
12 
Market Highlights 
Here are some highlights of the report: 
• Continuous Glucose Monitoring Drives POC Markets: Device innovation and 
new product launches by key players such as Abbott, Dexcom and Trinity will support 
11% (CAGR) growth through 2030.     
• Molecular Oncology: Molecular oncology has expanded beyond diagnosis into 
minimal residual disease (MRD) detection, where highly sensitive assays identify 
trace levels of circulating tumor DNA after treatment, allowing earlier detection of 
recurrence and more informed decisions regarding adjuvant therapy supporting 15% 
CAGR 2025-2030 
• Mass Spectrometry Benefitting from Precision Medicine Demand: High demand 
in specialized diagnostics, including precision medicine and oncology testing, will 
support growth of 9% CAGR 2025-2030. 
• Multiplex Testing Moving Beyond Just the Respiratory Arena: In the post-
pandemic era, multiplex tests help to meet laboratory needs created by personnel 
shortages, less hands-on time, fewer reagents, and fewer laboratory resources. There 
has been a proliferation of respiratory testing involving SARS-CoV-2, flu A & B and 
RSV. Now, multiplex testing is moving into other areas, such as differentiating 
between bacterial and viral microorganisms to help physicians prescribe the proper 
treatment. As an example, Spindiag's proprietary microfluidic technology enables the 
company’s Rhonda to deliver quick, accurate, and convenient results for an array of 
infectious diseases.  
• HPV Molecular Markets Holding at Double-Digit Growth: HPV molecular 
markets remain strong and will continue to demand 11% CAGR (2025-2030), driven 
by expanded preventive programs and a wider adoption of core lab integration. 
• Molecular Transplant Testing Market Gaining Momentum. After a slow couple 
of years, the molecular transplant market has recently grown and is expected to 
continue growing through the forecast period (2025-2030), increasing at a 10% 
CAGR. 
• U.S. Percentage of World Market Holds Strong: COVID-19, mass spectrometry, 
continuous glucose testing, and nucleic acid testing are contributing to the product 
segment in maintaining a steady market share.  

 
 
The Worldwide Market for IVD Tests, 19th Edition 
Chapter 1: Executive Summary 
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• Hematology Markets Outpace Expectations: Growth in the hematology core lab 
market is trending stronger than previously anticipated due to demand for integration 
in core lab platforms (CAGR, 6.3%). Instrument replacements during the COVID-19 
pandemic bode well for hematology markets, with upgrades that allowed high-
throughput hematology analyzers and market expansion opportunities on the table. 
• Nucleic Acid Assays Show Strong Promise: The nucleic acid assay segment is 
increasing with double growth and is expected to post 13.7% CAGR performance 
through the forecast period 2025-2030. 
• Bio-Rad Remains Top Contributor to Growing Quality Control Market: This  
19th edition continues to estimate quality control in support of immunoassay and 
molecular IVD use.  The market for quality control is estimated at $1.2 billion for 
2025, with 68% of the market utilizing immunoassay techniques and the remainder 
molecular.  As it does not reflect direct in vitro diagnostic test revenue, this number 
is not included in the IVD market totals, but it is important for advancing the 
technology and testing.  
• Sepsis Concerns Still High Priority: Sepsis continues to be a growing problem and 
has only increased the attention of caring for infected patients.  Early detection is 
crucial for patients. The industry has responded by increasing rapid sepsis testing 
options and continuing steady utilization for lab-based techniques.  This industry push 
in rapid sepsis testing is contributing 14% growth in the market. Approximately 1.7 
million individuals in the US develop sepsis each year.  Procalcitonin (PCT) and 
lactate are two established biomarkers for sepsis. 
 
 

 
 
The Worldwide Market for IVD Tests, 19th Edition 
Chapter 1: Executive Summary 
May 2026 © Kalorama Information 
14 
Market Assumptions 
The IVD industry faces a mix of risks and opportunities shaped by global economic 
conditions, policy shifts, and evolving healthcare needs. To provide context for the market 
estimates and forecast, Kalorama Information considers some key assumptions driving the 
market outlook.  These assumptions include, but are not limited to, trade and tariff 
uncertainties, regulatory challenges, and ongoing supply chain vulnerabilities. Combined 
these factors create uncertainty in the market and could shift market results from the forecasts 
presented in this edition of the IVD market. At the same time, favorable currency movements, 
rising investment in R&D, and rapid advances in digital and AI integration are creating 
positive momentum for long-term growth. 
 
 
 
 

 
 
The Worldwide Market for IVD Tests, 19th Edition 
Chapter 1: Executive Summary 
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15 
Table 1-2: IVD Market Assumptions 2025 Outlook  
Transitioning to 
2026 Outlook 
Assumptions 
Impact/Comment 
Company Examples 
Weight of 
Impact on IVD 
Market 
Trade tariff 
uncertainty 
Negative impact on 
operating revenue - 
persistent but stabilizing 
Abbott flagged cost 
risks from U.S.-China 
tariffs. 
bioMérieux noted 
ongoing EU import 
concerns. 
Moderate to 
high 
Currency 
fluctuations 
Mixed impact 
Roche benefited from 
FX in early 2025 but 
noted normalization. 
Siemens Healthineers 
continues to benefit 
from euro weakness in 
exports. 
Low to 
moderate 
Regulatory 
changes 
Continued delays and 
increased compliance 
burden under IVDR 
transitions 
bioMérieux is still 
impacted by IVDR 
bottlenecks. 
BD highlighted ongoing 
EU compliance costs 
and SKU rationalization. 
Moderate  
Supply chain 
disruptions 
Global risk is low; 
however,   localized 
constraints remain 
Siemens Healthineers 
reported improved 
reagent 
availability/supply. 
Thermo Fisher is still 
managing select raw 
material sourcing 
challenges. 
Low to 
moderate 
R&D investment 
levels 
Continued increase to 
support innovation 
pipeline - stronger focus 
on AI-enabled workflows 
Thermo Fisher 
sustained high R&D 
increases. 
Roche is expanding AI, 
digital pathology, and 
molecular platforms 
with advanced 
technologies 
Moderate 
Pricing pressures 
in key markets 
Margin compression 
expected, with 
increasing tender 
pressure and value-
based pricing 
BD reported 
continued pricing 
pressures in APAC. 
Abbott cited 
competitive pricing in 
LATAM and the US, 
reducing margins. 
Moderate 
Demand for 
COVID-19 testing 
Significant decline vs. 
prior years - transitioned 
from a revenue driver to 
a baseline diagnostic 
category 
QuidelOrtho revenues 
stabilized at a lower 
base. 
Roche COVID-19 
revenue is now a 
minimal contributor. 
Varied: High for 
COVID-invested 
portfolios 
Growth in chronic 
disease testing 
Positive long-term 
demand driver - 
accelerating with aging 
populations and 
decentralization 
strategies 
Danaher (Cepheid) is 
expanding test menus 
beyond infectious 
disease. 
Siemens Healthineers 
launched new kidney 
disease assays. 
High 
Source: Kalorama Information 

 
 
The Worldwide Market for IVD Tests, 19th Edition 
Chapter 1: Executive Summary 
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16 
Competitive Picture in IVD 
 The sheer size and breadth of reach, both product-wise and 
geographically, allow IVD giants such as Abbott, Roche, and 
Danaher to contribute to the overall growth of the IVD market 
worldwide. At the top of the IVD list, Abbott Diagnostics (2025 IVD 
revenues of $16,935 million) is the market leader in the POC market, 
which generates an estimated $11 billion of the company’s total IVD 
revenues. Abbott is expected to maintain a leading position in POC 
with a wide market share margin 
Roche Diagnostics (2025 estimated IVD revenue is $16,607 million), is the second largest 
global provider of IVD products. As the IVD landscape continues to evolve, Roche also 
adapts and grows its presence in key markets. The company recently expanded its 
commitment to sequencing technologies through strategic collaborations and is using AI-
enabled technologies to enhance its diagnostic product lines, including companion 
diagnostics. Roche is the leading vendor in core molecular diagnostics and generates revenue 
in nearly every broad segment of IVD clinical products.    
The diagnostic companies of Danaher Corporation (2025 IVD revenue $9,940 million) 
include Beckman Coulter, Cepheid, Leica Biosystems, Radiometer, and SCIEX Diagnostics. 
The result of the company’s acquisition strategy of key IVD players (most specifically 
Beckman Coulter and Cepheid) catapulted Danaher into the number three market position. 
Danaher generates a large proportion of its sales in North America, Europe, and 
Asia/Australia.  
The significant gains made by companies that market infectious-disease immunoassays, 
cardiac markers, cancer diagnostics, histology, and molecular diagnostics illustrate several 
important market phenomena.  One is that these areas have been the growth engines in the 
past and will continue to be so for the near future.  On the other hand, companies including 
bioMérieux (2025 revenue $3,756 million) and Sysmex (2025 revenue $3,216 million) have 
capitalized on their investments in emerging markets in molecular and infectious-disease 
testing. Companies such as Exact Sciences (2025 revenue $3,247 million) remain strong in 
niche market segments, providing the company with a strong growth stream. 
Chapter 2 provides more details on the competitive situation, and Chapter 14 details the major 
companies in the market. 

 
 
The Worldwide Market for IVD Tests, 19th Edition 
Chapter 1: Executive Summary 
May 2026 © Kalorama Information 
17 
Finding What You Are Looking For in the 19th Edition 
Table 1-3: Finding What You Are Looking For in the 19th Edition 
Looking For… 
Location 
Blood Donation Testing 
Chapter 12 
Cancer Testing Markets 
Chapter 13 – Histology, Chapter 7 – Immuno Biomarkers, 
Chapter 8 – Genetic Cancer Markers   
China IVD Market 
Chapter 3 
Clinical Chemistry 
Chapter 6 
COVID-19 Testing 
Chapter 5, Chapter 7, Chapter 11   
Distribution Agreements 
Chapter 2 
Flu Tests, Respiratory Tests 
Chapter 11 
Glucose Testing 
Chapter 5 
hbA1c 
Chapter 5 – POC and Chapter 7 – Lab-based 
Hematology 
Chapter 9 
HIV, Hep. Other Pathogens 
Chapter 11 
ID/AST and Blood Culture 
Chapter 11 
IHC and In Situ Hybridization 
Chapter 13 
LATAM IVD Market 
Chapter 3 
Market Share of Top Companies 
Chapter 2 
Point of Care 
Chapter 5 
PT and Other Coagulation Tests 
Chapter 10 
Test Services 
Chapter 2 and Chapter 28 [not included in market data] 
US IVD Market 
Chapter 3 
Source: Kalorama Information 

 
 
The Worldwide Market for IVD Tests, 19th Edition 
Chapter 2: Introduction 
May 2026 © Kalorama Information 
18 
Chapter 2: Introduction 
IVD Landscape  
Scope 
This report offers a comprehensive analysis of all major segments within the in vitro 
diagnostics (IVD) industry, with detailed discussions of the global factors shaping each 
segment, including demographic, social, and economic trends. Each segment analysis 
includes insights into relevant regulatory developments, clinical practices, and recent 
market approvals, as well as sales data for 2025 with projections through 2030. The 
report also profiles key market leaders and companies active within each segment. 
Broader population and healthcare delivery trends in major world regions are 
evaluated for their impact on diagnostic laboratory markets. 
While the report emphasizes the market impact of current and emerging diagnostic 
technologies, it does not delve into the technical specifications of testing modalities such 
as molecular assays, immunoassays, or flow cytometry, nor does it provide extensive 
clinical background on disease etiology, physiology, or manifestations, except when 
necessary to explain the role of diagnostics in patient care. Current products and 
technologies are evaluated based on their role in establishing or enhancing standards 
of care and their value propositions to payers. However, despite the potential of new 
diagnostic approaches to improve outcomes, adoption may be constrained by 
cost-benefit considerations within healthcare systems. 
Market estimates and forecasts presented in this edition may differ from those in the 
18th edition or other Kalorama publications due to updates in company-reported 
revenues and the latest financial and interview-based information available at the time 
of writing. 
While the acute phase of the COVID-19 pandemic has passed, its aftereffects continue to 
impact the IVD industry in 2025, particularly with the decline in pandemic-related testing 
revenues. In response, many companies have shifted their focus to multiplex respiratory 
panels that include COVID-19, influenza A & B, and, in some cases, RSV, to sustain 

 
 
The Worldwide Market for IVD Tests, 19th Edition 
Chapter 2: Introduction 
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19 
relevance and utility. Several segments are emerging as key growth areas through 2030, 
including HPV molecular, molecular diagnostics, mass spectrometry, POC testing, and 
molecular HLA testing. Ongoing global health threats such as obesity, diabetes, cancer, 
cardiovascular disease, and infectious diseases are driving demand for increasingly specific 
and sensitive diagnostic tools. However, as advanced technologies such as genomics, 
microfluidics, and IT integration expand testing capabilities, the cost associated with these 
tests has drawn scrutiny from payers and regulators.  
Still, the overall IVD market has improved since the previous year of Kalorama's global 
diagnostics report, fueled by continued technological progress, the proliferation of 
syndromic/multiplex testing, greater use of robotics and AI, ongoing biomarker discovery, 
and increased investment in R&D. Diagnostics that reduce long-term treatment costs or 
hospital stays remain favored, particularly in settings where reimbursement is favorable. 
Looking ahead, the IVD industry is expected to experience moderate, gradual growth over 
the next 5–10 years, with modest gains in developed countries and faster expansion in 
emerging markets. In these regions, growth is driven by a rising middle class, expanding 
private insurance coverage, and greater access to healthcare. Particular attention is being paid 
to infectious and chronic diseases, including rising rates of cancer, cardiac, and autoimmune 
conditions. Global initiatives such as those led by the Clinton and Gates Foundations have 
also expanded access to diagnostics for diseases such as TB, HIV, malaria, and STDs. In 
addition, the rise of emerging infectious diseases, including Chagas, dengue, chikungunya, 
monkeypox, and continuing COVID-19 variants, has underscored the persistent threat of 
infectious diseases in an increasingly interconnected world. 
Edition-Specific Notes 
Shifting Areas of Concentration 
Since the 18th edition was published, Kalorama Information has identified specific areas of 
concentration. These include 
• Portfolio expansion 
• Customization 
• Digital health 

 
 
The Worldwide Market for IVD Tests, 19th Edition 
Chapter 2: Introduction 
May 2026 © Kalorama Information 
20 
During research for the 19th edition, Kalorama Information identified that companies seem 
to be focusing on expanding their portfolios rather than investing in new products. This is 
not to say that IVD companies are replacing innovation with portfolios, but rather that they 
are shifting toward portfolio expansion, menu expansion, and acquisitions to drive primary 
growth, rather than relying on new platforms or products.  
Portfolio expansion is a core strategy, achieved by offering larger test menus on existing 
platforms and venturing into adjacent disease areas.  Acquisitions are playing a bigger role 
as companies acquire test portfolios or companies, such as Abbott’s acquisition of Exact 
Sciences, to expand cancer diagnostics, and BD’s restructuring to focus on other strengths in 
its portfolio.  
Digital health is expanding through connectivity, data management and AI. Digital health 
has enabled companies to move toward a more integrated solution approach that supports 
revenue streams, strengthens customer relationships, and creates differentiation in an 
increasingly competitive market. 
New products are still entering the market, especially in certain key growth areas like 
proteins, but so far, there have not been as many entirely new instrument platforms or 
disruptive technologies. True innovation is continuing in molecular diagnostics, companion 
diagnostics, POC molecular diagnostics, digital pathology, and AI-driven diagnostics but 
even in these areas, companies are acquiring or partnering with other companies instead of 
building internally.  
Report Design 
In this 19th edition of The Worldwide Market for In Vitro Diagnostic (IVD) Tests, Kalorama 
Information provides an enhanced report format designed to align with its integration into 
the Kalorama Knowledge Center. This platform provides subscribers with full access to 
Kalorama’s extensive library of market research reports, along with downloadable content, 
including spreadsheets and Word documents, from these and other reports. While the layout 
has been updated for improved usability within the Knowledge Center, the report maintains 
the familiar structure and chapter organization of previous editions, including dedicated 
sections profiling key IVD market areas. Notably, this edition features expanded profile 
chapters on companies engaged in circulating tumor cell diagnostics, prenatal testing, and 
test service offerings, and segments that reflect the most prominent and emerging trends 
within the IVD industry. This edition has attempted to remove historical and product data 

 
 
The Worldwide Market for IVD Tests, 19th Edition 
Chapter 2: Introduction 
May 2026 © Kalorama Information 
21 
that are not relevant to understanding the information contained in the study.   For more 
details on the Knowledge Center, visit www.kaloramainformation.com. 
 
 
 

 
 
The Worldwide Market for IVD Tests, 19th Edition 
Chapter 2: Introduction 
May 2026 © Kalorama Information 
22 
PAMA and CMS 
PAMA is intended to introduce a more organic methodology for reimbursement adjustments 
for lab testing under Medicare and will replace uniform cuts implemented across the Clinical 
Laboratory Fee Schedule (CLFS) under the Affordable Care Act (ACA) and other prior 
legislation.  
PAMA created a new category of assays, called advanced diagnostic laboratory tests 
(ADLTs), which CMS has defined as tests developed and offered by a single lab that use a 
unique algorithm to analyze multiple DNA, RNA, or protein markers, and which provide 
new clinical diagnostic information that can't be obtained by any other test. Each test is 
identified by unique codes, but the ADLT definition remains controversial among industry 
players. Test developers are awaiting further clarification from CMS regarding the 
requirement that ADLTs must provide new clinical diagnostic information. These tests will 
be paid full list price for three quarters after their introduction, then payment will be based 
on weighted median private payor rates, like all other tests. 
In the ADLT category, Veracyte's Afirma Gene Expression Classifier (CPT code 81546), for 
distinguishing which thyroid nodules are benign and which are suspicious of cancer, had a 
price increase from $3,222 to $3,600, while CareDx's AlloMap test for gauging cardiac 
transplant rejection risk (CPT code 81595) increased from $2,841 to $2,917. 
PAMA has been challenging for POC participants. The cost of the test is a factor in use. POC 
tests, traditionally higher-cost, would be particularly affected by reimbursement cuts. 
Industry participants feel that one way to address the issue would be to assign POC tests a 
different billing code rather than lumping them together with high-volume, low-margin tests. 
This is a trend that the industry needs to keep abreast of to develop strategies to counter 
reimbursement cuts for POC testing.  
CMS releases new waived tests annually. Some of these additions include: 
•  83036QW September 27, 2023, Abbott Diagnostics Technologies AS AS100 
Analyzer  
• 87635QW August 10, 2023, Abbott ID NOW Instrument (Nasal and Nasopharyngeal 
Swabs)  

 
 
The Worldwide Market for IVD Tests, 19th Edition 
Chapter 2: Introduction 
May 2026 © Kalorama Information 
23 
• 80061QW, 82465QW, 83718QW, 84478QW September 20, 2023, Alere San Diego 
Inc. Cholestech LDX {Lipid Profile cassette} (Whole Blood)  
• 80305QW May 15, 2023, American Screening Corporation Discover Plus Multi-
Panel Drug Test Cup  
• 80305QW May 15, 2023, American Screening Corporation G-Card Drug Test Dip 
Card  
• 80305QW May 15, 2023, American Screening Corporation G-Cup Multi-Panel Drug 
Test Cup  
• 80305QW May 15, 2023, American Screening Corporation Onescreen Multi-Panel 
Drug Test Cup  
• 80305QW May 15, 2023, American Screening Corporation Precision DX Drug Test 
Dip Card  
• 80305QW May 15, 2023, American Screening Corporation Precision DX Multi-
Panel Drug Test Cup  
• 80305QW May 15, 2023, American Screening Corporation Precision Plus Drug Test 
Dip Card  
• 80305QW May 15, 2023, American Screening Corporation Precision Plus Multi-
Panel Drug Test Cup  
• 85610QW July 27, 2023, ARKRAY USA Assure PT Care Prothrombin Time PT/INR 
Monitoring System Professional Use  
• 80305QW July 11, 2023, Azure Biotech Inc. Fastep QuickCup Multi Drug Urine Test 
M2000  
• 80305QW July 11, 2023, Azure Biotech Inc. Fastep QuickCup Multi Drug Urine Test 
M300  
• 
 80305QW July 11, 2023, Azure Biotech Inc. Fastep QuickCup Multi Drug Urine 
Test  
• 87631QW May 5, 2023, Biofire Diagnostics SPOTFIRE Respiratory Panel Mini  
• 80305QW August 23, 2023, BTNX Inc. Rapid Response Multi-Drug One Step Cup  
• 80305QW July 11, 2023, BTNX Inc. L-Cup Home Rapid Test (Urine)  

 
 
The Worldwide Market for IVD Tests, 19th Edition 
Chapter 2: Introduction 
May 2026 © Kalorama Information 
24 
• 80305QW May 19, 2023, Carethetic Group Corporation Carethetic Marijuana test kit 
(THC urine test)  
• 80305QW May 19, 2023, Carethetic Group Corporation Carethetic Multi Drug Test 
Cup  
• 80305QW May 19, 2023, Carethetic Group Corporation Carethetic Multi Drug Test 
Panel  
• 80305QW August 28, 2023, Citest Diagnostics Inc. Citest Multiplex DOA Home Test 
Cup (Urine)  
• 80305QW August 28, 2023, Citest Diagnostics Inc. Citest Multiplex DOA Home Test 
Panel (Urine)  
• 80305QW August 24, 2023, Clarity Diagnostics LLC. Clarity Multi-Drug Urine Test 
Cup (Urine)  
• 87635QW June 20, 2023, Cue Health Inc. Cue Health Monitoring System (For use 
with Anterior Nasal Swabs)  
• 80305QW October 2, 2023, Dochek USA Inc. Amazewell Multi-Drug Urine Test 
Cup  
• 80305QW August 2, 2023, Easy Healthcare Corporation Easy@Home Single Drug 
Screen Test (Cocaine Urine Test)  
• 80305QW August 28, 2023, Genabio Diagnostics Inc. GenaCheck Rapid Self-Test 
Kit For Cannabis 
• G056QW June 27, 2024, Infectious agent detection by nucleic acid; hepatitis C, 
screening, amplified probe technique 
• 81515QW January 1, 2025, Cepheid GeneXpert Xpress 
• 87563QW January 16, 2025, Infectious agent detection by nucleic acid, Mycoplasma 
genitalium, amplified probe technique 
• 87491QW January 16, 2025, Infectious agent detection by nucleic acid, Chlamydia 
trachomatis, amplified probe technique 
• 0563UQW July 1,2025, Infectious disease (bacterial and/or viral respiratory tract 
infection), pathogen-specific nucleic acid (DNA or RNA), 11 viral targets and 4 

 
 
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bacterial targets, qualitative RT-PCR, upper respiratory specimen, each pathogen 
reported as positive or negative 
• 87494QW January 1, 2026, Infectious agent detection by nucleic acid (DNA or 
RNA); Chlamydia trachomatis and gonorrhea, multiplex amplified probe technique 
• 87812QW January 1, 2026 Infectious agent antigen, detection by immunoassay with 
direct optical observation; severe acute respiratory syndrome coronavirus 2 and 
influenza types A and B.  
PAMA remains an ongoing concern. The precedent set by funding reductions in other areas 
of healthcare suggests that similar cost-cutting mechanisms could be reintroduced to 
laboratory reimbursements, potentially reviving PAMA-related cuts. Industry groups in 
diagnostics and laboratory medicine have cautioned that 2025 and 2026 may not benefit from 
the same legislative relief or deferrals that Congress has granted in prior years. 
 
 

 
 
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Market Analysis of IVD Market Segments 
The global market for in vitro diagnostics is estimated at $116 billion in 2025 and is expected 
to grow 5% annually to $150 billion by 2030.  This includes all commercial laboratory- and 
hospital-based products, some research-use products used in clinical laboratories, and OTC 
product sales (not test services).   
The reader is reminded that this is an estimate; the number of tests performed is expected to 
increase as more of the population has access to healthcare and aging populations in 
developed countries require medical care.  However, with pricing pressures in the major 
markets, the dollar value of market segments does not automatically increase in direct 
proportion to the increase in the number of tests performed. The next chapter assesses the 
world market situation, and the following chapter presents major market trends. A 
comprehensive analysis of each IVD product segment is found in the appropriate chapter.  
 
 
 

 
 
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Table 2-1: Global In Vitro Diagnostic (IVD) Sales, by Product Segment, 2025-2030 ($ million) (%) 
 
[Blood Bank Molecular; Blood Bank Screening; Drugs of Abuse; Blood Grouping/Typing; Circulating Tumor 
Cells; Clinical Chemistry; Coagulation; Histology/Cytology; Continuous Glucose; COVID-19 Dx; Diabetes 
HbA1c Immunoassays, Lab-Based;  Hematology;  HPV, Molecular; Immunoassays - Infectious Disease;  
Immunoassays - Other; Mass Spectrometry; Microbiology (ID/AST); Molecular Microbiology; POC, OTC 
Diabetes; POC, OTC Other; POC, Professional; Other] 
Product Segment 
2025 
Market (%) 
2030 
Market (%) 
CAGR  
2025-2030 
POC Professional 
13,537 
11.7% 
16,751 
11.1% 
4% 
Immunoassays - Infectious Disease 
13,165 
11.4% 
15,494 
10.3% 
3% 
Immunoassays - Other 
12,610 
10.9% 
15,267 
10.1% 
4% 
Continuous Glucose 
12,458 
10.8% 
20,600 
13.7% 
11% 
Clinical Chemistry 
10,978 
9.5% 
13,308 
8.8% 
4% 
Molecular Microbiology 
8,672 
7.5% 
10,631 
7.1% 
4% 
POC, OTC Diabetes 
6,693 
5.8% 
7,020 
4.7% 
1% 
Microbiology (ID/AST) 
5,586 
4.8% 
6,314 
4.2% 
2% 
Hematology 
5,495 
4.8% 
7,455 
5.0% 
6% 
Histology/Cytology 
5,017 
4.3% 
6,597 
4.4% 
6% 
Molecular Oncology 
4,705 
4.1% 
9,500 
6.3% 
15% 
POC, OTC Other 
3,642 
3.2% 
4,489 
3.0% 
4% 
Coagulation 
1,794 
1.6% 
2,098 
1.4% 
3% 
D-dimer 
1,475 
1.3% 
1,710 
1.1% 
3% 
HbA1c Immunoassays, Lab-Based 
1,342 
1.2% 
1,700 
1.1% 
5% 
Molecular Genetic/Inherited 
1,332 
1.2% 
1,950 
1.3% 
8% 
Blood Bank Molecular 
1,330 
1.2% 
1,790 
1.2% 
6% 
HPV, Molecular 
1,270 
1.1% 
2,145 
1.4% 
11% 
Blood Grouping/Typing 
1,045 
0.9% 
1,150 
0.8% 
2% 
Mass Spectrometry 
1,032 
0.9% 
1,580 
1.1% 
9% 

 
 
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Product Segment 
2025 
Market (%) 
2030 
Market (%) 
CAGR  
2025-2030 
Blood Bank Screening 
834 
0.7% 
885 
0.6% 
1% 
Drugs of Abuse 
333 
0.3% 
353 
0.2% 
1% 
Circulating Tumor Cells 
152 
0.1% 
185 
0.1% 
4% 
Other 
1,062 
0.9% 
1,474 
1.0% 
7% 
Total 
115,559 
100.0% 
150,446 
100.0% 
5% 
COVID-19 
4,727 
-- 
5,090 
-- 
1% 
Note: Values rounded, may not add to 100% 
Source: Kalorama Information 
Table 2-2: Additional Global In Vitro Diagnostic (IVD) Markets of Interest (Not in Totals), Sales by Product 
Segment, 2025-2030 ($ million) (%)  
 
[Clinical Sequencing; Drugs of Abuse, Criminal; Drugs of Abuse, Employment (non IVD); DTC Genetic 
Testing; Flow Cytometry; Prenatal Test Services] 
Markets of Interest (Not in Totals) 
2025 
2030 
CAGR 2025-2030 
Clinical Sequencing 
7,505 
11,550 
9% 
Flow Cytometry 
1,765 
2,230 
5% 
DTC Genetic Testing 
1,195 
1,970 
11% 
Prenatal Test Services 
1,040 
1,500 
8% 
Drugs of Abuse, Employment (non IVD) 
818 
876 
1% 
Drugs of Abuse, Criminal 
374 
395 
1% 
Total 
12,697 
18,521 
8% 
Note: *Clinical sequencing total includes related services 
 
 
 
 
Source: Kalorama Information 
 

 
 
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Top Suppliers and Niche Players 
Introduction 
 
In 2025, the top IVD companies are estimated to account 
for $92 billion in IVD product sales, compared with $88 
billion in 2024 and $85 billion in 2023. These product sales 
represent approximately a 4.9% increase in top-tier 
revenues for 2024-2025. This research shows that revenues 
generated by the major IVD companies account for almost 
80% of the global IVD market in 2025. The remaining 20% 
is held by hundreds of companies worldwide, some of 
which specialize in specific test segments and others that 
serve local markets.   
There is no doubt that the top and second-tier companies will continue to dominate the IVD 
industry due to their global reach and multi-segment participation and/or concentrated 
excellence in a particular test segment.  This market power is evident in the latest revenue 
expansion.   
Most of the companies profiled in 
this report attribute much of their 
revenue 
growth 
to 
the 
commercialization of advanced-
technology products for cancer 
and infectious disease testing.  
More importantly, their continued 
penetration 
of 
routine 
and 
specialized test markets in the top 
12 emerging countries (Brazil, 
China, India, Indonesia, Korea 
(South), Malaysia, Mexico, Saudi Arabia, South Africa, Thailand, Turkey, and Vietnam) is 
a significant driver of revenue growth. 

 
 
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As IVD markets in North America and Europe offer limited growth opportunities for the vast 
number of tests, even top-tier companies have begun to count on emerging markets for 
growth.  Several factors influence growth opportunities within these markets, including a 
growing clinical market, nascent consumer demand, and increased government investment. 
Specific factors by emerging country include: 
• Brazil - rising private healthcare, BRICS debate centrality 
• China - aging population, rising healthcare services demand (cautiously optimistic, 
government spending controls) 
• India - growing pharma exports, government support of medical tourism, chronic 
disease uptick, testing demand increases fueled by consumer and professional 
demand 
• Indonesia - universal coverage, insurance expansion 
• Malaysia - specialized treatments and medical tourism growth, growing fertility 
markets 
• Mexico - launch of specialized drug treatments, growing middle class, urbanization 
• Saudi Arabia - government infrastructure and strategy - Vision 2030 reform program 
allocates funding for healthcare infrastructure and private sector partnerships; rising 
chronic diseases, strong e-health, AI-enabled devices, molecular technology growth 
and telemedicine market demand 
• South Africa - health investment, burgeoning medical tourism presence 
• South Korea - advanced elective procedures, medical tourism, advanced technology 
adoption 
• Thailand - long-established, high-volume medical tourism market; increasing 
demand for advanced technologies 
• Turkey - cosmetic and specialized medical tourism growth, growing middle class 
• Vietnam - rapid healthcare expansion, fueled by increases in both public and private 
sector healthcare spending, growing middle class, POCT markets expanding 
. 

 
 
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Overview of the Top Tier Companies 
The following company abstracts are presented in relation to their ranking among the top 
companies in the IVD market: largest to smallest; see the table below. In some cases, specific 
IVD revenues are not reported by vendors and estimates are provided.  
Table 2-3: Clinical Diagnostic Revenues of Selected Top 20 IVD Companies, 2024 and 2025 ($ million) 
Company* 
 
2024 
2025 
% Change 2024-2025 
Abbott Diagnostics 
16,146  
16,935  
4.9% 
Roche Diagnostics (all) 
15,866  
16,607  
4.7% 
Danaher (all) 
9,787  
9,940  
1.6% 
Thermo Fisher Scientific 
4,512  
4,742  
5.1% 
Dexcom 
4,033  
4,662  
15.6% 
Siemens Healthineers 
4,577  
4,659  
1.8% 
bioMérieux 
3,497  
3,756  
7.4% 
Illumina 
3,671  
3,709  
1.0% 
Exact Sciences 
2,760  
3,247  
17.6% 
Sysmex Corporation 
2,947  
3,216  
9.1% 
Becton Dickinson 
3,416  
3,117  
-8.8% 
QuidelOrtho 
2,783  
2,708  
-2.7% 
Werfen 
2,300  
2,407  
4.7% 
Natera 
1,694  
2,307  
36.2% 
Mindray 
2,208  
1,908  
-13.6% 
Hologic 
1,805  
1,821  
0.9% 
Agilent 
1,688  
1,771  
4.9% 
Bio-Rad Laboratories 
1,538  
1,562  
1.6% 
QIAGEN 
1,021  
1,435  
40.5% 
Revvity 
1,428  
1,424  
-0.3% 
Top Tier Total 
87,677  
91,933  
4.9% 
*Note: Public companies 
Source: Kalorama Information 

 
 
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Abbott Diagnostics 
Abbott Diagnostics is the leader in the IVD market in 2025.  There are several reasons why 
Abbott has remained a strong IVD leader in the market due to:  
• Strong presence in the POC market, demonstrating 30% market share, with a target 
on cardiometabolic disease, infectious disease, and toxicology.  Abbott’s portable 
strip tests, along with its benchtop systems and analyzers, can provide immediate, 
actionable test information. 
• Focus on the development of advanced diabetes care products with 38% market share  
• Core focus on infectious disease testing, with a significant portion of sales generated 
in the European Union, emerging markets, and the U.S. The company is preparing 
for the future by developing next-generation systems, informatics to help labs manage 
and retrieve test data, new infectious disease diagnostics, and gene-based oncology 
tests for targeted therapeutics.  Although demand for COVID-19 testing has waned, 
Abbott still maintains a strong market presence.  
Abbott is a leader in immunoassays (number 2 worldwide) and is translating this expertise 
into molecular assays.  Abbott is making a huge effort to improve its molecular test menu.  
Abbott Molecular analyzes DNA, RNA, and proteins at the molecular level.  In general, 
Abbott Molecular focuses on tests for the evaluation and management of cancer, prenatal 
disorders, infectious diseases, and other genetic diseases.   
Roche Diagnostics 
Roche is a world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a 
frontrunner in personalized health care and diabetes management.  Roche's personalized 
healthcare strategy aims to provide medicines and diagnostic tools for patients' disease 
management.     
Technological advancements in molecular (PCR) IP, chemistries, immunoassays, HPV 
testing and its diabetes franchise (even though it is not as strong as it once was) are pushing 
the company forward.  The company has reinforced its molecular and sequencing offerings, 
and branched out into prenatal analysis, genomics, hematology, microbiology and cfDNA 
for cancer testing.  This strategy has secured Roche’s leading presence in lab-based molecular 
markets. 

 
 
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Danaher Corporation 
Danaher Corporation is a diversified company whose business segments include Professional 
Instrumentation, Medical Technologies, Industrial Technologies and Tools & Components.  
The Medical Technologies segment encompasses three key businesses: Dental Equipment 
and Consumables, Life Sciences, and Diagnostics. The diagnostic companies of Danaher 
Corporation include Beckman Coulter, Cepheid, Leica Biosystems, Radiometer, and SCIEX 
Diagnostics. Danaher is the third largest IVD manufacturer with the combined diagnostic 
group of companies.  
Cepheid 
Cepheid is a molecular diagnostics company that is dedicated to easy-to-use molecular 
systems and tests.  The company made its mark with rapid molecular tests for tuberculosis, 
hospital-acquired infections, and respiratory diseases.  Cepheid has roughly 11% market 
share of molecular diagnostics.  
Radiometer 
Radiometer is the world's leading provider of blood gas analyzers.  Radiometer’s products 
and solutions are used in hospitals, clinics and laboratories in over 130 countries, to provide 
information on the most critical parameters in acute care testing.  Radiometer also provides 
accessories, IT systems and support services for blood gas testing, POC systems and 
immunoassays.   
Beckman Coulter  
Beckman Coulter is a subsidiary of Danaher Corporation (DHR), develops, manufactures 
and markets IVD tests for more than 80 years.  Beckman Coulter is a leading provider in the 
clinical chemistry; they compete strongly with Roche. Strength in the market includes routine 
chemistry and UA segments.  

 
 
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Thermo Fisher Scientific 
Thermo Fisher Scientific is a major manufacturer and distributor of clinical diagnostics 
reagents, instruments and supplies.  The Thermo Fisher conglomerate serves healthcare, drug 
discovery, academia, government and industrial laboratories.  Thermo Fisher offers a range 
of scientific instruments from basic equipment to advanced mass spectrometers. It also sells 
chemicals, agents, and antibodies for biotech research. Thermo Fisher has a strong presence 
in immunoassays and core laboratory segments. The company also participates in 
microbiology markets.  
Dexcom  
Dexcom is a medical device company that specializes in the design, development, and 
commercialization of continuous glucose monitoring (CGM) systems for people with 
diabetes and healthcare providers.  The company conducts manufacturing activities at its San 
Diego, CA headquarters facility.  Dexcom is the second-largest provider of POC glucose 
testing devices, with a 22% market share in 2025.  
Siemens Healthineers 
Siemens Healthineers is a major player in medical imaging, laboratory diagnostics, and 
medical information technology.  The diagnostics division includes products for clinical 
chemistry, drug testing, hematology, coagulation, immunoassay, infectious diseases, 
microbiology, molecular diagnostics, plasma proteins, point-of-care testing, blood 
gases/electrolytes, and urinalysis.  In addition, Siemens operates a clinical laboratory and 
offers laboratory informatics and automation.   Siemens Healthineers holds the third-largest 
market share in lab-based immunoassays.  
bioMérieux 
bioMérieux provides diagnostic solutions (reagents, instruments, software), which are used 
for diagnosing infectious diseases, blood bank screening, blood culture, cancer screening and 
monitoring and cardiovascular emergencies.  

 
 
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bioMérieux is leveraging its dominant position in microbiology to build a molecular testing 
business focused on oncology and infectious diseases. The company is the second largest 
provider in the molecular segment, following closely behind Danaher.  
Illumina  
Illumina is a leading developer, marketer, and manufacturer of integrated systems for large-
scale analysis of genetic variation and function. The heart of its business, Illumina’s 
sequencers, offer a broad range of genomic applications, including whole-genome 
sequencing, targeted resequencing, de novo sequencing, amplicon sequencing, SNP 
discovery, identification of copy number variations, and chromosomal rearrangement.  The 
company’s sequencing products have been developed to meet the growing demand for next-
generation sequencing. Illumina generates $4.3 billion in total revenues. 
Exact Sciences  
Exact Sciences was founded in 1995 through a collaboration with the Mayo Clinic. The 
company expects continued growth from Cologuard and its Oncotype products. The 
company was acquired by Abbott. 
Sysmex Corporation 
Sysmex Corporation is an integrated manufacturer of laboratory software and diagnostic 
systems involved in the development, production, marketing, and servicing of clinical 
laboratory testing devices and reagents.  Since its establishment in 1968, Sysmex has 
concentrated on hematology and urinalysis.  More recently, Sysmex has expanded into 
hemostasis, immunochemistry, and clinical chemistry, and has expanded its global 
operations in hematology, coagulation, immunochemistry, and urinalysis. Sysmex is 
expanding its presence in molecular analysis and liquid biopsy testing, primarily for cancer.  
Sysmex is the undisputed leader in the hematology market, with a 33% worldwide market 
share.  The company made its mark by introducing the first 5-part differential and then 
marketing several innovations.  Sysmex has gained market share in the U.S. by establishing 
its own sales force and negotiating contracts with reference labs and hospital systems. 

 
 
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Becton Dickinson & Co 
Becton Dickinson is a leading global medical technology company that develops, 
manufactures and sells medical devices, instrument systems and reagents.   The company 
serves healthcare institutions, life science researchers, clinical laboratories, the 
pharmaceutical industry and the general public.    
BD’s legacy IVD involvement is in infectious disease testing and flow cytometry, where the 
company is an industry leader. BD is a leader in cervical cancer screening.   
QuidelOrtho Corporation 
QuidelOrtho Corporation markets POC and lab-based products, including immunoassays, 
under the QuickVue, D3 Direct Detection, and Thyretain brand names, as well as under the 
new Sofia brand. The portfolio includes tests for influenza, respiratory syncytial virus, fecal 
occult blood, Strep A, pregnancy, thyroid disease, bacterial vaginosis, infectious 
mononucleosis, HSV, H. pylori, and chlamydia.   
Werfen 
Werfen maintains its position in the IVD industry by concentrating on reinforcing its main 
areas of expertise in coagulation and autoimmune testing and has added to its acute care 
diagnostics.  
Werfen specializes in the areas of clinical chemistry (8% global market share), clinical 
software, hemostasis (20% market share) and acute care diagnostics through its acquisition 
of Instrumentation Laboratory. In the area of autoimmunity, it specializes through its 
company, Inova Diagnostics.  Werfen also provides OEM manufacturing for third parties 
(reagents and biomaterials) and infectious disease serology through its company, Biokit. 
Additionally, the company strengthened its presence in the transfusion and transplant markets 
with the acquisition of Immucor in March 2023.  
Natera 
Natera is a genetic testing and diagnostics company specializing in genetic diseases. Natera 
established a solid presence in the non-invasive prenatal testing market by developing and 

 
 
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offering a suite of tests, including the Panorama Prenatal test, Horizon Carrier Screen, Anora 
Miscarriage test, and Spectrum Pre-implantation Genetic Screening and Diagnosis tests. The 
company is among the fastest growing IVD companies worldwide.  
Mindray 
Mindray is the leading developer, manufacturer and marketer of medical devices in China, 
with a presence globally.  Mindray’s products are available in over 190 countries and regions.  
Mindray reported it has developed a more advanced biochemistry analyzer, an upgraded 
hematology analyzer, other biochemistry analyzers and several reagents, as well as a number 
of upgraded urine sediment analyzers. 
Hologic 
Hologic, Inc. is active in several markets: diagnostic products, medical imaging systems, and 
surgical products.  The company operates four core business units focused on diagnostics, 
breast health, gynecological surgical and skeletal health. Hologic is a microbiology 
molecular manufacturer, generating nearly $1.3 billion in 2025; it is also the leading provider 
in the traditional PAP market. 
Agilent 
Agilent Technologies Inc is a technology leader in chemical analysis, life sciences, 
electronics and communications. Agilent operates in three business segments – life science 
and applied market, diagnostics, and genomics. The company is among the market leaders in 
the histology/cytology market, generating revenues of over $1 billion annually.  
Bio-Rad Laboratories 
Bio-Rad Laboratories, Inc. markets a broad range of products for the life science research 
and clinical diagnostic markets.  The company offers more than 3,000 products covering 
more than 300 clinical diagnostic tests to clinical diagnostic customers, including hospital 
laboratories, reference laboratories, transfusion laboratories, and physician office 
laboratories. Bio-Rad has more than $1.5 billion in IVD sales and continues to stand out as 
one of the market’s most reliable growth leaders.  

 
 
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QIAGEN N.V. 
QIAGEN N.V. is a holding company with subsidiaries in Germany, the United States, China, 
Japan, the United Kingdom, Switzerland, France, Italy, Australia, Norway, Austria, Canada, 
Sweden, and the Netherlands.  QIAGEN is a leading global provider of molecular sample 
and assay technologies.  
Revvity 
Revvity is focused on human and environmental health and has been a leader in prenatal and 
newborn screening for more than 30 years. Revvity also provides immunoassays, genetic 
screening, drug discovery, life science research, and analytical solutions.  
Revvity’s diagnostic offerings include prenatal, neonatal and infectious disease screening, 
along with molecular diagnostics solutions, through its wide range of instruments, reagents 
and assay platforms, and software.  Revvity also provides DNA/RNA sequencing services to 
accelerate target identification, biomarker discovery, and diagnostic applications.  The lab 
provides end-to-end sequencing and bioinformatics services. The company’s $1.4 billion in 
estimated IVD sales is driven by strong contributions across immunoassay and molecular 
microbiology testing, positioning it as a reliable player in key diagnostic markets.  
Overview of Selected Second-Tier Companies 
Niche players in histology, molecular assays, and rapid tests for infectious diseases play their 
part as drivers of IVD industry growth.  The table below presents the revenue growth of a 
selection of niche players from 2024 to 2025.   
These second-tier companies have developed innovations in their respective diagnostic areas 
that have significantly enhanced the strength and efficiency of clinical diagnostic products. 

 
 
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Table 2-4: Revenues of Selected Top 20 Niche IVD Players, 2024 and estimated 2025 ($ million) 
Company* 
2024 
2025 
% Change 2024-2025 
Diasorin 
1,282  
1,352  
5.5% 
Bruker - CALID 
1,094  
1,211  
10.7% 
Guardant Health 
738  
981  
32.9% 
Myriad Genetics 
838  
825  
-1.6% 
Grifols 
718  
708  
-1.4% 
Diagnostica Stago 
617  
695  
12.6% 
BGI Genomics 
618  
606  
-1.9% 
Sekisui Diagnostics 
498  
552  
10.8% 
Arkray 
400  
422  
5.5% 
GeneDx 
295  
416  
41.0% 
Fujirebio 
397  
397  
0.0% 
Fulgent Genetics 
284  
323  
13.7% 
Seegene 
304  
333  
9.5% 
Horiba 
223  
282  
26.5% 
Randox 
320  
280  
-12.5% 
Eiken Chemical Co. 
243  
272  
11.9% 
Nihon Kohden 
220  
269  
22.3% 
Meridian 
248  
257  
3.6% 
Menarini Diagnostics 
187  
192  
2.7% 
Haemonetics 
131  
168  
28.2% 
Second Tier Total 
9,655  
10,541  
9.2% 
*Note: Public companies 
Source: Kalorama Information 

 
 
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Figure 2-1: Top Tier Market Distribution, 2024 and estimated 2025 (%) 
 
Source: Kalorama InformationThe following is a summary of the top 20 selected second-tier companies. 
Diasorin Group 
The Diasorin Group develops, produces, and markets immunoassay kits and instrumentation 
worldwide.  Diasorin offers a broad range of specialty tests in the immunodiagnostics market 
and new tests in the molecular diagnostics market. Diasorin’s acquisition of Luminex 
strengthened its presence in molecular microbiology. Diasorin maintains a strong presence 
in immunoassays, the core of its global reach.  
Bruker/CALID Group 
Bruker’s microbiology and diagnostics products are part of the company’s CALID group, 
which includes Bruker Daltonics, Bruker Detection, and Bruker Optics Divisions. These 
divisions cover mass spectrometry, chromatography, and life-science automated sampling 
and sample-preparation robots, reagent kits, and other disposable products used to conduct 
tests or assays, as well as bioinformatics software.  

 
 
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Guardant Health 
Guardant Health develops and commercializes liquid biopsy diagnostic tests that utilize the 
company’s proprietary “Digital Sequencing” technology.  The company provides innovative 
products that offer unique IVD testing. 
Myriad Genetics  
Myriad Genetics is a publicly traded personalized medicine company that focuses on the 
discovery, development and commercialization of molecular diagnostic tests for various 
diseases, including cancer, rheumatoid arthritis, and neuropsychiatric disorders.  
The company focuses on six medical specialties - oncology, urology, preventive care, 
dermatology, neuroscience and autoimmune diseases – for which it has developed several 
molecular diagnostics tests that aid patients and medical professionals in diagnosing and 
treating various diseases.  Myriad’s tests are based on its proprietary technologies, which 
include DNA sequencing, RNA expression analysis, and protein analysis.    
Grifols S.A. 
Grifols S.A. offers in vitro diagnostic products for laboratory analyses, including blood 
transfusion testing, blood typing, coagulation, and automatic immunoassay analyzers, as well 
as reagents for hospital blood banks and transfusion centers.   
Diagnostica Stago 
Diagnostica Stago has dedicated all its resources to developing the field of coagulation. With 
more than 350 coagulation products, Stago offers a wide product portfolio through its highly 
effective commercial network.  The companies belonging to the Stago Group are Stago, 
Tcoag, Agro-Bio, BioCytex, Thrombinoscope, Synapse and DSRV.  
Stago's product line extends from routine PT/INR tests to the investigation of highly 
specialized coagulation parameters.   Stago also offers a complete range of analyzers and 
systems designed to meet the requirements of all laboratories that can be integrated into a 
Laboratory Automation System. 

 
 
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BGI Genomics 
BGI, known as the BGI Group and BGI Genomics in the U.S., is a genome sequencing 
company headquartered in Shenzhen, Guangdong, China. BGI’s stated mission is to support 
the development of science and technology, build strong research teams, and promote the 
development of scientific partnerships in the genomics field. 
Sekisui Diagnostics 
Sekisui Diagnostics product lines include clinical chemistry and coagulation systems and 
reagents as well as infectious disease rapid tests, LINE immunoassays and ELISA kits. 
Sekisui Diagnostics is reportedly the leading coagulation vendor in Japan. 
ARKAY 
ARKRAY markets fully automated urine analyzers and sediment analysis systems, as well 
as dry-chemistry analyzers designed for small- to mid-sized laboratories and decentralized 
testing environments. The company has also strengthened its portfolio in HbA1c testing with 
both laboratory-based and point-of-care systems, supporting diabetes management across 
care settings. 
GeneDx 
GeneDx is a genomic diagnostics company focused on translating complex genetic data into 
clinically actionable insights, with a strong emphasis on rare and pediatric diseases. The 
company offers a broad portfolio spanning whole genome sequencing, whole exome 
sequencing, and targeted gene panels, supported by curated variant databases and advanced 
interpretation capabilities.  
Fujirebio 
Fujirebio has more than 50 years of accumulated experience in the IVD industry.  The 
company operates offices in the United States, Europe, Latin America and Asia and markets 
through an international distribution network. Fujirebio has a strong presence in lab-based 
immunoassay markets.  

 
 
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Fulgent Genetics 
Fulgent Genetics developed a proprietary technology platform that enables the company to 
offer a flexible, expandable test menu. The company combines NGS with its technology 
platform to perform full-genome sequencing. 
Seegene 
Seegene has developed a suite of proprietary PCR chemistries designed to enhance 
multiplexing capability, sensitivity, and specificity. These technologies enable simultaneous 
detection and quantification of multiple pathogens within a single reaction, supporting 
efficient and comprehensive molecular diagnostics 
Horiba 
The Horiba Group's Medical Diagnostic Instruments & Systems segment primarily focuses 
on hematology analyzers. The company’s product line includes hematology analyzers, 
equipment for measuring immunological responses, clinical chemistry analyzers, and blood 
sugar measurement systems, but 80% of sales are generated from hematology reagents and 
instruments. 
Randox 
Randox is a privately owned diagnostic reagent and equipment manufacturer.  Established in 
1982, Randox has sales and distribution agreements in 130 countries and international offices 
with representation in the continents of Africa, Asia, Australia, Europe, North America and 
South America.  The company's core products and services are Biochip Array Technology, 
clinical chemistry automation systems, external quality assurance schemes, Internet-driven 
QA systems, quality control materials, antibodies, recombinant proteins, clinical reagents, 
and environmental diagnostics. 
Eiken Chemical Co 
Eiken Chemical Co., LTD was established in 1939 and was the first Japanese company to 
successfully commercialize the manufacture of powdered culture media for microbiological 

 
 
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investigations.  Eiken’s businesses include clinical diagnostics, food and environment and 
animal testing.  Although the Eiken company and its products are not widely known 
internationally, the company is a major player in Japan and across Asia/Pacific. 
Nihon Kohden 
Nihon Kohden is a multi-faceted company that is one of Japan’s leading suppliers of medical 
technology Nihon Kohden’s expertise is in hematology.  
Meridian 
Meridian Bioscience is a fully integrated life science company that manufactures, markets 
and distributes a broad range of diagnostic test kits, purified reagents and related products 
and offers biopharmaceutical enabling technologies.  Meridian has strong market positions 
in the areas of gastrointestinal and upper respiratory infections, serology, parasitology and 
fungal disease diagnosis.  
In addition, Meridian is a supplier of rare reagents, specialty biologicals and related 
technologies used by biopharmaceutical companies engaged in research for new drugs and 
vaccines. The company markets its products and technologies to hospitals, reference 
laboratories, research centers, veterinary testing centers, diagnostics manufacturers and 
biotech companies in more than 60 countries around the world.  
Menarini Diagnostics 
Menarini Diagnostics S.r.l focuses on cell pathology, diabetes, autoimmunity, hemoglobin 
analysis and other lab-based tests. Menarini Diagnostics has a worldwide network of 
subsidiaries in Austria, Belgium, France, Germany, Greece, Italy, the Netherlands, Portugal, 
Spain, and the United Kingdom.  The product line includes: glucose self-testing and 
laboratory systems, clinical chemistry (dry, wet, and urinalysis), hematology (blood typing, 
ESR, cell counting), cell pathology, and autoimmune immunoassays. 

 
 
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Haemonetics 
Haemonetics is a provider of blood and plasma supplies and services. It solutions include 
meeting the needs of critical care patients; full scope of plasma collection technologies and 
products to collect blood components.  
 
 

 
 
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IVD Companies Mergers & Acquisitions 
Merger and acquisition activity in the IVD industry accelerated in 2025 and continues into 
the first half of 2026, reflecting a sustained effort to build broader technology portfolios, 
expand market access, and strengthen competitive positioning. The industry increasingly 
depends on integrating multiple technologies, including molecular diagnostics, 
immunoassays, sequencing, and digital tools, making partnerships and acquisitions essential. 
No single company possesses all of the capabilities required to support next-generation 
diagnostics, and companies continue to pursue acquisitions to access new technologies, enter 
adjacent markets, expand product portfolios, and improve operational scale and supply chain 
resilience. 
Recent activity also reflects several structural shifts in the industry. There is a continued 
movement toward decentralized and point-of-care testing, increased investment in flow 
cytometry and cell-based analysis, and strong participation from private equity. Companies 
are actively streamlining portfolios to focus on higher-growth segments, while consolidation 
in areas such as digital PCR has reduced the number of independent platform providers. 
These trends are expected to persist over the next several years as diagnostics become more 
integrated, data-driven, and clinically focused. 
Notable transactions include Werfen’s acquisition of Immucor in 2023, strengthening its 
position in transfusion and transplant diagnostics, and Biosynex’s acquisition of Chembio 
Diagnostics, expanding its presence in rapid and point-of-care testing. Randox acquired 
Cellix to enhance its capabilities in microfluidics and flow cytometry, while Bruker’s 
acquisition of PhenomeX and later ELITech expanded its presence in cellular analysis and 
microbiology. Exact Sciences acquired Resolution Bioscience from Agilent to strengthen its 
oncology testing portfolio, and Roche acquired LumiraDx to expand its point-of-care 
diagnostics capabilities. 
Activity continued through 2024 with acquisitions aimed at expanding molecular, genomic, 
and AI-driven diagnostics. Natera acquired select reproductive health assets from Invitae, 
while Illumina acquired Fluent BioSciences to advance single-cell analysis. Labcorp 
expanded its oncology and genetic testing capabilities through acquisitions of Invitae assets 
and other laboratory services businesses. OraSure acquired Sherlock Biosciences to 
strengthen its molecular testing portfolio, and Roche acquired Poseida Therapeutics to 
expand its presence in cell and gene therapy, reflecting increasing convergence between 
diagnostics and advanced therapeutics. 

 
 
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In 2025 and into 2026, consolidation continued with Bio-Rad’s acquisition of Stilla 
Technologies, reinforcing its position in digital PCR, and QIAGEN’s acquisition of Genoox, 
enhancing bioinformatics and sequencing data interpretation capabilities. One of the most 
significant recent developments is the completion in 2026 of the combination of BD’s 
Biosciences and Diagnostic Solutions business with Waters Corporation, creating a large-
scale life sciences and diagnostics entity with expanded capabilities across flow cytometry, 
analytical technologies, and clinical diagnostics. 
Another major transaction reshaping the competitive landscape is Abbott’s acquisition of 
Exact Sciences, completed in 2026. This deal significantly expands Abbott’s presence in 
cancer screening and precision oncology, adding established products such as Cologuard and 
Oncotype DX, as well as a growing pipeline of liquid biopsy and early cancer detection 
technologies. The acquisition positions Abbott as a major competitor in oncology diagnostics 
and reflects the broader industry shift toward early detection, personalized treatment, and 
longitudinal disease monitoring. 
Mergers and acquisitions remain a crucial growth strategy in the diagnostics industry, 
supporting the transition toward more automated, connected, and clinically integrated testing 
environments. 
The table below details selected mergers and acquisitions from 2023 to 2026 (first half). 
 
 

 
 
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Table 2-5: Selected IVD Mergers and Acquisitions, 2023-2026 (first half) 
Date 
Acquiring Company 
Company Acquired 
Comments 
Apr-26 
Profusa 
PanOmics 
Adds to the core for precision medicine 
Apr-26 
Blackstone and TPG 
Hologic 
 
Mar-26 
Adidtxt 
Ignite Proteomics 
Expands targeted therapies in cancer 
Mar-26 
Axonia Medical 
51% of Dipylon Medical 
Expands Axonia position in molecular diagnostics 
and clinical microbiology market   
Mar-26 
CoaguSense 
DOASENSE 
Expands CoaguSense’s portfolio to include rapid, 
POC testing 
Mar-26 
Agilent Technologies 
Biocare Medical 
IHC antibodies and reagents into Agilent existing 
pathology division 
Mar-26 
Abbott 
Exact Sciences  
Expand Abbott’s oncology business 
Mar-26 
Thermo Fisher 
Clario Holdings 
Adds to clinical research offerings  
Feb-26 
Waters 
BD Biosciences and 
Diagnostic Solution 
Global expansion and expertise in chemistry, 
physics, and biology 
Feb-26 
Devyser 
Cybergene AB  
Strengthens customer offerings 
Feb-26 
Novacyte 
Southern Cross 
Diagnostics 
Allows access to the Australian diagnostic market 
Jan-26 
YD Bio 
EG BioMed 
Integration of advanced analytics and clinical 
execution 
Jan-26 
Genomate 
Oncompass Medicine 
Global expansion in Europe 
Dec-25 
Natera 
Foresight Diagnostics 
Reinforces Natera in precision oncology 
Nov-25 
QIAGEN 
Parse Biosciences 
Adds to growth in sample-to-answer and high-end 
molecular omics platform 
Oct-25 
Warburg Pincus 
Sebia 
Pinus will have a large minority stake 
Oct-25 
Tokuyama Corp 
JSR IVD business 
Expanded footprint of the new company 
Oct-25 
Blackstone Group 
Hologic (diagnostics 
and women’s health 
imaging) 
Private equity interest and integration of imaging 
and assay businesses under one ownership 

 
 
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Date 
Acquiring Company 
Company Acquired 
Comments 
Sept-25 
Labcorp 
Certain assets from 
BioReference Health 
Expands Labcorp’s diagnostic and oncology 
portfolio 
Aug-25 
Sonic Healthcare USA 
Cairo Diagnostics 
Expands Sonic’s footprint in oncology testing 
Aug-25 
Tempus AI 
Paige 
Advances Tempus AI’s position in precision 
oncology 
Aug-25 
MDxHealth 
Exosome Diagnostics 
Enhances MDxHealth’s precision diagnostics in 
urologic cancers 
Jul-25 
QuidelOrtho 
LEX Diagnostics 
Change in company direction – Savanna MDx 
system discontinuation 
Jul-25 
Waters 
BD Biosciences DX 
business 
Expand clinical footprint for Waters Pending 
Jun-25 
Fujirebio 
Plasma Service Group 
Strengthen IVD capabilities 
Jun-25 
bioMérieux 
Day Zero Diagnostics 
Facilitate growth in NGS infectious disease 
diagnostics 
Jun-25 
Bruker 
Biocrates 
Boost MS-based quantitative metabolomics 
May-25 
Mapmygenome 
Microbiome Insights 
Boosting global expansion 
May-25 
Castle Biosciences 
Previse 
GI expanded offerings 
Apr-25 
Eurofins 
SYNLAB 
Becomes the leading clinical diagnostic operator in 
Spain 
Apr-25 
QIAGEN 
Genoox 
Software analysis 
Apr-25 
GeneDx 
Fabric Genomics 
Additional screening opportunities 
Apr-25 
Source BioScience 
Cambridge Clinical Labs 
Increases the company's clinical diagnostics 
portfolio 
Mar-25 
Duomed Belgium NV 
Launch Diagnostics 
(Avacta Therapeutics) 
Expanding test unit 
Mar-25 
NeoGenomics 
Pathline 
Increase penetration rates in California, Florida, 
and Texas to support oncologists 
Mar-25 
Angsana Molecular & 
Diagnostics Laboratory  
Pathonova Laboratories 
Merged to form a new company – Archerfish 
Feb-25 
Bio-Rad 
Stilla Technologies 
Complement existing digital PCR portfolio 

 
 
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Date 
Acquiring Company 
Company Acquired 
Comments 
Jan-25 
bioMérieux 
SpinChip 
POC expansion 
Dec-24 
Labcorp 
Lenexa 
Increase pathology assets 
Dec-24 
OraSure 
Sherlock 
Biotechnologies 
Expands diagnostic testing unit 
Nov-24 
Roche 
Poseida 
Increase footprint 
Oct-24 
Trinity Biotech 
EpiCapture 
Entrance to oncology space 
Sept-24 
Trinity Biotech 
Metabolomics 
Diagnostics 
Increase presence in maternal health 
Sept-24 
Labcorp 
Balland Health Lab 
Services 
Improvement of overall patient experience 
Aug-24 
Labcorp 
Invitae assets 
Add depth to Labcorp offerings in genetic testing 
for oncology 
Jul-24 
Roche 
LumiraDx POC 
Complement POC technology 
Jul-24 
Thermo Fisher 
Olink 
Proteonomic focus 
Jul-24 
Illumina 
Fluent BioSciences 
Single cell technology 
Jul-24 
Quest Diagnostics 
LifeLabs (OMERS) 
Enhance diagnostic services for Canadians 
Jun-24 
Quest Diagnostics 
Allina Health  
Lab assets  
Jun-24 
Quest Diagnostics 
PathAI Diagnostics Lab 
Accelerate adoption of AI and digital pathology 
May-24 
Bruker 
NanoString 
Adds to Bruker’s existing spatial biology portfolio 
May-24 
Bruker 
ELITech 
Complement to MALDI BioTyper platform 
Apr-24 
Maverix Medical 
Cirrus Bio 
Plans to develop lung cancer diagnostics 
Jan-24 
Hera Biotech 
Scailyte 
Tissue-based diagnostics for endometriosis 
Jan-24 
Myriad Genetics 
Intermountain 
Precision Genomics 
Acquired lab  
Jan-24 
Natera 
Invitae  
Reproductive assets 
Dec-23 
Biosynex 
Theradiag  
POC growth 

 
 
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Date 
Acquiring Company 
Company Acquired 
Comments 
Dec-23 
PerkinElmer 
Covaris 
Increase life science offerings 
Dec-23 
Imaware 
Binx Health  
At-home consumer business 
Dec-23 
Bruker 
Phasefocus 
Optical cell analysis 
Dec-23 
Roche 
LumiraDx 
Acquire POC technology 
Oct-23 
Bruker 
PhenomeX 
Entry into single cell solutions 
Sept-23 
Abbott 
Bigfoot Biomedical 
Expands diabetes care for its FreeStyle Libre 
Sep-23 
LabGenomics USA 
QSx Pathoogy 
Strengthen diagnostic test offerings 
Sep-23 
Exact Sciences 
Agilent’s Resolution 
Bioscience 
Advance Exact’s precision oncology portfolio 
Aug-23 
Sunbird Bio 
Glympse Bio 
Development of protein-based diagnostic for 
neurological diseases and cancer 
Jul-23 
EDP Biotech 
New Day Diagnostics 
Companies to merge  
Jul-23 
Fortis Life Sciences 
International Point of 
Care 
Enables Fortis to provide customizable support for 
customers 
Jun-23 
Biosynex 
ProciseDx! 
Increases footprint in the United States 
Jun-23 
Avacta 
Coris Bioconcept 
Provides professional use rapid test produce 
portfolio 
Jun-23 
Bio-Techne 
Spatial Biology  
Access to Lunaphore technology 
Jun-23 
Quest Diagnostics 
Haystack Oncology 
Adds sensitive MRD liquid biopsy technology 
Jun-23 
Randox 
Cellix Ltd 
Broadens flow cytometry for Randox 
May-23 
MedGenome 
Prognosis Laboratories 
Expands market presence 
May-23 
Freenome 
Oncimmune 
Access to EarlyCDT Lung blood test 
May-23 
Nuclein 
Minute Molecular 
Diagnostics 
Merger 
Apr-23 
Pfizer 
Lucira Health 
At-home diagnostics 
Apr-23 
Quest 
NY Presbyterian Lab 
Enlarge footprint 

 
 
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Date 
Acquiring Company 
Company Acquired 
Comments 
Apr-23 
Biosynex 
Chembio Dx 
Adds to complementary portfolio 
Mar-23 
Quest 
Northern Light Lab 
Access to advanced testing 
Mar-23 
Werfen 
Immucor 
Allows expansion of Werfen’s specialized 
diagnostics 
Feb-23 
Sherlock BioSciences 
Sense Bioscience 
Provide attachments in forensic science 
Feb-23 
SD Biosensor 
Meridian 
Meridian will continue to operate independently 
under new ownership 
Jan-23 
QIAGEN 
Verogen 
Provide advancements in forensic science 
Source: Kalorama Information  
 
 

 
 
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Collaboration, Partnership, Alliance Agreements 
Almost daily, there is news of a new partnership or collaboration. Research indicated that 
there were several new collaborations, partnerships and alliances in 2024, 2025 and 
continuing into 2026. Examples of selected collaborations, partnerships and alliances from 
the companies include: 
• In January 2024, Agilent signed an agreement with Incyte for the development of 
companion diagnostics for Incyte’s hematology and oncology portfolio. 
• In January 2024, Predicine entered into a collaboration with Janssen to develop a 
urine-based assay as a companion diagnostic to identify patients with bladder cancer 
that would benefit from targeted therapies.  
• In February 2024, Becton Dickinson partnered with Camtech Health Partner to 
increase cervical cancer screening in Singapore.  
• In February 2024, BioMark Diagnostics and Rubics LS signed a partnership to 
develop liquid biopsy cancer screening for underserved communities.  
• In February 2024, Standard BioTools and Next Gen Diagnostics announced a 
partnership to provide complete automation of sample preparation for pathogen 
whole genome sequencing.  
• In April 2024,  Predicine partnered with Apollomics to develop a NSCLC liquid 
biopsy assay.  
• In June 2024, Myriad Genetics entered into a collaboration with GSK for the 
development of an ovarian cancer testing program.  
• In June 2024, Foundation Medicine partnered with Repare Therapeutics to develop 
CDx for lunresertib.  
• In June 2024, DiaCarta entered into a collaboration with Capstone Health Alliance to 
provide precision diagnostics using liquid biopsy in cancer and infectious diseases.   
• In July 2024, MGI Tech and  Predica Diagnostics entered into a partnership to 
develop RNA-based cancer screening tests.  
• In July 2024, Labcorp and Ultima Genomics are collaborating on a NGS cancer test.  
• In July 2024, BD and Quest entered into a collaboration on development of flow 
cytometry-based companion diagnostics for cancer.  

 
 
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• In July 2024, MGI Tech and Predica Diagnostics entered into a partnership to develop 
RNA-based cancer screening tests.  
• In July 2024, Labcorp and Ultima Genomics are collaborating on an NGS cancer test.  
• In August 2024, Detect-Ion entered into a partnership with the Moffitt Cancer Center 
to develop a breath-based POC test for the early detection of lung cancer. 
• In August 2024, Foundation Medicine entered into a collaboration with Merus N.V. 
to develop an RNA platform as a companion diagnostic for Merus’s biospecific 
antibody zenocutuzumab (Zeno) to treat patients with neuregulin 1 fusion cancer.  
• In September 2024, QIAGEN entered into a collaboration with Eli Lilly to develop 
an assay to detect genotypes that will indicate Alzheimer’s disease risk.  
• In September 2024, Roche entered into a collaboration with Stratipath to integrate the 
Stratipath Breast solution, an AI-based precision diagnostic solution, into Roche’s 
Navify Digital Pathology.  
• In September 2024, A. Menarini Diagnostics and Nucleix entered into a strategic 
partnership for the exclusive marketing of Bladder EpiCheck in Europe. This non-
invasive CE-marked test detects primary or recurrent bladder and upper tract urinary 
cancers. 
• In September 2024, Foundation Medicine entered into a partnership with Syndax 
Pharmaceuticals to develop a companion diagnostic based on the FoundationOne 
Heme platform for a leukemia drug that is under development by Syndax.  
• In September 2024, QIAGEN and Bio-Manguinhos/Fiocruz agreed to collaborate on 
enhancing malaria and dengue detection in Brazil’s national blood screening 
program. Bio-Manguinhos can now launch an advanced PCR-based molecular 
screening platform to detect malaria alongside HIV, hepatitis B, and C virus (HCV 
and HBV), a capability previously unavailable in Brazil’s blood donation program. 
• In October 2024, Trinity Biotech entered into a strategic investment with Novus 
Diagnostics to advance rapid sepsis testing.  This investment will accelerate the 
development and commercialization of Novus’ POC diagnostic solution.  
• In November 2024, Agilent signed a co-marketing agreement with Tagomics. The 
two companies will give customers access to Tagomics and Agilent technologies. 
Tagomics has developed a multiomics platform called Interlace that unlocks disease-
associated DNA biomarkers.  

 
 
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• In November 2024, Dexcom entered into a partnership with OURA to help 
individuals monitor activity and glucose data. The glucose data is collected by Oura 
Ring and will be combined with Dexcom’s glucose data.  
• In December 2024, GeneDx announced it had accepted new partners to its Patient  
Access Program for pediatric epilepsy, which provides access to whole exome 
sequencing.  
• In December 2024, ESYA Labs partnered with Alamar Biosciences to collaborate on 
the detection and quantification of biomarkers for neurological and inflammatory 
diseases using Alamar’s Nulisa platform and Argo HT System. ESYA Labs will be a 
certified service provider for Alamar.  
• In January 2025, Scopio Labs extended its strategic alliance with Siemens 
Healthineers to include the global distribution of Scopio’s Full-Field Bone Marrow 
Aspirate application. The Full-Field Bone Marrow Aspirate is the world’s first digital 
bone marrow aspirate review solution. 
• In January 2025, Revvity entered into a collaboration with Element Biosciences to 
advance DNA and multiomic sequencing solutions. The partnership involves a 
comprehensive IVD solution tailored for newborn sequencing.  The new solution will 
be part of the next step in expanding Element’s AVTI sequencing system and 
Revvity’s newborn sequencing research workflow.  
• In January 2025, the upstart AlterDiag, based in France, partnered with the Institut 
Pasteur to develop rapid diagnostics for infectious diseases. The companies plan to 
utilize single-domain antibodies in conjunction with immunochromatography to 
detect pathogens. Since its inception in July 2024, AlterDiag has raised over €2 
million in seed funding for the project.  
• In February 2025, Flatiron Health and Exact Sciences entered into a partnership to 
advance Exact Sciences’ molecular residual disease test, Oncodetect.  
• In February 2025, Siemens Healthineers signed an agreement with ABL that will 
allow ABL to manufacture and commercialize Siemens Healthineers’ PCR testing 
product technologies. The agreement involves intellectual property from the defunct 
Fast Track Diagnostics, which Siemens acquired and closed in 2024. 
• In February 2025, Foundation Medicine announced that it would launch hereditary 
germline tests in the United States in partnership with Fulgent Genetics. These tests, 

 
 
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offered through a partnership with Fulgent, are next-generation sequencing tests that 
analyze 50 genes associated with hereditary cancers.  
• In February 2025, Foundation Medicine entered into a collaboration with Sumitomo 
Pharma America (SMPA) to develop a companion diagnostic to identify acute 
leukemia patients who may be eligible for treatment with SMPA’s Menin inhibitor 
enzomenib (DSP-5336). The collaboration will utilize Foundation One’s Heme 
platform to identify patients with JMT2A rearrangements or NPM1 mutations who 
may benefit from enzomenib.  
• In February 2025, Renovaro Biosciences agreed to partner with BioSymetrics. The 
partnership is designed to enhance Renovaro's precision medicine solutions for cancer 
and other critical disease areas through BioSymetrics’ proprietary Elion platform, an 
AI and machine-learning engine.  
• In February 2025, DiaCarta and OncoAssure established a collaboration to launch 
OncoAssure’s prostate test, designed to identify patients with a lower risk of prostate 
cancer recurrence.  
• In February 2025, Imagene entered into a collaboration with Tempus AI to advance 
AI-driven diagnostics for NSCLC. The partnership is designed to advance cancer 
diagnostics by accelerating biomarker prediction and integrating AI-powered tools.  
• In March 2025, Mainz Biomed entered into an agreement with Liquid Biosciences to 
access a portfolio of mRNA biomarkers for the detection of pancreatic cancer. Mainz 
Biomed will have the rights to develop a test using Liquid Biosciences’ biomarkers. 
The companies plan to develop this blood-based test for potential future FDA 
applications. Liquid Biosciences developed the Emerge platform to identify a panel 
of clinically relevant mRNA biomarkers   
• In March 2025, T-NeuroDx entered into a collaboration with Beckman Coulter to 
develop diagnostics for neurodegenerative diseases, including Alzheimer’s disease. 
The companies will share knowledge on biomarker research for the detection of early 
Alzheimer’s disease.  The partnership combines T-Neuro-Dx’s research in 
Alzheimer’s disease with Beckman Coulter’s expertise in flow cytometry.  
• In April 2025, AccuStem Sciences announced that it was partnering with EmeritusDX 
to commercialize the MSC test for lung cancer screening. The collaboration will 
likely enhance the accuracy of lung nodule stratification. The MSC test analyzes 24 
microRNAs to distinguish high-risk from low-risk cases, saving time and potentially 

 
 
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minimizing unnecessary procedures.  The launch date for the MSC test is expected to 
be in 2026.  
• In April 2025, Grifols entered into a partnership with IBL International to develop 
advanced biomarker panels for neurological and oncological conditions. Grifols' 
technology can detect disease signals in the early stages.  
• In June 2025, QIAGEN entered into a collaboration with Incyte to develop 
companion diagnostics for patients with mutant CALR-expressing myeloproliferative 
neoplasms (MPN). QIAGEN will develop a multimodal panel using NGS technology 
and the Illumina NextSeq 550Dx platform. 
• In June 2025, QIAGEN entered into a partnership with Gencurix for the development 
of oncology assays for use on the QIAcuityDx platform.  
• In June 2025, QIAGEN entered into a partnership with two companies – Tracer 
Biotechnologies to develop blood-based MRD tests on the QIAcuity platform and 
Foresight Diagnostics to develop a kit version of its Clarity NGS assay for us in 
lymphoma. 
• In July 2025, Viome and Scripps partnered to develop the first at-home RNA test 
designed to detect precancerous colon polyps. 
• In July 2025, Personalis and Tempus AI expanded their collaboration, adding a new 
indication, colorectal cancer, to the existing agreement. Personalis and Tempus AI 
will collaborate to bring NeXT Personal, an ultra-sensitive, tumor-informed MRD 
test, to detect cancer recurrence across four areas: breast, lung, colorectal, and solid 
tumor immunotherapy monitoring.  
• In August 2025, Exact Sciences and Humana expand their partnership for the 
Cologuard Plus Test. This partnership will provide Cologuard Plus for in-network 
Medicare Advantage members.  
• Additionally, in August 2025, Exact Sciences entered into a collaboration with 
Freenome to develop certain blood-based screening and diagnostic products for 
colorectal cancer.  
• In August 2025, Siemens Healthineers partnered with Carna Health to accelerate the 
adoption of Carna’s AI-enabled chronic kidney disease platform. The agreement will 
improve early detection and CKD management for high-risk and underserved 
populations.  

 
 
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• In September 2025, AccuStem Sciences entered into a partnership with EmeritusDX 
to expand its blood-based testing capabilities. The two companies are building out 
their product portfolios to meet the demand for cancer diagnostics and treatment 
planning.  This expansion will include installing AccuStem’s Promega Maxwell RSC 
System at EmeritusDX, enabling consistent microRNA extraction from blood 
samples.  
• In September 2025, Myriad Genetics entered into a collaboration with SOPHiA 
Genetics to develop a global liquid biopsy companion diagnostic test. The partnership 
will use Myriad’s advanced laboratory capabilities to support global testing for 
clinical trials and SOPHIiA’s decentralized network. 
• In October 2025, Revvity announced that it had entered into a partnership with Sanofi 
to develop a T1D 4-plex IVD assay based on its 3-plex assay. Early detection of T1D 
enables options for patients and caregivers to improve outcomes through intervention 
to prevent diabetic ketoacidosis.  
• In October 2025, Bluejay Diagnostics entered into an extended agreement with 
SanyoSeiko to expand its partnership in advancing the Symphony Platform, a near-
patient testing system designed to provide rapid results for key biomarkers such as 
IL-6 in sepsis management.  
• In October 2025, Bio-Rad extended its partnership with Gencurix. Gencurix will 
leverage Bio-Rad’s established network and clinical diagnostics experience to expand 
its Droplex oncology testing kits, which are built on Bio-Rad’s ddPCR technology 
and designed for use with Bio-Rad’s QXDx ddPCR Systems.  
• In October 2025, GRAIL and Samsung entered into a collaboration to provide 
GRAIL’s multicancer early detection test to key Asian markets such as South Korea, 
Japan and Singapore.  
• In October 2025, SOPHiA Genetics and A.D.A.M. Innovations entered into an 
agreement to collaborate on bringing liquid biopsy genomic testing to Japan. The 
partnership will focus on launching liquid biopsy – MSK-ACCESS powered with 
SOPHiA DDM. The test is designed to detect actionable genomic alterations and 
analyze ctDNA.  
• In November 2025, SOPHiA Genetics entered into a collaboration with Element 
Biosciences to integrate SOPHiA's AI-powered analytics platform, SOPHiA DDM, 

 
 
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with Element’s AVITI24 5D multi-omic and AVITI sequencing systems to provide 
an NGS workflow.  
• In November 2025, Roche and Freenome cemented a $200 million licensing and 
commercialization deal for Freenome’s cancer screening tests. Freenome will 
evaluate Roche’s upcoming Sequencing by Expansion (SBX) technology for future 
development applications.  
• In January 2026, Arima Genomics entered into a partnership with Fox Chase Cancer 
Center to advance 3D genome diagnostics for cancer care. The partnership will help 
physicians identify genomic changes that can affect the diagnosis and treatment of 
cancers.  
• In January 2026, Daisy Genomics and New Day Diagnostics entered into a 
partnership to advance the development of CRC tests. This partnership will also 
include the University of Tennessee. The collaboration will utilize New Day’s CRC 
liquid biopsy technology and Daisy Genomics sequencing platform.  
• In January 2026, InterVenn Biosciences entered into a partnership with Aranscia to 
facilitate the commercialization of GlycoKnow, a proprietary blood-based liquid 
biopsy test that distinguishes ovarian cancer from a benign pelvic mass.  
• In January 2026, Mirxes entered into a partnership with N Health to introduce Mirxes’ 
advanced microRNA screening solutions to N Health’s 60 hospitals across Thailand. 
This announcement comes on the heels of Mirxes' approval of FITRapid and 
HELICORapid tests for at-home testing.  
• In January 2026, Guardant Health entered into a multi-year collaboration with Merck 
to develop companion diagnostics using Guardant’s Infinity Smart platform.  
• In February 2026, Targeted Genomics entered into a collaboration with  Pathology 
Reference Laboratory to distribute the  GlutenID test and celiac genetic testing 
services to Texas physicians. The testing service, CeliacDx, allows physicians to 
order a saliva-based GlutenID test for patients to rule out celiac disease. Additionally, 
consumers can purchase GlutenID 
•  In February 2026, Watchmaker Genomics and Visby Medical entered into a 
collaboration to develop next-generation diagnostic tests for respiratory pathogen 
detection in the at-home setting. This collaboration will combine Visby Medical’s 
instrument-free PCR testing technology with Watchmaker’s expertise in engineering 
enzymes to address performance gaps.  

 
 
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• In February 2026, PacBio entered into a collaboration with iHope to integrate 
PacBio’s HiFi long-read whole-genome sequencing into iHope’s network. iHope 
supports over 1,000 patients in its network and is the largest rare-disease genomic 
testing network. By adding PacBio’s HiFi long-read whole-genome sequencing, the 
company will help to expand the range of genomic insights supporting iHope’s 
network and strengthen its ability to interrogate challenging regions of the genome.  
• In March 2026, C2N Diagnostics signed an agreement with BeauBrain Healthcare to 
provide PrecivityAD2, a breakthrough diagnostic test for Alzheimer’s disease, to 
South Korea. The test, PrecivityAD 2, is an innovative blood test that helps detect 
amyloid plaques in the brain. The agreement will allow physicians in South Korea to 
provide access to C2N’s blood test intended for use in patients with signs or 
symptoms of mild cognitive impairment or dementia, which is a pathological 
hallmark of Alzheimer’s disease.  
• In March 2026, MicrosensDx announced a partnership with ProteoGenix to advance 
novel biomarker tests for sepsis. MicrosensDx is developing a rapid, reliable 
diagnostic test for sepsis that will combine ProteoGenix’s design solution, which 
combines high-throughput single B-cell screening, enabling identification of rare and 
highly specific binders, with a targeted approach designed to engage a defined region 
of the protein.  
• In March 2026, Discovery Life Sciences entered into a partnership with Mindpeak, 
an AI-powered digital pathology. The partnership will aid in biopharma R&D and 
clinical research by improving biomarker quantification.  
• In March 2026, Diasorin signed an agreement with McKesson Medical Surgical to 
expand the distribution of the LIAISON NES molecular POC platform. This 
agreement will support the commercialization of the LIAISON NES platform and its 
first FDA-cleared assay, the Flu A/B. RSV, and COVID-19 Panel.  
• In April 2026, CellCarta  and Pillar Biosciences entered into a partnership to expand 
rapid, decentralized tumor profiling for oncology. The collaboration will focus on 
producing relevant tumor profiling and combining Pillar’s portfolio of oncoReveal 
NGS-based kitted panels with CellCarta’s expertise.  
• In April 2026, Leica Biosystems entered into a collaboration with CellCarta to 
combine their expertise, accelerating precision diagnostics in China. The 
collaboration will start in China and expand globally.  Under this agreement, Leica 

 
 
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and CellCarta will combine their expertise to offer biopharmaceutical companies 
access to companion diagnostics.  
 
 

 
 
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Test Services 
The test service model has become a major route for highly sophisticated and specialized 
tests. The most successful company-owned test services involve anatomical pathology 
(histology/cytology) and molecular assays, primarily in situ hybridization (ISH) and PCR 
analysis of biopsied tissue for cancer analysis. 
The company-owned test service business model is primarily a U.S. phenomenon, with a 
long history of commercializing highly specific assays as test services.  U.S. reference labs 
were the first to introduce many groundbreaking tests in viral load testing, anatomical 
pathology, special analyses, and molecular assays.  This sensitized the medical community 
to the value of these test services.  The first generation of these tests targeted small markets 
where the financial investment for FDA market clearance – especially the PMA route that 
would have been required for these unique tests – would have been difficult to recuperate 
with a commercial test kit. 
Test services remain one of the fastest-growing segments of the IVD market, far outpacing 
any other in the IVD industry.  
Figure 2-2: Clinical Laboratory Test Service Market Forecasted Growth, by Segment, 2024-2029 (%) 
 
Source: Kalorama Information 

 
 
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For further test services information, please see Kalorama Information’s The Worldwide 
Market for Clinical Laboratory Services 10th Edition 
Hospital-based labs perform tests for hospitalized patients, patients seen in hospital 
emergency rooms and clinics, and sometimes serve as a reference lab for other 
hospitals.  Independent (reference) labs are situated outside a hospital, and they perform tests 
on samples sent to them from physician offices, clinics and hospitals.  The term POL is used 
in this report as a catch-all for tests performed in physician office labs, clinics, community 
health centers, retail clinic sites, and other settings. 
The largest portion of the global market for clinical lab services is held by hospital-based 
labs. The global market for clinical laboratory services is estimated at $159.2 billion in 2024 
and is projected to reach $197.1 billion in 2029.  Market segmentation in 2024 is presented 
in the table below. 
Table 2-6: Global Lab Market Segmentation, 2024 ($ billion) 
 
[Hospital and Acute Care Labs, Independent Labs, Physician Office Labs] 
Segment 
Revenues 
% Mkt 
Hospital and Acute Care Labs 
94.9 
60% 
Independent Labs 
56.6 
35% 
Physician Office Labs 
7.7 
5% 
Total 
159.2 
100% 
Source: Kalorama Information 
The clinical laboratory test services market in the United States was worth roughly $86.4 
billion in 2024. Most major independent clinical laboratories have reported an annual 
increase in laboratory test volumes in both routine and specialty segments.   
A trend toward preventive and risk-factor testing has been noted across several disciplines, 
particularly in oncology, endocrinology, and gynecology.  Physicians in these areas are 
taking full advantage of testing for early detection and disease prevention.   

 
 
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New technologies in testing will likely continue to fuel growth, alongside an aging 
population, rising disease incidence and prevalence, a focus on prevention and early 
detection, and emerging trends in personalized medicine.  Some key areas of growth include 
genomic and esoteric testing, anatomic pathology, and specialized testing in oncology and 
infectious disease.  The market for COVID-19 is expected to continue to slow.  It is likely to 
have a presence in the market, however. 
Quest Diagnostics is a pioneer, innovator and leading provider of diagnostic testing services 
through its network of laboratories and patient service centers and provides interpretive 
consultation through its extensive medical and scientific staff.  Quest’s diagnostic testing 
services range from routine tests such as cholesterol panels, Pap testing and white blood cell 
counts to sophisticated cancer testing, gene-based and molecular testing. 
Quest has developed a network of labs and collaborators worldwide.  Quest’s Nichols 
Institute performs specialized testing for hospitals and laboratories in the Americas, Europe, 
Asia and Australia.  Quest also has operations in Brazil, India, Ireland, Mexico, Puerto Rico, 
and the United Kingdom. 
Quest also provides a broad range of solutions for employers, including workplace drug 
testing for employers and government agencies; the Blueprint for Wellness employee 
wellness service; and risk assessment services for the life insurance industry 
Quest Diagnostics Health Trends reports examine disease trends using the company’s United 
States database. Quest Diagnostics Drug Testing Index reports examine trends in workplace 
drug testing and have been considered a benchmark for U.S. workforce drug positivity trends 
since 1988. 
Quest offers a wide range of tests in the U.S. through a national network of 2,400 patient 
service centers. Most of Quest’s services are provided in the U.S. The company provides 
services to approximately one-third of all U.S. adults, half of all U.S. hospitals and half of all 
physicians.  
The core of Quest Diagnostics’ business is rooted in routine and pathology tests. However, 
gene-based and esoteric testing services are helping to drive revenues.  Along with its main 
competitor, Labcorp. Quest is a major supplier of cancer histology and pharmacodiagnostic 
tests to physicians and hospital labs. 

 
 
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Labcorp is the largest private laboratory worldwide, and a pioneer in commercializing new 
diagnostic technologies.  It was the first in its industry to offer genomic testing. The company 
employed nearly 70,000 people and performed more than 700 million tests for patients 
globally in 2024. As one of the largest clinical laboratories, Labcorp operates nearly 2,200 
PSCs. Additionally, the company offers services through a number of network branches and 
STAT laboratories.  
Physicians using Labcorp's services for patient testing are among the main sources of the 
company’s revenue. Revenues are paid directly by physicians, patients, insurance providers, 
and Medicare or Medicaid.  
In March 2025, Labcorp acquired select assets of OPKO BioReference Health’s oncology 
clinical testing services business. Through this acquisition, patients will gain greater access 
to Labcorp's oncology offerings.  
Table 2-7: Total Revenues for Leading U.S.-based Reference Labs, 2023-2025 ($ million) 
Company 
2023 
2024 
2025 
Labcorp 
12,162 
13,009 
13,950 
Quest Diagnostics 
9,252 
9,872 
11,035 
Bio-Reference Lab/OPKO 
515 
481 
370 
Source: Kalorama Information, company reports 
POLs are primarily a U.S. phenomenon and are also common in Europe.  Strict regulations 
on the quality control of tests performed have decreased the number of physician offices that 
perform tests, and most of these POLs can perform only a short list of CLIA-waived 
tests.  According to CLIA statistics, there are approximately 133,062 in-office labs in the 
U.S.  The tests most commonly performed in POLs are for disease screening, including 
diagnosis of common infectious diseases such as strep A, flu, mononucleosis, H. pylori, and 
RSV, as well as routine monitoring tests for patients with common chronic diseases such as 
diabetes and cardiovascular risk. 
The most lucrative tests for labs are those that are unique and proprietary to the lab that 
developed them.  These are generally known as lab-developed tests (LDTs).  These tests are 

 
 
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usually low-volume and address very specific medical problems, such as viral load 
monitoring and cancer management.  These tests are offered in CLIA, or CAP (College of 
American Pathologists) certified laboratories operated by independent laboratory services 
companies, hospital labs, or by the actual test manufacturer.  The past few years have seen a 
literal explosion of these tests in the market.  
The test service model is becoming a major route for highly sophisticated and specialized 
molecular and personalized medicine tests.  The most successful company-owned test 
services involve anatomical pathology (histology/cytology), sequencing studies, and 
molecular assays, primarily in situ hybridization (ISH) and PCR analysis of biopsied tissue. 
 
 

 
 
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Historical IVD Market vs Today 
The evolution of the IVD industry can be viewed through a traditional product development 
lens, moving from introduction to rapid growth and into maturity, although in reality the 
industry continues to cycle through new growth phases driven by technological innovation. 
Prior to the 1970s, laboratory medicine consisted of a relatively limited number of tests, 
largely performed manually using basic tools such as test tubes, microscopes, and early 
spectrophotometers. The 1970s marked a major technological shift with the introduction of 
radioimmunoassays, immunoelectrophoresis, and early clinical chromatography methods, 
laying the foundation for modern diagnostics. In the 1980s, the emergence of enzyme 
immunoassays and the first generation of automated chemistry and immunoassay analyzers 
significantly expanded laboratory capacity and efficiency. Around the same time, PCR was 
introduced, and although it did not replace immunoassay-based testing, it established the 
foundation for molecular diagnostics, which would later become a major growth driver in 
areas such as infectious disease, oncology, and genetic testing. Through the 1990s and 2000s, 
advances in molecular biology, proteomics, and genomics, including the sequencing of the 
human genome, further expanded the diagnostic test menu and clinical applications. 
The IVD industry reflects both maturity and renewal. It continues to attract investment, 
consolidation, and participation from large global players, while also facing ongoing pressure 
from reimbursement constraints and the need to demonstrate positive clinical and economic 
value. Growth is increasingly tied to the development of medically actionable tests, 
integration with digital and informatics platforms, and the ability to offer value-based 
healthcare models. In addition, the industry is being reshaped by the continued shift toward 
decentralized testing across point-of-care and at-home settings, the expansion of multiplex 
and syndromic assays that improve clinical efficiency, deeper integration of informatics and 
connectivity solutions that link diagnostic results to clinical decision-making, and the 
growing role of companion diagnostics in precision medicine, particularly in oncology. 
Ongoing consolidation and strategic partnerships, combined with innovation from smaller 
and specialized companies in areas such as liquid biopsy, sequencing, and AI-enabled 
diagnostics, are further accelerating this transformation and reinforcing the expanding role 
of clinical diagnostics in  healthcare. 

 
 
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In the Beginning to Now 
Over the past two decades, Kalorama has closely monitored the evolution of the  IVD 
industry, witnessing significant shifts in technology and market composition. In the 1990s, 
the IVD market was largely dominated by routine chemistries and immunoassays, which 
together accounted for approximately 58% of total market sales. By 2000, this share had 
declined to around 50%, and as of 2025, these core segments represent only about 32% of 
the market. This decline reflects the industry's transition toward more advanced diagnostic 
modalities, particularly molecular diagnostics and POC testing. Molecular diagnostics, once 
nearly absent in clinical settings two decades ago, now constitute approximately 22% of the 
market, with growth significantly accelerated by the COVID-19 pandemic and the associated 
demand for rapid POC molecular testing. The industry has also embraced smaller-footprint 
testing systems and genomic data to enable more precise disease detection and management.  
This chart shows the percentage change in each category over time from 2000 to today.  
Figure 2-3: Share of Global IVD Market, by Segment, 2000 and 2025 Compared (%) 
 
[Blood Banking (imm & typing); Clinical Chemistry; Coagulation; Hematology; Immunoassays; 
Microbiology [ID/AST]; Molecular; POC – Other; Histology/Cytology; POC Diabetes; Others] 
 
Source: Kalorama Information 

 
 
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Future 
As indicated in prior editions, the future of the IVD industry remains both promising and 
somewhat unpredictable. The COVID-19 pandemic introduced significant disruption across 
healthcare, including diagnostics, but it also accelerated innovation and the adoption of new 
technologies. The rapid implementation of molecular diagnostic platforms during the 
pandemic expanded the installed base and helped integrate molecular testing into routine 
clinical workflows, particularly in decentralized and point-of-care settings. While pandemic-
driven testing volumes have declined, the broader use of molecular systems continues to 
support market growth as test menus expand into infectious disease, oncology, and other 
applications.  
Prior to COVID-19, limited system penetration constrained growth, but this barrier has 
largely been reduced, enabling further technological advancement. Key developments 
shaping the future of IVD include the growing convergence of diagnostics with information 
technology, where artificial intelligence and data-driven tools are increasingly used to 
enhance workflow efficiency, result interpretation, and clinical decision-making. Molecular 
testing in physician office laboratories and near-patient settings continues to expand, 
particularly for respiratory and syndromic testing, although adoption is influenced by cost 
and reimbursement considerations. The direct-to-consumer and at-home testing segments 
have established a lasting presence, with continued growth driven by consumer demand for 
convenience and increased comfort with self-testing. Wearable glucose monitoring devices 
with real-time connectivity have become standard in many developed markets and are 
expanding into broader patient populations and geographies. In addition, home-based sample 
collection, including HPV testing, is gaining traction as regulatory acceptance increases, 
further supporting the shift toward more decentralized models of care. 
Next-Generation Sequencing 
Next-generation sequencing represents a powerful platform that enables the parallel 
sequencing of millions to billions of DNA fragments, supporting comprehensive analysis of 
genetic variation across the genome. It has become a key driver of advances in personalized 
medicine, genetic disease testing, and clinical diagnostics. Compared to earlier sequencing 
methods, NGS offers improved scalability, higher throughput, and lower cost per base, 
making it a foundational technology in modern molecular testing, although costs and 
turnaround times can still vary by application and setting. 

 
 
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The most widely adopted clinical NGS technologies are provided by Illumina and Thermo 
Fisher Scientific, with additional competition emerging from newer platform developers. 
Thermo Fisher continues to advance its Ion Torrent–based semiconductor sequencing 
technology, centered on platforms such as the Ion GeneStudio S5 series, which are designed 
for targeted sequencing applications in clinical and translational settings. These systems 
detect nucleotide incorporation through pH changes generated during DNA synthesis, 
eliminating the need for optical detection. Illumina remains the leading provider of 
sequencing-by-synthesis technology, which uses reversible terminator nucleotides and 
optical imaging to generate highly accurate sequence data. Its portfolio spans benchtop 
systems such as MiSeq, MiniSeq, and iSeq 100, as well as mid- to high-throughput platforms 
such as the NextSeq and NovaSeq families, with continued enhancements focused on speed, 
cost efficiency, and broader accessibility. 
Innovation in sequencing platforms has accelerated with the introduction of new systems 
designed to improve performance and reduce cost barriers. Emerging competitors are 
advancing both short-read and long-read sequencing technologies, with long-read platforms 
improving the resolution of structural variation and complex genomic regions. New 
sequencing approaches and chemistries are being developed to enhance accuracy, simplify 
workflows, and expand multiomic applications. Additionally, there is increasing emphasis 
on automation, integrated sample-to-answer workflows, and improved bioinformatics to 
address ongoing challenges in data analysis and interpretation. 
NGS continues to play a critical role in clinical decision-making, particularly in oncology, 
rare disease diagnostics, and infectious disease testing. While North America and Europe 
remain the largest markets, adoption in Asia Pacific has expanded significantly, supported 
by national genomics initiatives, investment in precision medicine, and growing laboratory 
infrastructure. The COVID-19 pandemic accelerated the use of sequencing for pathogen 
surveillance, and NGS remains an essential tool for monitoring viral and emerging infectious 
diseases, with ongoing integration into public health. 
In addition to sequencing platforms, companies such as QIAGEN market supporting 
technologies for NGS workflows, including library preparation, sample processing, and 
bioinformatics solutions. These tools help streamline laboratory operations and improve 
efficiency, supporting broader adoption in both research and clinical environments.                    

 
 
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Cancer Testing (Liquid Biopsy) 
Liquid biopsy is an important component of clinical oncology, enabling noninvasive 
assessment of tumor biology through analysis of circulating tumor DNA, circulating tumor 
cells, and other tumor-derived biomarkers such as extracellular vesicles. The technology 
continues to progress and is now used in advanced cancer care for genomic profiling, therapy 
selection, and disease monitoring, with growing application in minimal residual disease 
detection and early recurrence assessment. Clinical adoption has expanded significantly; this 
is supported by broader reimbursement and guideline inclusion, with comprehensive 
genomic profiling assays such as Guardant360 achieving widespread coverage across 
multiple advanced solid tumors.  
Product development has focused on expanding the clinical utility of liquid biopsy across 
several segments of IVD. Multi-cancer early-detection assays, such as new blood-based 
screening tests that can identify multiple tumor types from a single sample, represent a 
rapidly emerging segment. At the same time, minimal residual disease testing has become 
one of the fastest-growing areas, with highly sensitive personalized assays, including 
NeoGenomics’ RaDaR, designed to detect recurrence at very low levels of circulating tumor 
DNA. Companies such as Guardant Health have expanded their portfolios with blood-based 
screening tests and enhanced monitoring assays, while Exact Sciences has introduced multi-
cancer detection platforms to complement its existing cancer diagnostics portfolio. 
Strategic acquisitions and partnerships continue to strengthen liquid biopsy capabilities 
across the industry. Labcorp expanded its genomic profiling and liquid biopsy offerings 
through the acquisition of Personal Genome Diagnostics, while Myriad Genetics has 
incorporated liquid biopsy into precision medicine workflows through collaborations with 
clinical partners. Technology development continues at the platform level, with Bio-Rad 
offering circulating tumor cell workflows through tools such as Celselect Slides, and 
companies such as OraSure enabling more flexible sample collection through saliva-based 
systems that support certain molecular applications. Additionally, emerging multi-omic 
approaches combine genomic, epigenomic, and protein biomarkers to improve detection 
sensitivity and clinical performance. 

 
 
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Companion Diagnostics 
Companion diagnostics (CDx) have become an essential part of personalized medicine, 
particularly in oncology, where they are used to identify patients most likely to benefit from 
targeted therapies. While the concept of linking diagnostics to treatment decisions has existed 
for decades, the modern CDx market began to take shape in the late 1990s and 2000s with 
the emergence of targeted therapies. Early examples such as trastuzumab and imatinib helped 
establish the clinical and commercial value of aligning diagnostics with therapy selection. 
Since then, the field has expanded significantly beyond oncology into other therapeutic areas, 
although cancer remains the primary driver of CDx development. 
A wide range of technologies is used in companion diagnostics and personalized medicine. 
Traditional PCR-based assays continue to play an important role in detecting specific 
mutations, while more advanced methods such as next-generation sequencing are 
increasingly used for broader genomic profiling. In hereditary cancer testing, single-gene 
analysis has largely been replaced by multigene panels that assess mutations across a wide 
range of clinically relevant genes, reflecting the complexity of cancer risk and tumor biology. 
Tumor characterization also incorporates phenotypic and molecular features; for example, 
microsatellite instability can be assessed using PCR or NGS-based approaches, while 
classifications such as triple-negative breast cancer are determined by protein expression and 
then further evaluated with genomic testing to guide treatment decisions. 
The complexity of hereditary and somatic cancer diagnostics continues to drive the adoption 
of more comprehensive technologies. Multigene panels and NGS-based assays allow 
simultaneous analysis of numerous cancer-associated genes, improving the ability to identify 
actionable mutations. Techniques such as digital PCR and NGS have largely replaced older 
sequencing approaches in many settings, particularly where sensitivity and scalability are 
required. Broad genomic profiling assays, including FoundationOne CDx, have further 
advanced the field by enabling simultaneous assessment of multiple biomarkers across solid 
tumors, supporting more personalized treatment strategies. 
Companion diagnostics continue to evolve alongside targeted therapies, with increasing 
collaboration between diagnostic companies and pharmaceutical developers. Tests such as 
BRACAnalysis CDx are used to identify patients with specific genetic alterations who may 
benefit from targeted treatments, including PARP inhibitors in cancers such as ovarian, 
breast, and prostate. Many more companion diagnostics are listed throughout the report.  

 
 
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Chapter 3: The Global Picture for In Vitro 
Diagnostic Markets 
Scope 
This section focuses on global events related to the sale of clinical diagnostics and 
provides several country IVD market profiles to establish the global market context.  
The report uses this information to discuss opportunities and threats for IVD 
manufacturers and marketers in specific geographic markets.  While this report 
concentrates on developments at work in the mature markets of North America, the 
European Union and Japan, it also provides some insight to opportunities in emerging 
nations, primarily Saudi Arabia, China, Turkey, Southeast Asia, South Korea and 
Latin America. Finally, this chapter details ‘next wave’ countries, while not fully 
developed or commonly targeted IVD markets, that should be on the IVD marketer’s 
watch list.  
 
 

 
 
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Overview 
IVD are growing in all parts of the world.  Some areas are growing faster than others. Social 
and economic events in selected countries will continue to influence the IVD market but 
overall, the IVD market plays an important role in the evolution of the healthcare industry 
worldwide.   
Simultaneous Threats: Chronic and Acute 
Two major trends continue to shape the global healthcare landscape. As populations age, 
demographic shifts are driving a steady increase in the prevalence of chronic diseases such 
as arthritis, autoimmune disorders, asthma, diabetes, cancer, and cardiovascular disease. 
Longer life expectancy, combined with lifestyle factors, is contributing to a growing burden 
of noncommunicable diseases worldwide. 
At the same time, infectious diseases are a persistent and evolving challenge. Globalization, 
urbanization, climate change, and increased human mobility have contributed to the 
continued spread and re-emergence of infectious diseases, including dengue, Chagas disease, 
Lyme disease, West Nile virus, and periodic outbreaks of emerging pathogens such as SARS-
related viruses and mpox. In addition, long-standing global health challenges such as 
hepatitis, tuberculosis, HIV, and sexually transmitted infections continue to place a 
significant strain on healthcare systems. 
This combination of rising chronic disease burden alongside ongoing infectious disease 
threats reflects a dual challenge for healthcare systems, particularly in regions with aging 
populations and limited resources. 
Expected World IVD Market Developments 
The next five to ten years are expected to bring steady but meaningful evolution in IVD 
product markets. Key trends likely to shape the industry include: 
• Continued expansion of rapid and POC testing, particularly in molecular diagnostics, 
as platforms become faster, more portable, and easier to use in decentralized settings. 
• Increased automation across laboratory workflows driven by staffing shortages, rising 
labor costs, and the need for greater efficiency and standardization. 

 
 
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• Growth in partnerships, collaborations, and strategic alliances as manufacturers 
combine technologies, expand test menus, and support integrated solutions such as 
companion diagnostics and precision medicine. 
• An aging global population that will drive higher testing volumes, particularly for 
chronic disease management, while also increasing pressure from governments and 
payers to control costs and reimbursement. 
• Moderate growth in developed markets, with stronger volume growth in emerging 
regions, although pricing pressures and reimbursement limitations may constrain 
revenue expansion. 
• Expanding healthcare access and insurance coverage in key emerging markets, 
including China, India, Brazil, Mexico, Saudi Arabia, and other Gulf states, creating 
new opportunities for diagnostic testing adoption. 
• Continued growth in Southeast Asia, parts of Latin America, and the Middle East, 
which are becoming increasingly important markets for IVD companies seeking 
geographic expansion. 
• Ongoing development of diagnostic systems designed for decentralized and resource-
limited settings, including portable, lower-cost, and easy-to-use platforms. 
• Increased adoption of multiplex and syndromic testing, particularly in infectious 
disease diagnostics, enabling simultaneous detection of multiple targets from a single 
sample. 
• Greater integration of digital tools, artificial intelligence, and connectivity solutions 
to provide workflow optimization, remote diagnostics, and population health 
management. 
• Continued shift toward decentralized and near-patient testing, including use in clinics, 
pharmacies, and home settings, supported by telehealth and digital health platforms. 
• Growing use of multi-omics approaches that combine genomic, proteomic, and other 
data to provide more comprehensive diagnostic insights, particularly in oncology and 
complex disease management. 
• Increased focus on supply chain resilience and regional manufacturing capacity, 
driven by lessons learned from recent global disruptions. 

 
 
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• Ongoing regulatory complexity and changing compliance requirements, alongside 
continued reimbursement pressure, which will influence product development, 
market access, and pricing strategies 

 
 
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Global Population and Aging 
The world's population exceeds 8.2 billion.  Average growth currently stands at about 1% 
with a projected population of 9.7 billion for 2050. Despite slowing population growth, it is 
still growing. This has led to renewed concerns about whether the Earth's land and resources 
can support a population that continues to swell.  While many countries in the developed 
world face low birth rates and aging populations, growth in developing countries, particularly 
in sub-Saharan Africa, continues largely unabated. 
Figure 3-1: Global Fertility Rate vs. Population Size, 1950-2050 (billion) 
 
Source: Compiled from data retrieved from United Nations Population Fund 
In terms of population, the Asia Pacific region hosts the most individuals with 4.1 billion 
people; the European region has the second most individuals with 748 million, followed by 
Latin America with 656 million and North America (excluding Latin American countries) 
with 371 million. 

 
 
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Figure 3-2: Global Population Distribution, 2025 
 
Source: Compiled from data retrieved from United Nations Population Fund 
Even when the aging process is slower, there are challenges. Africa, for instance, is projected 
to still have a young population in 2050; the number of older Africans is expected to almost 
quadruple, with 150 million older Africans joining the global population.   
According to the U.S. Census Bureau, about 13.5% of the population is currently over the 
age of 60.  By 2050, about 21.4% of the population is projected to be over the age of 60.  This 
supports a growing need for health services and more specifically, services which are 
personalized to patients, age groups and disease profiles. 
Demographic aging puts pressure on a nation’s ability to support its elderly citizens. A 
commonly used indicator of this pressure is the elderly support ratio, calculated as the number 
of working-age people aged 15 to 64 divided by the number of people aged 65 or older. This 
ratio serves as a rough indicator of the number of potential providers of support (including 
healthcare costs) per potential elderly dependent. In 1950, there were 12 working-age people 
for every elderly person in the world. By 2010, this ratio declined to 9, with the largest decline 

 
 
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occurring in more developed countries. However, China and other BRIC economies are 
expected to feature elderly support ratios in 2050 near or below those of developed countries 
such as France and the United States, where stable fertility rates and immigration will 
stabilize ratios that otherwise declined in past decades. 
Table 3-1: Elderly Support Ratio in Various Countries, 2010 and 2050 
 
[Australia; Brazil; Canada; China; China, Hong Kong SAR; France; Germany; India; Italy; Japan; Mexico; 
Saudi Arabia; Singapore; South Africa; Spain; Turkey; United Kingdom; United States; World] 
Region/Country 
2010 
2050 
Australia 
5 
3 
Brazil 
10 
3 
Canada 
5 
2 
China 
9 
2 
China, Hong Kong SAR 
6 
2 
France 
4 
2 
Germany 
3 
2 
India 
13 
5 
Italy 
3 
2 
Japan 
3 
1 
Mexico 
11 
3 
Saudi Arabia 
23 
4 
Singapore 
8 
2 
South Africa 
14 
6 
Spain 
4 
1 
Turkey 
9 
3 
United Kingdom 
4 
2 
United States 
5 
3 
World 
9 
4 
Source: Kalorama Information 

 
 
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Workforce Reduction 
Aging populations mean fewer workers on the job.  This is evidenced in a milestone reached 
in 2016, the year the world’s advanced economies reached a critical milestone. For the first 
time since 1950, their combined working-age population declined per UN data.  By 2050, 
that population will shrink 5%. Among advanced countries, the working-age population will 
shrink 26% in South Korea, 28% in Japan, and 23% in both Germany and Italy, according to 
the U.N. For middle-income countries, it will rise 23%, led by India at 33%. But Brazil’s will 
edge up just 3% while Russia’s and China’s will contract 21%.   
Along with age comes the timing of retirement, which is changing.  Over the past 50 years, 
labor force participation among persons aged 65 or over has declined by more than 40 percent 
globally. And more aging means healthcare costs rise both as the number of patients grows 
and as the complexity of their treatment (illness tends to be more expensive for the old than 
for the young) increases.   

 
 
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WHO Essential IVD List 
WHO released the First WHO Model List of Essential In Vitro Diagnostics (EDL).  The list, 
similar to the ongoing publication of Essential Medicines List, the WHO Model List of 
Essential Medicines contains the medications considered to be the most effective and safe to 
meet the most important needs in a health system, thus advancing these strategic priorities. 
Access to high-quality, affordable IVDs that enable healthcare providers to make timely 
diagnoses and provide the most appropriate treatment is also essential to achieving these 
goals.  
A second WHO model list of essential IVD products was released in 2019. A third edition 
was released in January 2021, and selected categories are listed. The fourth edition was 
released in mid-2023. It provides evidence-based recommendations on the accessibility of 
essential products, helping countries make decisions about which diagnostic products to use. 
An updated release of the WHO Essential Medicines List was released in September 2025. 

 
 
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Table 3-2: WHO Model List of Essential In Vitro Diagnostics (EDL) 
Category 
Diagnostic Test 
For Primary Health Care 
Includes IVDs for health posts, community health centers, doctors’ 
offices, outreach clinics and ambulatory care. 
Hematology 
Hemoglobin (Hb) 
Clinical chemistry and immunoassays 
Albumin 
Bilirubin 
Glucose 
Hemoglobin A1c (HbA1c) 
Blood transfusion 
Blood typing 
Serology 
Human chorionic gonadotropin (hCG) 
Microbiology, mycology and parasitology 
Urine dipstick and urine microscopy 
Microscopy 
Hepatitis B 
Hepatitis B surface antigen (BHsAg) 
Hepatitis B e antigen (HBeAg) 
Hepatitis C 
Hepatitis C virus antibody (anti-HCV Ab) 
Hepatitis E 
IgM antibodies to hepatitis E virus RDT 
HIV infection 
HIV 1/2 antibody (anti-HIV Ab) 
Combined HIV antibody/p24 antigen (anti-HIV/p24 Ag) 
Malaria 
Plasmodium spp. Antigens; species specific (e.g., HRP2) and/or pan-
species-specific (e.g., pan-pLDH) 
Plasmodium spp. 
Tuberculosis 
Mycobacterium tuberculosis 
Immune response 
Syphilis 
Antibodies to Treponema pallidum 
Combined antibodies to T. pallidum and to HIV 1/2  

 
 
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Category 
Diagnostic Test 
Chagas disease 
Trypanosoma cruzi IgG antibody 
Cholera 
Vibrio cholerae antigen 
Coronavirus 
SARS-CoV-2 benchtop or handheld 
For Health Care Facilities with Clinical 
Laboratories 
District, regional, provincial or specialized hospitals or laboratories 
and national reference laboratories.  
Clinical chemistry and immunoassays 
Alanine amino-transferase (ALT) 
Albumin 
Alkaline phosphatase 
Aspartate amino-transferase (AST) 
Bilirubin 
Blood pH and gases 
Blood urea nitrogen (BUN) 
Creatinine 
D-dimer 
Electrolytes 
Glucose 
Hemoglobin A1c (HbA1c) 
C-reactive protein (CRP) 
Lipid profile 
Basic metabolic panel (BMP) 
Comprehensive metabolic panel 
Amylase and lipase 
Troponin T/I 
Urinalysis 
Blood transfusion 
Blood cross-matching 

 
 
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Category 
Diagnostic Test 
Transfusion-transmitted infections 
Serology 
Human chorionic gonadotropin (hCG) 
Microbiology, mycology and parasitology 
Urine dipstick and urine microscopy 
Microscopy 
Culture 
Blood culture 
Antimicrobial susceptibility testing 
Hematology 
Hematocrit (Hct) 
Prothrombin time test and international normalized ratio (PT/INR) 
Platelet count 
Complete blood count (CBC), automated, differential 
Hepatitis B 
Hepatitis B surface antigen (HBsAg) 
Virological (HBV DNA – quantitative) 
Hepatitis B e antigen (HBeAg) 
IgM-specific antibodies to hepatitis B core antigen (IgM anti-HBc) 
Antibodies to hepatitis B surface antigen (anti-HBs) 
Hepatitis C 
Antibodies to HCV (anti-HCV) 
Antibodies to HCV (anti-HCV) and HCV core antigen (HCV cAg) 
HCV core antigen (HCV cAg) 
HCV RNA (qualitative or quantitative) 
HIV infection 
Antibodies to HIV 1/2 (anti-HIV) test 
Combined HIV antibody/p24 antigen (anti-HIV/p24 Ag test) 
Qualitative or quantitative virological test 
Quantitative virological test 
CD4 cell enumeration (quantitative) 

 
 
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Category 
Diagnostic Test 
Cryptococcal antigen test 
Malaria 
Plasmodium spp. Antigens: species-specific (e.g., HRP2) and/or pan-
species-specific (e.g., pan-pLDH) 
Plasmodium spp. 
Glucose-6-phosphate dehydrogenase activity (G6PD) 
Tuberculosis 
Mycobacterium tuberculosis bacteria 
M. tuberculosis DNA 
M. tuberculosis DNA mutations associated with resistance 
Drug susceptibility testing in M. tuberculosis culture 
Lipoarabinomannan (LAM) antigen 
Immune response 
HPV infection 
Human papillomavirus (HPV) nucleic acid 
Syphilis 
Antibodies to Treponema pallidum 
Combined antibodies to T. pallidum and to HIV 1/2 (anti=HIV) 
Source: WHO 
Increase in Chronic Diseases 
The prevalence of chronic medical conditions significantly impacts the growth and 
development of the IVD market.  Conditions such as hypertension, cancer, HPV, and 
hormone imbalances have a high incidence and require continuous evaluation.  IVD tests are 
necessary for diagnosis and monitoring disease progression, treatment, and overall patient 
health.  
Around the world, millions of people lose their battle with a chronic disease each year.  
Chronic diseases account for about 44 million deaths annually.  Ischemic heart disease is the 
leading cause of death worldwide, with around 9 million deaths annually. 

 
 
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Figure 3-3: Leading Causes of Death Globally, 2021* (number of deaths in millions) 
 
Notes: The world’s biggest killer is ischaemic heart disease, responsible for 13% of the world’s total deaths. Since 2000, the largest 
increase in deaths has been for this disease, rising by 2.7 million to 9.1 million deaths in 2021. As a newly emerged cause of deaths, 
COVID-19 was directly responsible for 8.8 million deaths in 2021, and consequently, largely pushed down other leading causes of death 
by one place. Instead of being the second and third leading causes of death as in 2019, stroke and chronic obstructive pulmonary 
disease became the third and fourth in 2021, responsible for approximately 10% and 5% of total deaths, respectively. 
Lower respiratory infections remained the world’s most deadly communicable disease other than COVID-19, ranked as the fifth leading 
cause of death. However, the number of deaths has gone down substantially: in 2021 it claimed 2.5 million lives, 370 000 fewer than in 
2000. 
Deaths from other noncommunicable diseases were also on the rise. Trachea, bronchus and lung cancers deaths have risen from 1.2 
million in 2000 to 1.9 million in 2021 and are now ranked sixth among leading causes of death. 
In 2021, Alzheimer’s disease and other forms of dementia ranked as the seventh leading cause of death, killing 1.8 million lives. Women 
are disproportionately affected. Globally, 68% of deaths from Alzheimer’s and other forms of dementia are women. 
Diabetes was also among the top 10 causes of death, following a significant percentage increase of 95% since 2000. 
Other diseases which were among the top 10 causes of death in 2000 are no longer on the list. HIV and AIDS are among them. Deaths 
from HIV and AIDS have fallen by 61%, moving from the world’s seventh leading cause of death in 2000 to the twenty-first in 2021. 
Similarly, deaths due to diarrhoeal diseases have dropped by 45%, from sixth leading cause of death in 2000 to thirteenth in 2021. 
In contrast, kidney diseases have risen from the world’s nineteenth leading cause of death to the ninth, with number of deaths 
increasing by 95% between 2000 and 2021  
* Note: 2021 is the most recent data available 
Source: WHO Global Health Estimates. 

 
 
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By 2030, there will likely be 67.2 million deaths reported, with chronic diseases accounting 
for 77% of total deaths, or 52 million.  The rate of growth in chronic disease mortality from 
2016 to 2030 is estimated at 1.3% compounded annually, compared with 0.6% for acute 
disease mortality over the same period.   
In the United States, nearly 8 in 10 seniors are living with at least one chronic health 
condition; 50% have two or more.  About 25% of older Americans are obese; 20% have been 
diagnosed with diabetes; more than 70% have heart disease; nearly 60% have arthritis, a 
leading cause of disability.  Adults 65 and older spend nearly twice as much on health care 
each year as those aged 45 to 64; they spend three to five times as much as all adults younger 
than 65. 
These statistics demonstrate the enormous pressures on healthcare systems around the world 
and emphasize the need for highly efficient tests and systems for chronic diseases of aging, 
at a time when emerging viruses and infectious diseases remain an ongoing concern.  

 
 
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COVID-19 
Coronavirus (COVID-19) is a virus that is identified as the cause of an outbreak of respiratory 
illness first detected in Wuhan, China and has resulted in an ongoing pandemic worldwide. 
The pandemic has turned the spotlight on the IVD industry. The industry stepped up with 
rapid development of diagnostics, fast-tracked regulatory clearance and ramped up 
distribution.  
This table includes information about authorized SARS-CoV-2 molecular diagnostic tests in 
2024 and 2025. The EUAs have been issued for each individual test with certain conditions 
of authorization required of the manufacturer and authorized laboratories.  
 
 

 
 
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Table 3-3: Selected Molecular EUA Tests for COVID-19, 2024-July 2025 
Date EUA 
Issued 
Manufacturer 
Diagnostic 
 (Letter of Authorization) 
Technology 
Authorized 
Setting(s)¹ 
7/25/2025 
BioFire Defense 
BioFire COVID-19 Test 
RT, Nested multiplex PCR, 
Pooling, Saliva, Multiple targets 
H.M 
4/3/2025 
Visby Medical 
Visby Medical Respiratory 
Health Test 
RT-PCR, Multi-analyte, multiple 
targets 
H, M,W 
2/21/2025 
Aptitude Medical 
Systems 
Metrix COVID/Flu Test 
RT, LAMP, Over the Counter 
(OTC) Home Testing, Multi-
analyte, Multiple Targets 
Home, 
H,M,W 
1/17/2025 
Pfizer 
Lucira by Pfizer COVID-19  
& Flu Home Test 
RT, LAMP, Over the Counter 
(OTC) Home Testing, Multi-
analyte, Multiple Targets 
Home, 
H,M,W 
10/31/2024 
DNA Genotek 
ORAcollect RNA OR-100 and 
ORAcollect RNA ORE-100 
saliva collection device 
Saliva collection device 
N/A 
10/3/2024 
Luminex 
NxTAG Respiratory Pathogen 
Panel + SARS-CoV-2 
RT-PCR Multiple targets, 
Multianalyte 
H 
8/20/2024 
CDC 
Influenza SARS-CoV-2, 
Multiplex Assay 
RT-PCR single target, 
Multianalyte 
H 
8/9/2024 
Roche Molecular 
cobas liat SARS-CoV-2 
influenza A/B & RSV nucleic 
acid test 
RT-PCR Multiple targets, 
Multianalyte 
H,M,W 
7/1/2024 
SalivaDirect 
SalivaDirect for use with DTC 
Kits 
DTC Home collection kit, RT-PCR 
saliva, screening, pooling single 
target 
H 
7/1/2024 
SalivaDirect 
SalivaDirect 
DTC Home collection kit, saliva, 
screening 
N/A 
7/1/2024 
SalivaDirect 
SalivaDirect 
real-time RT-PCR pooling saliva 
multiple targets 
H 
6/7/2024 
Roche Molecular 
cobas liat SARS-CoV-2 
Influenza A/B & RSV nucleic 
acid test 
real-time RT-PCR multiple 
targets, multi-analyte 
H,M,W 
5/14/2024 
3EO Health 
3EO Health COVID-19 Test 
RT, LAMP, OTC home testing 
multiple targets 
Home, 
H,M,W 

 
 
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Date EUA 
Issued 
Manufacturer 
Diagnostic 
 (Letter of Authorization) 
Technology 
Authorized 
Setting(s)¹ 
4/16/2024 
ADL Diagnostics 
dba Anavasi 
Diagnostics 
The AscencioDx COVID-19 
and the AscencioDx 
Molecular Detector 
RT-LAMP multiple targets 
H,M,W 
4/12/2024 
Aptitude Medical 
Metrix COVID-19 Test 
RT, LAMP, OTC home testing 
multi-analyte, multiple targets 
Home, 
H,M,W 
4/4/2024 
GenMark 
ePlex Respiratory Pathogen 
Panel 2 
RT-PCR and electrochemical 
detection, multi-analyte 
multiple targets 
H,M 
4/1/2024 
LMSI dba 
Lighthouse Lab 
SalivaNow SARS-CoV-2 Assay 
real-time RT-PCR single target 
H 
3/26/2024 
Nanobiosym 
Precision Testing 
The Nano Test for COVID-19 
real-time RT-PCR pooling saliva 
multiple targets 
H 
3/19/2024 
Tetracore 
EZ-SARS-CoV-2 Real-Time RT-
PCR 
real-time RT-PCR multiple 
targets 
H 
1/31/2024 
Revvity 
New Coronavirus Nucleic 
Acid Detection Kit 
real-time RT-PCR pooling saliva 
multiple targets 
H 
1/26/2024` 
Revvity 
Respiratory SARS-CoV-2 RT-
PCR Panel 1 
real-time RT-PCR multiple 
targets, multi-analytes 
H 
1/25/2024 
Uh-Oh Labs 
UOL COVISD-19 Test 
RT-LAMP single target 
H,M,W 
 ¹ Authorized settings include the following: 
H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet 
requirements to perform high complexity tests. 
M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet 
requirements to perform moderate complexity tests. 
W - Patient care settings operating under a CLIA Certificate of Waiver. 
Source: FDA 
 
 

 
 
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Antigen tests are rapid tests that produce results in about 15 minutes. Antigen tests detect 
structural features on the surface of the virus that cause a color change. These tests 
proliferated during the pandemic, both in the professional arena and the POC/self-tests.  
There are a significant number of SARS-CoV-2 antigen immunoassay tests that have been 
granted emergency use authorization (EUA) by the FDA.  
 
 

 
 
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Table 3-4: Selected Antigen Immunoassay Tests for SARS-CoV-2, 2024-2025 
Date EUA 
Issued 
Manufacturer 
Diagnostic  
(Letter of Authorization) 
Technology 
Authorized 
Setting(s)¹ 
10/7/2025 
CorDx 
CorDx TyFast Flu A/B & 
COVID-19 At Home 
Multiplex Rapid Test 
Lateral Flow, Visual Read, OTC 
Home Testing, Multi-analyte, 
Single Target 
 Home, H,M,W 
7/25/2025 
Wondfo USA 
WELLlife COVID-19/ 
Influenza A/B Home Test 
Lateral Flow, Visual Read, Over the 
Counter (OTC) Home Testing, 
Multi-analyte, Single Target 
Home, H,M,W 
7/1/2025 
Sekisui 
OSOM Flu SARS-CoV-2 
Combo Test 
Lateral Flow, Visual Read, Over the 
Counter (OTC) Home Testing, 
Multi-analyte, Single Target 
Home, H,M,W 
7/1/2025 
ACON 
Flowflex Plus COVID-19 and 
Flu A/B Home Test 
Lateral Flow, Visual Read, Over the 
Counter (OTC) Home Testing, 
Multi-analyte, Single Target 
Home, H,M,W 
6/17/2025 
iHealth Labs 
iHealth COVID-19/Flu A&B 
Home Test 
Lateral Flow, Visual Read, Over the 
Counter (OTC) Home Testing, 
Multi-analyte, Single Target 
Home, H,M,W 
6/10/2025 
LumiraDx 
(Roche) 
LumiraDx SARS-CoV-2 Ag 
Test  
Microfluidic Immunofluorescence 
Assay, Instrument Read, Serial 
Screening, Single Target 
 H,M,W 
3/27/2025 
Healgen 
Healgen COVID-19/Flu A&B 
Ag Combo Rapid Test  
Cassette 
Lateral Flow, Visual Read, Multi-
analyte, Single Target 
H,M,W 
3/20/2025 
iHealth 
IHealth COVID-19/Flu A&B 
Rapid Test Pro 
Lateral Flow, Visual Read, Multi-
analyte, Single Target 
H,M,W 
2/3/2025 
Wondfo USA 
WELLife COVID-19Influenza 
A&B Test 
Lateral Flow, Visual Read, Multi-
analyte, Single Target 
H,M,W 
1/14/2025 
CorDx 
CorDx TyFast Flu A/B & 
COVID-19 AT home 
Multiplex Rapid Test 
Lateral Flow, Visual Read, Multi-
analyte, OTC, Single Target 
Home, H,M,W 
11/18/2024 
NanoDitech 
Nano-Check Influenza + 
COVID-19 Dual Test 
Lateral Flow, Visual Read, Multi-
analyte, Single Target 
H,M,W 
10/23/2024 
Princeton 
BioMeditech 
VirDA SARS-CoV-2/Flu A/B 
Rapid Antigen Test 
Lateral flow, visual read, serial 
screening, single target 
H,M,W 
10/18/2024 
OSANG 
QuickFinder COVID-19/Flu 
Antigen Self Test 
Lateral flow, visual read, OTC,  
serial screening, single target 
Home, H,M,W 

 
 
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Date EUA 
Issued 
Manufacturer 
Diagnostic  
(Letter of Authorization) 
Technology 
Authorized 
Setting(s)¹ 
10/9/2024 
iHealth 
IHealth COVID-19/Flu A&B 
Rapid Test 
Lateral flow, visual read, OTC,  
serial screening, single target 
Home, H,M,W 
9/12/2024 
SD Biosensor 
STANDARD Q COVID-19 Ag 
Test 2.0 
Lateral flow, visual read, serial 
screening, single target 
H,M,W 
9/12/2024 
OraSure 
InteliSwab COVID-19 Rapid 
Test 
Lateral flow, visual read, OTC,  
serial screening, single target 
Home, H,M,W 
9/4/2024 
SKEISUI 
OSOM Flu SARS-CoV-2 
Combo Home Test 
Lateral flow, visual read, OTC,  
serial screening, single target 
Home, H,M,W 
7/10/2024 
Genabio Dx 
Genabio COVID-19 Rapid 
Self-Test Kit 
Lateral flow, visual read, OTC,  
serial screening, single target 
Home, H,M,W 
7/8/2024 
Maxim 
Biomedical 
MaximBio ClearDetect 
COVIDS-19 Antigen Home 
Test 
Lateral flow, visual read, OTC,  
serial screening, single target 
Home, H,M,W 
7/1/2024 
Advin Biotech 
Advin COVID-19 Antigen 
Test @Home 
Lateral flow, visual read, OTC,  
serial screening, single target 
Home. H,M,W 
5/8/2024 
Watmind USA 
Speedy Swab Rapid Covid-19 
+ Flu A&B Antigen Self-Test 
Lateral flow, visual read, OTC,  
serial screening, single target 
Home, H,M,W 
4/30/2024 
CTK Biotech 
ImmuView COVID-19 
Antigen Home Test 
Lateral flow, visual read, OTC,  
serial screening, single target 
Home, H,M,W 
2/1/2024 
iHealth 
iHealth COVID-19 Antigen 
Rapid Test Pro 
Lateral flow, visual read, serial 
screening, single target 
H,M,W 
1/23/2024 
Xiamen Boson 
Biotech 
Rapid SARS-CoV-2 Antigen 
Test Card 
Lateral flow, visual read, OTC,  
serial screening, single target 
Home, H,M,W 
¹ Authorized settings include the following: 
H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet 
requirements to perform high complexity tests. 
M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet 
requirements to perform moderate complexity tests. 
W - Patient care settings operating under a CLIA Certificate of Waiver. 
Source: FDA 
 
 

 
 
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Emerging and Emerged Markets 
The maturation of IVD markets in developed countries has IVD companies continuing to 
cast their nets in developing countries, where rising incomes and standards of living are 
anticipated to spark a new health-conscious population with growing demands for quality 
medical care.  While once the focus was on the BRIC countries, Kalorama Information has 
identified 12 top emerging markets of interest, including: 
• Brazil 
• China 
• India 
• Indonesia 
• Malaysia 
• Mexico 
• Saudi Arabia 
• South Africa 
• South Korea 
• Thailand 
• Turkey 
• Vietnam 
Developed and developing markets are classified using the United Nations economic 
framework. The following table highlights global developed and developing economies by 
region. Despite growth in developing regions, developed markets for IVD command the 
largest share of revenues, 78.6%. Much of this hefty market share is due to major companies’ 
presence in developed markets, consumer demand in those regions, and reduced pricing 
sensitivity. These factors will likely influence the forecast period to maintain, and slightly 
grow, the developed market at a faster pace than the developing regions. 

 
 
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Table 3-5: Developed/Developing Economies, UN Classification* Table, 2025 
Developed Economies 
Developing Economies 
U.S. 
Eastern Europe: Poland, Czech Republic, Romania, Slovakia, 
Hungary, Croatia, Slovenia, Bulgaria, Russia, Estonia, Latvia, 
Lithuania, Albania, Belarus, Bosnia, Herzegovina, Kosovo, 
Macedonia, Moldova, Montenegro, Serbia, Ukraine 
Canada 
Asia & Pacific: China, India, Vietnam, Indonesia, Thailand, Malaysia, 
Philippines 
Europe: Germany, Italy, France, Spain, UK, 
Belgium, Netherlands, Portugal, Greece, 
Sweden, Austria, Denmark, Finland, Ireland, 
Luxembourg, Switzerland, Norway 
Latin America: Brazil, Mexico, Colombia, Argentina, Ecuador, Chile, 
Peru, Venezuela, Bolivia, Costa Rica, Cuba, Dominican Republic, El 
Salvador, Guatemala, Guyana, Haiti, Honduras, Nicaragua, Panama, 
Paraguay, Uruguay 
Asia Pacific: Japan, South Korea, Australia, 
New Zealand, Singapore 
Middle East: Egypt, Iran, Turkey, Iraq, Saudi Arabia, United Arab 
Emirates, Jordan 
Middle East: Israel 
Africa: South Africa 
Note: *Status according to the United Nations system (UN M49/UNDP), which uses the developed economies / developing economies / 
LDC framework. 
Source: Kalorama Information 
 
 

 
 
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Figure 3-4: Developed vs. Developing IVD Market Shares, 2025 and Projected 2030 (%) 
 
 
Source: Kalorama Information 
Where are the best markets?  As a starting point, one major aspect of commercial potential 
is examining the available market. For this report, the percentage of the population that is 
urban can be used, since urban populations usually have greater access to healthcare, 
including physicians, hospitals, clinics, etc.  As governments in developing countries expand 
healthcare infrastructure in rural communities, the diagnostics market is expected to grow 

 
 
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significantly.  These diagnostics would cover many primary care segments, including 
diabetes, anemia, hypertension, infectious diseases, sexually transmitted diseases, and cancer 
screening. 
The following table demonstrates how increases in urbanization provide a large available 
market.  Among the countries listed, China has made the greatest effort to bring healthcare 
to its rural population; however, recent changes to healthcare infrastructure, aimed at 
controlling spending, are expected to limit overall growth in the country. Despite changes 
and potential slowing of growth, China remains an important market opportunity with an 
aging population. 
 
 

 
 
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Table 3-6: Countries To Watch for IVD Opportunities, by Total Population and Percent Urban, 2025  
 
[Australia; Brazil; China; France; Germany; Hungary; India; Mexico; Netherlands; Poland; Romania; Saudi 
Arabia; South Africa; South Korea; Sweden; Switzerland, Turkey; United Kingdom; United States] 
Country 
Pop (M) 
% Urban 
China 
1,416 
65% 
India 
1,409 
36% 
United States 
342 
83% 
Brazil 
220 
88% 
Mexico 
131 
82% 
Turkey 
84 
78% 
Germany 
84 
78% 
United Kingdom 
69 
85% 
France 
68 
82% 
South Africa 
60 
69% 
South Korea 
52 
82% 
Poland 
39 
60% 
Saudi Arabia 
37 
85% 
Australia 
27 
87% 
Netherlands 
18 
93% 
Romania 
18 
55% 
Sweden 
11 
89% 
Hungary 
10 
73% 
Switzerland 
9 
74% 
Source: Kalorama Information 
 
 

 
 
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There is an expectation that, with economic growth, the growing middle class will invest and 
spend dollars on Western-style healthcare. It is Kalorama Information’s experience that 
members of the middle and more affluent classes in developing countries are clients of 
private healthcare providers. 
The United Nations (UN) describes it as a historic shift not seen for 150 years. Throughout 
history, the vast majority of people in the now most affluent emerging markets (India and 
Brazil) lived in desperate poverty, living on a dollar a day or less. Yet, these countries are 
undergoing a remarkable transformation, one that is unfortunately not shared by most of the 
population.  UN statistics indicate that 1.8 billion people made up the worldwide middle class 
in 2009, 3.5 billion in 2020, and 4.8 billion in 2030. By 2030, Asia will be the home of 3.49 
billion middle-class people. It would be 10 times more than in North America and 5 times 
more than in Europe. By 2050, they are forecast to account for nearly half of world output, 
far surpassing the G7.   
Indonesia is experiencing rising per capita incomes among working professionals and the 
middle class, which is prompting a shift from self-medication to clinical and hospital 
treatment, supported by subsidized healthcare services. Maternal and child healthcare has 
improved in recent years, reducing the child mortality rate.   
There is also substantial growth in the rest of the emerging world. The middle class in Latin 
America is expected to grow from 181 million to 313 million by 2030, with Brazil leading 
the growth. In Africa and the Middle East, it is projected to more than double, from 137 
million to 341 million. 
According to the United Nations and the Organization for Economic Co-operation and 
Development (OECD), members of the middle class vary widely, from people who earn $10 
per day to those who earn $100 per day or more.  This gives them enough disposable income 
to invest in consumer goods such as household electronics and cars, but it also allows them 
to buy healthcare insurance or to become members of healthcare clubs. 
While several developing countries will make significant progress in improving prosperity, 
most will not generate sufficient GDP growth to upgrade their medical delivery systems to 
developed-world standards. Moreover, ongoing political strife and corruption will preclude 
many Asian, African, Central and South American, Middle Eastern, and Eastern European 
nations from realizing needed economic and healthcare gains. Although remaining 
prosperous, the United States and the vast majority of Western European and other developed 

 
 
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countries (e.g., Australia, Canada, Israel, Japan, New Zealand, Singapore, South Korea, 
Taiwan, and the United Arab Emirates) will continue to encounter an increasing healthcare 
cost burden, forcing the adoption of more stringent cost containment initiatives. This was 
particularly evident in China's growing economic status in recent years and in the 2025 shift 
in government health structures to control rapid health spending in the country. 
Currently, the IVD market in emerging countries and especially the top seven is dominated 
by established players such as Abbott Diagnostics, Roche Diagnostics, Danaher, Siemens 
Healthineers, QuidelOrtho and Becton Dickinson.  However, literally 100s of domestic 
players, such as Transasia, SRL, JMitra, Horiba, Kehua, Mindray, Wama, and others, have 
expanded the distribution of IVD products from urban to rural areas in their respective 
markets. 
In many emerging markets, these domestic players are not only improving distribution in 
rural and underserved areas but also strengthening their competitive position through 
localized manufacturing, lower-cost platforms, and greater technological capability. In some 
segments, particularly in rapid testing and routine diagnostics, and in mid-tier instruments, 
regional companies are gaining share and competing more directly with multinational 
suppliers. 

 
 
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Size and Forecast for the Global IVD Market 
The global market for traditional in vitro diagnostics is estimated at $116 billion in 2025 and 
is expected to reach $150 billion by 2030. 
These figures represent the traditional IVD market; however, additional revenues of $12.7 
billion can be found in the combined segments of flow cytometry, clinical sequencing, 
prenatal test services, direct-to-consumer genetic testing, digital imaging and other 
specialized market segments. Major markets, North America, Western Europe, and Japan, 
with shares of 42%, 27%, and 5%, respectively, make up 74% of the total IVD market in 
2025. By 2030, major markets (North America, Western Europe, and Japan) will continue to 
dominate, accounting for 75% of sales. Overall, developing markets will experience 5% 
annual growth, while the developed world will see approximately 4.8% annual growth.   
 
 
 

 
 
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Table 3-7: Global In Vitro Diagnostic Market, Major Country/Region Markets, 2025 and 2030 ($ million)  
 
[Australia; Brazil; Canada; China; Eastern Europe; EU 15/W. Europe; India; Japan; Mexico; Peru; Russia; 
Saudi Arabia; South Africa; South Korea; Turkey; UAE; United States; Vietnam; Rest of World] 
Country/Region 
2025 
% Mkt 
2030 
% Mkt 
CAGR  
2025-2030 
United States 
48,349 
42% 
64,131 
43% 
6% 
EU 15/W. Europe 
31,491 
27% 
41,236 
27% 
6% 
China 
5,997 
5% 
7,361 
5% 
4% 
Japan 
5,726 
5% 
6,810 
5% 
4% 
Canada 
3,429 
3% 
4,233 
3% 
4% 
Eastern Europe 
2,712 
2% 
3,363 
2% 
4% 
Australia 
1,976 
2% 
2,508 
2% 
5% 
Brazil 
1,885 
2% 
2,581 
2% 
6% 
India 
1,390 
1% 
1,803 
1% 
5% 
Russia 
1,307 
1% 
1,509 
1% 
3% 
Turkey 
1,093 
1% 
1,473 
1% 
6% 
Mexico 
839 
1% 
1,077 
1% 
5% 
Saudi Arabia 
676 
1% 
898 
1% 
6% 
South Korea 
521 
0% 
728 
0% 
7% 
South Africa 
377 
0% 
463 
0% 
4% 
UAE 
259 
0% 
318 
0% 
4% 
Peru 
175 
0% 
214 
0% 
4% 
Vietnam 
137 
0% 
172 
0% 
5% 
ROW 
7,220 
6% 
9,568 
6% 
6% 
Total 
115,559 
100% 
150,446 
100% 
5% 
Source: Kalorama Information 

 
 
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Table 3-8: Global In Vitro Diagnostic Market, Regional Markets, 2025 and 2030 ($ million)  
 
[Africa, Asia Pacific, Europe, Latin America, Middle East, North America] 
Regional Markets 
2025 
% Mkt 
2030 
% Mkt 
CAGR 
North America  
(United States/Canada) 
51,778 
45% 
68,364 
46% 
5.7% 
Europe  
(Western/Eastern) 
36,176 
31% 
46,931 
31% 
5.3% 
Asia Pacific 
18,249 
16% 
23,203 
15% 
4.9% 
Latin America 
4,333 
4% 
5,652 
4% 
5.5% 
Middle East 
3,969 
3% 
5,032 
3% 
4.8% 
Africa 
1,054 
1% 
1,264 
1% 
3.7% 
Total 
115,559 
100% 
150,446 
100% 
5.4% 
Source: Kalorama Information 
 
 
 
 
 

 
 
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The following tables show the 2024-2025 year-over-year growth for specific segments as 
calculated by Kalorama Information.  
Table 3-9: Global In Vitro Diagnostic Market, YOY Growth, by Segment, 2024-2025 (%) 
 
[Blood Bank Molecular; Blood Bank Screening – Immunoassays; Blood Grouping/Typing; Clinical 
Chemistry; Coagulation (PT/INR, Molecular); D-dimer; Diabetes HbA1c, Lab; Drugs of Abuse; Hematology - 
Core Lab; Histology/Cytology; Immunoassays - Infectious Disease; Immunoassays - Other Immunos; Mass 
Spectrometry (Micro/Non-Micro); Microbiology (ID/AST); Microbiology (Molecular); NAAT – Oncology; 
NAAT – Genetic/Inherited; POC, OTC Glucose OTC; POC Continuous Glucose; POC, OTC Other; POC, 
Professional/Hospital] 
Segment 
2024-2025 (YOY %) 
POC continuous glucose 
16.1% 
HPV, molecular 
12.3% 
Hematology - core lab 
7.3% 
Mass spectrometry (micro/non-micro) 
6.3% 
NAAT - oncology 
5.7% 
Non-infectious – immunoassays 
5.3% 
Coagulation - (PT/INR, molecular) 
5.2% 
Histology/cytology 
5.0% 
Diabetes HbA1c, lab 
4.4% 
POC, professional/hospital 
4.4% 
Clinical chemistry 
4.0% 
Microbiology (ID/AST) 
3.2% 
Blood grouping/typing 
3.0% 
Blood bank screening – molecular 
2.6% 
NAAT - Genetic/Inherited 
2.4% 
Drugs of abuse – immunoassays 
1.8% 
D-dimer 
1.4% 
POC, OTC other 
1.1% 

 
 
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Segment 
2024-2025 (YOY %) 
Infectious disease – Immunoassays 
0.8% 
POC Glucose OTC 
0.7% 
Microbiology (molecular) 
-1.5% 
Blood bank screening – immunoassays 
-3.5% 
Other (circulating tumor cells, transplant testing, other, etc.) 
14.7% 
Source: Kalorama Information 
Table 3-10: Global In Vitro Diagnostic Market, Regional Markets, 2024-2025 YOY Change (%) 
 
[Africa, Asia Pacific, Europe, Latin America, Middle East, North America] 
Region 
2024-2025 (YOY %) 
Latin America 
5.5% 
Middle East 
5.3% 
North America (United States/Canada) 
5.2% 
Asia Pacific 
4.1% 
Europe (Western/Eastern) 
3.5% 
Africa 
2.9% 
Source: Kalorama Information 
 

 
 
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The IVD Market in the United States 
The U.S. market dominates the IVD industry.  In 2025, IVD systems and related consumables 
accounted for $48,349 million ($48.3 billion), representing 41% of the global IVD market.  
The U.S. major IVD market is in a state of flux, trying to manage a myriad of issues, all of 
which collide with a huge system that costs more than any other in the world.  
 
 

 
 
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Table 3-11: United States IVD Market Share, by Segment, 2025 (%)  
 
[Blood Grouping; Clinical Chemistry; Coagulation; Hematology; Histology; Immunoassay Infectious 
Disease; Immunoassay Other; Microbiology ID/AST; Microbiology Molecular; Nucleic Acid Assays; POC 
Diabetes; POC Other; Others] 
Segment 
Share (%) 
POC Diabetes 
20.4% 
POC Other 
13.5% 
Immunoassay Infectious Disease 
13.2% 
Immunoassay Other 
10.9% 
Microbiology Molecular 
9.2% 
Clinical Chemistry 
8.3% 
Nucleic Acid Assays 
6.5% 
Histology 
4.7% 
Hematology 
4.7% 
Microbiology ID/AST 
3.8% 
Coagulation 
2.3% 
Blood Grouping 
1.1% 
Others 
1.4% 
Total 
100% 
 
 
Total Market ($ million) 
$48,349 
Clinical Sequencing ($ million) 
$3,203 
Source: Kalorama Information 
Healthcare in the United States is in a continuous cycle of change through various 
administrative policies. In the U.S., the American Hospital Association estimates that at least 
70% of hospitals are members of a hospital system or participate in a group purchasing 
organization.  Thus, the majority of labs located in the largest single market for IVD products, 

 
 
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the U.S., acquire their instruments, reagents, and supplies for routine tests at negotiated and 
large discounted prices.   
CMS released a report highlighting expenditures. The major findings for national health 
expenditures 2023-2032 were: 
• National health spending is projected to grow at an average annual rate of 5.6 percent 
for 2023-2032. 
• Because national health expenditures are projected to grow 4.3 percentage points 
faster than gross domestic product per year on average over 2023–2032, the health 
share of the economy is projected to rise from 17.3 percent in 2022 to 19.7 percent in 
2032.  
• Among major payers, Medicare is expected to experience the fastest spending growth 
(7.4 percent per year over 2023-2032), largely as a result of having the highest 
projected enrollment growth. 
• Medicaid projected spending is projected to be 5.2% - stabilizing after 2024. 
• Private health insurance spending over 2023-2032 is projected to be 5.6%  
• Out-of-pocket spending is projected to average 4.7% during 2023-2032. 
• Average annual retail prescription drug spending is expected to be 6% over 2023-
2032.  
PAMA and Reimbursement Changes 
For the foreseeable future, healthcare payers will continue to wrestle with escalating 
healthcare costs. Each year, CMS releases new payment rates for medical products and 
procedures. The “Protecting Access to Medicare Act of 2014” (PAMA) marked the first 
substantial change to the clinical laboratory fee schedule since it was created nearly 30 years 
ago.  These PAMA regulations reflect changes based on usage and other factors; they are 
designed to incorporate economies of scale and reduce excess expense, but significant year-
over-year changes for some products can create major problems for manufacturers.  
After decades of program cuts, reconfigurations and substitutions, momentum is increasing 
around a new model: value-based care and its corollary, value-based reimbursement. This 
initiative is part of the Merit-based Incentive Payment System (MIPS), which combines 

 
 
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elements of the Physician Quality Reporting System (PQRS), the Value-based Payment 
Modifier (VBM), and the Medicare Electronic Health Record Incentive Program into a single 
program under the Medicare Access and CHIP Reauthorization Act (MACRA). 
PAMA was designed to introduce a more market-based approach to Medicare reimbursement 
for laboratory testing by aligning Clinical Laboratory Fee Schedule rates with private payer 
pricing, replacing earlier broad-based reductions with a data-driven methodology. In 
practice, the law has exerted downward pressure on reimbursement for many routine, high-
volume tests, although the pace and magnitude of cuts have been moderated by ongoing 
legislative delays and adjustments. The pricing environment has contributed to continued 
consolidation within the clinical laboratory market and has increased focus across the IVD 
industry on developing higher-value, more specialized, and clinically actionable assays. 
Smaller and independent laboratories have faced greater challenges adapting to these changes 
due to limited scale and pricing flexibility, reinforcing competitive advantages for larger, 
more diversified companies. 
Impact of CARES Act on PAMA 
As a response to the Coronavirus at the start of 2020, the US Congress passed an amendment 
to the PAMA reductions scheduled for 2021.  This amendment includes a suspension of the 
reimbursement rate reductions.  On February 3, 2026, requirements were passed for CDLTs 
that are not ADLTs. The next reporting period will be from May 1, 2026, to July 31, 2026, 
and, based on the updated data, the collection period is set for January 1, 2025, through June 
30, 2025.  There is no phase-in reduction in 2026.  

 
 
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Table 3-12: Proposed Clinical Diagnostic Laboratory Test (CDLT) Rates, 2020-2027 
CDLT Rates 
Based on Reporting Period 
Reduction Cap 
2020 
January 1, 2017 - May 30, 2017 
10% 
2021 
January 1, 2017 - May 30, 2017 
0% 
2022 
January 1, 2017 – May 30, 2017 
0% 
2023 
January 1, 2017 – May 30, 2017 
0% 
2024 
January 1, 2017 – May 30, 2017 
0% 
2025 
January 1, 2017 – May 30, 2017 
0% 
2026 
January 1,2017 – May 30, 2017 
0% 
2027 
May 1, 2026 -July  31, 2026 
15% 
Source: Centers for Medicare and Medicaid.  
Saving Access to Laboratory Service Act (SALSA) 
 
Legislation known as the Saving Access to Laboratory Services Act (SALSA) has been 
proposed to make significant, more permanent modifications to PAMA requirements 
governing how Medicare Clinical Laboratory Fee Schedule rates are determined. The 
legislation is intended to address ongoing concerns around data reporting methodology and 
the magnitude of reimbursement reductions for routine laboratory testing. Industry groups, 
including the American Clinical Laboratory Association, have continued to advocate for 
reform through initiatives such as the Stop Lab Cuts campaign, emphasizing the impact of 
sustained reimbursement pressure on patient access, laboratory sustainability, and investment 
in innovation. While there has been bipartisan interest in addressing these issues, SALSA has 
faced repeated delays and has not yet been enacted as a permanent solution, leaving 
reimbursement uncertainty as an ongoing challenge for the clinical laboratory and IVD 
sectors. 

 
 
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LDT Update 
The laboratory-developed test (LDT) market can be viewed as a subset of the broader IVD 
industry. The FDA defines an LDT as an in vitro diagnostic test that is designed, 
manufactured, and used within a single laboratory operating under a CLIA certificate. LDTs, 
often referred to as in-house or “home brew” tests, are considered medical devices under the 
Federal Food, Drug, and Cosmetic Act. Historically, however, the FDA has exercised 
enforcement discretion, choosing not to actively regulate most LDTs through premarket 
review, while CMS maintains oversight of laboratory operations and test performance under 
CLIA. 
LDTs were originally developed to address unmet clinical needs where no commercial tests 
were available, but advances in technology have significantly increased their complexity. 
Many LDTs now resemble commercially distributed IVD tests in terms of sophistication, 
clinical application, and risk profile. This evolution has driven ongoing debate over the 
appropriate level of regulatory oversight. For decades, the FDA has maintained that it has 
authority to regulate LDTs but has taken a limited approach, while laboratories have 
continued to develop and offer these tests under CLIA, provided they are not distributed as 
kits to other laboratories. 
Efforts to formalize FDA oversight, including proposals such as the VALID Act, have been 
discussed for several years but have not been enacted, leaving the regulatory framework 
unsettled. In April 2024, the FDA issued a final rule intended to bring LDTs more fully under 
its medical device regulatory framework. However, in March 2025, a federal court vacated 
the rule, determining that the FDA’s approach exceeded its statutory authority under existing 
law. Following this decision, the FDA declined to appeal and in late 2025 formally reverted 
to its prior enforcement discretion framework, restoring the long-standing regulatory 
approach under CLIA. 
As a result, LDTs are offered without FDA clearance under the traditional enforcement 
discretion model, while debate over future oversight continues among regulators, industry 
stakeholders, and policymakers. The court decision has shifted the path forward toward 
potential legislative action rather than agency rulemaking, leaving the long-term regulatory 
framework unresolved. As advances in molecular diagnostics, precision medicine, and point-
of-care testing continue to expand the scope and clinical impact of LDTs, laboratories and 
developers will need to remain adaptable, ensuring robust analytical and clinical validation 
while preparing for potential future changes in regulatory requirements. 

 
 
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Bundled Insurance Payments for ESRD Patients 
Under updated Medicare payment policies, certain patient populations are subject to bundled 
reimbursement models, most notably patients receiving dialysis for end-stage renal disease 
(ESRD). In January 2011, CMS implemented the ESRD Prospective Payment System (PPS), 
which introduced a comprehensive dialysis payment bundle. This system combined 
previously separate payments for dialysis services, including many routine laboratory tests 
associated with dialysis treatment, into a single per-treatment payment. Over time, the bundle 
has been refined and expanded, reinforcing the shift toward consolidated reimbursement for 
dialysis-related care. The bundled approach primarily applies to laboratory tests directly 
related to ESRD management, while unrelated tests may still be billed separately. Although 
oral medications were initially excluded and covered under Medicare Part D, CMS has 
continued to evaluate and phase in certain ESRD-related oral drugs into the bundled payment 
structure, with implementation timelines extending into the later part of the decade.  
 
 

 
 
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Table 3-13: Laboratory Tests Subject to ESRD Consolidated Billing  
Test Code 
Description 
Test Code 
Description 
80047 
Basic Metabolic Panel (ionized) 
84157 
Assay of protein by other source 
80048 
Basic Metabolic Panel (total) 
84295 
Assay of serum sodium 
80051 
Electrolyte Panel 
84466 
Assay of transferrin 
80053 
Comprehensive Metabolic Panel 
84520 
Assay of urea nitrogen 
80069 
Renal Function Panel 
84540 
Assay of urine/urea-N 
80076 
Hepatic Function Panel 
84545 
Urea-N clearance test 
82040 
Assay of serum albumin 
85014 
Hematocrit 
82108 
Assay of aluminum 
85018 
Hemoglobin 
82306 
Vitamin D, 25 hydroxy 
85025 
Complete CBC, automated (HgB, HCT, RBC, WBC, 
and Platelet Count) and automated differential WBC 
82310 
Assay of calcium 
85027 
Complete CBC, automated (HgB, HCT, RBC, WBC, 
and Platelet count) 
82330 
Assay of calcium, iodized 
85041 
Automated RBC count 
82374 
Assay, blood carbon dioxide 
85044 
Manual reticulocyte count 
82379 
Assay of carnitine 
85045 
Automated reticulocyte count 
82435 
Assay of blood chloride 
85046 
Reticyte/HgB concentrate 
82565 
Assay of creatinine 
85048 
Automated leukocyte count 
82570 
Assay of urine creatinine 
86704 
Hepatitis B core antibody, total 
82575 
Creatinine clearance test 
86705 
Hepatitis B core antibody, IGM 
82607 
Vitamin B12 
86706 
Hepatitis B surface antibody 
82652 
Vitamin D1, 25 dihydroxy 
87040 
Blood culture for bacteria 
82668 
Assay of erythropoietin 
87070 
Culture, bacteria, other 
82728 
Assay of ferritin 
87071 
Culture, bacteria aerobic other 
82746 
Blood folic acid serum 
87073 
Culture, bacteria anaerobic 

 
 
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Test Code 
Description 
Test Code 
Description 
83540 
Assay of iron 
87075 
Culture, bacteria, except blood 
83550 
Iron binding test 
87076 
Culture, anaerobic identify, each 
83735 
Assay of magnesium 
87077 
Culture, aerobic identify 
83970 
Assay of parathormone 
87081 
Culture screen only 
84075 
Assay alkaline phosphatase 
87340 
Hepatitis B surface AG, EIA 
84100 
Assay of phosphorus 
87341 
Hepatitis B surface AG, EIA 
84132 
Assay of serum potassium 
G0499 
HepB screen high risk indiv 
84134 
Assay of prealbumin 
G0306 
CBC/diff WBC w/o Platelet 
84155 
Assay of protein, serum 
G0307 
CBC w/o Platelet 
84157 
Assay of protein by other source 
- 
Protein composition of CSF 
84295 
Assay of serum sodium 
- 
Sodium concentration in serum, plasma or whole 
blood 
Source: CMS ESRD PPS Consolidated Billing List 
 
 

 
 
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Under the previous reimbursement structure, a composite rate system was used to pay 
dialysis facilities, with rates set at a fixed amount per treatment and adjusted through 
Congressional action. While this system covered certain core dialysis services, many items, 
such as drugs and laboratory tests, were reimbursed separately. Medicare generally serves as 
the primary payer for ESRD patients who are not covered by employer-sponsored insurance, 
typically after an initial coordination period, and is available to individuals age 65 and older 
as well as to younger patients with qualifying disabilities or ESRD. Patients who do not 
qualify for Medicare may access state assistance programs, while certain populations, such 
as veterans, may receive care through other federal systems. 
Under the Medicare ESRD program, Medicare typically covers 80% of the approved 
reimbursement amount, with patients responsible for the remaining 20%, although this 
portion is often supplemented by secondary insurance or Medicaid. While bad debt levels in 
the dialysis industry are relatively low, they are largely associated with uncollected patient 
co-insurance obligations. 
Since the implementation of the ESRD Prospective Payment System (PPS) in 2011, 
reimbursement has shifted to a bundled payment model that includes dialysis-related 
services, drugs, and many laboratory tests. CMS continues to update the ESRD PPS annually. 
For calendar years 2024 and 2025, CMS finalized modest payment increases along with 
ongoing policy refinements. For calendar year 2026, CMS continued this trend, increasing 
the base rate to approximately $281.71 and projecting a modest overall payment increase of 
just over 2%. The bundled reimbursement structure remains unchanged, with ongoing 
refinements to wage index adjustments, outlier payment thresholds, and add-on payments for 
drugs, equipment, and training. However, providers continue to face cost pressures from 
labor, staffing, and operating expenses, underscoring the importance of efficiency within the 
bundled payment framework. 
Advanced Laboratory Tests (ADLT) 
Advanced laboratory tests are evaluated separately for payment structures.  To qualify as an 
ADLT, the test must meet one of the following criteria: 
Criterion (A): The test: 
• Is an analysis of multiple biomarkers of DNA, RNA, or proteins. 

 
 
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• When combined with an empirically derived algorithm, it yields a result that predicts 
the probability a specific individual patient will develop a certain condition or 
conditions, or respond to a particular therapy or therapies; 
• Provides new clinical diagnostic information that cannot be obtained from any other 
test or combination of tests; and 
• May include other assays. 
• Criterion (B): The test is cleared or approved by the FDA. 
• Laboratories requesting ADLT status under Criterion (B) are required to submit 
documentation of premarket approval or premarket notification from the FDA. 
 
 

 
 
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Table 3-14: List of Approved ADLTs, March 2026 
Test Code 
Company 
Test Name 
Test Descriptor 
Approval 
Date 
New ADLT 
Initial 
Period 
Payment 
Amount for 
Dates of 
Service 
Before Initial 
Period 
Payment 
Amount for 
Dates of 
Service 
During New 
ADLT Initial 
Period 
0537 U 
Guardant 
Health 
Shield 
Oncology analysis of cell-
free DNA for epigenomic 
patterns, NGS >2500 
differentially methylated 
regions, plasma, 
algorithm, reported as 
positive or negative 
09/10/2025 
4/1/2025-
12/31/2025 
Contractor 
Priced  
$1,495 
0473 U 
Tempus AI 
xT CDx 
ONC SLD Tum BLD/SLV 
648 GENE 
06/26/2024 
7/1/2024-
3/31/2025 
Contractor 
Priced 
$4,500 
0356U 
Naveris 
NavDx 
Oncology eval of 17 DNA 
biomarkers using ddPCR, 
cell-free DNA, algorithm 
reported as a prognostic 
risk score for cancer 
recurrence 
03/18/2024 
4/1/2024-
12/31/2024 
Contractor 
Priced 
$1,800 
0315U  
Castle 
Biosciences 
DecisionDx-SCC 
Oncology (cutaneous 
squamous cell 
carcinoma), mRNA gene 
expression 
profiling by RT-PCR of 40 
genes (34 content and 6 
housekeeping), utilizing 
formalin-fixed paraffin-
embedded (FFPE) tissue, 
algorithm reported as a 
categorical risk result 
(i.e., Class 1, Class 2A, 
Class 2B) 
06/30/2023 
7/1/2023-
3/31/2024 
Contractor 
Priced 
$8,500 
0360U 
Biodesix 
Nodify CDT 
Oncology (lung), enzyme-
linked immunosorbent 
assay (ELISA) of 7 
autoantibodies (p53, NY-
ESO-1, CAGE, GBU4-5, 
SOX2, MAGE A4, and 
HuD), 
plasma, algorithm 
reported as a categorical 
result for risk of 
malignancy 
06/30/2023 
n/a 
n/a 
n/a 

 
 
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Test Code 
Company 
Test Name 
Test Descriptor 
Approval 
Date 
New ADLT 
Initial 
Period 
Payment 
Amount for 
Dates of 
Service 
Before Initial 
Period 
Payment 
Amount for 
Dates of 
Service 
During New 
ADLT Initial 
Period 
0295U 
PreludeDx 
DCISionRT 
Oncology (breast ductal 
carcinoma in situ), 
protein expression 
profiling by 
immunohistochemistry of 
7 proteins (COX2, FOXA1, 
HER2, Ki-67, p16, PR, 
SIAH2), with 4 
clinicopathologic factors 
(size, age, margin status, 
palpability), utilizing 
formalin-fixed paraffin-
embedded (FFPE) tissue, 
algorithm reported as a 
recurrence risk score 
03/23/2023 
4/1/2023-
12/31/2023 
Contractor 
Priced 
$2.350 
01080 
Castle 
Biosciences 
TissueCypher 
Barrett’s 
Esophagus Assay 
Gastroenterology 
(Barrett’s esophagus), 
whole slide–digital 
imaging,  
including morphometric 
analysis, computer-
assisted quantitative  
immunolabeling of 9 
protein biomarkers (p16, 
AMACR, p53, CD68, COX-
2,  
CD45RO, HIF1a, HER-2, 
K20) and morphology, 
formalin-fixed paraffin-
embedded tissue, 
algorithm reported as risk 
of progression to high-
grade  
dysplasia or cancer 
03/24/22 
4/1/22-
12/31/22 
Contractor 
Priced 
$2,350 
TBD 
Natera 
Signatera 
TBD 
6/17/21 
7/1/21-
3/31/22 
Contractor 
Priced 
$3,500 
0242U 
Guardant 
Health, Inc. 
Guardant360 
CDx 
Targeted genomic 
sequence analysis panel, 
solid organ neoplasm, 
cell-free circulating DNA 
analysis of 55-74 genes, 
interrogation for 
sequence variants, gene 
copy number 
amplifications, and gene 
rearrangements 
3/18/2021 
4/1/21 – 
12/31/21 
Contractor 
Priced 
$5,000 

 
 
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Test Code 
Company 
Test Name 
Test Descriptor 
Approval 
Date 
New ADLT 
Initial 
Period 
Payment 
Amount for 
Dates of 
Service 
Before Initial 
Period 
Payment 
Amount for 
Dates of 
Service 
During New 
ADLT Initial 
Period 
0239U 
Foundation 
Medicine, 
Inc. 
FoundationOne 
Liquid CDx 
Targeted genomic 
sequence analysis panel, 
solid organ neoplasm, 
cell-free DNA, analysis of 
311 or more genes, 
interrogation for 
sequence variants, 
including substitutions, 
insertions, deletions, 
select rearrangements, 
and copy number 
variations 
1/25/2021 
4/1/21 – 
12/31/21 
Contractor 
Priced 
$3,500 
81554 (eff. 
7/1/2020) 
Veracyte 
Envisa Genomic 
Classifier 
Pulmonary disease 
(idiopathic pulmonary 
fibrosis [IPF]), mRNA, 
gene expression analysis 
of 190 genes, utilizing 
transbronchial biopsies, 
diagnostic algorithm 
reported as categorical 
result (eg, positive or 
negative for high 
probability of usual 
interstitial pneumonia 
[UIP]) 
9/17/2020 
10/1/20- 
6/30/21 
Contractor 
Priced 
$5,500 
0172U (eff. 
7/1/2020) 
Myriad 
myChoice CDx 
Oncology (solid tumor as 
indicated by the label), 
somatic mutation analysis 
of BRCA1 (BRCA1, DNA 
repair associated), BRCA2 
(BRCA2, DNA repair 
associated) and analysis 
of homologous 
recombination deficiency 
pathways, DNA, formalin-
fixed paraffin-embedded 
tissue, algorithm 
quantifying tumor 
genomic instability score 
12/11/2019 
1/1/20-
9/30/20 
Contractor 
Priced 
$4,040.00  
0090U 
Myriad 
myPath 
Melanoma 
Oncology (cutaneous 
melanoma), mRNA gene 
expression profiling by 
RTPCR of 23 genes (14 
content and 9 
housekeeping), utilizing 
formalin-fixed paraffin-
embedded tissue, 
algorithm reported as a 
categorical result (i.e., 
benign, indeterminate, 
malignant) 
9/6/2019 
10/1/19-
6/30/20 
Contractor 
Priced 
$1,950.00  

 
 
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Test Code 
Company 
Test Name 
Test Descriptor 
Approval 
Date 
New ADLT 
Initial 
Period 
Payment 
Amount for 
Dates of 
Service 
Before Initial 
Period 
Payment 
Amount for 
Dates of 
Service 
During New 
ADLT Initial 
Period 
0080U 
Biodesix 
BDX-XL2 
Oncology (lung), mass 
spectrometric analysis of 
galectin-3-binding protein 
and scavenger receptor 
cysteine-rich type 1 
protein M130, with five 
clinical risk factors (age, 
smoking status, nodule 
diameter, nodule 
spiculation status and 
nodule location), utilizing 
plasma, algorithm 
reported as a categorical 
probability of malignancy 
5/17/2019 
7/1/19-
3/31/20 
Contractor 
Priced 
$3,520.00  
81529 (eff. 
1/1/2021) 
Castle 
Biosciences, 
Inc. 
DecisionDx-
Melanoma 
Oncology (uveal 
melanoma), mRNA, gene-
expression profiling by 
real-time RT-PCR of 15 
genes (12 content and 3 
housekeeping genes), 
utilizing fine needle 
aspirate or formalin-fixed 
paraffin-embedded 
tissue, algorithm 
reported as risk of 
metastasis 
5/17/2019 
7/1/19-
3/31/20 
Contractor 
Priced 
$7,193.00  
81552* 
(eff. 
1/1/2020) 
(Previously 
0081U) 
Castle 
Biosciences, 
Inc. 
DecisionDx-UM 
Oncology (uveal 
melanoma), mRNA, gene-
expression profiling by 
real-time RT-PCR of 15 
genes (12 content and 3 
housekeeping genes), 
utilizing fine needle 
aspirate or formalin-fixed 
paraffin-embedded 
tissue, algorithm 
reported as risk of 
metastasis 
5/17/2019 
N/A 
N/A 
N/A 
81538* 
Biodesix 
Veristrat 
Oncology (lung), mass 
spectrometric 8-protein 
signature, including 
amyloid A, utilizing 
serum, prognostic and 
predictive algorithm 
reported as good versus 
poor overall survival 
(VeriStrat, Biodesix, Inc.) 
12/21/2018 
N/A 
N/A 
N/A 

 
 
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Test Code 
Company 
Test Name 
Test Descriptor 
Approval 
Date 
New ADLT 
Initial 
Period 
Payment 
Amount for 
Dates of 
Service 
Before Initial 
Period 
Payment 
Amount for 
Dates of 
Service 
During New 
ADLT Initial 
Period 
0037U 
Foundation 
Medicine, 
Inc. 
FoundationOne 
CDx 
Targeted genomic 
sequence analysis, solid 
organ neoplasm, DNA 
analysis of 324 genes, 
interrogation for 
sequence variants, gene 
copy number 
amplifications, gene 
rearrangements, 
microsatellite instability 
and tumor mutational 
burden 
5/18/2018 
7/1/18 - 
3/31/19 
Contractor 
Priced 
$3,500.00  
*Existing ADLT. An existing ADLT is a laboratory test for which ADLT status has been granted by CMS and payment for the test has been 
made under the Medicare CLFS prior to January 1, 2018. 
See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/Guidance-for-Laboratories-
on-ADLTs.pdf for more information. 
Source: CMS 
Precision Medicine and NGS 
Precision medicine refers to the tailoring of disease prevention, diagnosis, and treatment to 
the individual characteristics of each patient. While traditional medical approaches have 
historically followed a one-size-fits-all model, it is now well understood that patients can 
respond very differently to the same therapy. Advances in precision medicine have led to the 
development of targeted therapies and diagnostic tools based on genetic, molecular, and 
phenotypic characteristics, particularly in oncology, where molecular testing is now routinely 
used to guide treatment decisions, improve clinical outcomes, and reduce unnecessary 
toxicity. 
The success of precision medicine is closely tied to the quality and depth of diagnostic 
testing. Next-generation sequencing has become a cornerstone technology, enabling rapid 
and comprehensive analysis of large portions of the genome. These tests allow clinicians and 
researchers to identify genetic variants that inform diagnosis, guide therapy selection, and 
improve understanding of disease biology. As a result, NGS has moved from a specialized 
research tool to a core component of clinical care in areas such as cancer, rare disease, and 
infectious disease. 

 
 
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The FDA continues to play a role in ensuring that NGS-based tests are accurate, reliable, and 
clinically meaningful. The large volume and complexity of data generated by sequencing 
technologies present regulatory challenges compared to traditional single-analyte tests. In 
response, the FDA has worked with stakeholders across industry, academia, and healthcare 
to support more flexible regulatory approaches that incorporate evolving standards, curated 
genomic databases, and advanced bioinformatics methods. Earlier guidance helped establish 
pathways for demonstrating analytical and clinical validity. 
In recent years, NGS-based companion diagnostics have become increasingly common, 
supporting the use of targeted therapies across a range of cancers. Assays such as Oncomine 
Dx Target Test and FoundationOne CDx reflect the growing integration of genomic profiling 
into routine oncology care. More recently, precision medicine has continued to evolve toward 
highly individualized approaches, with growing interest in therapies designed for very small 
patient populations or even single patients, particularly in rare diseases. Advances in artificial 
intelligence, gene editing technologies, and bioinformatics are expanding the ability to 
identify actionable targets, optimize treatment selection, and support clinical decision-
making. In addition, sequencing technologies are increasingly used not only for diagnosis 
but also to support therapy development, safety assessment, and clinical trial design 
IVD Market in Europe 
The IVD industry in Europe is undergoing significant regulatory change under the In Vitro 
Diagnostic Regulation (IVDR 2017/746), which replaced the previous IVDD framework. 
Although the regulation formally took effect on May 26, 2022, full implementation has been 
phased in through extended transition timelines that now run into 2027–2028 for many 
devices. The IVDR introduces stricter compliance requirements, expanded expectations for 
clinical evidence, and a risk-based classification system designed to enhance patient safety, 
improve product performance, and increase market transparency. 
Key developments include: 
• Notified Bodies are now designated to assess IVD devices under IVDR; however, 
capacity constraints remain, contributing to longer certification timelines and ongoing 
bottlenecks. 
• IVDs are classified into risk categories (Classes A–D), with higher-risk devices 
subject to more rigorous conformity assessment and oversight. 

 
 
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• Many manufacturers have experienced delays in transitioning to IVDR due to 
increased regulatory complexity, higher data requirements, and limited Notified Body 
availability. 
• Transitional provisions have been extended to avoid supply disruptions, allowing 
legacy devices to remain on the market while manufacturers work toward 
compliance. 
The impact of IVDR is increasingly evident across the European IVD market. Many 
manufacturers are rationalizing their product portfolios, prioritizing higher-volume, higher-
margin assays while discontinuing lower-volume or niche tests due to increased compliance 
costs and complexity. This has raised concerns about potential gaps in test availability, 
particularly for specialized or rare disease diagnostics. 
Notified Body capacity, while improved compared to earlier years, remains constrained 
relative to demand, requiring manufacturers to plan submissions well in advance. At the same 
time, regulatory scrutiny of laboratory-developed tests has increased, prompting hospital and 
reference laboratories to reassess their test menus and documentation processes to ensure 
compliance, potentially shifting some testing toward commercially available IVD kits. 
The cost of compliance has risen significantly, driven by requirements for clinical evidence, 
performance evaluation, post-market surveillance, and quality system upgrades. Smaller 
companies in particular face challenges in meeting these requirements, contributing to 
ongoing market consolidation. Despite these challenges, IVDR is expected to improve 
overall quality, transparency, and standardization in the European IVD market, while 
strengthening alignment between diagnostics, clinical evidence, and precision medicine 
applications. 
The European IVD market has stabilized following pandemic-related disruption, although 
economic growth remains modest. Ongoing geopolitical tensions and elevated energy and 
commodity costs continue to influence the broader economic environment. Growth in the 
region has been relatively slow but stable, with gradual improvement expected as regulatory 
clarity increases and healthcare systems adapt to new requirements. In the IVD sector, the 
market continues to show gains across all segments in 2025. 
Glucose testing is roughly 18% of the European IVD markets. Despite the increasing number 
of type 2 diabetic patients, there remains a significant barrier to adoption due to cost. Prior 
to COVID-19, European markets were experiencing improved economic stability and rising 

 
 
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GDP. There is still a great deal of uncertainty about economic stability due to the lingering 
Russia-Ukraine conflict. The following information from the European Commission 
describes economic indicators from 2020 through 2024 for select European countries. 
Kalorama Information’s research indicates that the UK has increased demand for precision 
medicine; France has seen technological advancements that are driving growth; and Germany 
has increased demand for early disease detection.  
Figure 3-5: International Monetary Fund Inflation Map, Global 2024 
 
Source: International Monetary Fund 
 
 

 
 
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In 2025, the countries in Western Europe account for 27% of the global IVD market.  Country 
market estimates are detailed below. 
Table 3-15: Western European IVD Market, by Country, 2025 ($ million, estimated)  
 
[Austria; Belgium; Denmark; Finland; France; Germany; Greece; Ireland; Italy; Luxembourg; Netherlands; 
Norway; Portugal; Spain; Sweden; Switzerland; UK] 
Country 
Sales 
Germany 
9,244 
France 
4,958 
UK 
4,160 
Italy 
3,465 
Spain 
2,667 
Netherlands 
1,301 
Switzerland 
1,256 
Sweden 
741 
Belgium 
737 
Austria 
692 
Denmark 
437 
Portugal 
407 
Greece 
363 
Ireland 
356 
Finland 
321 
Norway 
216 
Luxembourg 
170 
Total 
31,491 
Source: Kalorama Information 

 
 
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EU Regulation 
The European Directive 98/79/EC on in vitro diagnostic medical devices provides Europe 
with one single regulation for in vitro diagnostics (IVD). Devices receiving the CE mark after 
a successful conformity assessment procedure can be introduced into 32 European member 
countries and those that have signed agreements. 
The IVDR introduces a new risk-rule classification system based on the Global 
Harmonization Task Force (GHTF) classification rules, which, for the first time, takes patient 
impact into account.  This change to the classification system will affect all IVD 
manufacturers. The majority of IVDs are currently self-declaring devices, but under the new 
regulation, about 80% of IVDs require some form of conformity assessment by a Notified 
Body. 
Under the IVD Directive, approximately 80% of IVDs on the EU market are self-declared 
devices, in which the manufacturer has sole responsibility for meeting the directive's 
requirements. Under the new regulation, 80% of IVDs will require some form of conformity 
assessment by a Notified Body.  The new in vitro diagnostic medical device regulations 
contain a series of important improvements to modernize the current system. These include: 
• Classification and Conformity Assessment - In the new classification system, IVD 
devices will be divided into four classes of risk: A (lowest risk), B, C and D (highest 
risk). Using the seven classification rules, devices will be divided into one of four 
classes that dictate notified body involvement. The conformity assessment procedure 
for the lowest-risk Class A devices will be the manufacturer's sole responsibility. 
Class B, C, and D devices are characterized by increasing risk levels and will all 
require involvement of a notified body. 
• Clinical Evidence -  A performance evaluation report that includes the scientific 
validity report, the analytical performance report, the clinical performance report, and 
an assessment of these reports will be required; the reinforcement of clinical evidence, 
including an EU-wide coordinated procedure for authorization of multi-center clinical 
investigations. 
• Identification and Traceability - Manufacturers must have a UDI (unique device 
identification) on the device label. Additionally, manufacturers of high-risk Class C 
and D devices are to make publicly available a summary of safety and performance.  

 
 
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• Notified Bodies - The position of notified bodies in relation to manufacturers will be 
significantly strengthened. They have a right and duty to carry out unannounced 
factory inspections and to conduct physical or laboratory tests on devices. The 
regulation also requires rotation of the notified body’s personnel involved in IVD 
assessments at appropriate intervals to strike a reasonable balance with the knowledge 
and experience required to carry out thorough assessments. 
• Vigilance and Market Surveillance - An electronic portal will be introduced, where 
manufacturers can report serious incidents, safety corrective actions, field safety 
notices and periodic summary reports. There is also a reduction for reporting a serious 
incident to the national competent authority within 15 days of the manufacturer 
becoming aware of the incident. 
• Companion Diagnostics - Companion diagnostics will be classified in Class C and 
will require notified body involvement. 
Concerns about the capacity of the European Union’s notified body system to support timely 
certification under the Medical Device Regulation and In Vitro Diagnostic Regulation remain 
an issue in the regulatory landscape in 2026, although conditions have improved compared 
to the early implementation period. The approval pathway was slower than expected, creating 
significant bottlenecks for manufacturers seeking conformity assessment. While the number 
of designated notified bodies has increased substantially since then, capacity remains uneven 
across product categories and risk classes, particularly for complex and higher-risk devices 
and IVDs. As a result, manufacturers continue to face extended timelines and must engage 
early with notified bodies to secure review slots. 
The MDR became applicable in May 2021 following a one-year pandemic-related delay, and 
the IVDR became applicable in May 2022. Since that time, additional legislative measures 
have extended transition periods, in some cases into the latter part of the decade, allowing 
for a more gradual implementation and helping to reduce the risk of product shortages and 
certification backlogs. Guidance from European regulatory authorities has expanded 
significantly, providing greater clarity, although the interpretation of requirements, 
particularly in areas such as clinical evidence, performance evaluation, and post-market 
surveillance, continues to evolve, placing ongoing demands on manufacturers. 
 

 
 
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The regulatory framework is now firmly established but remains under operational pressure. 
The notified body network has expanded, yet access to capacity and specialized expertise 
continues to limit the pace of certification and recertification, especially for higher-risk IVDs. 
At the same time, the gradual rollout of systems such as EUDAMED, along with continued 
regulatory refinements, reflects a transition toward stabilization rather than disruption. The 
system is functioning, but it remains resource-constrained, and manufacturers are 
increasingly taking a more strategic approach to portfolio management and regulatory 
planning. Early engagement with notified bodies and proactive compliance strategies 
remains essential for maintaining market access in Europe. 
 

 
 
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Table 3-16: IVD Market Per Capita, Europe, 2025 Estimates  
 
[Bulgaria; Croatia; Czech Republic; France; Germany; Greece; Hungary; Italy; Lithuania; Netherlands; 
Poland; Romania; Russia; Serbia; Slovakia; Slovenia; Spain; Sweden; Switzerland; Ukraine; UK] 
Country 
USD ($) 
Bulgaria 
13.97  
Croatia 
33.33  
Czech Republic 
24.91  
France 
70.16  
Germany 
107.69  
Greece 
32.38  
Hungary 
29.29  
Italy 
55.70  
Lithuania 
35.38  
Netherlands 
71.80  
Poland 
26.85  
Romania 
22.98  
Russia 
9.08  
Serbia 
34.18  
Slovakia 
26.96  
Slovenia 
46.67  
Spain 
54.59  
Sweden 
68.87  
Switzerland 
163.03  
Ukraine 
6.89  
United Kingdom 
59.37  
Source: Kalorama Information 

 
 
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Precision Medicine in Europe 
Precision medicine is an important component of European healthcare strategies as 
governments balance cost pressures with the need to improve clinical outcomes. While 
Europe was initially slower than the United States to implement precision medicine, adoption 
has accelerated significantly, particularly in oncology and rare diseases, where biomarker-
driven testing is now part of routine clinical practice in many markets. Reimbursement 
systems across Europe remain fragmented and continue to adapt to the complexity of 
advanced diagnostics, but they are no longer uniformly constrained. Germany, the UK, and 
France continue to lead with more structured reimbursement pathways, due to established 
national genomics programs, health technology assessment frameworks, and targeted 
investment in precision medicine infrastructure. The UK stands out for its coordinated 
national approach to genomics and testing, while other countries, including the Netherlands 
and the Nordic region, have made meaningful progress in integrating precision diagnostics 
into clinical care, although funding levels and access continue to vary. 
Despite this progress, there is still no fully harmonized EU-wide system for reimbursement 
of precision medicine diagnostics, as coverage and pricing decisions remain at the national 
level. However, coordination across Europe in evaluating clinical evidence is increasing, 
supported by emerging EU-level health technology assessment frameworks and greater 
alignment among regulatory and HTA bodies. This has begun to reduce duplication and 
improve consistency in clinical review, although it has not eliminated differences in 
reimbursement outcomes. As a result, precision medicine in Europe is no longer confined to 
pilot programs, but it is also not yet uniformly accessible, with ongoing disparities in 
reimbursement, infrastructure, and clinical implementation across the region. 
Brexit 
In June 2022, new regulations were published by the UK’s Medicines and Healthcare 
products Regulatory Agency (MHRA). The new regulations improve the safety of medical 
devices. At present, these regulations only apply to Great Britain. The MHRA will allow 
products that have CE marking to remain on the market until July 2028.  

 
 
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Japan 
Japan remains a strong IVD participant. It is highly structured, and it has a strong regulatory 
architecture. Japan’s regulatory process remains rigid.  Japan’s IVD sector is well organized 
and it provides long-range opportunities. There has been an uptick in demand for CDx tests. 
Japan’s IVD sector emphasizes domestic manufacturing, which concentrates in hematology, 
immunochemistry, companion diagnostics, molecular diagnostics, and point-of-care testing.  
Japan’s IVD sector encourages AI-enhanced platforms, rapid immunoassays and at-home 
testing.  
 In 2025, the Japanese market for IVDs is estimated at nearly $5,726 million, growing at an 
average annual rate of 3.5%. The market will reach roughly $6,810 million in 2030.  Japan 
is the second-largest single-country market after the U.S. and thus holds an important place 
in the IVD market.  While the market for IVDs in Japan remains stable, the Japanese 
government battles significant challenges in containing overall healthcare costs as its 
population ages and the national budget deficit continues to expand.  
Healthcare spending represents about 10.8% of GDP in Japan. Exacerbating the issue is the 
“2025 problem”, in which all baby boomers in Japan will have at least reached the age of 75, 
which will increase healthcare costs even further, as the government foots a greater portion 
of the bill for citizens who reach that age.  The Japanese government will continue to evaluate 
budget requests to address growing demands for health services.  
Overall, this is a large market but not a growth opportunity for new IVD vendors.  Global 
leaders have a strong grip on the market, and significant local competition is also a factor. 
Entry into the Japanese IVD market is hard, with many regulatory hoops to navigate and a 
strong domestic market. 
General influences affecting the level and mix of clinical chemistry product demand in Japan 
include a prosperous but slow-growing economy; a steadily aging, gradually shrinking 
population; and an advanced, well-distributed medical delivery system.  More direct 
influences include hospitalization, surgical, and outpatient consultation rates that are well 
above global averages, as well as tight government controls on healthcare benefits and costs. 
Healthcare coverage in Japan is provided through a broad-based social insurance system 
operated by the Ministry of Health and Welfare (MHW).  The system incorporates two major 

 
 
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types of health plans, occupational and regional.  Occupational plans, managed either by 
health insurance societies or government agencies, cover private employees, government 
workers, merchant seamen, teachers, and their dependents.  Specific benefits include up to 
80 percent reimbursement for hospital care, outpatient care, nursing care services, and 
ambulance transportation.  In addition, the plans pay for up to 70 percent of prescription 
drugs and medical supplies.  Dependent coverage is set at 80 percent for inpatient services 
and 70 percent for outpatient care and medical products. 
Funding for occupational health plans is obtained from payroll taxes and employer 
contributions, with the MHW absorbing all or part of the administrative expenses.  In addition 
to primary healthcare, these plans provide varying levels of benefits for lost wages, maternity 
leave, and funeral costs.  About two-thirds of the population is eligible for occupational 
health insurance.  Residents who are not enrolled in occupational health plans (including 
retirees, agricultural workers, self-employed individuals, unemployed persons, and their 
dependents) are covered by regional health insurance plans.  Administered by municipalities 
and trade associations, these schemes pay for between 70 and 80 percent of primary 
healthcare services.  In addition to regional plans, elderly residents are eligible for 
supplemental health insurance through the Health and Medical Services System for the 
Elderly.  This program provides partial reimbursement for most home healthcare procedures, 
nursing home care, and various other services. 
Because of the extensive nature of public coverage, private health insurance plays a very 
limited role in the Japanese medical delivery system.  Most private plans provide upgraded 
inpatient accommodations and cover selected outpatient services and medications that are 
not eligible for public reimbursement.  Due to a potentially adverse effect on cost 
containment, private health insurance, by law, is not permitted to absorb patient copayments 
required by the national health insurance system.   
The rapid aging of the population will expand the need for clinical chemistry testing in Japan.  
Moreover, the country’s advanced medical delivery system will strive to keep current with 
advances in reagent and instrument technologies.  This trend will have a favorable impact on 
demand posted by most clinical chemistry product groups.  On the downside, hospital, 
clinical laboratory and point-of-care markets will become increasingly price-sensitive as the 
national health insurance imposes tighter constraints, and often reductions, on reimbursement 
rates for patient tests.  Other diagnostic tests will be purchased as Japan faces new disease 
threats.   

 
 
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Table 3-17: Japan IVD Market, Share by Segment, 2025 (%)  
 
[Clinical Chemistry; Coagulation; Hematology; Histology; Immunoassay Infectious Disease; Immunoassay 
Other; Microbiology ID/AST; Microbiology Molecular; POC Diabetes; POC Other; Others] 
Segment 
Share 
POC Other 
15% 
POC Diabetes 
14% 
Immunoassay Other 
13% 
Histology 
12% 
Microbiology ID/AST 
9% 
Clinical Chemistry 
8% 
Microbiology Molecular 
8% 
Hematology 
7% 
Immunoassay Infectious Disease 
5% 
Coagulation 
4% 
Others 
6% 
Total 
100% 
Market in $ million = $5,726 
Source: Kalorama Information 

 
 
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Eastern Europe: Growth Region 
The Eastern European IVD market is making steady gains, mainly due to rising rates of 
chronic diseases and growing demand for rapid, non-invasive diagnostic tests. The market, 
with government support, has encouraged the adoption of advanced technologies such as 
liquid biopsies, NGS, immunoassays and point-of-care testing. Many companies are seeking 
out Eastern Europe as a place to make gains.   
Table 3-18: Eastern European IVD Market, by Country, 2025 ($ million)  
 
[Bulgaria; Croatia; Czech Republic; Hungary; Poland; Romania; Slovakia; Slovenia; Ukraine; Other] 
Country 
Sales 
Poland 
1,047 
Romania 
428 
Hungary 
304 
Czech Republic 
273 
Ukraine 
218 
Slovakia 
151 
Croatia 
140 
Slovenia 
97 
Bulgaria 
96 
Other Eastern Europe* 
624 
Total 
3,378 
Note: *Albania, Belarus, Bosnia, Estonia, Herzegovina, Kosovo, Latvia, Lithuania, Macedonia, Moldova, Montenegro, Serbia 
Source: Kalorama Information 
 

 
 
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Figure 3-6: Eastern Europe IVD Market, by Country, 2025 ($ million)  
 
[Bulgaria; Croatia; Czech Republic; Hungary; Poland; Romania; Slovakia; Slovenia; Ukraine; Other] 
 
Source: Kalorama Information 
 

 
 
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China: Current IVD Market 
During 2025, several diagnostics and medical device companies reported slower sales growth 
in China, reflecting changes in reimbursement, pricing, and public procurement policies that 
reduced demand for higher-priced IVD products. At the same time, China and Malaysia 
launched a mutual regulatory reliance pathway for medical devices and in vitro diagnostics, 
aimed at streamlining reviews and accelerating market access. The pilot program, 
implemented by China’s National Medical Products Administration and Malaysia’s Medical 
Device Authority, went into effect on July 30, 2025. 
In 2025, the Chinese market for IVDs is estimated at nearly $5,997 million and is expected 
to grow at an annual rate of 2.1% to reach $7,361 million in 2030.  Glucose monitoring is a 
major focus area in the Chinese IVD market, accounting for roughly 21% of the market value.   
China is one of the largest IVD markets globally and a key region in the Asia Pacific; 
however, growth has slowed relative to earlier revenue expectations. The market has 
experienced pricing pressure and slower expansion due to healthcare reforms and centralized 
and volume-based procurement programs. The country has implemented increased cost 
controls, particularly affecting reagent pricing and routine testing. While the number of 
domestic IVD companies has continued to grow, consolidation is beginning to emerge as 
smaller players face margin pressure and increased regulatory requirements. The decline in 
testing volumes following the COVID-19 pandemic has also contributed to slower growth, 
particularly in molecular diagnostics. 
 
 

 
 
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Table 3-19: China IVD Market, Share by Segment, 2025 (%)  
 
[Blood Bank Screening; Clinical Chemistry; Coagulation; Hematology; Histology; Immunoassay Infectious 
Disease; Immunoassay Other; Microbiology ID/AST; Microbiology Molecular; POC Diabetes; POC Other; 
Others] 
Segment 
Share 
POC Diabetes 
21% 
POC Other 
13% 
Clinical Chemistry 
12% 
Immunoassay Other 
9% 
Microbiology ID/AST 
8% 
Immunoassay Infectious Disease 
8% 
Hematology 
8% 
Microbiology Molecular 
5% 
Histology 
5% 
Coagulation 
3% 
Blood Bank Screening Molecular 
2% 
Others 
6% 
Total 
100% 
Market in $ million = $5,997 
Source: Kalorama Information 
Along with India, the People’s Republic of China is one of the world’s most populous 
countries, with more than 1.4 billion people. Of these, more than 1.39 billion live in mainland 
China and about 7 million live in Hong Kong. At present, the Chinese population is growing 
at an annual rate of 0.5%. The government's goal is to stabilize the population and population 
growth early in the 21st century. 
The population distribution is expected to shift toward the 65-and-over group, which is 
projected to account for 27% of the total Chinese population by 2050, up from less than 3% 

 
 
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in 2010.  Both the 15-64 and 0-14 population groups are declining considerably, accounting 
for 60% and 13% of the population in 2050, respectively; this is down from 73% and 18% in 
2010.  The two most impactful reasons for changing demographics are a lower birth rate and 
increasing life expectancy.   
Table 3-20: Total Midyear Population, by Broad Age Group: China, 2010-2050 (million persons) 
Age Group 
2010 
2020 
2030 
2040 
2050 
CAGR 
2010-2050 
% of Total 
China 
Population 
(2010) 
% of Total 
China 
Population 
(2050) 
0-14 
240.2 
241.1 
221.1 
178.8 
170.8 
-0.8% 
18% 
13% 
15-64 
981.5 
980.9 
944.1 
859.4 
782.7 
-0.6% 
73% 
60% 
65+ 
115.0 
172.0 
238.7 
326.5 
348.1 
2.8% 
9% 
27% 
Total 
1,336.7 
1,394.0 
1,403.9 
1,364.7 
1,301.6 
-0.1% 
100% 
100% 
Source: Kalorama Information 
China spends only about $4.19 per person per year on IVD products, indicating a 
significantly underserved market.  To address the growing demand for health services, recent 
improvements to the medical insurance system were announced, and these changes may 
boost opportunities in the diagnostic market. In September 2021, the State Council 
announced a Five-Year Plan for National Medical Security and outlined improvements to the 
medical insurance system to better address the growing needs of the Chinese population, 
including access to medical services and drugs. This piggybacks on the 13th Five-Year Plan, 
which wrapped up in 2020 and led to increased medical coverage for the population.  
In a geographical sense, the IVD market distribution in China is fragmented, with the 
invigoration of rural healthcare and the rising profile of second-tier cities outside the already 
highly competitive first-tier cities of Hong Kong, Shanghai, Beijing, Guangzhou, Tianjin, 
and Shenzhen. However, distribution to these urbanized provinces and emerging cities 
involves new regulatory authorities, including those outside of first-tier markets with slight 
oversight by central authorities. China is a highly price-sensitive market as a middle-income, 
developing country. The healthcare market trait is reinforced by highly decentralized pricing 
and reimbursement schemes and diversified purchasing strategies. There are 33 provinces, 

 
 
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each of which operates a Provincial Pricing Bureau. All products must be assigned a price 
before distribution and sales. Pricing of routine reagents and semi-automated instruments has 
been fairly straightforward with established precedents in the healthcare sector. 
China’s hospital density per 100,000 population is estimated at about 0.9, again showing a 
significant disproportion when compared with other Asian countries, such as Japan, which 
exceeds 7/100,000, and Korea, with 3.42/100,000.   
Most hospitals in China are evaluated as three major levels (I, II, and III). Each of these levels 
is further divided into A, B and C.  With this classification, class III A is the best. Most testing 
is done in hospital laboratories. There is virtually no physician office laboratory testing in 
China, and commercial laboratories account for only 2% of the IVD market value. 
China is changing its reimbursement policy, which will no longer allow differentiation based 
on testing methodology. This could hurt CLIA testing and other automatic immunoassay 
systems. There are thousands of domestic IVD manufacturers, who are becoming major 
suppliers of ELISA and point-of-care tests, but CLIA systems, which are the prevailing 
hospital laboratory immunoassay technology in Europe and the U.S., are still behind. 
The majority of the population cannot benefit from immunoassay technology for the time 
being due to poor cold-chain transportation, high costs, and a lack of reliable electricity and 
trained laboratory technicians. Rapid testing is the first technology that can reach remote yet 
major potential users, while manual ELISAs and an open system are ideal for this market. 
China faces cancer as a mounting health challenge, as cancer is believed to be the leading 
cause of death in China. The burden of several forms of cancer, such as lung, stomach, liver, 
colorectal, and esophageal, proportional to the population, is significantly above global 
averages. Among urban Chinese, cancer is the leading killer, with lung cancer as the most 
dominant contributor.  
This reflects a rising public health threat from cancer throughout both developed and 
developing nations. According to the American Cancer Society, 1 in 8 deaths worldwide are 
due to cancer, and globally, cancer causes more deaths than HIV/AIDS, tuberculosis, and 
malaria combined. It is the leading cause of death in economically developed countries and 
the second leading cause of death in developing countries, and imposes a substantial burden 
on the world economy.  

 
 
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Tobacco is one of the main culprits for much of the increase in cancer in developing 
countries, especially in the Asia Pacific, where one-third of the world’s smokers live. China 
alone is home to 350 million smokers. According to a report from the International Agency 
for Research on Cancer (IARC), about 15% of cancers in low- and middle-income countries 
are linked to tobacco use, and that figure is expected to climb sharply. People in developing 
countries are also adopting other Western habits, such as overeating and exercising too little. 
Meanwhile, they have less access to resources for prevention and treatment. In China, the 
country with the world’s highest population of smokers, annual lung cancer mortality rates 
have risen by 500% over the past 25 years, representing about 626,000 lung cancer deaths 
annually. 
The prevalence of non-communicable chronic diseases associated with risk factors such as 
inactivity, smoking, diet and urban air quality has risen across the Chinese population in the 
past several decades due to modernization and income mobility. The scourge of diabetes has 
already been noted in this chapter. Cardiovascular disease has also seen significant movement 
in the past decade or has remained elevated in the Chinese population relative to global 
averages.  Hypertension is another condition that has resulted in an increasing morbidity rate 
for Chinese urban populations in recent years. 
China is seeing a rise in chronic lifestyle diseases overall. Roche offers the cobas pro 
integrated solutions for the core laboratory. The product is a scalable, modular serum work 
area analyzer for mid- to high-volume clinical chemistry and immunochemistry testing. 
Clinical Laboratory Market in China 
The clinical laboratory testing market in China is valued at $3.4 for 2024.  The China National 
Accreditation Service (CNAS) database contains records of over 500 accredited laboratories 
across the country.  Of these, the majority are hospital-based laboratories (73%), followed 
by university laboratories (21%) and independent or reference laboratories (6%). 
China has begun encouraging the private sector to invest in hospitals to help ease the burden 
placed on the public health-care system, which is grappling with surging rates of chronic 
conditions such as diabetes and heart disease.  Chinese patients are often reluctant to choose 
private hospitals because they rarely receive government reimbursement for medical 
treatment. 

 
 
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Globally, about 20,000 independent clinical laboratories are currently operational, and China 
represents a major market opportunity due to its favorable demographics. Demand for service 
from the growing urban middle class has spurred the development of private labs.  There are 
about 110 independent clinical laboratories in China, but most are small and lack China 
National Accreditation Service (CNAS) accreditation—roughly 1/3 of facilities are 
accredited.     
China is home to an estimated 10% of all laboratories worldwide providing clinical genetic 
testing services; 15% of all NGS systems used in research or applied testing; and nearly 10% 
of global revenue from cancer testing services. Outside of North America, Europe and Japan, 
China is primed to emerge as the leading market for clinical NGS and molecular cancer 
testing.   
Volume-Based Procurement in China 
Chinese healthcare has undergone significant reform in recent years as the government seeks 
to control costs amid an aging population and rising rates of chronic disease. Historically, 
procurement of drugs and in vitro diagnostics was decentralized, but this approach proved 
insufficient to manage growing healthcare expenditures. In response, the government 
introduced a more centralized and structured system through volume-based procurement 
(VBP), overseen by the National Healthcare Security Administration in coordination with 
regional and national procurement bodies. This system centralizes operations to negotiate 
lower prices, fundamentally reshaping purchasing dynamics across the healthcare sector. 
The impact on the IVD industry has been significant, with substantial pricing pressure and 
margin compression across many product categories. While the degree of price reduction 
varies, the overall effect has been a shift toward lower-cost procurement, creating challenges 
for both domestic and multinational companies. Rather than exiting the market, most 
companies have adjusted their strategies by focusing on innovative and differentiated 
products that are less exposed to VBP pricing, while also increasing collaboration with local 
partners and strengthening their presence within China’s domestic system. 
China’s healthcare system remains highly diverse, requiring a multifaceted commercial 
approach. Demand is driven primarily by hospital and public laboratory networks, but also 
includes private hospitals, reference laboratories, rural healthcare systems, and research 
institutions. The country’s tiered hospital system remains a central focus of reform, with 
efforts to strengthen primary care and expand access to higher-quality services at larger 

 
 
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medical centers. At the same time, China has continued to promote domestic manufacturing 
and local innovation, increasing competition across the IVD market. 
Reimbursement reform is also ongoing, with broader adoption of case-based payment 
systems such as Diagnosis-Related Groups and Diagnosis-Intervention Packet models. These 
approaches are being implemented across many regions to standardize payments and 
improve cost control, although adoption and execution vary geographically. Policies aimed 
at modernizing healthcare infrastructure and expanding access to medical equipment are 
creating selective growth opportunities, even as pricing pressure remains a defining feature 
of the market. 
Kalorama Information believes that the outlook for business in China remains challenging 
for the short term.  However, the long-term outlook is favorable by focusing on differentiated, 
high-value products, which are not subject to VBP impact.  
 

 
 
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India: Population and Opportunity 
Along with China, India is one of the most populous countries in the world, with 1.4 billion 
people residing in the country in 2025.  It is the seventh-largest country in Asia, behind China.  
Despite a declining birth rate, India’s population will continue to increase, reaching 1.46 
billion by 2030.  An increase in life expectancy will more than offset the lower births in the 
country over the next decade.  Considering the health consequences of aging, the over-65-
year-old group will likely require additional health care, which is also likely to be more 
comprehensive.  Through 2060, the aging population is expected to grow by 3.2% annually, 
reaching 317.7 million, up from 95.2 million in 2020. 
The IVD market in India is considered complex in its regulatory process and has a fragmented 
system for device registration and geographical market penetration.  Despite the challenges, 
the IVD market is growing at a 5% CAGR and attracting steady foreign investment.   India 
is highly dependent on medical imports and continues to grow despite the increasing number 
of domestic medical equipment suppliers.   
India is high in its utilization of public health care but there is a growing demand for private 
services.  This is driving demand in areas such as molecular testing and advanced testing 
technologies.  The burden of obesity, diabetes, and cardiovascular disease is among the major 
drivers for the market, which has increased demand for POC testing, in particular, at the 
consumer level. 
India’s new classification and adverse event systems will provide consistency to harmonize 
regulatory control 
The IVD market in India is valued at $1,390 million in 2025.  The market is expected to grow 
at a 5% CAGR through 2025-2030, reaching $1,803 million in sales.    
 
 

 
 
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Table 3-21: India IVD Market, Share by Segment, 2025 (%)  
 
[Clinical Chemistry, Hematology, Coagulation; Histology/Cytology; Immunoassays; Microbiology/Virology; 
POC Glucose; POC Other; Others] 
Segment 
Share 
Point-of-Care - Other 
39% 
Chemistry, Hematology, Coagulation 
24% 
Immunoassays 
16% 
Microbiology/Virology 
11% 
Point-of-Care - Glucose 
3% 
Histology/Cytology 
4% 
Other segments 
3% 
Total 
100% 
Market in $ million = $1,390 
Source: Kalorama Information 
India is home to over 100 cities with populations large enough to generate demand for 
diagnostic centers that cater to a wide range of requirements. Large metropolitan cities with 
more than one million people include Mumbai, Delhi, Madras, Calcutta, Hyderabad, and 
Bangalore. Cities with people of around one million include Ahmadabad, Kanpur, 
Chandigarh, Patna, Dehradun, Pondicherry, Pune, etc. have a population of around one 
million.  
In terms of population, the country is vast; however, the IVD market remains limited in value 
despite high demand.  The country is classified as a very high degree of risk for infectious 
disease and struggles to diagnose and treat conditions which overwhelm the health 
infrastructure, including: 
• Food- water-borne diseases: bacterial diarrhea, hepatitis A and E, typhoid fever 
• Vector-borne diseases: dengue fever, Crimean-Congo hemorrhagic fever, Japanese 
encephalitis, malaria, and, more recently, COVID-19 

 
 
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• HIV: more than 2.3 million people in India are living with HIV, which is the second 
highest ranking country in the world, second to South Africa. 
• Tuberculosis affects between 2.5 and 3 million people each year in India, accounting 
for more than one-fourth of the world's TB cases.  The high rate of TB in the country 
prompted Honorable Prime Minister Shri Narendra Modi to announce an aggressive 
and ambitious plan to end TB by 2025 with increased notifications of cases and better 
patient-provider support. This initiative has been renewed with an end date of 2030.  
In addition to infectious disease, India is struggling to control its growing rate of obesity, 
where a total of 5% of the population is classified.  In contrast, the country is also facing a 
high rate of underweight and malnutrition in children under the age of 5 years (35% 
underweight).   
Lifestyle and communicable diseases are no longer restricted to urban centers and are 
spreading to rural areas as well. As a large portion of rural areas lack even basic healthcare 
facilities, several cases remain undiagnosed. Both the government and private sector provide 
healthcare in India, but patients increasingly turn to private hospitals and clinics for quality 
treatment and better facilities. According to estimates from industry sources, India has about 
100,000 listed labs, with the majority in tier I cities, and more than double that number of 
unlisted and unregulated labs in tier II and tier III cities. This includes specialized 
laboratories, laboratory facilities in hospitals and nursing homes, and small testing centers 
with basic facilities.  
Leading IVD companies have established themselves in India and are seeking long-term 
growth in the country, with significant investments needed to gain market share and develop 
products for the domestic market and international distribution.  
Although private healthcare expenditures continue to outpace public expenditures by a factor 
of 3 to 1, and out-of-pocket spending accounts for 90% of private expenditures, health 
insurance coverage in India is rising. The growth of private insurance is fast. In addition to 
private insurance, government-provided insurance is available, although it is limited both in 
terms of recipients (typically those who otherwise cannot afford care) and in the amount of 
coverage. Most of these policies have an upward limit of about $3,000 for an entire family, 
and this often suffices for simple conditions and routine care. 
As in other technology sectors, India’s rapidly expanding healthcare industry offers many 
opportunities for globally trained scientists to transfer knowledge and expertise gained 

 
 
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abroad into growing companies. Demand is particularly strong in segments requiring a high 
degree of technical know-how, which is often not available within India’s domestic industry, 
such as pre-clinical contract research and biotechnology. Even more than in the 
pharmaceutical sector, India’s biotech companies offer many opportunities for globally 
trained scientists to transfer the knowledge and expertise they have gained. 
Clinical Laboratory Market in India 
India is a fragmented market; the nation boasts approximately 100,000 laboratories, 
including specialized laboratories, hospital and nursing home laboratories, and small testing 
centers with only basic capacity. Test volumes range from 50 to 100 samples per day at a 
laboratory in a small town to several thousand samples per day at a major laboratory. The 
clinical laboratory service market in India is estimated at roughly $1.1 billion for 2025. 
The quality of services provided by these laboratories also varies widely. The National 
Accreditation Board for Testing and Calibration Laboratories (NABL) was established to 
accredit the laboratories; however, the number of accredited laboratories has remained low 
since its establishment.   
This emerging trend of corporate players establishing diagnostic centers in small towns and 
rural areas will provide opportunities for the import of automated systems and imported 
reagents.  
Government laboratories procure equipment and supplies through tenders where price plays 
a major role in the decision-making process. Private hospitals and laboratories, however, 
make their own purchase decisions and consider both quality and price.  The Government of 
India does not require a license to import equipment and reagents. In fact, imports provide 
approximately 60% of the diagnostic medical equipment and supplies market.  
Several Indian and foreign companies are active in the equipment and reagent market: 
Transasia Bio Medical, Roche Diagnostics, Accurex, Siemens Healthineers, Becton and 
Dickinson, bioMérieux India, Nicholas Piramal, Wipro Biomed, Johnson and Johnson, 
Olympus Diagnostics/Beckman Coulter/Danaher, SigmaAldrich, Hitachi, QuidelOrtho, 
Ranbaxy Diagnostics, and Bio-Rad Laboratories. 
The Indian medical diagnostics laboratory sector is market-driven and poised to grow rapidly 
to meet rising demand from a growing middle class that supports the private healthcare 

 
 
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sector.  Existing hospitals are upgrading their medical laboratory facilities, and new hospital 
projects and stand-alone medical laboratories are being incorporated in the country.  These 
developments continue to contribute to the growth of the medical laboratory reagents.   
IVD Regulation  
The Medical Device Regulation Act of 2020 is the regulatory framework for medical devices. 
Medical devices and IVDs are controlled by the Drug Controller General of India. 
According to a recent notification, from April 1, 2020, medical devices that meet the 
following definition will be regulated as drugs under the “DCA and MDR”: “All devices, 
including an instrument, apparatus, appliance, implant, material, or other article, whether 
used alone or in combination, including software or an accessory, intended by their 
manufacturer to be used specially for human beings or animals, which does not achieve the 
primary intended action in or on the human body or animals by any pharmacological, 
immunological, or metabolic means, but which may assist in its intended function by such 
means for one or more of the aforementioned- 
• Diagnosis, prevention, monitoring, treatment, alleviation, or assistance for any 
disease or disorder; 
• Diagnosis, monitoring, treatment, alleviation or assistance for any injury or disability; 
• Investigation, replacement or modification or support of the anatomy or of a 
physiological process; 
• Supporting or sustaining life; 
• Disinfection of medical devices; and 
• Control of conception 
The new regulations will ensure that all medical equipment undergoes quality control before 
being released in the Indian market.  
India’s Mukt Bharat Campaign 
The Indian Ministry of Health launched the 100-day TB Mukt Bharat campaign. The 
campaign will focus on vulnerable populations, tribal communities and the nation’s poor. 
This will help bring attention to the issue and enhance early detection and access to TB 

 
 
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services. Previously, India had committed to eliminating TB by 2025. However, due to 
unforeseen circumstances, the goal was not met, but it did achieve a 21% reduction in TB 
incidence and a 25% decline in TB mortality over the past decade.  
The Mukt Bharat, also known as “Yes! We Can End TB,” emphasizes a whole-community 
approach and the strengthening of technology-driven interventions. These include rapid, 
accurate diagnostics to improve early detection and increased access to testing.  
Co-Diagnostics, along with its partner, CoSara Diagnostics is committed to helping the Mukt 
Bharat campaign. Co-Diagnostics has begun shipping its PCR Pro instruments, PCR 
Mycobacterium tuberculosis (MTB) and NPOC TB test kits for TB to support clinical 
performance studies of the TB tests. The Co-Diagnostic platform aligns with the WHO 
guidance for TB protocols. The test uses sputum or tongue swabs to obtain the sample. 
The Co-Diagnostics platform is under regulatory review and not yet available on the market.  
 
 
 

 
 
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Rest of Asia 
Outside of China, India and Japan, IVD manufacturers have found markets in Asia and the 
rest of the region will be a source of revenues for IVD manufacturers for the coming years.  
In December 2020, the World Economic Forum (WEF) released its 2020 Global 
Competitiveness Index.  In the prior year, the Index was based on the policies, institutions, 
and other factors that influence a nation’s productivity and relative level of prosperity, which 
led to a ranking system.  The World Economic Forum looks at indicators such as labor market 
efficiency, market size, education level, and technological readiness. In 2025, the IMD World 
Competitiveness Report showed that: 
• Malaysia ranked 23 up three positions from 2023. It is the highest-ranked out of 
developing Asian countries.   
• Thailand moved  to 30 
• China was in the 16th position. Low levels of innovation and inefficient bureaucracy 
continue to drag down China’s competitiveness level. 
• Other Asian notables include Taiwan (6), South Korea (27), Hong Kong (3), and 
Singapore (2). 
• India continues to move to 41.   
However, despite encouraging economic and infrastructure statistics, IVD growth in Asian 
countries is largely constrained by shortages of skilled healthcare workers and laboratory 
facilities.  Government reimbursement for medical technologies is also expanding around the 
region, making the therapies more affordable. Western medical product companies should 
find increasing opportunities in the Asian medical markets. 
A growing number of nations in Southeast Asia, including Malaysia, Thailand, Cambodia, 
and Indonesia, offer basic medical coverage to their citizens. This trend is driving rapid 
growth in demand for medical devices, drugs, and diagnostic test kits and reagents, benefiting 
Western companies marketing their products in the region. 
South Korea is increasing government healthcare funding, which has boosted sales in the 
country. Product registration in South Korea is more difficult; however, the newly introduced 
Immediate Market Entry is available for cutting-edge technologies. The country is also 
developing the first guideline for generative AI device reviews.  

 
 
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Table 3-22: Asia Pacific Region IVD Market, by Country, 2025 ($ million)  
 
[Australia; China; India; Indonesia; Japan; Malaysia; Philippines; Singapore; South Korea; Thailand; Vietnam] 
Country 
2025 Revenues 
China 
5,997 
Japan 
5,726 
Australia 
1,976 
India 
1,390 
South Korea 
521 
Indonesia 
307 
Thailand 
199 
Philippines 
152 
Vietnam 
137 
Malaysia 
132 
Singapore 
113 
Rest of AP 
1,599 
Total 
18,249 
Source: Kalorama Information 

 
 
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Brazil 
Brazil has implemented significant regulatory changes, such as ensuring compatibility with 
international markets and raising product manufacturing standards, that are helping to drive 
the IVD market forward. Brazil is the largest health market in Latin America and only second 
to the U.S. in the entire Americas. The largest country in Latin America and the sixth most 
populous in the world, Brazil’s 218 million people have long been a target for major IVD 
vendors. Growth is evident; Brazil's population will likely reach 232 million by 2050, 
representing an average annual increase of 0.7% between 2010 and 2050. That population 
growth is also an aging growth. The 65+ population in the consideration segment is forecast 
to grow at an average annual rate of 4%, reaching 50 million by 2050. This is more significant 
given that it is up from just 13.1 million in 2010.  
The majority of the Brazilian population is concentrated in the southeast region and consists 
of the cities of Sao Paolo, Brasilia and Rio de Janeiro.  There is a growing trend of 
urbanization.   Approximately 86% of the population is urban: Sao Paulo boasts almost 10% 
of the nation’s population; Rio de Janeiro has over 13 million; and Belo Horizonte, Brasilia, 
Fortaleza and Recife also have large populations. 
The Brazilian government has been largely involved in providing healthcare to its people. 
The constitution of 1988 and the Organic Health Law of 1990 structured the country’s 
universal healthcare system.   
This system provides access to healthcare for all citizens of Brazil through designated public 
and private hospitals. Healthcare is government-reimbursed, but funding for the healthcare 
system comes from both the public and private sectors.  
There are nearly 6,200 hospitals operating throughout Brazil, with additional outpatient 
service centers, home care facilities, and other medical facilities, further increasing the total 
number of facilities in the country.  The distribution to public versus private is about 40:60 
and more than two-thirds are for-profit entities.   In Brazil, there are about 2.2 hospital beds 
for every 1,000 people.  The number of available beds has not kept pace with the growing 
population and need.  In 1975, there were about 4.5 beds per 1,000 population, but over the 
years, the number of beds has declined and may not adequately accommodate the population 
if the demand increases. 

 
 
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The market for IVDs in Brazil is estimated at $1,885 million in 2025 and, with 5.5% annual 
growth, will reach $2,581 million in 2030.  The diagnostics market is divided between 42% 
in the public sector and 58% in the private sector. There are significant variations by market 
segment. For example, allergy, cancer, and hormones are predominantly a private market, 
while the public sector is stronger in flow cytometry. 
Advancements in molecular techniques, increasing awareness and acceptance of precision 
medicine, the rising prevalence of chronic diseases, and the need to diagnose these diseases 
at early stages are key factors driving growth in the molecular diagnostics market. On the 
other hand, the development of a wide variety of reagents and analytical techniques, along 
with inexpensive, automated POC testing, is a key driver of growth in the reagents market.  
Table 3-23: Brazil IVD Market, by Broad Segment, 2025 (%)  
 
[Core Lab; Histology; Immunoassays; Microbiology/Virology; Point-of-Care - glucose; Point-of-Care - other] 
Segment 
Share 
Immunoassays 
38% 
Core Lab 
23% 
Microbiology/Virology 
17% 
Point-of-Care - glucose 
10% 
Histology 
4% 
Point-of-Care - other 
3% 
Others 
5% 
Total 
100% 
Market in $ million = $1,885 
Source: Kalorama Information 
Disease Trends 
Infectious and parasitic diseases are common in Brazil; government bulletins cite Brazil as 
having a very high risk of contracting an infectious disease and list the most common food- 
and waterborne diseases as bacterial diarrhea and hepatitis A; vector-borne diseases as 

 
 
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dengue fever and malaria; and water-contact diseases as schistosomiasis.  There is also an 
increasing number of people diagnosed with cancer, diabetes, and respiratory diseases.  This 
provides a foundation for diagnostic testing markets and advanced technologies. 
Diabetes affects more than 20 million people in Brazil, or 10% of the population.  The market 
for diabetes treatments in Brazil has grown at nearly 12% annually, with more than $100 
million spent each year.  A contributing factor to the growing diabetes prevalence is the 
increase in adult and pediatric obesity.  The population is facing unprecedented obesity rates 
in adults of more than 22% of the population. 
There are more than 440,000 new cases of cancer affecting Brazilians each year, with 
225,000 deaths reported.  Today, cancer is the second leading cause of death in Brazil.   
Cancer in Brazilian men accounts for just over 51% of cases, with roughly 225,000 reported 
versus 215,000 for women.  The risk of getting cancer before the age of 75 is approximately 
21% for the total Brazilian population. 
Brazil has one of the highest rates of HIV infection in the Americas with more than 827,000 
people currently living with the disease, nearly 0.4% of the population.  More than 35% of 
these cases are women.  Additionally, 15,000-16,000 Brazilians die each year from the 
disease.  For these reasons, Brazil is a highly attractive region for HIV testing skills and 
technologies, with strong government support.  Brazil has an active HIV prevention strategy 
and offers a wide range of treatment options through the public healthcare system at little or 
no cost.  
Malaria continues to be a widespread problem in Brazil, with 42% of all malaria cases in 
Latin America distributed in Brazil.  Malaria affects about 150,000 people each year and 
results in about 35 deaths.  Although the country has been proactive in reducing case 
numbers, it still struggles to control the disease. 
Dengue is classified as an ongoing public health problem in Brazil by PAHO and WHO, 
despite efforts to control the disease.  Dengue is an infectious disease caused by the dengue 
virus and primarily transmitted by the Aedes aegypti female mosquito.  The definitive 
diagnosis of dengue infection requires the detection of specific antibodies in a patient's blood 
sample.  The recommended testing method is serological methods with viral isolation and 
identification for a complete detection profile. The last two years have seen an uptick in 
dengue cases due to El Niño, which has raised temperatures and increased rainfall from the 
Pacific. Brazil has already had about 194,000 dengue cases in 2025.  

 
 
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The outbreak of the Zika virus in 2015 prompted the Brazilian medical delivery system to 
focus increased attention on controlling the spread of potentially life-threatening infectious 
diseases. In addition to the Zika virus, the country has sought to reduce the incidence of 
several other widespread infectious diseases, including bacterial diarrhea, dengue fever, 
hepatitis A, and schistosomiasis.  
It is expected that the high rate of infectious disease will continue to present growth 
opportunities for infectious disease IVD products, although constraints on healthcare 
spending will hold down overall demand gains. 
Clinical Laboratory Market in Brazil 
Currently, there are more than 12,500 diagnostic laboratories operating throughout the 
country with an additional 45,700 collection sites.  The distribution of hospital vs. 
commercial laboratories is estimated at 46%-54%. 
There is a growing trend among medical facilities in Brazil to align with U.S. and European 
standards.  The growing private health system is becoming well known for its exceptional 
standard of care that, in some instances, exceeds that of developed nations.  There are roughly 
8,200 hospitals operating throughout Brazil, with additional outpatient service centers, home 
care facilities, and other medical facilities, bringing the total to more than 8,200.  There are 
currently 63 organizations accredited by the Joint Commission International, which is 
considered the 'gold standard' in global health care. 
There are three large diagnostic laboratory service groups operating throughout Brazil: 
Diagnosticos da America, Grupo Fleury, and AFIP Diagnostic Medicine 
These four operators account for about 60% of the volume of laboratory services. 
Diagnosticos da America (DASA).  Diagnosticos da America (DASA) is the largest clinical 
laboratory group in Latin America and is credited with being the fifth-largest in the world.  
The group is the result of a merger of Club DA, Delboni Auriemo and Lavoisier in São Paulo.  
The DASA lab chain operates more than 500 collection centers and 12 central laboratories 
that serve as a reference lab for hospitals.  The group also provides complementary services 
and support to an additional 5,000 laboratories throughout Brazil, offering products under its 
Alvaro brand.  DASA reports generating R10 billion in annual revenue, with about one-third 
attributed to its clinical laboratory services.   The company initially responded to the COVID-
19 pandemic in 2020 by forming a partnership with the Brazilian Ministry of Health to donate 

 
 
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human resources and infrastructure, expanding processing capacity to up to 3 million RT-
PCR samples for virus detection. 
Grupo Fleury is the largest provider of clinical laboratory services in Brazil, performing 90 
million tests annually, or more than 7 million each month. The group operates more than 250 
care centers and generates more than R7.8 billion in revenue in 2024. Grupo Fleury acquired 
Hermes Pardini, the third-largest clinical laboratory service provider in Brazil. 
AFIP Diagnostic Medicine (AFIP Medicina Diagnostica) offers laboratory diagnostic tests 
for medical and scientific research purposes.  Its specialties include serology, immunology, 
hematology, radioimmunology, parasite, urinalysis, pathology, anatomy, cytology, 
molecular biology, and validation for procedures and inputs.  It prides itself on operating 
only with the most advanced, state-of-the-art technology. The lab processes 5 million tests 
per month.  
IVD Regulation 
ANVISA is the regulating authority overseeing pharmaceuticals, medical devices, cosmetics 
and any medical product or service produced or consumed in Brazil.  ANVISA is regulated 
by Brazil's Ministry of Health, which periodically restructures and assigns duties to the 
agency.  
The agency is tasked with protecting and promoting public health throughout Brazil and, in 
doing so, monitors the performance and risks of products and services, including processes, 
ingredients, and technologies that pose health risks to the population.  ANVISA continues to 
be one of the more heavily regulated regulatory bodies for medical devices, largely due to 
concerns about domestic medical device manufacturers who are slow to adopt Good 
Manufacturing Practices for Medical Devices and to manufacture to high standards.  The 
country continues to depend heavily on imports from the U.S., Canada, and European 
markets to meet the demand for high-tech medical devices.  Despite its requirement for 
imported devices, the import system is complex and costly, contributing to barriers to entry 
for smaller device manufacturers.   
Classification of medical devices in Brazil includes Classes I, II, III, and IV, which are 
determined by the level of risk they pose to the health of consumers, patients, operators, or 
third parties involved.   

 
 
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After approval is granted in Brazil, this opens opportunities within other select South 
American countries, including Argentina, Paraguay, and Uruguay.  Brazil and these countries 
are member states of Mercosur, which allows for improved opportunities for market 
participation among member states once approval is granted.   

 
 
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Mexico 
Mexico's IVD market is worth about $839 million in 2025 and expected to reach nearly 
$1,077 million by 2030, representing a CAGR 6.5%. Growth is supported by continued 
acceptance of advanced equipment and growing distribution channels. Immunoassay, 
Histology, Others) 
Table 3-24: Mexico IVD Market, by Broad Segment, 2025 (%)  
 
[Clinical Chemistry, Hematology, Coagulation; Histology; Immunoassays; Microbiology; Point-of-Care; 
Others] 
Segment 
Share 
Immunoassays 
30% 
Clinical Chemistry, Hematology, Coagulation 
25% 
Point-of-Care 
22% 
Microbiology 
14% 
Histology 
6% 
Others 
3% 
Total 
100% 
Market in $ million = $839 
Source: Kalorama Information 
The second largest country in Latin America, behind Brazil, is Mexico.  In terms of 
population, Mexico accounts for 20% of the region's total.  Mexico is the twelfth most 
populous country in the world, with 130 million people residing in the country.  Following 
current population growth trends, Mexico's population will likely reach 155 million by 2050, 
with an average annual increase of 0.7% between 2010 and 2050.    
The distribution of the population is expected to shift toward the 65-and-over population, 
which is projected to account for 18% of the total population in the country by 2050, up from 
6% in 2010.  The 15-64 population group is expected to remain relatively stable; while the 
0-14 population is declining considerably, accounting for 18% of the population in 2050, 

 
 
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down from 30% in 2010. Mexico's healthy life expectancy at birth is estimated by the World 
Health Organization to be 69 years, which is 8 years less than the country's total life 
expectancy at birth.  Despite the increase in life expectancy and a slight increase in healthy 
life expectancy, the population is expected to face increasing chronic disease, disability, and 
morbidity due to lifestyle trends resulting in obesity and diabetes. 
The majority of Mexico's population is concentrated in the middle to middle-upper regions 
of the country, in the cities of Mexico City, Guadalajara, and Monterrey; these cities 
combined account for about 25% of the total population.  There is a growing trend of 
urbanization with a 1.57% annual increase since 2010.  Approximately 80.7% of the 
population is urban; 17% of the population resides in the capital, Mexico City.   
Mexico currently spends an average of 5.4% of GDP on healthcare and has the second-largest 
health market in Latin America behind Brazil. Roughly 52% of health spending is funded by 
public and government sources, while the remaining 48% is funded by private payors. Out-
of-pocket spending on health care is a major barrier to health utilization and is reflected in 
several economic and health indicators.  The Mexican government offers publicly subsidized 
health insurance to its population through the Seguro Popular de Salud (The People's 
Insurance), or SPS. The system can be classified as a mixed health plan, combining both 
public and private resources.   
Despite the challenges, Mexico’s economy and health system are expected to show gradual 
improvement and expand through various changes and enhancements to the country’s 
economic and health structures.  In the past few years, Mexico has become an attractive target 
for foreign investments and with new trade deals and partnerships between major export and 
import countries, it demands a watchful eye. 
The H1N1 flu epidemic in 2009 exposed deficiencies and imbalances in the availability and 
accessibility of patient testing services in Mexico.  As a result, government health authorities 
planned to expand the number of clinical laboratory and point-of-care testing sites throughout 
the country.  These efforts were designed to boost demand for infectious disease IVD 
products.  However, due to ongoing constraints on the national healthcare budget, reagents 
and instruments for basic procedures continue to account for the majority of sales.   

 
 
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The Russian Federation 
The Russian health system is facing significant challenges due to the ongoing conflict in 
Ukraine. Since the collapse of the Soviet Union and the birth of the Russian Federation 
(Russia) in 1991, the health status of the Russian population has declined dramatically. Rates 
of tuberculosis, cancer, and heart disease are the highest rates of any industrialized country. 
Spending on healthcare, which was approximately 7% of GNP in the 1960’s, was reduced to 
approximately 3% in 1991.  Since then, the country has slowly worked to increase this to 
some 5-6% of GNP by the mid-2000s.  Healthcare spending is somewhat stuck at this rate 
due to a lack of resources to support the huge, lumbering system.  
Russia’s first major economic meltdown in the late 1990s had a significant effect on the IVD 
industry there.  The lack of government funds meant that hospitals and labs could not afford 
to purchase foreign-made products, primarily reagents.   The result was that some of Russia’s 
high-tech manufacturers shifted from defense production to basic, routine reagents for 
chemistry, hematology, and immunoassays.  These companies still hold a major share of the 
routine test segments. 
Domestic production accounts for only 15%-25% of the market, depending on the diagnostic 
product type.  These products include a limited variety of semi-automated analyzers and 
spectrophotometers, laboratory furniture and glassware, laboratory scales, sterilizers, 
incubators, thermostats, microscopes, and a wide range of reagents for testing blood, 
hormones, viruses, and urine.  
A few elite Russian hospitals and clinics, predominantly in Moscow and St. Petersburg, can 
afford to use the latest advanced diagnostics, including immunoassays and molecular tests. 
However, most hospitals and clinics, especially in Russian regions, can only perform simple 
clinical and selected biochemical tests.  
Yet, despite the barriers and apparent downfalls, it is a compelling IVD market because of a 
large population and a vast healthcare infrastructure with more hospitals, doctors, etc. (per 
capita), than many other countries in the world.  Russia is also the ninth most populous nation 
in the world, with about 142 million inhabitants, but its population is declining, and it will 
fall in population rank by 2050.  There are other issues as well; Russia is unable to take care 
of its population.  Life expectancy is on the decrease, TB and sexually transmitted diseases 
are on a rampage, and non-communicable diseases, especially heart problems and 
hypertension, are a major source of suffering and death. 

 
 
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The rise in the incidence of infectious diseases in Russia over the past several years has led 
to a significant increase in demand for high-quality laboratory diagnostic equipment and 
reagents.  The official statistics show substantial increases in tuberculosis (130,000 people 
or 86.1 per 100,000 of the population), HIV (1.5 million infected), and sexually transmitted 
diseases (1 million).  The number of drug addicts in Russia is some 3 million and more than 
2.5 million people have diabetes.  
The Russian Federation’s strategy for healthcare in 2025 includes hepatitis C prevention, 
early diabetes screening, and expanding access to high-tech and specialized services. 
During 2022, the Russian invasion of Ukraine and the ongoing war in Ukraine from 2023 to 
2026 have impacted the IVD market through the retraction of some foreign businesses.  The 
market for IVDs is estimated at $1,307 million in 2025, with a CAGR of 2.9%, reaching 
$1,509 million in 2030. This shows slower-than-average growth in the region due to the 
lasting effects of the invasion of Ukraine.  

 
 
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Canada 
Demographics and healthcare spending fuel Canada’s relatively large IVD market. The 
population of Canada will retain a slightly younger age distribution than that of its U.S. 
neighbor but will grow in line with U.S. trends.  A moderately high birth rate and a 
comparatively low death rate will account for overall demographic changes.  Due to the low 
death rate and increasing longevity, Canada’s 65-and-older segment will grow much faster 
than the total population, reaching approximately 8 million in 2025.  Growth in elderly age 
groups will intensify the country’s healthcare cost burden.  This trend will prompt the 
provincial health plans to impose tighter controls on the coverage and cost of medical 
services, including IVD procedures.  
The publicly funded Medicare universal health insurance program covers all Canadian 
residents for hospital care, physicians’ consultations, mental health counseling, laboratory 
testing, and nursing home care.  In addition, elderly and low-income residents are eligible for 
varying prescription drug benefits.  Medicare is funded through federal and provincial 
income taxes.  The administration and payment of benefits are delegated to the 10 provincial 
governments, each operating a separate plan that complies with general guidelines set by 
federal law.  Most government funding (94%) comes from the provincial level. 
Hospital care and lab testing are delivered by publicly funded hospitals in Canada. Most 
public hospitals, each of which is an independent institution incorporated under provincial 
Corporations Acts, are required by law to operate within their budgets.  The amalgamation 
of hospitals and labs in the 1990s has reduced competition between hospitals. As the cost of 
patient care has increased, hospitals have been forced to cut costs or reduce services. Growth 
will reflect the testing activities of 1,500 hospitals, nearly 100,000 physicians, and 3,500 
clinical laboratories.    
Under the Canada Health Act, public funding is required to cover medically necessary care, 
but only if it is delivered in hospitals or by physicians. There is considerable variation across 
the provinces and territories in the extent to which costs for out-of-hospital prescription 
medications, laboratory tests, physical therapy, long-term care, dental care, and ambulance 
services are covered. 
There is no service fee for lab tests in Canada.  The majority of testing is performed in 
hospital labs that operate under a fixed annual budget.  Therefore, doing more with less is a 
fact of life for most lab professionals. As in other developed countries, resources to support 

 
 
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medical laboratory testing are dwindling, even as physicians order more tests and labs must 
spend it on acquiring new diagnostic technologies.  Therefore, Canada’s network of private 
laboratories has undergone significant consolidation.    
The IVD market is strongly represented within Canadian manufacturing companies and is 
complemented by the strength of the strong research community. Similar to the U.S., the 
Canadian IVD market is dominated by the top IVD companies.  However, the Canadian IVD 
market is highly fragmented, with numerous SMEs, both Canadian and international 
manufacturers, competing for market share.  Canada’s IVD market is estimated at 
approximately $3,429 million in 2025.   

 
 
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Emerging Markets 
The countries covered in the previous section are known markets of opportunity.  The 
following section examines several markets identified by IVD vendors as the next growth 
areas.  The countries range from relatively well-known countries such as Turkey, South 
Africa, Vietnam, and South Korea to riskier but potentially high-growth areas such as the 
Philippines, Malaysia, and Thailand.     
Saudi Arabia IVD Market 
Saudi Arabia is the home to some 33.7 million people, 79% of whom live in cities.  It is a 
young country, with only 3% of the population aged 65 or over; however, the country's aging 
population is increasing, as shown in the population pyramid comparison below. Immigrants 
make up nearly 40% of the total population, according to data released by the United Nations.  
Saudi Arabia is an oil-rich nation that occupies the majority of the Arabian Peninsula. It 
wields considerable military and political power in Middle Eastern affairs and is the sole 
Arab nation to be part of the G-20. Over the past decade, Saudi Arabia benefited from 
increased crude oil production. Health and living standards in Saudi Arabia are very good. 
About 85% of the population has ready access to medical providers.  All residents are covered 
for basic and essential healthcare services through a national health insurance scheme 
coordinated by the Ministry of Health.  
Expansion of overall healthcare services and laboratory facilities is required to meet the 
increasing demands on Saudi Arabia’s healthcare system due to the mix of infectious diseases 
and chronic conditions.  Unlike elsewhere, in Saudi Arabia, publicly funded hospitals are 
perceived to provide higher-quality healthcare than private-sector hospitals. 
The Ministry of Health (MOH) and other government-affiliated hospitals account for 77% 
of Saudi Arabia’s healthcare infrastructure, with private healthcare comprising the remaining 
23%.  However, private facilities serve some 65% of the population, including expatriates 
(30% of the population) and private-sector employees (35% of the population) and their 
families, who do not have access to public institutions.   
The prevalence of diabetes is expected to continue to increase from its current 24.3%, and 
other lifestyle diseases, such as cardiovascular diseases, are expected to grow and add 
pressure to the current healthcare infrastructure. 

 
 
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IVDs play an essential role in the government’s healthcare plans.  Currently, only 1.5% of 
the overall healthcare expenditure in Saudi Arabia is spent on IVD, reflecting a 
comparatively lower rate than the global average of 2%.  
The IVD market in Saudi Arabia is largely generated through imports from diagnostic 
companies outside the country; there is a nearly nonexistent domestic manufacturing market 
for diagnostics in Saudi Arabia.  In 2025, the diagnostics market in Saudi Arabia is estimated 
to reach $676 million. 
South Africa IVD Market 
South Africa’s population, regional dominance, and healthcare expenditure levels make the 
most attractive Sub-Saharan IVD market a notable entry on the list.  South Africa operates 
one of the most prosperous economies in sub-Saharan Africa but is adversely affected by 
imbalances in healthcare resources and significant epidemic problems. Only two-thirds of 
the population has access to medical services. Moreover, nearly 20% of adult residents are 
afflicted with HIV/AIDS. Other widespread infectious diseases include bacterial diarrhea, 
hepatitis A, schistosomiasis, and typhoid fever.  
South Africa has a two-tier healthcare system- a public system and a private system. 
Approximately 84% of South Africans use public healthcare 
Diagnostic firms keen to leverage opportunities in South Africa will have to account for a 
highly heterogeneous landscape. Discrepancies at the state level highlight the depth of 
healthcare inequality between South Africa's urban and rural landscapes. pricing strategies 
and an assessment of province-level variations.  
Like other countries around the world, South Africa is reporting strong growth in its over-65 
population relative to its total population. This will likely create stronger demand for medical 
devices over the next decade. Devices that focus on managing HIV/AIDS, heart disease, and 
stroke are likely to be major segments, as these are the three primary causes of death in the 
country. 
The IVD market in South Africa is estimated at $377 million in 2025, growing at a 4.2% 
CAGR to reach $463 million by 2030.  

 
 
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South Korea IVD Market 
South Korea, with a population of 52 million, boasts a higher per capita GDP than China and 
is closing in on Japan, underscoring the opportunity for a large and growing IVD market.   
The IVD market in South Korea is considered favorable due to its regulatory framework and 
foreign investment opportunities.  The healthcare industry is witnessing strong growth, 
driven by imports of high-tech equipment.  An increasing interest in molecular testing 
technologies and point-of-care glucose testing is driving market growth.  The burden of 
obesity, diabetes, cardiovascular disease, and cancer is among the major drivers for the 
market. 
Moreover, a national health insurance program covers virtually all residents for basic patient 
care services, including diagnostic testing. Health and living standards in South Korea are 
generally good. However, like Japan, the country has a relatively high incidence of age-
related medical conditions.  
The market for IVD products in South Korea benefits from the country’s advanced medical 
delivery system, which is readily available to more than 80% of the population. Kalorama 
estimates the IVD market in Korea to be $521 million in 2025 and with 6.9% growth will 
reach nearly $728 million by 2030. 
Turkey IVD Market 
Health and living standards in Turkey are generally good.  Turkey’s healthcare system is 
strong, with an emphasis on universal coverage and the integration of private healthcare 
options. The universal health insurance program covers the entire population for inpatient 
and outpatient services as well as medication. About 2% of residents are covered by private 
health insurance plans, which offer access to higher-quality, less-crowded procedures. 
Turkey is usually not impacted by major epidemic problems, but its aging population is 
vulnerable to common infections such as influenza and tuberculosis.  
Vendor sales remain strong, and utilization of private healthcare services has increased.  The 
Turkish Parliament approved an increase in the 2024 Ministry of Health budget, supported 
by initiatives to improve healthcare delivery for nearly 84 million people in the country, a 
goal of becoming an authority in digital health systems, and continued growth in bed capacity 
and hospital construction in recent years. 

 
 
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The market for diagnostics in Turkey is estimated at $1,093 million in 2025 and is expected 
to grow 6.1% annually to $1,473 million by 2030. Major IVD vendors with participation in 
Turkey include Roche and Grifols. 
United Arab Emirates (UAE) IVD Market 
The UAE’s healthcare system 2030 strategies are to enhance health services, become a global 
leader in healthcare innovation, and promote wellness. The UAE's per capita GDP is on par 
with that of leading Western European nations.  Its high oil revenues and moderate foreign 
policy stance have allowed the UAE to play a vital role in the region's affairs.  Six states – 
Abu Dhabi, Ajman, Al Fujayrah, Ash Shariqah, Dubai, and Umm al Qaywayn – merged in 
1971 to form the United Arab Emirates (UAE).  They were joined in 1972 by Ra's al 
Khaymah.   There are several factors boosting the market opportunity in this country.   
• The population in the UAE is estimated at nearly 10 million 
• Diabetes type 2 prevalence in the UAE is relatively high, about 20.7%.  
• Obesity rates are continuing to increase, currently representing 32% of the population. 
• Young, working-class population with low elderly dependency and aging 
populations. 
Health and living standards in the United Arab Emirates are very good.  A comprehensive, 
government-funded health service and a rapidly developing private health sector cover most 
residents for basic and essential medical services. More than 87% of the population enjoys 
ready access to the healthcare system.  The UAE now has 40 public hospitals, compared with 
only 7 in 1970. The Ministry of Health recently launched a multimillion-dollar program to 
expand health facilities, including hospitals, medical centers, and a trauma center, across the 
seven emirates.   
The UAE has one of the lowest concerns about an aging population, with just 1.9% of the 
population over the age of 65.  The elderly dependency ratio is just 1.5, and the median age 
of the population is about 38 years.   
The market for in vitro diagnostics in the UAE is estimated at $259 million in 2025. Point-
of-Care tests capture around 32% of the market, followed by microbiology with 19%, 
immunochemistry with 19%, and clinical chemistry/hematology/coagulation with 19%   

 
 
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Other Markets to Watch 
Chile 
More than 18.6 million people reside in Chile, making it the seventh most populous country 
in Latin America.  Over the last two decades, Chile has made great improvements in reducing 
its poverty rate, which is now lower than that of most Latin American countries. However, 
its severe income inequality ranks as the worst among members of the Organization for 
Economic Cooperation and Development. Unequal access to quality education perpetuates 
this uneven income distribution.  
Health expenditures in Chile are around 10.83% of GDP annually.  Continued reform of the 
health system is a priority for the Chilean government, with a focus on modernizing the health 
system, addressing the private health insurance schemes, and addressing growing 
expenditures.  One of the major public health issues affecting Chile today is the growing 
obesity rate.  According to the National Health Survey, 2024, Chile’s obesity rate was 
estimated at 33.7% of the population and ranked by the OECD as one of the top 10 countries 
with the highest obesity and overweight rates worldwide.   
At present, Chile provides nearly universal health coverage to its inhabitants in two separate 
subsystems: 
• A large public non-profit insurer (the National Health Fund, FONASA) covering 
between 73% and 75% of the population, including the indigent, low-income and 
middle-income citizens, and providing health services mostly through public 
providers. FONASA covers about 14.2 million inhabitants (2019 data) 
• For-profit private insurers (ISAPREs) cover about 19% of the population and provide 
services almost exclusively in the private sector. Each ISAPRES has several health 
plans, depending on where each member lives and the clinics and/or hospitals a 
member prefers to use  
• Additionally, more than 1.5 million Chileans are either insured through other welfare 
systems, such as the Armed Forces and the Police, or have commercial health 
insurance only, or have no insurance 
Two types of hospitals are present in Chile: public and private. Generally, hospitals specialize 
in a particular area of treatment (oncology, geriatric care, etc.).  There are about 425 hospitals 

 
 
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in the whole country, 230 in the public sector and 195 in the private sector. Certain private 
hospitals (usually named “Clinics”) do not accept patients with FONASA insurance.  Public 
hospitals accept both FONASA and ISAPRES customers.  ISAPRES customers are generally 
given better accommodation in private.  In Chile, social class is important, so people might 
choose a private room to avoid contact with the lower classes. 
The IVD market in Chile is estimated at $290 million in 2025. Major imports for medical 
devices are generated from the United States, Germany and China.  IVD companies offering 
diagnostic systems and services that meet Chilean market needs with high-quality, cost-
effective technology will succeed. Those focusing on meeting the growing demand for 
telehealth will also find niche growth opportunities. 
Colombia 
Besides Brazil, Colombia is a target for many IVD companies as a promising emerging 
market. Colombia is home to more than 49.6 million inhabitants and ranks 29th in the world 
by population.  Roughly 82% of the population is urban, with the urbanization rate increasing 
by 1% annually.  This is partially driven by the shift to service industries as the high 
fluctuations in pricing and exports in the energy and mining industries have led to higher 
unemployment and poverty rates, currently about 10% and 36%, respectively.  Not 
surprisingly, healthcare and thus, IVDs are best utilized in the urban areas. 
Colombia’s health system operates under two schemes, contributory and subsidized. Forty-
three percent (43%) of the Colombian population holds formal employment and receives 
health insurance through the contributory scheme that is paid for by both employees and 
employers, granting access to private hospitals. Forty-eight percent (48%) of the population, 
who do not hold formal employment, are subsidized by the public health system. 
The Colombian Ministry of Health and Social Protection institutes a 10-year revolving public 
health plan to guide improvements to the overall health system, reduce health inequities, and 
propose new objectives.  In the latest 10-year plan (2022-2031), the Colombian government 
plans to continue working toward health equity and focus on improving health in the 
following areas: 
• Mental health and social coexistence 
• Food and nutrition security 

 
 
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• Sexuality and sexual and reproductive rights  
• Healthy living and communicable diseases 
• Public health in emergencies and disasters 
• Healthy living and non-communicable conditions 
• Expand coverage in the occupational risk systems 
Colombia is expected to sustain fast-paced growth in IVD product demand. This trend will 
partially reflect ongoing improvements in healthcare quality and availability. In addition, the 
population's high risk of a variety of pathogenic conditions, including bacterial diarrhea, 
Chagas disease, dengue fever, leishmaniasis, malaria, rabies, Venezuelan equine 
encephalitis, West Nile virus, and yellow fever, will lead to an increasing volume of related 
patient testing.    
The IVD market in Colombia is estimated to be worth $279 million in 2025.   From the IVD 
perspective, immunoassays are the largest segment and will continue to perform at a rate 
similar to the total market.  By 2030, the Colombian IVD market is expected to reach $333 
million, representing 5.1% CAGR.   
Indonesia 
Next to India and China, Indonesia has the largest economic boom in Asia.  It is the 16th-
largest country worldwide by area; however, it is the fourth-largest by population, with 
roughly 270 million inhabitants.  Aging populations are a major concern among health 
systems; Indonesia’s health system is no exception.  In recent years, the government has 
placed Indonesian health as a priority agenda item with the construction of facilities and 
improved equipment and device import pathways. Despite attention to rising demand for 
health services, the country still lags behind its Asian counterparts in health delivery and 
access to care.  The increased attention to health systems and the growing needs assessment 
are expected to favorably impact demand for IVD products, resulting in about a 3.7% CAGR 
over the next five years.   For 2025, IVD sales are expected to be worth $307 million. 
A distributor is essential for selling into Indonesia as foreign companies cannot make direct 
sales.  There have been several cases where IVD companies with a solid product offering 
have struggled due to an underperforming, exclusive distributor holding their import license. 

 
 
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The country is moving toward universal healthcare coverage through the Jaminan Kesehatan 
Nasional program.  
Malaysia 
A young country in an aging world, with a median age of 29.2 years. The proportion of 
persons aged 65 and older in Malaysia has risen at an annual rate of 4.6%, faster than Japan 
(0.3%) and most OECD countries.  As is the case worldwide, even the youngest countries 
are confronting age-related issues.  Fertility rates in the country have declined in recent years 
due to economic development, cost-of-living inflation, and shifting attitudes; these factors 
are projected to curb future population growth in Malaysia. Malaysians enjoy a universal 
healthcare system and access to care superior to that available in most of Southeast Asia, 
with the exception of Singapore, and perhaps on par with Thailand. Per capita health 
spending in Malaysia is higher than in any other country in Southeast Asia, except Singapore. 
At over $900 international purchasing power parity (PPP) dollars, Malaysian per capita 
health spending is higher than in China and significantly higher than in India, but noticeably 
below spending levels in developed or OECD countries.  
Malaysia has a dual healthcare system comprising public and private sectors. The Ministry 
of Health regulates the public healthcare system that is designed for all citizens and legal 
residents.  
The IVD market, valued at $132 million in 2025, will benefit from increased patient testing 
volumes aimed at the early detection and treatment of bacterial diarrhea, dengue fever, 
leptospirosis, and other widespread infectious diseases. Malaysia operates a fairly efficient 
medical delivery system funded by a national health insurance scheme and supplemental 
private health plans. The system is readily available to approximately three-fourths of the 
population. 
Peru 
According to the National Institute of Statistics, the Peruvian population reached 32.6 million 
inhabitants in 2024 and is growing at a steady rate of about 0.5%.  The more significant 
demographic shift, though, is the aging population, which accounted for 9.2% in 2024 and 
will account for 22.7% by 2050.  In order to analyze population distribution, it is necessary 
to bear in mind the country's geographic complexity, which can be broadly divided into coast, 

 
 
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hills, and jungle, with major natural barriers and high infrastructure, communication, and 
transport costs, making national integration difficult and affecting social cohesion.  Today, 
about 79% of the population lives in urban areas, with the remaining 21% in rural areas, some 
of which are difficult to reach by public transport.  
Over the last decade, the health of the Peruvian population has improved significantly. This 
improvement has been mainly attributed to the urbanization process, the improvement in 
educational level, better access to sanitation facilities (such as safe tap water and sewage), 
changes in lifestyle and demographical changes, and the expansion of the first level of 
healthcare 
According to sources consulted, there are between 1,100 and 1,300 active clinical labs in 
Peru, of which 60% are located in Lima Capital and the metropolitan area.  The National 
Institute of Health of the Ministry of Health reported 122 laboratories approved for the 
molecular diagnosis of COVID-19 throughout the country.  In the country, there are 58 public 
laboratories, 6 university laboratories and 60 private laboratories with the capacity to perform 
molecular detection of SARS-CoV-2.   
The IVD market in Peru is valued at $175 million in 2025, with immunoassays accounting 
for roughly 39% of the market, followed by the combined clinical chemistry, hematology, 
and coagulation segment. Growth in the Peruvian IVD market is expected to outpace the 
overall Latin American region.  
Philippines 
The Philippines is emerging as a fast-growing nation and one of several for IVD companies 
to target.  The healthcare delivery system in the Philippines is dominated by the public sector 
(at the regional, provincial, municipal, and barangay levels) and supported by private 
healthcare service providers. The implementation of Universal Health Care is already driving 
the demand across all sectors of healthcare. However, the Philippines still requires a strong 
focus on infrastructure and skilled manpower. Efforts to improve upon a substandard medical 
delivery system that fails to reach more than half of the population, coupled with the 
widespread need to control high levels of illnesses such as bacterial diarrhea, dengue fever, 
hepatitis A, malaria, and typhoid fever, will boost growth prospects for a broad range of IVD 
products (3.7% annual growth).    

 
 
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The Philippine Health Facility Development Plan (PHFDP) 2020-2040 follows the Universal 
Health Care Act of 2019, including provisions for a needs-based approach to estimating the 
health facility requirements to address the future burden of disease at both the medium- and 
long-term level.  The plan highlights the following infrastructure and worker goals that will 
affect the IVD industry over the next several decades: 
• By 2040, outpatient visits and inpatient bed-days are expected to increase by 60% 
mostly due to noncommunicable diseases. 
• Increase government spending in health infrastructure and other capital formation; 
increase private sector spending and support sustained investments in health facilities.  
• The national and local governments must spend at least PHP 56 billion every year in 
the medium-term and encourage the private sector to increase and sustain its 
investments to substantially reduce the large health infrastructure gap. 
• A paradigm shift is needed to support the large public spending challenges without 
sacrificing the goal of equity and universal access. Health care provider networks of 
local governments should consider health infrastructure as investments that have 
income-generating potential. 
• Expand rural health units/health centers (RHU/HCs) to expand access for Filipinos to 
have access to an RHU/HC within 30 minutes of travel time. The country needs an 
additional 2,400 RHU/HCs by 2025. 
• More than 60,000 primary care physicians are needed to meet the current needs for 
primary care, assuming staffing requirements are based on physicians.  
• The country has approximately 105,000 hospital beds with a bed density similar to 
the poorest countries in the world (1.2 per 1,000 population). An additional 400,000 
beds are needed, the majority of which are Level 1 beds, to meet the projected hospital 
care needs by 2040 (around 2.7 beds per 1,000 population).  
• Investing in a framework for allocation of national government resources, anchored 
on equity.  
• Investments for government-run special health facilities are critical to complement 
primary care and hospital-based general health services. 
• Specialty centers for sixteen (16) specialties shall be established: cancer care, 
cardiovascular care, lung care, renal care and kidney transplant, brain and spine care, 

 
 
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trauma care, burn care, orthopedic care, physical rehabilitation medicine, infectious 
disease and tropical medicine, toxicology, mental health, geriatric care, neonatal care, 
dermatology care, and eye care. 
• Investment needs for infrastructure and equipment until 2025 total PHP 82 billion to 
expand DOH hospitals and are designated as National Specialty Centers, Advanced 
Comprehensive Specialty Centers, and Basic Comprehensive Specialty Centers 
• Upgrading and establishment of Specialized Laboratories, including the National, 
Sub-national, and Regional Reference Laboratories, shall require a total of PHP 1.1 
billion. 
• Capital investment requirements for Blood Service Facilities and Drug Abuse 
Treatment and Rehabilitation Facilities in the national, subnational, and regional 
levels total PHP 3.5 billion and PHP 8.4 billion, respectively. 
The IVD market for the Philippines is estimated at $152 million, demonstrating a growth rate 
of 3.7% from 2025-2030.  
Poland 
Poland is the largest country in Eastern Europe, with a population of 38.7 million and the 
largest GDP in the region at $1.6 trillion in PPP terms and $596 billion in constant terms.  
Poland is a high-revenue-industry economy, with 40% of its GDP generated by the sector.  
Major industries include manufacturing and mining.   Services account for roughly 58% of 
GDP, while agriculture accounts for about 2% 
Poland spends about 6.5% of its GDP, or $37-38 billion, on health care each year.  This is 
relatively low compared with other Western and Eastern European countries; however, 
spending is likely to increase in the near term due to an aging population, lower birth rates, 
and rising life expectancy. The Russia-Ukraine conflict has impacted Poland with an increase 
in Ukrainian residents entering the country, which also expands the health service 
requirements. 
The country continues to explore various options for healthcare reform to meet the growing 
demand for health services and maintain financial stability.  Despite its efforts, 
implementation continued to be unsuccessful, and financial woes are expected in the forecast.  

 
 
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One reason for the lack of implementation of healthcare reform is the complexity of the 
proposed changes, including pay structures, network contracting, and citizen participation. 
The IVD market in 2025 is estimated by Kalorama Information at $1,047 million and is 
expected to increase at 5.5% CAGR, reaching $1,370 million by 2030.  Factors promoting 
growth in this market will be a rising incidence of infectious disease, as well as an expanding 
problem of HAIs in hospitals. IVD products will also drive demand in Poland as a growing 
share of residents gain access to medical services.   
Romania 
It is challenging, but as a potential healthcare market, it is worth watching.  Kalorama 
estimates the Romanian IVD market at $428 million in 2025, serving the country's 18.1 
million residents.  The aging population continues to grow in the country while the overall 
population declines, a trend similar to that seen across other European countries.  It is 
estimated that about 20% of the population is over the age of 65, and this share will increase 
to 20% by 2030.  The market in Romania will also benefit from the increasing availability of 
laboratory services. The majority of IVD-related services are best served by the urban 
population, which represents about 54% of the total Romanian population, with Bucharest 
accounting for about 1.785 million, or nearly 10% of the population. 
Thailand 
Despite its relatively small size and regional GDP, Thailand’s healthcare expenditure levels, 
tourist-fueled economy, and position for trade with Southeast Asian nations presage a 
formidable IVD market.  It is the 53rd largest country worldwide yet is ranked 20th in terms 
of population with nearly 70 million inhabitants.  The country is poised to face a growing 
problem with a shift in aging populations and a high elderly dependency ratio due to the low 
birth rates over the past decades and just 0.26% population growth; compared to elderly 
population growth of 4.5%, representing 13% of the population today but nearly 20% by 
2030. 
A major boost to the health service market, the government has made healthcare even for 
poor citizens a priority: there is coverage for 99.9% of the population, comprehensive 
coverage represented by a health package that includes curative services, health promotion, 
disease prevention and rehabilitation, and full protection of households from financial health 

 
 
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risk.  The tax-financed universal health coverage scheme for 75% of the Thai population, 
which included a generous benefits package, was financially feasible as a closed-end budget 
through a mix of provider payments and the use of the Diagnostic-Related Group. On the 
downside, stringent cost containment measures are imposing restrictions on benefits and 
reimbursement rates for patient tests.  The IVD market in Thailand is valued at roughly $199 
million in 2025. 
Vietnam 
This nation has been one of Asia's fastest-growing economies. The official poverty rate in 
the country fell from 58% in 1993 to under 20% at present.  It is the 8th-largest country in 
Asia by population, accounting for just 2% of the region's total, largely due to the large 
populations of China and India.  The distribution of the population is expected to shift toward 
the 65-and-over population, which will account for 11% of the total population in 2030, up 
from 6.9% in 2020, an increase of 5.7 percentage points annually on average.  The shift in 
the aging population is expected to increase overall disease incidence, as older adults are 
more vulnerable to illness.  
Vietnam is considered a complex market for foreign suppliers.  The market landscape and 
regulatory environment require relationships with local distributors or a domestic agent for 
successful market entry.  Despite the barriers, the overall perception of U.S. and European 
medical equipment is highly favored and accepted.  Diagnostic equipment is in high demand 
and government support for private investments is increasing.  
It's not new that Vietnam is an IVD target market, currently worth $137 million in 2025.  
Roche Diagnostics Vietnam has established a nationwide network in the country for over 20 
years and has offices in Hanoi, Da Nag and Ho Chi Min City.  Abbott opened offices there 
for its nutrition division in 1995 and has diagnostics sales across all provinces; bioMérieux 
has also maintained a long-standing presence in the country.  Growth in this market will 
benefit from stepped-up efforts by internal and external medical groups to reduce cases of 
bacterial diarrhea, dengue fever, hepatitis A, Japanese encephalitis, malaria, typhoid fever, 
and other pathogenic conditions. Vietnam is attempting to improve its deficient and 
imbalanced medical delivery system, which reaches between 35% and 40% of the population.   

 
 
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IVD Market Opportunity by Country 
Table 3-25: IVD Market Opportunity, by Country (2025 Market Rank, Country CAGR 2025-2030) (%) 
2025 Rank ($ Revenues) 
IVD Region 
CAGR 2025-2030 
23 
South Korea 
6.9% 
11 
Brazil 
6.5% 
16 
Turkey 
6.1% 
1 
U.S. 
5.8% 
2 
Germany 
5.8% 
22 
Saudi Arabia 
5.8% 
5 
France 
5.7% 
19 
Sweden 
5.6% 
31 
Finland 
5.6% 
6 
United Kingdom 
5.5% 
17 
Poland 
5.5% 
30 
Ireland 
5.5% 
7 
Italy 
5.4% 
14 
Netherlands 
5.4% 
15 
Switzerland 
5.4% 
27 
Portugal 
5.4% 
12 
India 
5.3% 
26 
Romania 
5.3% 
9 
Spain 
5.2% 
21 
Austria 
5.2% 
25 
Denmark 
5.2% 
18 
Mexico 
5.1% 

 
 
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2025 Rank ($ Revenues) 
IVD Region 
CAGR 2025-2030 
33 
Hungary 
5.1% 
20 
Belgium 
5.0% 
45 
Luxembourg 
5.0% 
10 
Australia 
4.9% 
29 
Greece 
4.9% 
41 
Ukraine 
4.8% 
50 
Vietnam 
4.7% 
42 
Norway 
4.6% 
51 
Malaysia 
4.4% 
8 
Canada 
4.3% 
3 
China 
4.2% 
28 
South Africa 
4.2% 
37 
United Arab Emirates 
4.2% 
44 
Peru 
4.1% 
38 
Argentina 
3.9% 
32 
Indonesia 
3.7% 
46 
Philippines 
3.7% 
35 
Colombia 
3.6% 
43 
Thailand 
3.6% 
4 
Japan 
3.5% 
48 
Croatia 
3.5% 
34 
Chile 
3.2% 
49 
Iraq 
3.1% 
13 
Russia 
2.9% 

 
 
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2025 Rank ($ Revenues) 
IVD Region 
CAGR 2025-2030 
53 
Venezuela 
2.9% 
55 
Bulgaria 
2.9% 
40 
Iran 
2.8% 
24 
Egypt 
2.6% 
54 
Slovenia 
2.5% 
39 
Israel 
2.4% 
52 
Singapore 
2.4% 
47 
Slovakia 
2.3% 
36 
Czech Republic 
2.1% 
56 
Jordan 
1.3% 
57 
Belarus 
0.6% 
Source: Kalorama Information 
 
 
 

 
 
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Chapter 4: Company and Industry Trends 
Scope 
Advanced technologies are among the most influential factors shaping the in vitro 
diagnostics (IVD) market. These technological advancements have enabled the industry 
to evolve beyond traditional diagnostics, playing a critical role in the early identification 
and assessment of symptoms. A growing trend is the integration of genomics, 
information technology, and data analytics into routine clinical laboratory medicine, 
marking a significant shift in how diagnostics are developed and applied. 
This chapter highlights a selection of technologies, events, and trends that are poised to 
shape the future of IVD. While North America, particularly the United States, remains 
the largest market for clinical diagnostic and healthcare products, the trends discussed 
here are primarily reflective of the U.S. landscape. Where available, relevant 
international examples are also provided to offer a broader perspective. 
Although it is beyond the scope of this research to quantify the market impact of all the 
developments discussed, estimates of the potential quantitative effects are included 
when possible. The remainder of this chapter presents a discussion of key trends and 
developments that illustrate the evolving direction of clinical IVD laboratory medicine. 
These are not presented in order of importance but rather as an overview of the 
dynamic landscape of diagnostic innovation. 

 
 
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Edition-Specific Notes  
The Molecular Oncology IVD market is in a period of sustained, high-velocity 
expansion, growing from $4.1 billion in 2024 to $4.7 billion in 2025 at a double-digit 
year-over-year growth rate that exceeds the broader IVD sector. This growth is driven 
by the diversity of oncology assays across clinical, technological, and commercial 
settings. The rapid adoption of liquid biopsy and circulating tumor DNA (ctDNA) 
assays is a testament to the growing adoption of personalized medicine. Additionally, 
maturation in the next-generation sequencing platform segment has prompted vendors 
to innovate and expand current techniques. From early detection through treatment 
selection and monitoring, these assays provide a vital component of oncology care plans 
and long-term outcomes. Minimal residual disease (MRD) testing has emerged as the 
defining application of this cycle, with tumor-informed assays now capable of detecting 
cancer recurrence up to two years ahead of conventional imaging. Companion 
diagnostics are also creating strong, reimbursement-backed revenue streams that 
support the market's long-term trajectory. Adding to the market opportunity, 
expanding reimbursement profiles and coverage decisions from high-influence payers 
such as CMS are supporting a solid commercial opportunity. 
Kalorama Information maintains its projection of strong growth in the clinical 
sequencing segment. Demand is supported by the adoption of clinical applications in 
precision medicine and rare diseases supporting a CAGR of 9% through 2030. 
Oncology applications remain one of the leading drivers of the market and industry 
acceptance is noted through expanded reimbursement and increased attention on 
regulatory submissions and granted approvals.  
Advanced Medicine Without Borders 
Clinical and research diagnostics in developing countries, and in particular the emerging 
countries, as shown in the table below, are the beneficiaries of the trend for IVD companies 
to expand their reach beyond their traditional borders. 

 
 
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Table 4-1: Key Emerging IVD Markets, 2020-2025 ($ million) 
Market 
2020 
2021 
2022 
2023 
2024 
2025 
Brazil 
1,483 
1,701 
1,728 
1,658 
1,733 
1,843 
China 
4,697 
6,406 
6,602 
5,868 
5,920 
6,276 
India 
1,156 
1,452 
1,451 
1,299 
1,331 
1,390 
Indonesia 
298 
327 
319 
293 
298 
306 
Malaysia 
125 
135 
134 
124 
127 
132 
Mexico 
697 
797 
809 
770 
793 
832 
Saudi Arabia 
584 
675 
691 
612 
627 
675 
South Africa 
262 
377 
392 
355 
362 
377 
South Korea 
458 
511 
498 
474 
487 
509 
Thailand 
196 
218 
214 
193 
195 
199 
Turkey 
853 
1,054 
1,060 
992 
1,013 
1,085 
Vietnam 
112 
125 
136 
125 
131 
136 
Source: Kalorama Information 
As growth in developed markets such as the U.S., Europe, and Japan has matured, IVD 
companies have increasingly looked to international markets to expand their product 
portfolios and extend their commercial reach. This trend applies not only to large 
multinational firms but also to second-tier and emerging companies introducing advanced 
diagnostic technologies in developing regions. Expansion strategies have evolved beyond 
traditional distribution agreements to include localized manufacturing, strategic partnerships, 
and in-country product development efforts tailored to regional needs. 
China remains a central focus of this global expansion strategy due to the size of its healthcare 
system, ongoing investment in clinical infrastructure, and strong demand for advanced 
diagnostics. However, the market has become more complex and competitive, shaped by 
government policies, pricing controls, and increasing domestic innovation. Companies 
including bioMérieux, QIAGEN, Siemens Healthineers, Oxford Nanopore Technologies, 
and others have continued to pursue opportunities in China through a combination of 

 
 
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partnerships, localized operations, and targeted investment, reflecting both the potential and 
the challenges of operating in this rapidly evolving market. 
Many companies are increasingly diversifying beyond China into other high-growth regions 
such as India, Southeast Asia, the Middle East, and Latin America, both to capture new 
demand and to mitigate geographic and policy risk. This shift reflects a broader move away 
from export-driven models toward building localized systems that include manufacturing, 
research and development, and supply chain capabilities aligned with regional regulatory and 
procurement requirements. Government policies that prioritize domestic production and 
technology transfer are further influencing market entry strategies, while the expansion of 
private healthcare systems and independent laboratory networks is accelerating the adoption 
of advanced diagnostics. In addition, the growing role of digital health, connectivity, and 
cloud-based platforms is enabling companies to address infrastructure gaps and deliver more 
integrated diagnostic solutions, reinforcing the importance of flexible, region-specific 
strategies in global IVD expansion. 
China Market Update 
China is one of the largest IVD markets globally and a key region in the Asia Pacific; 
however, growth has slowed relative to earlier revenue expectations. The market has 
experienced pricing pressure and slower expansion due to healthcare reforms and centralized 
and volume-based procurement programs. The country has implemented increased cost 
controls, particularly affecting reagent pricing and routine testing. While the number of 
domestic IVD companies has continued to grow, consolidation is beginning to emerge as 
smaller players face margin pressure and increased regulatory requirements. The decline in 
testing volumes following the COVID-19 pandemic has also contributed to slower growth, 
particularly in molecular diagnostics. 
Despite this slowdown,  demand for IVD remains strong. China’s aging population and rising 
prevalence of chronic diseases such as diabetes, cardiovascular disease, and cancer continue 
to influence long-term demand for diagnostic testing. At the same time, the expansion of 
healthcare access and ongoing investment in hospital infrastructure are driving growth in test 
volumes, even as revenue growth is constrained by pricing dynamics. The market is 
increasingly segmented, with routine testing experiencing pricing pressure while higher-
value areas such as molecular diagnostics, oncology testing, and specialty immunoassays 
continue to grow. 

 
 
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Historically, multinational companies dominated the Chinese IVD market, but domestic 
manufacturers have significantly increased their market share over the past decade. Local 
companies such as Shanghai Kehua Bio-Engineering, DaAn Gene, Runda Medical, Autobio 
Diagnostics, Mindray, GeneCast Biotechnology, WuXi AppTec, and Wondfo Biotech have 
strengthened their positions through competitive pricing, government support, and expanding 
product portfolios. Many of these companies are now competing directly with global firms 
in core laboratory, molecular diagnostics, and point-of-care testing segments. At the same 
time, localization has become a critical strategic priority, with both domestic and 
multinational companies expanding local manufacturing, partnerships, and supply chain 
capabilities to align with regulatory requirements and procurement preferences. 
Companies such as Abbott, BD, Bio-Rad, bioMérieux, Danaher, Revvity, QIAGEN, Roche, 
and Thermo Fisher Scientific, maintain a strong presence in China, particularly in high-end 
instrumentation, advanced molecular diagnostics, and premium testing segments. However, 
they face increasing competition from domestic manufacturers, as well as ongoing pricing 
and reimbursement pressures. Investment in laboratory automation, digital infrastructure, and 
artificial intelligence is also increasing, particularly in large hospital networks, supporting 
more standardized workflows and improved operational efficiency. 
China continues to see an uptick in chronic lifestyle diseases. Companies such as Roche offer 
integrated solutions like the cobas pro platform, a scalable and modular system designed for 
mid- to high-volume clinical chemistry and immunoassay testing. While demand for 
advanced diagnostic platforms remains steady, purchasing decisions are increasingly 
influenced by cost efficiency, local sourcing preferences, and government procurement 
policies. The market has experienced pricing pressure and slower expansion due to healthcare 
reforms, centralized and volume-based procurement programs, and increased cost controls, 
particularly affecting reagent pricing and routine testing segments. 
Direct to Consumer Genetic Test Services 
Advances in genomics have led to an increase in genetic test services that predict a person’s 
risk of developing various chronic diseases such as diabetes, cardiovascular conditions, 
arthritis, Alzheimer’s, breast cancer, celiac disease, and psychological syndromes. 
23andMe was a pioneer in this area and has successfully provided many FDA-cleared DTC 
tests. The company filed for bankruptcy in March 2025. The company was acquired in July 
2025 by nonprofit research institute TTAM. Select products are still available from TTAM. 

 
 
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Color offers the Color Extended Kit for $249. It is designed to assess the risk of hereditary 
cancer and hereditary heart health by looking at 30 different genes, including those associated 
with colorectal cancer, melanoma, ovarian, pancreatic, stomach, prostate, and uterine 
cancers.  
Other IVD DTC genetic testing companies include Gene by Gene, Genesis HealthCare, Easy 
DNA, Veritas, and Myriad Genetics 
The patient can initiate testing and authorize an independent physician from an external 
network to order the test or have their physician order it.  
Genetic Testing in Disease 
Genetic testing is advancing rapidly, opening new avenues for diagnostic capabilities. 
Sequencing technologies are becoming increasingly accessible and cost-effective, enabling 
healthcare professionals to perform whole-genome sequencing more routinely. Genetic 
testing has significantly enhanced personalized medicine in several key areas, including: 
• Cancer diagnostics, by identifying specific cancer types and enabling more targeted 
treatments; 
• Pharmacogenetics, by tailoring drug therapies based on an individual’s genetic 
response to medications; and 
• Inherited disease detection, by identifying mutations early and enabling timely 
intervention. 
Kalorama Information identifies this field as one with tremendous potential. In the 
future, genetic testing may become a standard tool in personalized medicine and routine 
preventative screening. 
Genomic Testing 
Advances in genomic research and laboratory technology are bringing genomic medicine 
into routine clinical use. The next step is making sure that this information can be delivered 
in a practical way so clinicians can use it in everyday decision-making. This depends on 
systems that can translate complex genomic data into clear, clinically useful results. 

 
 
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Next-generation sequencing has made it possible to analyze large amounts of genetic 
information quickly and at a lower cost. However, generating data is only part of the process. 
Interpreting that data and turning it into clinically relevant information requires strong 
bioinformatics support and reliable analysis tools. 
Genomic testing is now used more widely, especially in the diagnosis of rare diseases and in 
pediatric cases, where it can help shorten the time to diagnosis and improve outcomes. 
Testing is also moving beyond DNA alone, with increasing use of methods that combine 
different types of biological data to give a broader view of disease. 
In oncology, genomic testing continues to expand through larger gene panels and the use of 
liquid biopsy for treatment selection and disease monitoring. There is also growing interest 
in using these tools earlier, including in screening and early detection. Improvements in data 
analysis are helping laboratories and clinicians handle more complex information and make 
better use of results. 
Laboratory workflows are also improving, with more automation and better integration 
across different steps in the testing process. This helps reduce turnaround time and simplifies 
operations. Newer technologies, such as optical genome mapping, are also being introduced 
to complement sequencing by improving the detection of certain types of genetic changes 
that may be missed by standard methods. 

 
 
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Gene Editing 
Gene editing is a process in which DNA is inserted, deleted, or replaced in the genome of an 
organism using engineered nucleases. There are three families of engineered nucleases in use 
today, including: 
•  Zinc finger nucleases (ZFNs) 
• Transcription Activator-like Effector-based nucleases (TALANs) 
• CRISPR-Cas System 
Gene targeting with ZFNs or TALENs is used to modify defective genes. An example is 
Sangamo BioSciences, which introduced the Delta 32 mutation (a suppressor of the CCR5 
gene, a co-receptor for HIV-1 entry into T cells and therefore enabling HIV infection) using 
Zinc Finger Nuclease (ZFN). Researchers at SGMO mutated CCR5 in CD4+ T cells, thereby 
producing an HIV-resistant T-cell population. 
CRISPR is a technology used to modify genetic material by making precise changes to DNA. 
It is based on a natural defense system found in bacteria, which helps protect them from 
viruses and other foreign genetic material. This system works by recognizing specific DNA 
sequences from invading organisms and cutting them to prevent infection. 
The CRISPR system includes short repeating DNA sequences along with nearby genes 
known as CRISPR-associated (Cas) genes. These genes produce enzymes that can cut or 
unwind DNA. Among these enzymes, Cas9 is the most widely used. Originally identified in 
the bacterium Streptococcus pyogenes, Cas9 can be guided to a specific DNA sequence, 
where it cuts the DNA, allowing targeted gene modification. 
Because of its precision and flexibility, CRISPR-Cas9 has become an important tool for gene 
editing, enabling researchers to study gene function and develop new approaches in medicine 
and biotechnology. 
 
 
 

 
 
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Table 4-2: Selected Gene Editing / CRISPR Innovations 
Company 
Location 
Details 
Agilent Technologies 
U.S. 
SureGuide pooled CRISPR libraries for functional genomics 
Agilent Technologies 
U.S. 
Cas9 endonuclease kit 
Arbor BioSciences 
U.S. 
CRISPR/Cas-driven myNGS Guides, controls 
Bio-Rad Laboratories 
U.S. 
ddPCR with CRISPR gene editing 
Bio-Rad Laboratories 
U.S. 
CRISPR applications for ddPCR & flow cytometry  
Broad Institute 
U.S. 
CRISPR-based SHERLOCK Zika in stool, COVID 
Caedea Bio 
U.S. 
CRISPR Chip graphene biosensor 
Cepheid 
U.S. 
GeneXpert sARS-CoV-2, with Sherlock Biosystems 
Clontech 
U.S. 
Guide-it CRISPR/Cas9 Gesicle Production System 
DefiniGen 
U.K. 
CRISPR gene editing disease models 
EdiGene 
China 
Genome editing platforms 
Evotec 
Germany 
Licensed CRISPR gene Cas9 technology from ERS Genomics 
Evotec 
Germany 
CRISPR-Cas0 technology from ERS Genomics 
Illumina 
U.S. 
Desktop Genetics' CRISPR gene editing software 
Inscripta 
U.S. 
new CRISPR enzyme free for research 
Locus Biosciences 
U.S. 
with IDbyDNA, DNA & RNA sequencing, pathogen ID   
Mammoth Biosciences 
U.S. 
CRISPR POC & OTC detection platform 
MIT, Broad Institute 
U.S. 
POC Sherlock, paper-based CR 
ISPR device, viruses 
Origene Technologies 
U.S. 
CRISPR/Cas9 Genome Editing 
Oxford Nanopore Technologies 
U.K. 
Minion CRISPR sequencing 
Promega 
U.S. 
Broad’s CRISPR Cas 9 with knock-in gene editing 
Sherlock Biosciences 
U.S. 
SHERLOCK, smart amplification detection 
Sphere Fluidics 
UK 
Cyto-Mine, CRISPR with single-cell analysis  

 
 
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Company 
Location 
Details 
Thermo Fisher Scientific 
U.S. 
Invitrogen GeneArt CRISPR products 
TwinStrand Biosciences 
U.S. 
CRISPR-DS sequencing for ovarian cancer 
U. of CA, Berkeley  
U.S. 
POC developing CRISPR chip 
U. of North Carolina 
U.S. 
Gene editing, Hunter or Hurler syndrome 
Source: Kalorama Information, company reports 
CRISPR as a Diagnostic Tool 
One of the most important new applications of CRISPR is in the diagnosis of infectious 
diseases. CRISPR pioneers Jennifer Doudna and Trevor Martin have co-founded Mammoth 
Biosciences to develop a device that uses CRISPR to detect infectious diseases, including 
malaria, tuberculosis, and Zika.   The company is working on a credit card-sized paper test 
and smartphone app combo for disease detection.   
Mammoth reported that the theory behind their product development is that CRISPR can be 
used for more than just gene editing. CRISPR can target precise bits of genetic code, so it 
can be engineered to detect a genetic sequence belonging to a particular virus, like Zika.  
When combined with special enzymes, CRISPR can be turned into a precise diagnostic tool. 
Mammoth Biosciences is not alone in this endeavor.  Researchers around the world are 
finding innovative ways to employ CRISPR technology to detect diseases in some of the 
most remote, challenging areas, including Lassa fever, Zika, and dengue fever.  Mammoth 
BioSciences offers DETECTR BOOST SARS-CoV-2 reagent kit. The platform is the first 
with a high-throughput solution that combines the power of CRISPR with laboratory 
automation for SARS-CoV-2 testing. It uses Agilent Bravo BenchCel BD liquid handling 
platform.  
Fellow CRISPR pioneer, Feng Zhang at the Massachusetts Institute of Technology, 
developed a CRISPR paper test offered by SHERLOCK. SHERLOCK is scaling up access 
to its diagnostic tests at high volume. The company is also working on another test called 
INSPECTR, which people would be able to use in their homes, rather than in a lab setting. 
That synthetic biology-based product would be able to provide users with a positive or 

 
 
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negative result on a strip of paper. In March 2022, the company raised $80 million in 
financing to provide at-home diagnostic testing.  
The African Centre of Excellence for Genomics of Infectious Diseases in Nigeria uses a 
CRISPR diagnostic test to look for Lassa virus in a blood sample. 
In 2025, several companies are expected to demonstrate significant advancements in trial 
data. By using CRISPR in detection of disease, there will likely be improved sensitivity, 
specificity and speed of CRISPR -based assays. Current CRISPR -based diagnostic tools 
include: 
• SHERLOCK – Sherlock Biosciences (OraSure) 
•  DETECTR - Mammoth 
• COMET - Lunaphore 
• CRISPR-Chip – Paragraf 
CRISPR and the Food Industry 
In the near future, the first foods from plants or animals whose DNA has been "edited" are 
expected to begin selling. It's a different technology from today's controversial "genetically 
modified" foods, more like faster breeding that promises to boost nutrition, spur crop growth, 
make farm animals hardier, and make fruits and vegetables last longer. Now, gene-editing 
tools promise to alter foods more precisely without necessarily adding foreign DNA, as is 
the case with genetically modified organisms. Instead, they act like molecular scissors to alter 
an organism's own genetic code. 
The U.S. National Academy of Sciences declared gene editing one of the breakthroughs 
needed to improve food production so the world can feed billions more people amid a 
changing climate.  Yet governments are wrestling with how to regulate this powerful new 
tool.  After years of confusion and opposition to genetic modification, will shoppers accept 
gene-edited foods or view them as GMOs in disguise? 
Some initiatives include wheat with triple the usual fiber, or that's low in gluten; mushrooms 
that don't brown; better-producing tomatoes; drought-tolerant corn; rice that no longer 
absorbs soil pollution as it grows, and infection-resistant animals for human consumption.   

 
 
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Some developmental innovations that are using CRISPR technology include: 
•  Tropic Biosciences using CRISPR to delete the caffeine production of the gene 
• Tomatoes that are spicy  
• Wine that does not produce a hangover after overindulgence 
• Control of pests 
• Producing allergy-free foods  such as IngateyGen working on a hypoallergenic peanut 
using CRISPR 
• Revival of extinct species – California Biotech has started a passenger pigeon project 

 
 
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Microbiome 
Associations between the human microbiome and inflammatory, metabolic, gastrointestinal, 
immune, dermatologic, oncologic, and neurologic disease continue to attract significant 
research and commercial interest. The gut microbiome remains the most studied area, but 
attention has also expanded to the oral, skin, urogenital, and tumor-associated microbiomes. 
Microbes in the gut, mouth, skin, and other body sites have been linked to conditions such as 
inflammatory bowel disease, irritable bowel syndrome, obesity, diabetes, allergies, 
autoimmune disease, cancer, infectious diarrhea, and mental health disorders. While these 
associations are biologically important, the field is still working to determine which 
microbiome signatures are clinically actionable and reproducible enough for routine 
diagnostic use. 
In clinical diagnostics, microbiome testing remains an emerging and relatively narrow 
market. Most testing is still performed through service providers, academic laboratories, 
specialty reference laboratories, or research-use platforms. Sequencing-based approaches, 
including 16S rRNA profiling, shotgun metagenomics, metatranscriptomics, and targeted 
molecular assays, are being used to study dysbiosis, disease risk, treatment response, and 
microbial function. However, reimbursement, standardization, interpretation, and clinical 
utility remain barriers to broad adoption. Consequently, microbiome diagnostics have not yet 
become mainstream IVD products in the same way as infectious disease molecular assays or 
oncology companion diagnostics. 
Genetic Analysis remains one of the more established companies in microbiome-based 
diagnostics through its GA-map technology, a gene-based test designed to identify gut 
dysbiosis associated with conditions such as irritable bowel syndrome and inflammatory 
bowel disease. Luxia Scientific has also offered CE-marked microbiome testing through its 
1test1 platform, which analyzes gut bacterial composition using sequencing-based methods. 
These products illustrate the movement toward more standardized microbiome testing, 
although adoption remains limited and the European IVDR environment has increased the 
burden on companies seeking to maintain or expand clinical claims. 
OraSure Technologies remains active in the microbiome field primarily through its DNA 
Genotek and Diversigen businesses, which include stool and saliva collection devices and 
microbiome sequencing and analysis services. CoreBiome is generally treated as part of the 
Diversigen microbiome services brand rather than a separate, standalone business. These 

 
 
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offerings are important for research, pharmaceutical development, clinical studies, and 
sample collection, but they are not positioned as broad routine diagnostic tests. 
Bio-Rad’s earlier collaboration with Genetic Analysis and Bioaster reflected the industry's 
interest in identifying microbiome signatures associated with metabolic diseases, including 
diabetes and obesity. Thermo Fisher’s Applied Biosystems Axiom Microbiome Array also 
remains relevant as a research tool for broad microbial detection across bacteria, archaea, 
fungi, protozoa, and viruses. Illumina, Oxford Nanopore, and other sequencing platform 
providers continue to support microbiome research through sequencing instruments, library 
preparation tools, and bioinformatics workflows rather than disease-specific microbiome 
diagnostic kits. 
Microbiome links to cancer remain an active area of research. Certain pathogens already have 
well-established roles in cancer, including Helicobacter pylori in gastric cancer and HPV in 
cervical, anal, and some head and neck cancers. Beyond these established infectious causes, 
companies and academic groups continue to study whether tumor-associated or circulating 
microbial signatures can support early cancer detection, risk stratification, or treatment 
response monitoring. Companies such as Micronoma and Prescient Metabiomics have 
pursued microbiome-based cancer diagnostics, although this remains an early-stage field and 
has not yet produced widely adopted routine screening tests. 
The gut-brain axis also remains an active area of research, with studies linking gut microbial 
composition and microbial metabolites to depression, anxiety, Parkinson’s disease, and other 
neurologic or psychiatric conditions. However, these findings are still largely investigational. 
Microbiome profiles are not yet used as standard diagnostic tests for mental health or 
neurologic disease. 

 
 
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Table 4-3: Selected Microbiome Test Innovations 
Company 
Location 
Details 
Bio-Rad Laboratories 
U.S. 
Gut microbiome & CE marked GA-map, genetic analysis 
BIOHM Health 
U.S. 
microbiome autism linkage 
CosmosID 
U.S. 
Collab with Zymo Research microbiome analysis 
DayTwo 
Israel 
Gut microbiome nutrition plan service 
Diversigen 
U.S. 
Collab with Norgen Biotek, microbiome seq and analysis 
DNA Genotek / OraSure 
U.S. 
Omnigene microbiome collection devices  
Genetic Analysis 
Norway 
GA-map microbiome imbalance 
GenomeAsia 100K  
Singapore 
sequencing data with microbiome, personal info for disease risk  
Helomics/Precision Therapeutics 
U.S. 
Cancer with Viome link microbiome with ovarian cancer 
Luxia Scientific 
France 
1test1, bacterial content of the gut microbiome 
Microba 
Australia 
Collab with Macrogen microbiome research services 
Microbiome Insights 
Canada 
next-generation sequencing-based analytical testing  
One Codex 
U.S. 
public portal for microbiome data  
OraSure 
U.S. 
BoosterShot seq, microbiome services 
Phase Genomics 
U.S. 
AI computational platform for microbiome samples 
Prescient Medicine 
U.S. 
Seq with Metabiomics colon cancer 
QIAGEN 
Netherlands 
Biomillenia’s proprietary microbiome-on-a-chip technology 
Thermo Fisher 
U.S. 
Applied biosystems Axiom Microbiome array 
Thryve Inc. (Ombre) 
U.S. 
$99 gut health kit, DTC service 
Viome 
U.S. 
DTC microbiome test service stool 
Viome 
U.S. 
Gut microbiome & ovarian cancer, stool 
Source: Kalorama Information, company reports 
 

 
 
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Next-Generation Sequencing 
Next-generation sequencing has altered the field of genomics. Although the first clinical NGS 
system received FDA approval in 2013, making the IVD segment relatively new, there has 
already been substantial activity in laboratory-developed tests performed by certified clinical 
laboratories. Much of the current clinical sequencing market consists of instrument sales to 
reference and specialty laboratories, along with associated reagents, library preparation kits, 
and consumables. 
Clinical NGS adoption is led primarily by Illumina and Thermo Fisher Scientific. Thermo 
Fisher’s Ion Torrent technology began with the Personal Genome Machine and has since 
advanced to platforms such as the Ion GeneStudio S5 series, which support higher-
throughput clinical applications. This technology detects DNA synthesis by measuring pH 
changes that occur when nucleotides are incorporated, thereby avoiding the need for optical 
detection systems. 
Illumina’s platforms use sequencing-by-synthesis chemistry, relying on reversible terminator 
nucleotides and imaging to generate sequence data. Systems such as MiSeq, MiniSeq, iSeq 
100, and the NextSeq series are widely used in clinical and research settings. These platforms 
are designed to process large numbers of DNA fragments simultaneously, enabling efficient 
and accurate sequencing workflows. 
While PCR played a central role in diagnostic testing during the COVID-19 pandemic, 
sequencing was essential for tracking and understanding the virus. Many regions continue to 
require sequencing a portion of positive samples for surveillance purposes. 
NGS is especially useful in the study of inherited disorders that involve multiple genes. In 
conditions such as cardiomyopathies, where many genes contribute to a wide range of 
symptoms, NGS allows simultaneous analysis of numerous targets in a cost-effective 
manner. Other methods, such as microarrays, may still be appropriate in certain cases, 
including some neurological conditions. Selecting the most appropriate testing approach 
remains an important consideration in clinical practice. 
Two common NGS strategies are targeted gene panels and whole-exome sequencing (WES). 
Targeted panels focus on a defined set of genes, which helps limit incidental findings and 
simplify interpretation, but they may require updates as new disease-associated genes are 

 
 
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discovered. WES covers a broader portion of the genome and is particularly valuable in rare 
disease diagnosis, although it may not provide complete coverage of all regions. 
NGS has also become an important tool in companion diagnostics. Illumina and Thermo 
Fisher have worked with pharmaceutical companies to develop tests that identify patients 
who may benefit from specific therapies. These include assays that analyze genetic variants 
associated with targeted oncology treatments. At the same time, regulatory frameworks 
continue to evolve. In the United States, laboratory-developed tests have historically allowed 
faster market entry, but increasing regulatory oversight may affect the number of competitors 
and pricing dynamics. Similar regulatory alignment is taking place in Europe and Asia, where 
requirements for approved systems and kits are becoming more standardized. 
Table 4-4: Selected Clinical NGS Platforms on the Market 
Company                                     Platform Details and Assays 
Thermo Fisher Scientific 
(Life Technologies) 
Ion PGM Dx (FDA; CE-IVD); Oncomine Dx Target Test, ion semiconductor or sequencing 
by synthesis (SBS)  
Beijing Genomics Institute 
(BGI) 
BGISEQ-100 / BGISEQ-1000; Platform for CFDA-approved BGI NGS assays for NIPT; SBS 
method 
Illumina 
MiSeqDx (FDA; CE-IVD); Cystic Fibrosis 139-Variant Assay and MiSeqDx Universal Kit, 
extended RAS Panel; SBS method 
NextSeq 550Dx (FDA; CE-IVD); intended only for targeted sequencing of DNA libraries 
from human DNA  
Pac BioSciences 
PacBio Sequel II System, Onso 
QIAGEN 
PyroMark Q24 MDx (CE-IVD marked; pyrosequencing platform for companion assays in 
oncology), QIAseq Human Exome TR Insights 
Vela Diagnostics 
Sentosa SQ301; FDA-approved Thermo Fisher Ion Torrent-based platform; also performs 
CE-IVD marked NGS assays for HIV and HCV genotyping and oncogene panels 
Source: Kalorama Information 
The realization of a greater clinical sequencing market will depend on a variety of factors, 
including standardization of regulatory review of clinical sequencing products, the 
miniaturization of clinical sequencing systems, and technological improvements that reduce 
hands-on time and automate analysis to reduce the risk of user error. New sequencing tests 
will also be required to successfully demonstrate their clinical utility to justify 

 
 
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reimbursement, in terms of improved patient outcome when coupled with a particular therapy 
or to predict patient outcomes that allow patients to consider multiple care strategies. 
Adaptation of NGS to POC settings is still far off and will require a demonstration of 
significantly higher utility than other existing POC platforms.  
BGI offers its Homologous Recombination Deficiency Detection Kit. The kit is designed to 
provide qualitative detection of homologous recombination deficiency (HRD) in genomic 
DNA using high-throughput sequencing. Early HRD detection could predict the efficacy of 
PARP inhibitors in ovarian and breast cancer patients.  
Thermo Fisher Scientific offers its CE-marked Applied Biosystems TaqPath Seq HIV-1 
Genotyping Kit. The Applied Biosystems TaqPath Seq HIV-1 Genotyping Kit is a Sanger 
sequencing-based assay that identifies genetic variants of HIV that are most resistant to 
antiretroviral therapy.                          
 BGI Genomics markets its GPMeta, a metagenomic sequencing diagnostic tool to detect 
causative pathogens in clinical microbiological testing. The GPMeta can quickly diagnose 
pathogens using complex, large-scale mNGS data.  
Devyser provides two new products, LynchFAP and BRCA PALB2. These kits offer targeted 
analysis of genes associated with increased cancer risk with a simple NGS workflow.  
Illumina entered into a strategic partnership with Pillar Biosciences for the 
commercialization of Pillar’s oncology portfolio, which can be used on any of Illumina’s 
sequencers.  These assays help to identify mutations that create tumor growth. 
Agilent sold Resolution Bioscience to Exact Sciences. Resolution Bioscience develops and 
commercializes next-generation sequencing oncology solutions.  
 Oxford Nanopore offers TurBOT, a benchtop instrument offering NGS.  
Roche entered the market with unique technologies designed for clinical speed and precision. 
Roche offers the VENIO Edge System with features automated sample prep for liquid biopsy 
and tissue sequencing applications. Roche also offers Roche Sequencing by Expansion, a fast 
and accurate sequencing technology based on Xpand DNA for clinical WGS, oncology, and 
pathogen genomics applications.  

 
 
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Liquid Biopsy 
Liquid biopsy is an important emerging technology in patient care and precision medicine.  
Minimally invasive liquid biopsies of tumor cells and tumor DNA from the bloodstream can 
enable earlier primary and secondary diagnoses compared to solid tumor biopsies, as well as 
the detection of metastasis and/or residual disease, and real-time monitoring of treatment 
effectiveness, which is not practical with solid tumor biopsy methods.  
Genomic DNA amplified or sequenced from circulating tumor cells (CTCs), circulating 
tumor cell DNA (ctDNA) and circulating cell-free DNA (cfDNA) provide complementary 
information on mutations relevant for the treatment of individual cancer patients. These 
applications promise to impact clinical protocols and treatment regimens and will likely 
determine the future standard of care in oncology. 
The basic technology of circulating tumor cell testing has come a long way since the first 
application: in 2004, the FDA approved the CellSearch system for in vitro use of circulating 
tumor cell count in patients with metastatic breast cancer.  In its purist application, liquid 
biopsy has perfected the detection of rare cells or molecular products in a sea of “other” cells.  
The CellSearch systems are the first and only clinically validated blood test cleared by the 
FDA to detect and enumerate circulating tumor cells (CTCs) to help manage patients with 
metastatic breast, prostate, and colorectal cancers. The China Food and Drug Administration 
also approved the test for use in monitoring metastatic breast cancer patients. 
The term liquid biopsy had not yet been coined, and, in fact, when it was first introduced, the 
concept of testing for circulating tumor cells was not universally accepted.  Perhaps the 
CellSearch system was ahead of its time, but it also suffered from the owners’ inability to 
translate it into routine clinical use.  First offered by Immunicon, the CellSearch Circulating 
Tumor Cell Kit was exclusively marketed by Veridex, LLC.  Then Veridex was acquired by 
Johnson & Johnson’s Janssen Diagnostics.   
CellSearch found its most recent home in 2017 when Menarini-Silicon Biosystems, Inc. 
(Bologna, Italy and San Diego, CA) acquired all the assets and relevant business related to 
the CELLSEARCH Circulating Tumor Cell System from Janssen Diagnostics, LLC.  The 
CELLSEARCH product line, which includes the CELLTRACKS AUTOPREP SYSTEM, 
the CELLSEARCH Analyzer II and the CELLSEARCH CTC Kit, is combined with 
Menarini-Silicon Biosystems’ flagship DEPArray NxT System 

 
 
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More recently, circulating DNA in all its forms has overtaken CTC-based techniques in liquid 
biopsy tumor analysis.  The basic science of testing for circulating DNA in blood began with 
the detection of fetal DNA in maternal peripheral blood.  In 1970, researchers at Stanford 
University discovered a few cells in a pregnant woman's blood that must have come from her 
developing son, since they contained the male Y sex chromosome. 
The extension of this early research became a reality for prenatal testing through the proof-
of-principle work by Dennis Lo, M.D., a professor of Medicine and Chemical Pathology at 
the Chinese University of Hong Kong and Director of the Li Ka Shing Institute of Health 
Sciences.  This discovery has enabled a safer way for prenatal diagnosis of abnormalities in 
fetal development.  More importantly, it pushed the boundaries beyond basic count and 
established the proof of concept that was critical to the development of the various forms of 
circulating DNA, as shown below. 
Circulating tumor cells are of increasing interest to organizations involved in translational 
medicine, companion diagnostics and investigational research.  Automated workflows are a 
necessary precondition for the widespread adoption of CTCs as a sample type and for 
ensuring productivity and consistency in testing. 
Circulating tumor DNA is a small fragment of mutated DNA released by tumor cells into the 
bloodstream.   
Cell-free DNA  can be applied more broadly than ctDNA. cfDNA will determine the standard 
of care in oncology, transplant medicine and cardiovascular disease. This field is emerging 
as one of the most promising and exciting areas of medicine and has already made a huge 
impact on prenatal care. 
A crucial step in isolating cancer cells is also key to enabling liquid biopsy, in which cancer 
can be detected through a simple blood draw. This would eliminate the discomfort and cost 
of tissue biopsies, which use needles or surgical procedures as part of cancer diagnosis.  The 
commercialization of sample-collection and quality-control products specifically for liquid-
biopsy analyses demonstrates confidence in the technology.  Liquid biopsy could also be 
useful in tracking the efficacy of chemotherapy over the course of time, and for detecting 
cancer in organs difficult to access through traditional biopsy techniques, including the brain 
and lungs. However, isolating circulating tumor cells from blood is no easy task, as they are 
present in extremely small numbers.   

 
 
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Special blood tubes for cfDNA analyses are: Cell-Free DNA BCT tubes manufactured by 
Streck, Inc., and the K3EDTA tubes from BD Vacutainer. They prevent increases in 
background gDNA levels caused by temperature fluctuations or agitation that can occur 
during blood sample storage, shipping and processing.  These special blood-collection tubes 
provide a method for obtaining high-quality stabilized samples for rare DNA target detection 
and determining accurate cfDNA concentrations. 
OraSure Technologies, a participant in point-of-care diagnostics and specimen collection and 
stabilization devices, acquired Novosanis, an early commercial-stage producer and 
distributor of urine sample collection devices targeted primarily at liquid biopsy.  Novosanis’ 
primary product technology is Colli-Pee, an easy-to-use device designed for the standardized 
collection of first-void urine in the privacy of the user’s home or at a clinic. The initial 
commercial application is as a collection device for liquid biopsy tests in the prostate and 
bladder cancer markets.  
Bioengineers collaborating with those at the University of Illinois Cancer Center have 
developed a device that can isolate individual cancer cells from patient blood samples.  The 
microfluidic device separates the various cell types found in blood by size. The product is 
still in the research phase, but it may one day enable rapid, inexpensive liquid biopsies to 
help detect cancer and develop targeted treatment plans.   
Beckman Coulter Life Sciences entered into a partnership with Apostle Inc. for the launch of 
Apostle MiniMax High Efficiency Cell-Free DNA Isolation Kit, a magnetic nanoparticle-
based kit to extract cfDNA from plasma using manual or automated workflows.  
Vela Diagnostics offers its Sentosa SX cfDNA sample prep on SX101 instrument in China. 
Sysmex gained marketing approval in Japan for blood-based RAS Gene Mutation Testing 
for colorectal cancer.  The OncoBEAM RAS CRC Kit is used for blood-based molecular 
testing of circulating tumor DNA for mutations in the RAS gene.  
 Biocept entered into a collaboration with Quest Diagnostics to provide advanced NGS-based 
liquid biopsy testing for patients with lung cancer. The Biocept Target Selector NGS-based 
liquid biopsy assay is a less invasive, lab-developed test that can be used for genomic 
profiling in patients with advanced non-small cell lung cancer to help qualify them for 
advanced targeted therapies and to monitor treatment effectiveness. 

 
 
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The AML-MRD-SEQ is System Inostics’ CLIA-validated liquid biopsy test for detecting 
minimal residual disease in acute myeloid leukemia. The test uses a targeted NGS panel and 
offers reliable, more sensitive detection of molecular MRD.  
Foundation Medicine entered into a partnership with Sequanta to provide both liquid and 
tissue genomic profiling services to China. In the US, the company offers the FoundationOne 
Tracker with Medicare coverage. FoundationOne Tracker test is a personalized tissue-
informed circulating tumor DNA test to monitor cancer patients’ response to therapy.  
Guardant Health’s Shield Test, as a primary blood-based CRC screening test, has proven to 
be a valuable addition to the market.  
Labcorp received de Novo authorization for its PGDx elio plasma focus Dx. This is the first 
pan-solid tumor liquid biopsy test.  
Quality Assurance 
Quality control standards and controls are necessary to ensure that an assay is delivering 
accurate test results.  The availability of quality control products is a necessary step in moving 
a test from research to routine clinical testing.   A number of quality control products are 
coming to market.  The leaders are SeraCare Life Sciences and Horizon Discovery. 
SeraCare has developed a unique, patent-pending technology that produces a DNA fragment 
size distribution that closely mimics native cfDNA while reducing DNA damage relative to 
ultrasonicated material.  The result (according to SeraCare) is a renewable source of highly 
characterized material that exhibits performance similar to that of a patient sample when 
treated identically.  The Seraseq ctDNA v2 requires no special workflow considerations to 
generate informative data.  According to SeraCare it is especially important for validation 
studies that require strict adherence to standard operating procedures. 
Horizon Discovery has developed a range of cell-free DNA Reference Standards, derived 
from cell lines to closely mimic patient samples. Horizon reports that, with allelic frequencies 
as low as 0.1%, these Reference Standards are ideal for optimizing and validating liquid 
biopsy assays. 
Twist Bioscience provides circulating tumor DNA reference controls for development of 
liquid biopsy assays. 

 
 
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Product News 
Researchers have pushed the boundaries of blood-based tissue biopsy.  Circulating free 
nucleic acids have extended the reach of this technology beyond DNA to RNA, miRNA and 
exomes.  Although still emerging, circulating nucleic acids are anticipated to become a 
prominent technology in future molecular diagnostics, and they have, first, in prenatal fetal 
testing for genetic abnormalities, and now, as the basis of the liquid biopsy in cancer and 
pathogen analysis. 
Liquid biopsy testing has progressed beyond its earlier role as a primarily research tool and 
is now used in routine clinical practice in select oncology settings. It is widely applied for 
therapy selection, treatment monitoring, and the detection of resistance mutations, 
particularly in advanced and metastatic cancers. However, adoption is not yet universal 
across all tumor types or disease stages, and its use continues to expand as clinical evidence 
grows. While liquid biopsy remains especially valuable in complex or difficult-to-treat cases, 
it is increasingly being incorporated earlier in certain settings. At the same time, major cancer 
centers and healthcare systems continue to build large clinical and genomic datasets to further 
demonstrate clinical utility, support reimbursement, and guide broader integration into 
standard diagnostic workflows. 
Nevertheless, the diagnostics industry has rallied to support CTCs, ctDNA, and cell-free 
DNA testing with assays, testing services, sample-preparation reagents, and quality-control 
materials.  It has been 20 years since Johnson & Johnson formed Veridex, LLC to market 
Immunicon’s CellSearch systems for circulating tumor cells in peripheral blood.  This was 
the first commercial CTC system.  CellSearch has FDA approval for the prognosis and 
monitoring of patients with metastatic breast, metastatic colorectal and metastatic prostate 
cancer.   
IVD company efforts have been supported by the U.S. FDA’s Breakthrough Devices 
Program, which was established in 2016 as part of its "Expedited Access Pathway" (EAP).  
The process helps patients gain more timely access to devices and technologies that provide 
more effective treatment or diagnosis for life-threatening diseases that otherwise do not exist.  
The Breakthrough Devices Program expands on the EAP program by making future 510(k) 
approvals, Premarket Approval applications, and de novo device submissions eligible.  So 
far, several U.S. companies have benefited from this FDA program, including Foundation 
Medicine, Guardant Health, and Personal Genome Diagnostics. 

 
 
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Market Cleared Products 
Roche Diagnostics continues to expand its test offerings in frontier areas.  Roche’s cobas 
EGFR Mutation Test v2, cfDNA, PCR, and lung cancer were among the first liquid biopsy 
tests to receive FDA market clearance. Roche markets three next-generation sequencing 
(NGS) Avenio research-use liquid biopsy kits that provide insights into different stages and 
types of cancer.  In the future, Roche's Avenio product line of NGS solutions will include 
instruments and reagents designed to make sequencing simple and accessible for everyday 
use. 
Guardant Health claims to be a leading precision oncology company.  In pursuit of its goal 
to manage cancer across all stages of the disease, Guardant Health offers multiple liquid 
biopsy-based tests, Guardant360 and GuardantOMNI, for advanced-stage cancer patients, 
which fuel its development programs for recurrence and early detection, LUNAR-1 and 
LUNAR-2, respectively. According to Guardant Health, since its launch in 2014, 
Guardant360 has become the world's market-leading comprehensive liquid biopsy test and 
has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies, and 
all 27 of the National Comprehensive Cancer Network Centers.  Also, the Guardant360 assay 
has been ordered more than 70,000 times to help inform which therapies may be effective 
for patients with advanced-stage solid tumors.  It is supported by more than 70 peer-reviewed 
journal publications, which address its analytical validity, clinical validity, and clinical 
utility.  Guardant360 is also covered by several private payers, including Cigna and several 
Blue Cross Blue Shield plans. 
 Bio-Rad Laboratories markets the QXDx AutoDG ddPCR System, which uses Bio-Rad’s 
Droplet Digital PCR technology, and the QXDx BCR-ABL %IS Kit.  This is the company’s 
first liquid biopsy assay and Droplet Digital PCR system for diagnostic use.   
TFS markets its Ion Torrent Genexus System, an NGS platform featuring an automated 
specimen-to-report workflow that delivers results in a single day. The company also provides 
its Oncomine Precision Assay, an innovative pan-cancer panel for the Genexus platform. It 
enables comprehensive genomic profiling from formalin-fixed, paraffin-embedded (FFPE) 
tissue and liquid biopsy samples with a single assay. 
NeoGenomics offers the RaDaR assay for detecting molecular residual disease and 
recurrence. The company also has Medicare coverage in the US for the MolDX program, 

 
 
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including reimbursement for RaDaR clinical testing. RaDaR is a precision liquid biopsy 
assay that tracks a set of up to 48 tumor-specific variants.  
Labcorp acquired Person Genome Diagnostics, a cancer genomics lab with a portfolio of 
comprehensive liquid biopsy and tissue-based products. The addition of PGDx and its 
technology complements Labcorp’s liquid biopsy capabilities and expands its NGS genomic 
profiling.  
Myriad Genetics expanded its partnership with Intermountain Precision Genomics to add 
liquid biopsy therapy selection to the Precise portfolio solutions. However, in February 2024, 
Myriad Genetics completed acquisition of select assets from Intermountain Precision 
Genomics including the Precise Tumor Tests, Precise Liquid Test and the IPG CLIA lab in 
Utah.  
Cell-Free DNA BCT, which  received FDA De Novo clearance by the U.S. Food and Drug 
Administration when paired with the Guardant360 CDx, has quickly become the industry 
standard to maintain cell-free DNA samples and limit pre-analytical variation. 
Pillar Bioscience offers its OncoReveal CDx pan-cancer NGS test as a general solid tumor 
profiling test. The FDA originally granted approval to OncoReveal in 2021 for a specific 
therapy for patients with NSCLC and colorectal cancer.  The additional approval allows any 
hospital or lab running and Illumina MiSeq Dx NGS platform to adopt OncoReveal.  
Liquid Biopsy in Microbiology 
Diagnosis of life-threatening tissue-based infections currently requires invasive sampling of 
the infected tissue to provide a microbiologic diagnosis.  These procedures can lead to high 
morbidity since they take several days to get a result and in the case of fungal infections even 
weeks.  On the horizon are next-generation sequencing assays to detect pathogen-derived 
cell-free DNA in peripheral blood of patients.  The technique could eventually be used to 
identify invasive infections such as sepsis, bone and joint infections and post-transplant tissue 
infections with biopsy-proven invasive fungal infections.  
Karius offers a unique test.  The company offers a blood-based test for Mycobacterium 
chimera in addition to its Digital Culture Test, which can detect more than 1,250 pathogens, 
including Legionella and Mycobacterium tuberculosis, from a single blood draw.  Karius 
claims to produce results within one business day. The tests use next-generation sequencing 

 
 
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to detect cell-free DNA fragments that bacteria, viruses, fungi and other pathogens leave 
behind in the blood.  Karius markets the test to physicians and labs for $2,000.  While it is 
more expensive than traditional tests, Karius doesn’t see its product as a first-line diagnostic.  
Instead, it’s most useful in cases where the patient is critically ill and other tests come back 
negative. 
Bio-Rad markets its Celselect Slides, which offer an improved method of enumeration of 
CTCs in liquid biopsies. The Celselect Slides are designed to be used with Bio-Rad’s Genesis 
Cell Isolation System for use in genomics, digital PCR or stained on-slide for 
immunofluorescent applications.  
Liquid Biopsy Companies in 2022-2025 
A number of liquid biopsy companies have made inroads into the market. These include: 
• Roche – liquid biopsy that can identify 70 of the most commonly mutated genes in 
tumors, including microsatellite instability, which helps determine the type of 
immunotherapy-based treatment needed from a single blood sample. 
• QIAGEN - offers a complete workflow to facilitate liquid biopsy research 
• Ombre– working on commercializing CancerSEEK, a DNA and protein-based liquid 
biopsy 
• Biocept - test menu focuses on cancer biomarkers that are based on guidelines listed 
by the National Comprehensive Cancer Network. The results have molecularly 
characterized tumor cells and identified changes in protein expression, which are 
important for prognostic and therapeutic applications. Quest Diagnostics offers 
Biocept’s liquid biopsy test for lung cancer. 
• Myriad Genetics – liquid biopsy product is a 25-gene test that identifies elevated risks 
for 8 different types of cancer. The company has developed a suite of liquid biopsy 
tests.  
• QIAGEN offers FFPE and liquid biopsy PIK3CA diagnostics in Europe to enhance 
precision medicine in advanced breast cancer.  
• Guardant Health announced a collaboration with Amgen to develop a liquid biopsy 
companion diagnostic for AMG 510 (later branded LUMAKRAS), the first-in-class 
KRAS G12C inhibitor to advance to the clinic. At the time, Amgen was enrolling 

 
 
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patients in a potentially registrational Phase 2 study.  Guardant launched Guardant 
Reveal, the first blood-only liquid biopsy test designed to detect residual and recurrent 
colorectal cancer from a simple blood draw. Additionally,  Guardant360 CDx 
received CE-IVD marking for comprehensive genomic profiling in solid tumors. 
• Guardant entered into a collaboration with Daiichi Sankyo to pursue regulatory 
approval of Guardant360 CDx as a companion diagnostic for Enhertu, a HER2-
directed antibody-drug conjugate, including use in advanced NSCLC. In May 2021, 
Guardant received FDA approval for Guardant360 CDx as the first and only liquid 
biopsy companion diagnostic for RYBREVANT, and as the first FDA-approved 
liquid biopsy CDx for Amgen’s LUMAKRAS in advanced NSCLC. 
• Guardant expanded its oncology portfolio with the launch of Guardant360 Response, 
the first commercially available blood-only test to monitor changes in circulating 
tumor DNA as an early indicator of treatment response, and Guardant360 TissueNext, 
the company’s first tissue-based assay to support biomarker-informed therapy 
selection when tissue testing is required. 
•  Myriad Genetics offers myChoice CDx test.  
• Biocartis is advancing the Idylla technology toward customization 
• Sysmex Inostics developed a liquid biopsy test for the detection of minimal residual 
disease in AML called AML-MRD-Seq.  
• HelioLiver offers a liquid biopsy test for the early detection of liver cancer 
• Personalis markets NeXT Personal, a tumor-informed liquid biopsy assay for MRD 
• Twist Bioscience provides circulating tumor DNA  reference controls for 
development of liquid biopsy assays 
• Angle markets its test (Parsortix)  for metastatic breast cancer  
• Bio-Rad offers its Celselect Slides, which offer an improved method of enumeration 
of CTCs in liquid biopsies. The Celselect Slides are designed to be used with Bio-
Rad’s Genesis Cell Isolation System for use in genomics, digital PCR, or stained on-
slide for immunofluorescent applications. 
• Foundation Medicine entered into a collaboration with Karyopharm Therapeutics to 
develop FoundationOne CDx as a companion diagnostic for Xpovio.  
• Additionally, Foundation Medicine markets the FoundationOne Liquid CDx to be 
used as a companion diagnostic to identify patients with ROS1-postive NSCLC or 

 
 
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patients with NTRK fusion-positive solid tumors who do not have a tissue sample 
available.  
• Biocartis provides the Idylla IDH1-2 FLEX Mutation Assay Kit. The assay is the first 
test developed using the new Idylla FLEX technology, which separates the generic 
components of an Idylla test from the test-specific components.  
• Biocartis markets the Idylla MSI test for use on the Idylla system. The Idylla MSI 
Test is a fully automated test that provides information on the MSI status of CRC 
tumors within approximately 150 minutes from just one section of formalin-fixed, 
paraffin-embedded (FFPE) tumor tissue, without the need for a paired normal tissue 
sample. 
• Biocartis entered into a collaboration with APIS Technologies to develop APIS’ 
Breast Cancer Subtyping assay on Biocartis’ rapid Idylla platform. APIS’ current 
Breast Cancer Subtyping Kit is an RNA-based diagnostic assay for detecting mRNA 
expression of standard biomarkers (HER2, ER, PR, Ki67) and novel proliferative 
biomarkers from pre-operative core-needle biopsy (CNB) or resected formalin-fixed 
paraffin-embedded (FFPE) breast tumor tissue. 
• Biocartis entered into a collaboration with HiloProbe that will lead to the 
commercialization of ColoNode, a CE-marked IVD gene expression signature test 
that can detect nodal metastasis in colorectal cancer. 
• FoundationOne Liquid CDx is offered as a companion diagnostic for Exkivity to 
identify patients with EGFR Exon 20 insertion mutations in advanced NSCLC.  
• FoundationOne Liquid CDx is offered to be used as a companion diagnostic for 
Braftovi in combination with cetuximab  to identify BRAF V6oooE alterations in 
mCRC.  
• Foundation Medicine entered into a collaboration with Merck to develop 
FoundationOne Liquid CDx for several selected marketed and pipeline treatments.  
• Additionally, the company offers its tissue-naive ctDNA monitoring assay, 
FoundationOne Monitor.  
• The RaDaR assay is a personalized liquid biopsy  for minimal/molecular residual 
disease MRD and recurrence detection. This was the first pan cancer coverage to be 
authorized by Blue Shield.  
• Foundation Medicine entered into a partnership with Sequanta to provide both liquid 
and tissue genomic profiling services to China. In the US, the company launched 

 
 
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FoundationOne Tracker with Medicare coverage. FoundationOne Tracker test is a 
personalized tissue-informed circulating tumor DNA test to monitor cancer patients’ 
response to therapy.  
• Guardant Health’s Shield Test is a primary blood-based CRC screening for colorectal 
cancer.  
• Labcorp received de Novo authorization for its PGDx elio plasma focus Dx. The is 
the first and only kitted, pan-solid tumor liquid biopsy test.  
• Tempus markets the xT CDx, a 648-gene NGS test for solid tumor profiling.  
• Natera offers its ultra-sensitive Signatera Genome assay that can detect circulating 
tumor DNA  
The Future for Liquid Biopsy 
The acceptance of liquid biopsy technologies has grown substantially in recent years, largely 
driven by the increasing availability of clinical and genomic data. As the volume and quality 
of evidence supporting liquid biopsy continue to expand, so too does its role in cancer 
diagnostics and management. 
The global liquid biopsy market is experiencing robust growth and is expected to continue 
its upward trajectory. Key factors fueling this expansion include: 
• The rising global incidence of cancer, 
• The growing demand for precision medicine, and 
• A clear shift toward non-invasive diagnostic approaches. 
Currently, liquid biopsy is most commonly used in the management of lung, melanoma, 
breast, ovarian, cervical, and bladder cancers. Despite growing clinical adoption, many liquid 
biopsy tests have yet to fully demonstrate clinical utility across broader patient populations 
and indications. For the field to reach its full potential, rigorous quality control—both in test 
performance and sample collection protocols—is critical. These standards are essential for 
the routine integration of liquid biopsy into oncology and other emerging medical disciplines. 
Looking ahead, the landscape will likely see a surge in strategic collaborations between 
pharmaceutical and liquid biopsy companies. One prominent example is the partnership 

 
 
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between GRAIL and AstraZeneca, which focuses on developing companion diagnostics to 
guide targeted therapies. 
Innovation is also accelerating, with companies introducing cutting-edge technologies to 
enhance sensitivity and applicability. Notable examples include: 
• Flomics  cfRNA + Ai assay for multi-cancer early detection  
•  University of Chicago’s RNA-based CRC screen  
• BioFluidica’s LiquidScan: A microfluidic chip platform capable of isolating rare 
biomarkers such as circulating tumor cells (CTCs), cell-free DNA (cfDNA), and 
exosomes from blood samples. 
• Caris Life Sciences’ Caris Assure: A comprehensive molecular profiling platform 
that analyzes DNA, RNA, and proteins, and sequences over 22,000 genes per test—
representing one of the most extensive sequencing assays currently available. 
For a more in-depth look at NGS and liquid biopsy, please see Kalorama Information’s 
2025 report The Worldwide Market for Liquid Biopsy, 7th Edition. 

 
 
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Information Technology Advances and Artificial Intelligence 
As a result of intensive studies from the Human Genome Project, most elements of the human 
genome, transcriptome, and proteome have now been curated. In parallel, rapid technological 
advances have made it faster and more affordable than ever to sequence a person’s genome. 
This sequencing process represents the first step in applying genome analysis—regardless of 
the specific technology used. The industry is still in the early stages of translating this 
genomic data into actionable laboratory tests. 
Information technology plays a critical role in this translation process, serving three essential 
functions: 
• Facilitating data sharing to build well-curated collections of gene variants, 
• Supporting the interpretation of those variants to inform testing guidelines, and 
• Distributing this information to clinicians to guide patient care. 
A thorough discussion of developments in IT and their implications for clinical laboratory 
medicine could easily fill a report of its own. In this section, however, Kalorama Information 
provides a high-level overview of key programs and initiatives that illustrate how the 
intersection of IT and diagnostics is evolving. 
Clinical scoring systems and algorithms have long been used in medicine. Recently, however, 
there has been a surge in the application of machine learning—a subset of artificial 
intelligence to enhance these tools. Unlike traditional algorithms, which rely on pre-
programmed logic, machine learning models analyze vast datasets to identify patterns and 
derive optimal calculations autonomously. These models are being developed to: 
• Predict outcomes such as diagnosis, mortality, or hospital readmission, 
• Improve risk assessment tools, 
• Reveal underlying contributors to disease progression, and 
• Advance precision medicine by forecasting individual responses to treatment. 
 

 
 
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AI is primarily being implemented as a means to analyze data more efficiently and accurately, 
uncovering insights that can streamline care from both clinical and operational standpoints. 
The overarching goal is to enable more precise, personalized patient care. 
In recent years, AI companies have developed increasingly sophisticated machine learning 
techniques aimed at reducing, and in some cases eliminating, inefficiencies in healthcare 
delivery. The  aim of these innovations is to standardize and assist in the interpretation of test 
results providing any clinician, regardless of specialty, to make informed decisions. Rather 
than replacing radiologists or pathologists, this technology is designed to augment their 
capabilities and support complex decision-making processes. 
Google has developed Med-PaLM 2, a large language model tailored for healthcare 
applications, which has been evaluated in collaboration with organizations such as Mayo 
Clinic and other health systems. While these efforts highlight the growing role of artificial 
intelligence in medicine, most implementations remain in early deployment or evaluation 
stages rather than widespread clinical use. 
Advances stemming from the Human Genome Project and subsequent research have enabled 
extensive mapping of the human genome, transcriptome, and proteome, although full 
functional understanding remains incomplete. At the same time, technological progress has 
significantly reduced the cost and time required to sequence an individual’s genome, making 
genomic analysis more accessible in clinical settings. 
Genomic testing is now an established component of diagnostics in areas such as oncology, 
rare disease, and reproductive health, but the broader integration of genomic data into routine 
laboratory testing continues to evolve. The industry is moving beyond data generation toward 
improving interpretation, clinical validation, and practical application of genomic insights in 
patient care. 
AI in Clinical Practice 
More than 950 medical devices have incorporated AI or machine learning software that have 
been cleared by FDA for clinical adoption. Artificial intelligence is growing at a fast pace, 
mainly due to the adoption of AI-based technologies. There is a move to connected health, 
which includes AI. AI has proved to be an invaluable tool to assist physicians in caring for 
their patients. The advanced capabilities of algorithms are serving to reduce workload and 
provide testing solutions. It is anticipated that increased use of machine learning and AI will 

 
 
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help to decrease errors and advance IVD technology. However, the lack of skilled AI 
personnel and reluctance among doctors to utilize these solutions have restrained growth.   
Similar to the product commercialization process that is evident in the liquid biopsy market, 
IVD companies’ efforts have been supported by the U.S. FDA’s efforts to give products 
expedited review.  This helps patients have more timely access to devices and technology 
that provide more effective treatment or diagnosis for life-threatening diseases.    
Digital pathology products and diabetes management devices were the first to come to market 
with data interpretation applications.  As shown in the table below, the last few years have 
seen the use of AI interpretation apps extended to a broader range of products including 
microbiology, disease genetics and cancer precision medicine.  The following are of 
particular interest. 
QIAGEN’s bioinformatics teams offers new software solutions and adding proprietary cloud-
based content to support the latest research and clinical trends in molecular testing, especially 
the interpretation of large volumes of data from next-generation sequencing.  In addition, 
QIAGEN is integrating these digital technologies with instruments and molecular content to 
provide seamless Sample-to-Insight workflows following the acquisition of OmicSoft.  
QIAGEN acquired OmicSoft Corporation, providing access to OmicSoft's multi-omics data 
management infrastructure solution as well as expertly curated 'omics' data sets that 
complement QIAGEN's bioinformatics portfolio, which offer insights into complex 
biological data. OmicSoft is recognized for its suite of software solutions that enable 
scientists and researchers to efficiently analyze and visualize their own data sets and compare 
them to massive volumes of publicly available 'omics' data sets,  such as The Cancer Genome 
Atlas operated by the U.S. National Cancer Institute,  and share results with colleagues.  
A few years ago, Philips announced that The Miami Cancer Institute signed a multiyear 
agreement to use Royal Philips' IntelliSpace Precision Medicine Genomics software platform 
in its new genomics laboratory.  The partnership will support the oncology genomic testing 
workflow at the institute, which is part of the Baptist Health South Florida system.   
RenalytixAI, a company focused on diagnostics for kidney disease and transplant 
management, received FDA Breakthrough Device designation for its KidneyIntelX test. The 
company has stated that this represents one of the first artificial intelligence-based 
diagnostics developed specifically for kidney disease. KidneyIntelX is intended to support 
the identification and management of patients with type 2 diabetes who are at risk for rapid 

 
 
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progression of kidney disease. The test combines blood-based biomarkers with electronic 
health record data, using machine learning to assess risk and guide clinical decision-making. 
The development of KidneyIntelX has been carried out in collaboration with the Mount Sinai 
Health System. 
Proscia markets DermAI, a module on its Concentriq digital pathology platform that 
streamlines workflows. DermAI can prescreen and classify skin biopsies. DermAI provides 
earlier insight into cases and speeds up the turnaround time for patients and physicians. It 
also helps the pathologist to prioritize the workload.  
The CompuCyst is an AI-driven test that helps identify which patients should undergo 
surgery and which can be safely followed. CompuCyst incorporates mutation status, loss of 
heterozygosity, aneuploidy, protein markers, and clinical data.  
Paige, an AI software company,  developed AI algorithms for analyzing pathology slides for 
prostate cancer, skin cancer and breast cancer. A series of deep learning algorithms was 
developed with an automated training and testing technique.  
Google partnered with Ascension to collect and analyze patient health data using cloud and 
AI technologies. Microsoft acquired healthcare AI developer Nuance for approximately 
$19.7 billion to strengthen Microsoft Cloud for Healthcare, and Oracle acquired Cerner in a 
$28.3 billion deal to expand its healthcare data and cloud capabilities. 
Hologic markets the Genius Digital Diagnostics System for cervical cancer screening.  The 
Genius Digital Diagnostics System is the next generation of cervical cancer screening, 
combining deep learning-based artificial intelligence with advanced volumetric imaging 
technology to help identify precancerous lesions and cervical cancer cells in women.  The 
Genius Digital Diagnostics System enables seamless, dynamic collaboration across 
laboratories within a network, connecting pathologists with remote review capabilities so that 
each patient can benefit from the collective knowledge of geographically dispersed experts.  
The Genius Digital Diagnostics System consists of the Genius Digital Imager for image 
acquisition, the Genius Cervical AI algorithm for analyzing images, the Genius Image 
Management Server for storing images and the Genius Review Station for case review. The 
complete system is scalable, designed to fit the present and future needs of laboratories. 
Agilent Technologies acquired advanced artificial intelligence technology developed by 
Virtual Control, an AI and machine learning software developer that creates innovative 
analysis solutions in lab testing. Agilent intends to integrate the software, known as ACIES, 

 
 
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into its industry-leading gas chromatography and mass spectrometry (GS/MS) platforms to 
improve the productivity, efficiency and accuracy of high-throughput labs the company 
serves around the world. 
To augment its ThinPrep test, Hologic offers the Genius Digital Diagnostics System for 
cancer screening. It uses AI to thoroughly analyze every cell and point out clinically relevant 
objects based on its algorithm. The Genius Digital Diagnostics System is the first and only 
FDA-cleared digital cytology system that combines deep-learning-based AI with advanced 
volumetric imaging technology to identify pre-cancerous lesions and cervical cancer cells.  
Trinity entered into a strategic collaboration with PulseAI, a medical artificial intelligence 
company. The collaboration has helped Trinity develop its AI-driven analytical platforms.  
Verily provided its first personalized, AI-powered chronic care solution with the launch of 
Lightpath Metabolic, a program for managing diabetes, hypertension, obesity, and 
hyperlipidemia. 
 
 

 
 
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Table 4-5: Selected AI Market Cleared Tests 
Company 
Location 
Area 
Details 
Adaptive 
Biotechnologies 
U.S. 
ca MRD 
clonoSEQ immunosequencing with AI, min residual disease 
Clever Culture  
Switzerland 
micro 
APAS platform culture-plate screening & interpretation 
Copan Diagnostics 
U.S. 
micro 
PhenoMATRIX culture plate analysis AI 
Genome Smart 
U.S. 
prec med 
GenomeBrain link patient with appropriate genetic test 
Gnosis Data Analysis 
Greece 
genome 
Just Add Data (JAD) Bio system AI for multi-omics  
Google 
U.S. 
histo 
AI research and digital pathology  
Ibex Medical 
Israel 
histo 
Second Read (SR) system, AI digital pathology 
Individumed 
Germany 
cancer 
AI added to IndivuType multi-omics cancer research platform 
IntegraGen 
France 
sequencing 
sequencing data with Google Cloud 
IQVIA 
U.S. 
genome 
E360 analytics technology genotypic-phenotypic database  
Maxwell Plus 
Australia 
genome 
machine learning with diagnostics, cancer, Alzheimer’s, etc. 
Medtronic 
Ireland 
diabetes 
Sugar.IQ app with IBM Watson IQcast AI 
Philips 
Netherlands 
cancer 
Clinical Pathways, a clinical decision platform, oncology  
Philips 
Netherlands 
genome 
IntelliSpace Precision Medicine Genomics software  
Qiagen 
Netherlands 
sequencing 
Qiagen Clinical Insight analysis and interpretation solutions 
RenalytixAI 
U.S. 
kidney 
KidneyIntelX AI diagnostic for kidney disease 
Siemens 
Healthineers 
Germany 
sequencing 
Fast Track cycler & FastFinder software 
Sophia Genetics 
Switzerland 
cancer 
Solid Tumor Solution molecular with AI analysis 
UgenTec 
Belgium 
PCR 
Fastfinder real-time PCR interpretation system  
Xifin 
U.S. 
prec med 
VisualStrata precision medicine informatics platform 
Source: Kalorama Information 

 
 
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There are currently over 1,020 healthcare algorithms approved by the FDA, most of which 
involve medical imaging. Most of the AI integration has been centered on molecular and 
digital pathology applications. Clinical chemistry and immunology are the next step. The 
industry is seeing the development of AI-powered automated hematology analyzers, such as 
the new DH-615 hematology analyzer from Dymind Biotechnology, which is based on 
fluorescent nucleic acid staining technology and the company’s AI Cube technology.  
Kalorama Information expects AI will continue to advance in clinical decision-making. 
However, there will be speed bumps along the way, such as questions and regulations 
centered around regulatory, ethical, and medical concerns.  
The core clinical IVD areas include digital pathology, as there are FDA-cleared tools to 
support primary diagnosis in histology and cytology, and scoring biomarkers; hematology, 
where AI is assisting in blood smear review classification; and microbiology plate reading, 
where AI auto-releases negative cultures, detects significant colonies, and integrates with 
MALDI-TOF ID pipelines.  
The molecular and genetic testing arena is benefiting from AI-based variant classification, 
liquid biopsy and ctDNA pattern recognition by filtering sequence noise and enhancing 
sensitivity for early cancer detection and MRD monitoring.  
Immunoassays are using AI to detect subtle shifts in serial biomarkers to alert to early signs 
of disease progression or relapse.  
AI Physician Usage 
There has been an uptick in the adoption of AI among physicians. A survey reported that 
clinical use of AI among physicians has increased to over 80 percent, doubling since 2023 
(the last time the survey was conducted).  Physicians use AI in two areas, medical research 
and clinical care documentation. In prior years, physicians were skeptical of AI, but over the 
past year or so, confidence in AI has grown.  
Physicians have found that the biggest advantages of using AI are improved work efficiency 
and diagnostic accuracy. Although many physicians are cautiously optimistic, Kalorama 
Information expects that, as the technology improves, AI will continue to find favor with 
physicians. One of the biggest concerns is patient privacy and the integrity of the patient -
physician relationship.  

 
 
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Physicians generally see AI as a helpful tool to automate tasks and speed diagnostic results. 
However, many are awaiting regulatory directives that establish clear liability frameworks to 
enable broader adoption and build trust with physicians. 
The Regulatory Pathway 
As artificial intelligence becomes more widely used in medical tests and devices, regulatory 
frameworks are still evolving to keep pace with these technologies. Oversight is increasingly 
focused not only on the performance of a specific product, but also on how the developer 
designs, trains, and maintains its algorithms. This includes evaluating the data used to build 
models, validating systems before deployment, and monitoring and updating performance 
over time with real-world data. 
Regulators have expanded their review of AI-enabled medical products in recent years, with 
a growing number of devices being cleared or authorized for clinical use. Guidance issued 
over the past few years has begun to establish a more structured approach to software and 
machine learning in healthcare, outlining expectations for transparency, validation, and 
ongoing performance management. 
Regulatory agencies in the United States, Europe, Canada, and the United Kingdom have 
also moved toward greater alignment, emphasizing common principles such as risk 
management, data quality, and clear documentation of how algorithms function. A key focus 
has been the need for lifecycle oversight, requiring manufacturers to continuously evaluate 
and update their systems as new data becomes available. 
More recent guidance has placed additional emphasis on practical implementation, including 
how companies manage algorithm changes after deployment and how they demonstrate that 
updates do not adversely affect safety or effectiveness. Regulators are also encouraging the 
development of standards and best practices to support innovation while maintaining patient 
safety. 
Product Initiatives 
The IVD industry and its partners have embarked on a full-force effort to advance AI-driven 
tests and devices. In the UK, the country aims to cut cancer deaths by 10% by using AI as 
the key driver of improved health outcomes.  The plan calls for the National Health Service, 

 
 
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the AI industry, and health charities to use data and AI to transform the diagnosis of chronic 
diseases, with the goal of reducing cancer deaths by around 22,000 each year by 2033.  
AI is making inroads into cardiovascular care based on innovations in diagnostics, biomarker 
detection and prognostic tools. This is an area to watch in the near future for more innovative 
diagnostic tools to aid in the diagnosis of cardiovascular events.  

 
 
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Table 4-6: Selected AI Product Initiatives in Development and Collaborations 
Company 
Location 
Area 
Details 
Auron Therapeutics 
U.S. 
cancer 
Elucidata's IT differentiation-based cancer therapies 
BGI Genomics 
China 
cancer 
collab with Fred Hutchinson Cancer Research Center 
Genomenon 
U.S. 
genome 
Diploid's Moon genome interpretation for rare diseases 
Genomenon 
U.S. 
genome 
variants reference datasets on Google BigQuery cloud 
Google 
U.S. 
cancer 
Augmented Reality Microscope  
Google 
U.S. 
histo 
AI research and digital pathology  
Google 
U.S. 
ptnt mgmt 
deep machine learning for electronic medical records 
Hitachi Ltd  
Japan 
ptnt mgmt 
risk of hospital readmissions  
Hitachi Ltd  
Japan 
risk 
algorithms for disease risk 
IBM Watson Health 
U.S. 
alz 
early Alzheimer's detection 
IBM Watson Health 
U.S. 
cancer 
collab with Broad Institute, drug resistance in cancer 
IBM Watson Health 
U.S. 
cardiac 
collab with Broad Institute, cardiac disease risk 
IBM Watson Health 
U.S. 
public health 
AI for public health via patient EHRs 
Inspirata 
U.S. 
histo 
Dynamyx digital pathology software 
Institut Curie 
France 
genome 
Intel AI tools for a genomics database 
Lucence Diagnostics 
Singapore 
cancer 
AI algorithms & database for cancer, liver, breast, gynie 
National Institute of Health 
U.S. 
cancer 
early cervical cancer analysis 
Natural Cycles Nordic AB  
Sweden 
womens 
Natural Cycles app to determine fertility 
Paragon Genomics 
U.S. 
sequencing 
Paragon CleanPlex NGS with Sophia Genetics AI platform 
Passport Health 
U.S. 
womens 
preterm birth risk 
Phase Genomics 
U.S. 
microbiome 
computational platform for microbiome samples 
Project Data Sphere 
U.S. 
cancer 
collab with the U.S. FDA cancer data analysis 
Source: Kalorama Information 

 
 
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AI in Liquid Biopsy 
Oncology faces two critical challenges: detecting cancers at an early stage when they are still 
small and more treatable, and providing precision, targeted treatment to cancer patients. One 
promising solution to these challenges is the integration of machine learning algorithms with 
liquid biopsy technologies. This combination enhances the ability to detect cell-free DNA 
and circulating tumor DNA from a simple blood draw. 
While liquid biopsies can detect minute traces of tumor DNA, interpreting their significance 
remains a challenge. Tumors are genetically unique, and many lack a consistent set of known 
mutations that can clearly identify their type or origin. Furthermore, sequencing these 
samples generates a large volume of data, some of which may not correlate directly with the 
tumor's site or type. In this context, machine intelligence becomes an invaluable tool. 
Role of AI in Liquid Biopsy Interpretation 
Artificial intelligence, particularly machine learning methods, is increasingly used to analyze 
the large and complex datasets generated by liquid biopsy testing. These tools help identify 
patterns in circulating tumor DNA and other biomarkers that may be difficult to detect 
through manual review, supporting faster and more consistent interpretation of results. As 
more clinical data becomes available, these systems continue to improve, helping refine risk 
assessment and disease monitoring. 
AI-supported analysis is now being incorporated into several liquid biopsy workflows, 
especially in oncology applications such as genomic profiling, minimal residual disease 
detection, and early cancer screening. In many cases, these tools are used alongside 
established testing platforms to support clinical decision-making rather than functioning as 
stand-alone diagnostics. 
While AI is playing an increasingly prominent role in liquid biopsy, most systems are 
integrated into broader testing platforms rather than being approved as independent 
diagnostic products. Regulatory frameworks are still developing, with oversight focused on 
how these tools are validated, monitored, and updated over time. 
Industry Leaders and Initiatives 
Several companies are pioneering the integration of AI and liquid biopsy: 

 
 
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• CareDx is expanding its transplant care offerings with a focus on AI. It markets blood-
based donor-derived cell-free DNA tests to assess transplant organ health. 
• GRAIL is conducting large-scale population studies to develop a multi-cancer early 
detection test. Using machine learning, GRAIL analyzes cfDNA and white blood cell 
genomes to build a library of normal and cancer-specific mutations. Their goal is to 
detect cancer before symptoms appear, which significantly improves survival rates. 
This involves high-intensity sequencing, advanced data science, and broad clinical 
validation. 
• LungLifeAI focuses on the early detection of lung cancer through a single blood test 
enhanced by AI. Their machine learning platform enables non-invasive diagnostics 
with an emphasis on early-stage disease, which is critical for improving patient 
outcomes. 
• Predicine and Flagship Biosciences have partnered to combine Predicine’s 
GeneRADAR molecular insights platform with Flagship’s AI-enabled cTA digital 
pathology platform. Their goal is to offer comprehensive biomarker profiling for 
immuno-oncology clinical trials, aiding treatment stratification and precision 
medicine. Flagship Biosciences also announced a strategic partnership with Offspring 
Biosciences to provide end-to-end assay development services, from early target 
identification to companion diagnostic development, further integrating AI across the 
clinical research pipeline. 
New Liquid Biopsy / AI Products in Development or Recently Launched 
Recent developments in liquid biopsy continue to focus on improving disease monitoring, 
early detection, and integration of advanced data analysis. Tempus has introduced the xM 
assay, a liquid biopsy test designed to monitor treatment response in patients with advanced 
cancer by tracking changes in circulating tumor DNA. The test is currently being introduced 
into clinical and research settings as part of a broader effort to expand longitudinal disease 
monitoring. 
Companies are also developing new approaches that combine multiple types of molecular 
data to improve clinical insight. Platforms that integrate gene expression profiling with 
circulating tumor DNA analysis are being advanced to support more precise patient 
stratification and treatment selection, although many of these solutions remain in early stages 
of commercialization. 

 
 
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New sample types and detection methods are also being explored. Saliva-based and other 
non-blood collection approaches are under development for cancer screening, while blood-
based tests such as Nanostics’ ClarityDx are being used to improve risk assessment for 
diseases such as prostate cancer by combining biomarkers with algorithmic analysis. 
Guardant Health continues to expand its liquid biopsy portfolio, including its Shield blood-
based colorectal cancer screening test, which is being deployed more broadly through clinical 
partnerships. The company is also developing multi-cancer screening approaches and 
expanding the use of its assays in minimal residual disease detection and treatment 
monitoring. 
Adoption of liquid biopsy is increasing at the healthcare system level, with growing use of 
circulating tumor DNA testing to support treatment decisions in oncology. At the same time, 
innovation from emerging companies is driving advances in areas such as extracellular 
vesicle analysis, improved detection of circulating tumor DNA, and microfluidic 
technologies for isolating rare cells. Many of these newer platforms are still in development 
but reflect continued expansion of the liquid biopsy field. 
Table 4-7: Selected AI/Liquid Biopsy Initiatives 
Company 
Location 
Details 
CareDx 
U.S. 
Cibiltec's (France) Predigraft, AI tool transplant rejection risk  
Euroclone Diagnostica 
Italy 
Precipio's Ice Cold-PCR DNA, liquid biopsy, EU  
Freenome 
U.S. 
machine learning to detect early colorectal cancer  
Johns Hopkins  
U.S. 
pan cancer liquid biopsy Dx with AI analysis 
LungLife AI 
U.S. 
early detection of lung cancer 
Predicine 
U.S. 
Predicine GeneRADAR liquid biopsy & Flagship Biosciences, AI digital pathology  
Source: Kalorama Information 
Future Trends 
Artificial intelligence systems, which simulate human intelligence by learning, reasoning, 
and self-correction, have the potential to be more accurate than doctors at making diagnoses 

 
 
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and performing surgical interventions.  However, AI-based product developers maintain that 
machines will never replace doctors entirely, because the inter-relational quality of the 
doctor-patient relationship is vital and cannot be replicated.  
Over the past several years, healthcare has witnessed a transformation, shifting from paper-
based record systems to electronic records and incorporating digital health monitoring 
devices and other advanced patient screening systems.  These advances have resulted in a 
data explosion that can best be managed and analyzed using AI.  The key driver of these AI 
implementations is to provide better patient care while reducing costs, administrative 
headaches, and bottlenecks.  
AI in healthcare has huge and wide-reaching potential and the future of healthcare and the 
future of machine learning and artificial intelligence in medicine are deeply interconnected. 
At present, there remains a lack of clinical trust; as a result, AI is rarely used in fully 
autonomous mode. Trust will be built over time as use increases and results are validated. 
However, AI use is expected to grow, especially in digital pathology, and the industry is 
seeing more clinical labs and products using AI to augment results.  

 
 
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Exosome Sequencing 
Exosomes are nanoscale extracellular vesicles released by all cell types into biofluids such 
as plasma, serum, urine, cerebrospinal fluid, and saliva. They act as intercellular messengers 
and carry a molecular cargo that includes RNA (mRNA, microRNA, lncRNA, and other 
species), DNA, and proteins from their cell of origin. This cargo reflects the physiological 
and pathological status of source tissues, making exosomes an exceptionally rich, stable, and 
noninvasive source of genomic and proteomic biomarkers. 
Exosomes have gained significant attention for their diagnostic utility across a wide range of 
diseases: 
• Cancer (primary and metastatic) 
• Neurodegenerative disorders (e.g., Alzheimer’s) 
• Autoimmune diseases 
• Cardiovascular, inflammatory, and metabolic disorders 
• Preterm birth and neonatal genetic conditions 
• Psychiatric and CNS diseases 
Their presence in diverse biofluids enables minimally invasive sampling, opening the door 
to novel diagnostics where traditional biopsies are limited or impractical. Moreover, their 
cargo is highly stable, even under varying storage conditions, making them ideal candidates 
for robust clinical tests. 

 
 
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Biotin Interference in Immunoassay Detection Errors 
Biotin has become a popular over-the-counter supplement in recent years for a variety of 
uses, medical or otherwise; the vitamin enhances skin and digestive health, and a deficiency 
can lead to neurological disorders. Pregnant and lactating women often take it as a dietary 
supplement, as it is important in perinatal development. 
The recommended daily intake of biotin is 300μg, but these supplements can sometimes be 
sold in megadoses of 5mg to 10 mg, or even more. As part of the B complex of vitamins, 
biotin is also called Vitamin B7, but is occasionally referred to by its former name, Vitamin 
H, which can be confusing for patients; it is also often found in multivitamins, which patients 
may overlook. 
Immunoassays efficiently separate immobilized antigens from free antigens using biotin-
based mechanisms. A protein called streptavidin is used as the binding site on particles that 
conjugate to biotinylated antibodies that have themselves bound to target antigens in the 
assays. However, if there is excess biotin in the sample being tested, it can also bind to the 
streptavidin, and the now-unbound biotinylated antibodies can be washed away during the 
regular processing of the immunoassay, leading to an artificially lower signal. In a sandwich 
assay, this indicates a lower concentration of the target molecule; in a competitive assay, it 
indicates a higher concentration. 
Some companies have taken notice and have begun introducing solutions that do not rely on 
biotin; Tosoh, in particular, boasts a full line of biotin-free immunoassays. As this issue has 
really only begun to emerge, such products appear to be rare, but if the trend of using large 
doses of supplemental biotin continues, we may expect to see more coming to market in the 
future. Below is a table of assays and devices that employ biotin-free detection 
methodologies. 

 
 
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Table 4-8: Biotin-free Offerings Currently on the Market 
Company 
Location 
Product 
Description 
Abbott 
US 
Architect i2000 analyzer 
does not use biotin-streptavidin capture 
Diasorin 
Italy 
Liaison XL analyzer 
Randox 
Laboratories 
UK 
Biotin-free Biochip Array technology 
uses antibodies bound to a solid substrate 
(biochip surface) instead of biotin-streptavidin 
Revvity 
US 
AlphaLISA biotin-free detection kits 
assays use anti-Digoxin donor beads instead of 
streptavidin 
Tosoh 
Bioscience 
Japan 
AIA-PACK assays for cardiac, thyroid, 
reproductive, tumor, metabolic, kidney, 
anemia, vitamin D, other applications 
assays use "immobilized antibodies" in lieu of 
streptavidin binding sites on magnetic particles 
Source: Kalorama Information 
However, on closer inspection, the furor over biotin interference may be exaggerated. 
Notably, Roche does not offer biotin-free alternatives to their available immunoassays. The 
company conducted a pharmacokinetic study, measuring and confirming the biotin tolerance 
thresholds of all of their assays. Among the conclusions reached were that tolerances for 
some of Roche’s assays were even higher than previously documented, and that subjects 
taking the supplement for five days at 5 mg and 10 mg doses were below the assays’ 30 ng 
mL-1 tolerance threshold within 3.5 and 8 hours, respectively. It is also taken into account 
that the majority of biotin sales are in doses under 2.5 mg, which would have no effect on 
Roche’s immunoassays. 
Taking all factors into account, several steps can be taken to mitigate biotin interference-
related errors in diagnosis. Adopting biotin-free methodologies may seem like the most 
obvious approach, but awareness and communication can go a long way as well. Patient 
records should clearly state whether biotin is being used as a treatment for a condition, and 
clinicians should ask patients whether they are taking it as a dietary supplement prior to 
laboratory testing. Furthermore, as stated above, the vitamin's nomenclature varies, and 
patients should be made aware of this to avoid confusion when assessing their supplemental 
intake. 

 
 
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The FDA issued an updated safety communication, UPDATE: FDA Warns that Biotin May 
Interfere with Lab Tests. This update discusses concerns with biotin interference in certain 
lab tests, namely, troponin levels. Biotin interference can cause false low troponin levels. As 
a result, the FDA has published a list of FDA-listed troponin IVD devices that are subject to 
biotin interference but have not addressed this risk.  These are listed at 
https://www.fda.gov/medical-devices/in-vitro-diagnostics/biotin-interference-troponin-lab-
tests-assays-subject-biotin-interferenc. 
 
 

 
 
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 Table 4-9: Biotin Interference with Troponin Lab Tests – Assays Subject to Biotin Interference 
Registered 
Establishment Name 
Assay Trade Name(s)/ Listed Name(s) 
510(k) Cleared Device Name 
INTERNATIONAL 
POINT OF CARE INC. 
Cardiac STATus 
SPECTRAL'S TROPONIN I 
INTERNATIONAL 
POINT OF CARE INC. 
Cardiac STATus 
SPECTRAL'S 2 IN 1 (TNI-MYO) 
NANO-DITECH 
CORPORATION 
Nano-CheckTM AMI 3 IN 1 cTnI/CK-
MB/Myo Test 
NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST 
FOR CARDIAC TROPONIN I, CREATINE KINASE MB 
AND MYOGLOBIN 
NANO-DITECH 
CORPORATION 
Nano-CheckTM AMI cTnI Test 
NANO-CHECK AMI CTNI CARDIAC MARKER TEST 
NANO-DITECH 
CORPORATION 
Nano-CheckTM AMI 2 IN 1 cTnI/Myo Test 
Nano-Check AMI 2 IN 1 Cardiac Marker Test, cTnI 
and Myoglobin; NANO-CHECK AMI 2 IN 1 
CARDIAC DISEASE TEST FOR CARDIAC TROPONIN 
I AND MYOGLOBIN 
QuidelOrtho 
VITROS Immunodiagnostic Products 
Troponin I ES Reagent Pack; VITROS 
Immunodiagnostic Products Troponin I ES 
Calibrators; VITROS Immunodiagnostic 
Products Troponin I ES Range Verifiers 
VITROS TROPONIN I ES ASSAY, INCLUDING 
REAGENT PACK, CALIBRATORS AND RANGE 
VERIFIERS, MODELS 680 2301, 2302 AND 2303 
PRINCETON 
BIOMEDITECH CORP. 
LifeSign MI Myoglobin/Troponin I 
LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID 
TEST 
PRINCETON 
BIOMEDITECH CORP. 
LifeSign MI Troponin I 
CARDIAC STATUS TROPONIN I 
PRINCETON 
BIOMEDITECH CORP. 
LifeSign MI CK-MB/Myoglobin/Trop I 
CARDIAC STATUS CK-
MB/MYOGLOBIN/TROPONIN I RAPID TEST 
ROCHE DIAGNOSTICS 
GMBH 
CARDIAC Control Troponin-T; Cardiac 
Reader IQC; CARDIAC READER SYSTEM; 
Cardiac T Quantitative 10Tests; ROCHE 
CARDIAC TEST STRIP TROPONIN T; TROPT 
Sensitive 5 Tests 
THE CARDIAC READER SYSTEM 
ROCHE DIAGNOSTICS 
GMBH 
Elecsys Troponin T STAT 
ROCHE ELECSYS TROPONIN T STAT (SHORT 
TURNAROUND TIME) 
ROCHE DIAGNOSTICS 
GMBH 
Elecsys Troponin I; Elecsys Troponin I STAT 
ELECSYS TROPONIN I AND TROPONIN I STAT 
TEST SYSTEMS 

 
 
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Registered 
Establishment Name 
Assay Trade Name(s)/ Listed Name(s) 
510(k) Cleared Device Name 
ROCHE DIAGNOSTICS 
GMBH 
Elecsys Troponin T Gen 5 STAT 
Elecsys Troponin T Gen 5 STAT Assay, Elecsys 
Troponin T Gen 5 STAT CalSet, Elecsys 
PreciControl Troponin, Elecsys Troponin T Gen 5 
CalCheck 5 
ROCHE DIAGNOSTICS 
GMBH 
ELECSYS TROPONIN T 
ELECSYS TROPONIN T 
Siemens 
Healthineers 
ADVIA Centaur TnI-Ultra; Atellica IM TnI-
Ultra 
TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR 
SYSTEM 
Siemens 
Healthineers 
Dimension Vista CTNI Flex reagent 
cartridge 
DIMENSION VISTA CTNI FLEX REAGENT 
CARTRIDGE 
Siemens 
Healthineers 
Dimension EXL LOCI Module TNI Flex 
reagent cartridge 
DIMENSION TNI FLEX REAGENT CARTRIDGE, AND 
CTNI SAMPLE DILUENT WITH MODELS, RF621, 
KD692 
Source: FDA 
Clinical Applications and Liquid Biopsy 
In oncology, tumor cells actively release exosomes enriched with tumor-specific RNA and 
DNA. These tumor-derived exosomes are often more abundant and accessible in blood or 
urine than cancer cells themselves, offering an alternative or complement to tissue biopsies. 
This is especially valuable for: 
• Monitoring tumor recurrence or treatment resistance 
• Identifying actionable mutations for precision therapy 
• Screening high-risk populations 
Routine exosome-based diagnostics could redefine the liquid biopsy paradigm, extending 
testing beyond cfDNA to include exoRNA and protein-based markers, particularly for tumors 
with low shedding or heterogeneous mutations. 
A growing number of molecular diagnostics and sequencing companies are leveraging 
exosome-related biomarkers and platforms: 

 
 
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• Agilent Technologies – Provides exome capture and target enrichment solutions used 
in oncology and genetic research, supporting next-generation sequencing workflows 
across a range of disease areas. 
• Labcorp – Offers whole exome sequencing services, particularly in pediatric and rare 
disease diagnostics, and has expanded its genomic testing portfolio through the 
acquisition of key assets from Invitae, incorporating hereditary disease and oncology 
sequencing capabilities into its broader diagnostic offerings. 
• Sysmex Corporation – Expanding its oncology and molecular diagnostics 
capabilities, including liquid biopsy-related technologies, with ongoing development 
efforts in Asia. 
• Thermo Fisher Scientific – Offers the Ion AmpliSeq Exome Kit for research use, 
supporting targeted exome sequencing applications in clinical research and 
translational studies. 
• Illumina – Continues to support high-throughput sequencing with NovaSeq X and 
NovaSeq X Plus systems, enabling large-scale genomic and exome sequencing in 
research and clinical settings. 
• Ambry Genetics + PacBio – Collaborating on rare disease sequencing initiatives, 
leveraging long-read sequencing to improve variant detection and genomic insights. 
The exosome diagnostics market is in early-stage commercial development but accelerating 
rapidly, particularly in: 
• Oncology 
• Neonatal and pediatric disease 
• Neurodegenerative diagnostics 
Tests are primarily offered as lab-developed services, though regulatory approvals (e.g., CE 
mark, LDT status) are beginning to appear. The next 3–5 years will likely see the emergence 
of FDA-cleared exosome tests, deeper AI integration, and multi-analyte diagnostics 
combining cfDNA, exoRNA, and proteomics. 
  

 
 
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Traumatic Brain Injury and IVD  
Traumatic brain injury (TBI) is caused by an external physical force that disrupts normal 
brain function, affecting cognitive and physical functions, including thinking and memory, 
vision, movement, and emotional function. Mild TBI is better known as a concussion, and 
accounts for 94.5% of all cases. TBI can cause severe cognitive and neurological impairment, 
reduce quality of life, and affect interpersonal relationships; it has been known to affect 
judgment and decision-making, it can lead to depression and anxiety, and has been thought 
to contribute to other psychiatric and neurological issues such as psychosis and Alzheimer’s 
disease. TBIs contribute to about 30% of all injury-related deaths.  
Traumatic brain injuries, including concussions, are responsible for over 4.8 million 
emergency room visits per year. Most of these (40%) are concussions caused by a slip and 
fall. Traumatic brain injuries are seen in the sports world.  Worldwide, there are 
approximately 10 million people affected by TBI. The primary goal of testing is to detect 
changes in the brain that could help determine whether it was injured.  
Abbott markets its i-STAT TBI Plasma test, a rapid assay designed to help assess patients 
with suspected mild traumatic brain injury. The test measures key brain injury biomarkers 
and provides results in less than 20 minutes, supporting faster clinical decision-making in 
emergency and acute care settings. It is part of Abbott’s i-STAT platform, which is widely 
used for point-of-care testing. In addition, Abbott expanded the use of its i-STAT TBI test to 
include whole-blood samples, allowing greater flexibility in testing environments. This 
advancement supports use outside of traditional laboratory settings, including emergency 
departments, urgent care centers, and field-based environments such as sports medicine, 
where rapid assessment is critical. 
bioMérieux offers the VIDAS TBI assay, a laboratory-based test designed to support 
evaluation of patients with mild traumatic brain injury. The assay measures biomarkers such 
as GFAP and UCH-L1, which are released into the bloodstream following brain injury, and 
is intended to assist clinicians in determining whether further imaging or intervention is 
needed. 
More recent developments continue to expand the role of blood-based biomarkers in brain 
injury assessment. There is growing interest in integrating these tests into broader clinical 
workflows, including emergency triage and concussion management. In addition, research 

 
 
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and product development efforts are focused on improving sensitivity, expanding testing to 
additional patient populations, and enabling use in decentralized and point-of-care settings. 

 
 
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Personalized Medicine 
Personalized medicine is also called precision medicine. Personalized medicine has a fairly 
broad meaning, but it is medicine that uses an individual’s unique genetic profile to guide 
decisions about prevention, diagnosis and treatment of disease. Personalized medicine is an 
innovative approach to tailoring treatment to each patient's individual characteristics. This is 
a relatively new field of medicine that combines pharmacology and genetics, and it is gaining 
momentum. 
IVD is an integral part of personalized medicine, as it provides critical information for 
making treatment decisions. Specific examples where IVD devices provide personalized 
medicine include blood glucose tests, pregnancy tests, cancer screening and in-home HIV 
testing.  
COVID-19 was instrumental in driving a sharp rise in demand for IVD products, leading to 
an unprecedented surge in PCR, NGS, and serology-based rapid tests. The pandemic also 
demonstrated the value of these products and helped to create a very supportive regulatory 
environment.  
Growth in the aging population will likely shift treatments to a more personalized approach 
tailored to the individual’s genetic makeup and lifestyle. This move will likely reduce 
unnecessary treatments that are expensive and ineffective for the individual.  Rising rates of 
chronic diseases and growing numbers of immunosuppressed individuals will also highlight 
the need for personalized diagnostics.  
One reason personalized medicine is advancing is that patients are demanding more 
personalized care; the one-size-fits-all model is not meeting their expectations. Patients are 
becoming increasingly engaged in personally directed care through the use of biometric 
indices, such as smartphones and smart wearables (e.g., watches, rings, or other monitors). 
These devices are generating a massive amount of data, providing insights into patient health 
and providing physicians with patient-specific data.  
The growing body of evidence on technologies that provide personalized data is likely to lead 
to better patient outcomes. Many IVD tests are benefiting from the uptake of personalized 
medicine, which is expected to continue to grow.  

 
 
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One of the most instrumental advances assisting personalized medicine is wearable 
diagnostics. Wearables are commonplace these days, with devices such as smart watches that 
can measure heart rate, oxygen saturation, and sleep patterns. These devices can also detect 
atrial fibrillation, respiration and body temperature. All of this information can be helpful in 
the early detection of diseases.  
The glucose arena has made significant strides in personalized medicine through continuous 
glucose monitoring. For those with diabetes, this was a life-changing tool. As technology 
evolves, it will likely expand the role of comprehensive health monitoring and disease 
prevention.  
Companion Diagnostics 
A companion diagnostic is a test that provides information that is essential for safe and 
effective use of pharmaceutical products. Companion diagnostics can identify patients who 
may be at risk of increased risk for side effects when dosed with a particular product; identify 
patients who are most likely to benefit from the particular treatment; and monitor response 
to treatment during the administration of a drug therapy. 
In June 2023, the FDA issued final guidance for oncology drug products used with certain in 
vitro diagnostic tests, establishing clearer expectations for the co-development and use of 
companion diagnostics. This guidance remains in effect in 2026 and continues to shape how 
oncology therapies are paired with diagnostic tests. Since its release, the FDA has taken a 
more active role in reinforcing requirements for analytical and clinical validation, particularly 
for tests used to guide treatment decisions. There is also increased regulatory focus on the 
use of laboratory-developed tests in oncology, with greater emphasis on ensuring that tests 
informing therapy selection are appropriately reviewed or aligned with FDA standards. As a 
result, the industry is seeing stronger alignment between drug approvals and companion 
diagnostic availability, along with increased pressure to support validated, regulatory-
compliant testing in clinical practice. 
 Below is a list of selected approved companion IVD diagnostics. 

 
 
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Table 4-10: Selected FDA Approved Companion Diagnostics 2025 
Diagnostic Name (Manufacturer) 
Indication - Sample Type 
Drug Trade Name (Generic) NDA / BLA 
AAV5 DetectCDx (ARUP 
Laboratories) 
Hemophilia A Patients - 
Plasma 
ROCTAVIAN (valoctocogene roxaparvovec-
rvox) BLA 125720 
Abbott RealTime IDH1 (Abbott 
Molecular, Inc.) 
Acute Myeloid Leukemia - 
Peripheral Blood or Bone 
Marrow 
Tibsovo (ivosidenib) NDA 211192 
Abbott RealTime IDH2 (Abbott 
Molecular, Inc.) 
Acute Myeloid Leukemia - 
Peripheral Blood or Bone 
Marrow 
Rezlidhia (olutasidenib) NDA 215814 
Agilent Resolution ctDx FIRST assay 
(Resolution Bioscience, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Plasma 
Idhifa (enasidenib) NDA 209606 
Bond Oracle HER2 IHC System 
(Leica Biosystems) 
Breast Cancer - Tissue 
Krazati (adagrasib) NDA 216340 
BRACAnalysis CDx (Myriad Genetic 
Laboratories, Inc.) 
Ovarian Cancer - Whole Blood 
Herceptin (trastuzumab) BLA 103792 
BRACAnalysis CDx (Myriad Genetic 
Laboratories, Inc.) 
Breast Cancer - Whole Blood 
Lynparza (olaparib) NDA 208558 
BRACAnalysis CDx (Myriad Genetic 
Laboratories, Inc.) 
Ovarian Cancer - Whole Blood 
Talzenna (talazoparib) NDA 211651 
BRACAnalysis CDx (Myriad Genetic 
Laboratories, Inc.) 
Pancreatic Cancer - Whole 
Blood 
Rubraca (rucaparib) NDA 209115 
BRACAnalysis CDx (Myriad Genetic 
Laboratories, Inc.) 
Metastatic Castrate Resistant 
Prostate Cancer (mCRPC) - 
Whole Blood 
Lynparza (olaparib) NDA 208558 
cobas 4800 BRAF V600 Mutation 
Test (Roche Molecular Systems, 
Inc.) 
Melanoma - Tissue 
Lynparza (olaparib) NDA 208558 
cobas EGFR Mutation Test v1 
(Roche Molecular Systems, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Cotellic (cobimetinib) NDA 206192 in 
combination with Zelboraf (vemurafenib) NDA 
202429 
cobas EGFR Mutation Test v2 
(Roche Molecular Systems, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Tarceva (erlotinib) NDA 021743 
cobas EGFR Mutation Test v2 
(Roche Molecular Systems, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Tagrisso (osimertinib) NDA 208065 

 
 
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Diagnostic Name (Manufacturer) 
Indication - Sample Type 
Drug Trade Name (Generic) NDA / BLA 
cobas EGFR Mutation Test v2 
(Roche Molecular Systems, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue or Plasma 
Iressa (gefitinib) NDA 206995 
cobas EGFR Mutation Test v2 
(Roche Molecular Systems, Inc.) 
Non-Small Cell Lung Cancer (NSCLC) - Tissue or Plasma 
cobas EZH2 Mutation Test (Roche 
Molecular Systems, Inc.) 
Follicular Lymphoma Tumor - 
Tissue 
Tarceva (erlotinib) NDA 021743 
cobas KRAS Mutation Test (Roche 
Molecular Systems, Inc.) 
Colorectal Cancer - Tissue 
Tazverik (tazemetostat) NDA 213400 
cobas KRAS Mutation Test (Roche 
Molecular Systems, Inc.) 
Colorectal Cancer - Tissue 
Erbitux (cetuximab) BLA 125084 
CRCDx RAS Mutation Detection 
Assay Kit (EntroGen, Inc.) 
Colorectal Cancer (CRC) - 
Tissue 
Vectibix (panitumumab) BLA 125147 
Dako c-KIT pharmDx (Dako North 
America, Inc.) 
Gastrointestinal Stromal 
Tumors - Tissue 
Gleevec (imatinib mesylate), NDA 021588 
Dako EGFR pharmDx Kit (Dako 
North America, Inc.) 
Colorectal Cancer - Tissue 
Erbitux (cetuximab) BLA 125084 
FerriScan (Resonance Health 
Analysis Services Pty Ltd) 
Non-Transfusion-Dependent 
Thalassemia - Tissue 
Vectibix (panitumumab) BLA 125147 
FoundationFocus CDxBRCA Assay 
(Foundation Medicine, Inc.) 
Ovarian Cancer - Tissue 
Exjade (deferasirox) NDA 021882 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Rubraca (rucaparib) NDA 209115 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Gilotrif (afatinib) NDA 201292 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Iressa (gefitinib) NDA 206995 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Tarceva (erlotinib) NDA 021743 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Tagrisso (osimertinib) NDA 208065 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Alecensa (alectinib) NDA 208434 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Xalkori (crizotinib) NDA 202570 

 
 
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Diagnostic Name (Manufacturer) 
Indication - Sample Type 
Drug Trade Name (Generic) NDA / BLA 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Zykadia (ceritinib) NDA 211225 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Breast Cancer - Tissue 
Tafinlar (dabrafenib) NDA 202806 in 
combination with Mekinist (trametinib) NDA 
204114 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Breast Cancer - Tissue 
Herceptin (trastuzumab) BLA 103792 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Breast Cancer - Tissue 
Perjeta (pertuzumab) BLA 125409 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Colorectal Cancer - Tissue 
Kadcyla (ado-trastuzumab emtansine) BLA 
125427 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Colorectal Cancer - Tissue 
Erbitux (cetuximab) BLA 125084 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Melanoma - Tissue 
Vectibix (panitumumab) BLA 125147 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Breast Cancer - Tissue 
Lynparza (olaparib) NDA 208558 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Piqray (alpelisib) NDA 212526 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Cholangiocarcinoma - Tissue 
Tabrecta (capmatinib) NDA 213591 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Metastatic Castrate Resistant 
Prostate Cancer (mCRPC) - 
Tissue 
Pemazyre (pemigatinib) NDA 213736 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Solid Tumors - Tissue 
Lynparza (olaparib) NDA 208558 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Solid Tumors - Tissue 
Keytruda (pembrolizumab) BLA 125514 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Solid Tumors - Tissue 
Vitrakvi (larotrectinib) NDA 210861 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Melanoma - Tissue 
Keytruda (pembrolizumab) BLA 125514 

 
 
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Diagnostic Name (Manufacturer) 
Indication - Sample Type 
Drug Trade Name (Generic) NDA / BLA 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Tecentriq (atezolizumab) BLA 761034 in 
combination with Cotellic (cobimetinib) NDA 
206192 and Zelboraf (vemurafenib) NDA 
202429 
FoundationOne CDx (Foundation 
Medicine, Inc.) 
Solid Tumors - Tissue 
BRAFTOVI (encorafenib) NDA210496 in 
combination with MEKTOVI 
(binimetinib) NDA210498 
FoundationOne CDx (Foundation 
Medicine, Inc.)     
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Rozlytrek (entrectinib)  
FoundationOne CDx  
Prostate Cancer - Tissue 
Rozlytrek (entrectinib)  
FoundationOne Liquid CDx 
(Foundation Medicine, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Plasma 
AKEEGA (niraparib + abiraterone acetate) 
NDA 216793 
FoundationOne Liquid CDx 
(Foundation Medicine, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Plasma 
Exkivity (mobocertinib) NDA 215310 
FoundationOne Liquid CDx 
(Foundation Medicine, Inc.) 
Metastatic Castrate Resistant 
Prostate Cancer (mCRPC) - 
Plasma 
BRAFTOVI (encorafenib) NDA210496 in 
combination with MEKTOVI 
(binimetinib) NDA210498 
FoundationOne Liquid CDx 
(Foundation Medicine, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Plasma 
Rubraca (rucaparib) NDA 209115 
FoundationOne Liquid CDx 
(Foundation Medicine, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Plasma 
Tabrecta (capmatinib) NDA 213591 
FoundationOne Liquid CDx 
(Foundation Medicine, Inc.) 
Solid Tumors - Plasma 
Rozlytrek (entrectinib) NDA 212725 
FoundationOne Liquid CDx 
(Foundation Medicine, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Plasma 
Rozlytrek (entrectinib) NDA 212725 
FoundationOne Liquid CDx 
(Foundation Medicine, Inc.) 
Breast Cancer - Plasma 
Alecensa (alectinib) NDA 208434 
Guardant360 CDx (Guardant 
Health, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Plasma 
Rybrevant (amivantamb) BLA 761210 
Guardant360 CDx (Guardant 
Health, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Plasma 
Lumakras (sotorasib) NDA 214665 
Guardant360 CDx (Guardant 
Health, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Plasma 
ENHERTU (fam-trastuzumab deruxtecan-
nxki) BLA 761139 
Guardant360 CDx (Guardant 
Health, Inc.) 
Breast Cancer - Plasma 
Orserdu (elacestrant) NDA 217639 

 
 
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Diagnostic Name (Manufacturer) 
Indication - Sample Type 
Drug Trade Name (Generic) NDA / BLA 
HER2 CISH pharmDx Kit (Dako 
Denmark A/S) 
Breast Cancer - Tissue 
Herceptin (trastuzumab) BLA 103792 
HER2 FISH pharmDx Kit (Dako 
Denmark A/S) 
Breast Cancer - Tissue 
Perjeta (pertuzumab) BLA 125409 
HER2 FISH pharmDx Kit (Dako 
Denmark A/S) 
Breast Cancer - Tissue 
Kadcyla (ado-trastuzumab emtansine) BLA 
125427 
HercepTest (Dako Denmark A/S) 
Breast Cancer - Tissue 
Herceptin (trastuzumab) BLA 103792 
HercepTest (Dako Denmark A/S) 
Breast Cancer - Tissue 
Perjeta (pertuzumab) BLA 125409 
HercepTest (Dako Denmark A/S) 
Breast Cancer - Tissue 
Kadcyla (ado-trastuzumab emtansine) BLA 
125427 
INFORM HER-2/neu (Ventana 
Medical Systems, Inc.) 
Breast Cancer - Tissue 
Herceptin (trastuzumab) BLA 103792 
INFORM HER2 Dual ISH DNA Probe 
Cocktail (Ventana Medical 
Systems, Inc.) 
Breast Cancer - Tissue 
Kadcyla (ado-trastuzumab emtansine) BLA 
125427 
InSite Her-2/neu (CB11) 
Monoclonal Antibody (BioGenex 
Laboratories, Inc.) 
Breast Cancer - Tissue 
Herceptin (trastuzumab) BLA 103792 
Ki-67 IHC MIB-1 pharmDx (Dako 
Omnis) (Agilent Technologies) 
Breast Cancer - Tissue 
Verzenio (abemaciclib) NDA 208716 
KIT D816V Assay (ARUP 
Laboratories, Inc.) 
Aggressive Systemic 
Mastocytosis - Bone Marrow 
Gleevec (imatinib mesylate) NDA 021588 
LeukoStrat CDx FLT3 Mutation 
Assay (Invivoscribe Technologies, 
Inc.) 
Acute Myelogenous Leukemia 
- Peripheral Blood or Bone 
Marrow 
Rydapt (midostaurin) NDA 207997 
LeukoStrat CDx FLT3 Mutation 
Assay (Invivoscribe Technologies, 
Inc.) 
Acute Myelogenous Leukemia 
- Peripheral Blood or Bone 
Marrow 
Xospata (gilterinib) NDA 211349 
LeukoStrat CDx FLT3 Mutation 
Assay (Invivoscribe Technologies, 
Inc.) 
Acute Myelogenous Leukemia 
(AML) - Peripheral Blood or 
Bone Marrow 
VANFLYTA (quizartinib) NDA 216993 
MRDx BCR-ABL Test (MolecularMD 
Corporation) 
Chronic Myeloid Leukemia - 
Peripheral Blood 
Tasigna (nilotinib) NDA 022068 
Myriad myChoice CDx (Myriad 
Genetic Laboratories, Inc.) 
Ovarian Cancer - Tissue 
Lynparza (olaparib) NDA 208558 

 
 
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Diagnostic Name (Manufacturer) 
Indication - Sample Type 
Drug Trade Name (Generic) NDA / BLA 
nAbCyte Anti-AAVRh74var HB-FE 
Assay (Labcorp Drug Development) 
Moderate to severe 
Hemophilia B patients - Serum 
BEQVEZ (fidanacogene elaparvovec) BLA 
125786 
ONCO/Reveal Dx Lung & Colon 
Cancer Assay (O/RDx-LCCA) (Pillar 
Biosciences, Inc.) 
Colorectal Cancer - Tissue 
Erbitux (cetuximab) BLA 125084 
ONCO/Reveal Dx Lung & Colon 
Cancer Assay (O/RDx-LCCA) (Pillar 
Biosciences, Inc.) 
Colorectal Cancer - Tissue 
Vectibix (panitumumab) BLA 125147 
ONCO/Reveal Dx Lung & Colon 
Cancer Assay (O/RDx-LCCA) (Pillar 
Biosciences, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
A tyrosine kinase inhibitor approved by FDA 
for that indication 
Oncomine Dx Target Test (Life 
Technologies Corporation) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Tafinlar (dabrafenib) NDA 202806 in 
combination with Mekinist (trametinib) NDA 
204114 
Oncomine Dx Target Test (Life 
Technologies Corporation) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Xalkori (crizotinib) NDA 202570 
Oncomine Dx Target Test (Life 
Technologies Corporation) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Hernexeos (zongertinib) 2025 
Oncomine Dx Target Test (Life 
Technologies Corporation) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Zegfrovy (sunvozertinib) 2025 
Oncomine Dx Target Test (Life 
Technologies Corporation) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Iressa (gefitinib) NDA 206995 
Oncomine Dx Target Test (Life 
Technologies Corporation) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Gavreto (pralsetinib) NDA 213721 
Oncomine Dx Target Test (Life 
Technologies Corporation) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Rybrevant (amivantamb) BLA 761210 
Oncomine Dx Target Test (Life 
Technologies Corporation) 
Cholangiocarcinoma - Tissue 
Tibsovo (ivosidenib) NDA 211192 
Oncomine Dx Target Test (Life 
Technologies Corporation) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Exkivity (mobocertinib) NDA 215310 
Oncomine Dx Target Test (Life 
Technologies Corporation) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
ENHERTU (fam-trastuzumab deruxtecan-
nxki) BLA 761139 
Oncomine Dx Target Test (Life 
Technologies Corporation) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Retevmo (selpercatinib) NDA 213246 

 
 
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Diagnostic Name (Manufacturer) 
Indication - Sample Type 
Drug Trade Name (Generic) NDA / BLA 
Oncomine Dx Target Test (Life 
Technologies Corporation) 
Medullary Thyroid Cancer 
(MTC) - Tissue 
Retevmo (selpercatinib) NDA 213246 
Oncomine Dx Target Test (Life 
Technologies Corporation) 
Thyroid Cancer (TC) - Tissue 
Retevmo (selpercatinib) NDA 213246 
Oncomine Dx Target Test (Life 
Technologies Corporation) 
Anaplastic Thyroid Cancer 
(ATC) - Tissue 
Tafinlar (dabrafenib) NDA 202806 in 
combination with Mekinist (trametinib) NDA 
204114 
PathVysion HER-2 DNA Probe Kit 
(Abbott Molecular Inc.) 
Breast Cancer - Tissue 
Herceptin (trastuzumab) BLA 103792 
PATHWAY anti-Her2/neu (4B5) 
Rabbit Monoclonal Primary 
Antibody (Ventana Medical 
Systems, Inc.) 
Breast Cancer - Tissue 
Herceptin (trastuzumab) BLA 103792 
PATHWAY anti-Her2/neu (4B5) 
Rabbit Monoclonal Primary 
Antibody (Ventana Medical 
Systems, Inc.) 
Breast Cancer - Tissue 
Kadcyla (ado-trastuzumab emtansine) BLA 
125427 
PATHWAY anti-Her2/neu (4B5) 
Rabbit Monoclonal Primary 
Antibody (Ventana Medical 
Systems, Inc.) 
Breast Cancer - Tissue 
Enhertu (fam-trastuzumab deruxtecan-
nxki) BLA 761139 
PD-L1 IHC 22C3 pharmDx (Dako 
North America, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Keytruda (pembrolizumab) BLA 125514 
PD-L1 IHC 22C3 pharmDx (Dako 
North America, Inc.) 
Cervical Cancer - Tissue 
Keytruda (pembrolizumab) BLA 125514 
PD-L1 IHC 22C3 pharmDx (Dako 
North America, Inc.) 
Head and Neck Squamous Cell 
Carcinoma (HNSCC) - Tissue 
Keytruda (pembrolizumab) BLA 125514 
PD-L1 IHC 22C3 pharmDx (Dako 
North America, Inc.) 
Esophageal Squamous Cell 
Carcinoma (ESCC) - Tissue 
Keytruda (pembrolizumab) BLA 125514 
PD-L1 IHC 22C3 pharmDx (Dako 
North America, Inc.) 
Triple-Negative Breast Cancer 
(TNBC) - Tissue 
Keytruda (pembrolizumab) BLA 125514 
PD-L1 IHC 22C3 pharmDx (Dako 
North America, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Libtayo (cemiplimab-rwlc) BLA 761097 
PD-L1 IHC 22C3 pharmDx (Dako 
North America, Inc.) 
Gastric or Gastroesophageal 
Junction (GEJ) 
Adenocarcinoma - Tissue 
Keytruda (pembrolizumab) BLA 125514 

 
 
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Diagnostic Name (Manufacturer) 
Indication - Sample Type 
Drug Trade Name (Generic) NDA / BLA 
PD-L1 IHC 28-8 pharmDx (Dako 
North America, Inc.) 
Non-small cell lung cancer 
(NSCLC) - Tissue 
Opdivo (nivolumab) BLA 125554 in 
combination with Yervoy (ipilimumab) BLA 
125377 
PDGFRB FISH Assay (ARUP 
Laboratories, Inc.) 
Myelodysplastic 
Syndrome/Myeloproliferative 
Disease - Bone Marrow 
Gleevec (imatinib mesylate) NDA 021588 
POMC/PCSK1/LEPR CDx Panel 
(PreventionGenetics, LLC) 
Obesity - Blood or Saliva 
Imcivree (setmelanotide acetate) NDA 213793 
Praxis Extended RAS Panel 
(Illumina, Inc.) 
Colorectal cancer - Tissue 
Vectibix (panitumumab) BLA 125147 
SeCore CDx HLA Sequencing 
System (One Lambda Inc. 
Uveal Melanoma – Whole 
Blood 
Kimmtrak (tebentafusp-tebn) BLA 761228 
SPOT-LIGHT HER2 CISH Kit (Life 
Technologies Corporation) 
Breast Cancer - Tissue 
Herceptin (trastuzumab) BLA 103792 
therascreen BRAF V600E RGQ PCR 
Kit (QIAGEN GmbH) 
Colorectal Cancer - Tissue 
Braftovi (encorafenib) NDA 210496 in 
combination with Erbitux (cetuximab) BLA 
125084 
therascreen EGFR RGQ PCR Kit 
(Qiagen Manchester, Ltd.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Gilotrif (afatinib) NDA 201292 
therascreen EGFR RGQ PCR Kit 
(Qiagen Manchester, Ltd.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Iressa (gefitinib) NDA 206995 
therascreen EGFR RGQ PCR Kit 
(Qiagen Manchester, Ltd.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Gilotrif (afatinib) NDA 201292 
therascreen EGFR RGQ PCR Kit 
(Qiagen Manchester, Ltd.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Vizimpro (dacomitinib) NDA 211288 
therascreen FGFR RGQ RT-PCR Kit 
(QIAGEN Manchester Ltd.) 
Urothelial Cancer - Tissue 
Balversa (erdafitinib) NDA 212018 
therascreen KRAS RGQ PCR Kit 
(Qiagen Manchester, Ltd.) 
Colorectal Cancer - Tissue 
Vectibix (panitumumab) BLA 125147 
therascreen KRAS RGQ PCR Kit 
(Qiagen Manchester, Ltd.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Lumakras (sotorasib) NDA 214665 
therascreen KRAS RGQ PCR Kit 
(Qiagen Manchester, Ltd.) 
Colorectal Cancer - Tissue 
Erbitux (cetuximab) BLA 125084 
therascreen KRAS RGQ PCR Kit 
(Qiagen Manchester, Ltd.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Krazati (adagrasib) NDA 216340 

 
 
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Diagnostic Name (Manufacturer) 
Indication - Sample Type 
Drug Trade Name (Generic) NDA / BLA 
therascreen PDGFRA RGQ PCR Kit 
(QIAGEN GmbH) 
Gastrointestinal Stromal 
Tumors (GIST) - Tissue 
AYVAKIT (Avapritinib) NDA 212608 
therascreen PIK3CA RGQ PCR Kit 
(QIAGEN GmbH) 
Breast Cancer - Tissue or 
Plasma 
Piqray (alpelisib) NDA 212526 
THXID BRAF Kit (bioMérieux Inc.) 
Melanoma - Tissue 
Mekinist (trametinib) NDA 204114 
THXID BRAF Kit (bioMérieux Inc.) 
Melanoma - Tissue 
Tafinlar (dabrafenib) NDA 202806 
THXID BRAF Kit (bioMérieux Inc.) 
Melanoma - Tissue 
Braftovi (encorafenib) NDA 210496 in 
combination with Mektovi (binimetinib) NDA 
210498 
Ventana ALK (D5F3) CDx Assay 
(Ventana Medical Systems, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Xalkori (crizotinib) NDA 202570 
Ventana ALK (D5F3) CDx Assay 
(Ventana Medical Systems, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Zykadia (ceritinib) NDA 211225 
Ventana ALK (D5F3) CDx Assay 
(Ventana Medical Systems, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Alecensa (alectinib) NDA 208434 
Ventana ALK (D5F3) CDx Assay 
(Ventana Medical Systems, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Lorbrena (lorlatinib) NDA 210868 
Ventana FOLR1 (FOLR-2.1) RxDx 
Assay  
Epithelial Ovarian Cancer, 
Fallopian Tube Cancer, or 
Primary Peritoneal Cancer - 
Tissue     
Elahere (mirvetuximab soravtansine-gynx) BLA 
761310 
Ventana HER2 Dual ISH DNA Probe 
Cocktail (Ventana Medical 
Systems, Inc.) 
Breast Cancer - Tissue 
Herceptin (trastuzumab) BLA 103792 
Ventana Met RxDx Assay 
NSCLC 
Emerlis(telisotumzumab vedotin 2025 
Ventana MMR RxDx Panel 
(Ventana Medical Systems, Inc.) 
Endometrial Carcinoma (EC) - 
Tissue 
Jemperli (dostarlimag-gxly) NDA 761174 
Ventana MMR RxDx Panel 
(Ventana Medical Systems, Inc.) 
Solid Tumors 
Jemperli (dostarlimag-gxly) NDA 761174 
Ventana MMR RxDx Panel 
(Ventana Medical Systems, Inc.) 
Endometrial Carcinoma (EC) - 
Tissue 
Keytruda (pembrolizumab) BLA 125514 in 
combination with Lenvima (lenvatinib) NDA 
206947 
Ventana PD-L1 (SP142) Assay 
(Ventana Medical Systems, Inc.) 
Urothelial Carcinoma - Tissue 
Tecentriq (atezolizumab) BLA 761034 

 
 
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Diagnostic Name (Manufacturer) 
Indication - Sample Type 
Drug Trade Name (Generic) NDA / BLA 
Ventana PD-L1 (SP142) Assay 
(Ventana Medical Systems, Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Tecentriq (atezolizumab) BLA 761034 
Vysis ALK Break Apart FISH Probe 
Kit (Abbott Molecular Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Xalkori (crizotinib) NDA 202570 
Vysis ALK Break Apart FISH Probe 
Kit (Abbott Molecular Inc.) 
Non-Small Cell Lung Cancer 
(NSCLC) - Tissue 
Alunbrig (brigatinib) NDA 208772 
Vysis CLL FISH Probe Kit (Abbott 
Molecular, Inc.) 
B-cell Chronic Lymphocytic 
Leukemia - Peripheral Blood 
Venclexta (venetoclax) NDA 208573 
xT CDx (Tempus Labs, Inc.) 
Colorectal Cancer (CRC) - 
Tissue (Matching Blood/Saliva) 
Erbitux (cetuximab) BLA 125084 
xT CDx (Tempus Labs, Inc.) 
Colorectal Cancer (CRC) - 
Tissue (Matching Blood/Saliva) 
Vectibix (panitumumab) BLA 125147 
Source: FDA Kalorama Information 

 
 
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Telehealth 
The telehealth industry experienced steady but modest growth prior to the COVID-19 
pandemic, which rapidly accelerated adoption and brought virtual care and remote patient 
monitoring into routine use. Since that time, utilization has stabilized at levels well above 
pre-pandemic norms. Growth is now more measured, but the market remains strong, 
supported by continued demand for convenience, expanded use of wearable devices, and a 
growing focus on managing chronic conditions outside of traditional care settings. 
State-level policy support is an important factor, with many states maintaining telehealth 
coverage requirements and a significant number continuing to support reimbursement 
policies that pay virtual visits at rates comparable to in-person care. At the federal level, 
telehealth flexibility for Medicare beneficiaries has been extended beyond the original 
pandemic period, allowing continued access to services such as home-based virtual visits and 
expanded provider eligibility. However, these policies remain subject to ongoing legislative 
review, and long-term reimbursement structures are still being defined. 
Private insurers and employers have also incorporated telehealth into standard benefit 
designs, including coverage within high-deductible health plans, further supporting 
utilization. At the same time, healthcare providers are increasingly adopting hybrid care 
models that combine in-person and virtual services, particularly in primary care, behavioral 
health, and chronic disease management. 
Internationally, telehealth adoption continues to expand, with countries such as Australia and 
others integrating virtual care into routine service delivery, particularly in mental health and 
community-based care settings. 
Technology development remains a key driver of growth. Advances in digital health 
platforms, artificial intelligence, and connected devices are improving the quality and 
usability of virtual care. New models, including remote monitoring, virtual triage, and digital-
first care pathways, are becoming more common. While telehealth is now a permanent part 
of the healthcare landscape, its long-term growth will depend on continued policy support, 
clear reimbursement frameworks, and integration into standard clinical workflows. 

 
 
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Blockchain 
Blockchain is a revolutionary concept that can help improve patient outcomes while bridging 
various entities within the healthcare market.  It is not understood by most participants in the 
industry, but the concept is gaining ground. It is essentially a tool that can securely store data 
in a distributed ledger, enabling it to be shared across networks.  The concept behind 
blockchain is that it has three components: 
• a widely distributed network 
• a shared ledger with validated access identities 
• digital transactions 
Blockchain technology is emerging in many other industries, but it has some unique 
challenges in healthcare.  The storage and transmission of patient data is often centralized 
through electronic medical records (EMRs). The concept of blockchain is decentralizing 
databases, making it harder for hackers to steal data. This level of security would directly 
benefit both caregivers and patients because it can be accessed only with permission. 
Blockchain could enable improvements in care delivery and cost savings. Although most 
industry participants would agree that blockchain does offer numerous opportunities, the 
reality is that in healthcare, change progresses at a snail's pace.  
Blockchain in the healthcare arena is still an emerging technology. However, many major 
vendors in the EMR space and others are moving quickly to embrace blockchain in healthcare 
systems. Federal IT officials are embracing the technology and promoting its use. Several 
companies have units dedicated to developing blockchain products, including healthcare 
applications. Those companies include IBM, Intel, Goggle, Microsoft and others. Examples 
of companies putting blockchain into action in healthcare: 
• Change Healthcare has developed a blockchain technology in healthcare products  
•  ShoCard and RF Ideas debuted a blockchain technology-enabled mobile credential 
reader system. ShoCard is a blockchain-based identity system management system 
that reads badges for in-building applications such as computer access, identification 
and secure print. This blockchain technology will allow healthcare providers to meet 
healthcare security compliance guidelines.  

 
 
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Clinical laboratories in particular, which use sophisticated laboratory information 
management systems and radiology information systems, must be responsive to 
cybersecurity threats. It will be interesting to see whether device manufacturers and 
healthcare IT companies can harness blockchain technology in the next few years for clinical 
labs, as well as for device users such as hospitals and patients. 
Blockchain in healthcare is still evolving, according to experts in the field. Blockchain 
technologies have great potential to improve patient care, reduce costs, and enhance the 
patient experience. However, there needs to be sufficient groundwork to implement these 
emerging technologies. Most experts believe that the majority of healthcare participants are 
not ready for prime time with blockchain, but the industry continues to evolve.  For example, 
Boehringer Ingelheim and IBM Canada are exploring the use of blockchain technology in 
clinical trials. Both companies believe there is a significant opportunity to improve the 
quality of clinical trials and record-keeping using blockchain technology by providing a 
decentralized framework that enables data integrity, provenance, transparency, and patient 
empowerment through automated processes.  
Over the last year, blockchain has continued to evolve, and many approaches have been 
developed to support its adoption. Over the forecast period, blockchain is expected to 
transform the healthcare system due to its many potential use cases and evolving technology. 
Hospital systems in Europe offer blockchain-based credentialing platforms to verify medical 
staff across borders, reducing administrative friction 
In South Korea, a private blockchain pilot enables patients to securely share their electronic 
health records between clinics, giving them greater control over their own data 
The MediLedger network has expanded in the U.S., enabling pharmaceutical companies and 
wholesalers to track drugs throughout the supply chain and combat counterfeits. 
 
 

 
 
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Substance Abuse 
The incidence of substance abuse has increased worldwide and in the United States over the 
years.  The U.S. Department of Health and Human Services estimates there are more than 
650,000 emergency department visits each year, with a primary reason for visit stating 
substance abuse.  Additionally, more than 300,000 involved alcohol or major illicit drugs.  
Cocaine alone accounts for more than 20% of all visits.  Worldwide, about 275 million people 
are estimated to have used an illicit drug at least once in 2016; additionally, about 3.3 million 
deaths are attributed to the overuse of alcohol each year and nearly 200,000 overdose deaths 
from drugs. 
Substance abuse statistics are improving. The growing public awareness of opioid abuse and 
an epidemic in the United States is driving a need for testing.  During the past several decades, 
drug abuse and dependence have become critical public health problems as evidenced by 
newspaper and Internet stories. Although drug abuse has existed throughout history, 
generally it has involved a relatively small minority of the population.   
The overall overdose deaths fell 27% in 2024. This may have been due to investment in 
treatment access, naloxone distribution and public health funding. There is still a huge 
number of fentanyl-related overdose deaths.  
Biomarkers and Substance Abuse 
Genetics may be part of the answer, and their increasing utility might presage an increase in 
testing.  Scientists identified 10 genes that show promise in predicting how patients will 
respond to opioid pain medications. Using these genetic markers, healthcare providers could 
potentially tailor opioid therapy better to curb the skyrocketing rate of deaths from these 
drugs.  But it is not just abuse of these medications that can lead to overdoses. Even in patients 
with severe pain and a legitimate need for opioids, the dose required to alleviate pain varies 
widely and unpredictably between individuals. This means that clinicians must essentially 
use a trial-and-error strategy to determine the correct type of opioid and dosage that will help 
a patient. This approach puts some patients at increased risk of life-threatening side effects 
such as respiratory depression, while leaving other patients undertreated and in pain.  
To date, researchers have identified numerous genes that could potentially guide opioid 
treatment to make it more precise and safer. Despite this, the medical community has only 

 
 
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developed treatment guidelines based on one of these genes (CYP2D6) and has not 
determined which of the other genes should be used in practice.    A team of researchers led 
by Ron H.N. van Schaik, PhD, of Erasmus University Medical Center in Rotterdam, the 
Netherlands, conducted a systematic review of 4,257 studies on opioid genetics. The 
researchers assessed the utility of each gene studied based on whether (a) several independent 
studies confirmed the gene’s effect on patient opioid response and (b) the gene’s frequency 
in the white population was high enough for use in screening tests. Using these criteria, van 
Schaik’s team pinpointed 10 genes that show the highest potential of refining the way opioids 
are prescribed and that healthcare providers should focus on implementing clinically. In 
addition to the well-known CYP2D6, the most notable among these 10 are SLC22A1, the 
OPRM1 118A>G variant, and COMT. 
Research shows that the presence of two inactive SLC22A1 genes leads to high blood 
concentrations of tramadol’s active metabolite and, in children, to significantly lower 
clearance of morphine. This means that patients with these mutations might be at increased 
risk of overdosing on tramadol and morphine, particularly if they also have certain CYP2D6 
mutations.   
HDAC5/SCN4B and Shisa7 are emerging molecular biomarkers tied to relapse and 
substance-specific addiction. Epigenetic brain-aging clocks offer a novel way to view 
substance abuse disorders as accelerated neurobiological aging. Multi‑omics biomarkers 
(genomic and proteomic) at Mayo Clinic show promise for personalizing alcohol abuse 
treatments. 
New therapeutic and diagnostic platforms (GLP‑1 drugs, DBS, VR) may both reduce 
cravings and serve as functional biomarkers in treatment trials. This represents a shift from 
symptom‑based intervention to biomarker-informed, precision approaches in addiction 
treatment. 
Clinical Laboratory Testing for Drugs of Abuse 
Clinical laboratory tests are widely recommended to curb abuse and are expected to see 
increased utilization.  However, it is not clear yet if this will come to fruition; many 
physicians working on the front lines of the opioid crisis may not be fully equipped with the 
knowledge for the task. For example, studies have shown that clinicians misunderstand the 
very urine immunoassay tests they order for patients. 

 
 
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It is anticipated that drug testing technology will become increasingly sensitive and easier to 
use, leading to more innovative and effective testing for drugs of abuse. The move from urine 
testing to oral fluid testing reduces privacy concerns and mitigates some of the issues 
associated with urine testing. Future drug testing practices must include identifying a greater 
number of drugs. Drug testing must become less expensive and more resistant to adulteration. 
Drug tests must rapidly identify newly emerging drugs of abuse. 
Healthcare professionals, employers, criminal justice personnel, and sports use drug tests as 
part of a comprehensive evaluation of individuals to reach a correct decision regarding the 
individuals’ actions, behaviors, or performances. 
Table 4-11: Global Drug Abuse Statistics 
Drug 
Number of Users 
All illicit drug use 
316,000,000 
Cannabis 
244,000,000 
Opioids 
61,000,000 
Opiates 
19,700,000 
Cocaine 
25,100,000 
Amphetamines 
30,000,000 
Methylenedioxymethamphetamine (Ecstasy) 
21,000,000 
Source: WHO, 2023 
There are a number of drug abuse test products on the market, encompassing point-of-care, 
point-of-laboratory, and home-use formats, as well as urine, oral/saliva, blood, and hair 
testing.  
Urine 
Urine testing for drugs of abuse is the gold standard of the industry because it is non-invasive, 
accurate, and reliable.  Urine drug testing is most often carried out first by point-of-care 
devices (e.g., a CLIA-waived collection cup or strip) and by hospital laboratories. The tests 

 
 
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designed for use in hospital laboratories are geared toward the emergency-medicine service, 
which is concerned with determining drug overdose. These tests detect classes of drugs such 
as opiates and benzodiazepines for which there are antidotes. The cutoffs used on these tests 
are set to detect high concentrations of abused drugs. These cutoffs are appropriate for 
emergency units, where the correlation between the patient's condition and the presence of 
high drug concentrations enables the treating physician to determine the appropriate 
supportive care. 
Alfa Scientific offers the Instant-view rapid drug tests. The tests are available for POC and 
at-home diagnostics.  These include the Instant-view Drug Screen, which is a rapid test that 
can be read in four to seven minutes and can test for up to 12 drugs at one time. Adulteration 
controls are also available in the test kit.  
Abbott offers the Alere iCassette, ICup DS IScreen Dip Card and E-Z Split Key Cup tests.  
The Alere iCup drug screen tests for up to 13 drugs in one device. Most of the company’s 
tests are urine-based.  The Alere DDS2 Mobile Test System is a portable analyzer that targets 
six commonly abused drugs. The company also offers the SEFRIA Fentanyl Urine Drug 
Screening Test. This was the first cleared fentanyl enzyme immunoassay to utilize SEFRIA 
technology, thereby making it available in CLIA-certified facilities.  
FirstCheck1 offers the First Check line of drug abuse tests. The 6920K Panel 5 Test Cup 
offers 25 tests per kit and offers a 5-minute qualitative detection of THC, cocaine, opiates, 
methamphetamines, and PCP. The company also offers the 6000-K Cocaine kit, which 
includes 25 tests. The test is a one-step, 3-minute qualitative detection of cocaine metabolite 
in urine. The company offers several other tests similar to the ones mentioned for a variety 
of other drugs of abuse.  
Siemens Healthineers’ drug-of-abuse test, the Syva Emit II Plus 6-Acetylmorphine Assay, 
enables fast, selective testing for heroin use. Urine presence of 6-Acetylmorphine , a heroin 
metabolite, confirms heroin use; the new assay tests for this metabolite and is intended for 
qualitative/semi-quantitative determination of 6-AM at a 10 ng/mL cutoff concentration. 
Providing high specificity without cross-reactivity to morphine, morphine metabolites and 
many common analgesics, the assay also delivers low analytical sensitivity (down to 1.1 
ng/mL) and greater than 99% agreement with the reference method (GC/MS). Siemens also 
offers the Syva RapidCup, which integrates specimen collection and drugs of abuse tests. 
The easy-to-use RapidCup enables a rapid drug test to be performed at the point of collection. 
The Syva RapidCup is available in configurations that can test up to 6 different drugs 

 
 
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simultaneously. The company also offers the Syva RapidTest, which can test up to 10 
different drugs simultaneously. The simplicity of the Syva RapidTest enables tests to be 
performed at POC or other sites where instrumentation for drug screens may not be available. 
RX series systems from Randox Laboratories can be used as dedicated analyzers for urine 
drugs of abuse screening in labs where demands for drug screening are increasing. The 
Ximola is a compact, fully automated random-access benchtop analyzer offering 400 
photometric tests and 240 ISE tests per hour. The system offers Windows-based software, 
user-defined QC capacity, low water usage, multi-speed stirring, low service requirements, 
reusable Pyrex cuvettes and multilevel password access. 
Many of BTNX’s rapid tests are lateral flow tests.  The company distributes its products 
under the Rapid Response brand.  The company provides single drug test strips for testing 
the presence of fentanyl and other drugs. The company also offers Xylazine Test Strips 
Shenzhen Superbio Technology markets the Bioeasy platform, which includes rapid tests 
designed for the qualitative detection of substances such as fentanyl in urine. These types of 
assays are part of a broader expansion in toxicology testing, particularly in response to the 
ongoing opioid crisis and the need for rapid screening in both clinical and field settings. In 
the United States, distribution has been supported through partners such as Carolina Liquid 
Chemistries, which provides access to select products within its diagnostic portfolio. 
Carolina Liquid Chemistries also offers the RYAN immunofluorescence analyzer, a portable 
system designed for in vitro diagnostic testing of urine samples. The analyzer supports 
fluorescence-based assays and is intended for use in both laboratory environments and point-
of-care settings. Compact instruments such as RYAN reflect a continued shift toward 
decentralized testing, where rapid results and ease of use are important for clinical decision-
making in emergency care, toxicology screening, and outpatient settings. 
Blood 
Due to the invasiveness of the collection procedure and the cost of laboratory analysis, 
routine screening of drivers' blood for drugs has generally been viewed as impractical. 
Forensic laboratories have seen an increasing number of specimens for the determination of 
drugs in blood as a result of "zero tolerance" laws and better-trained police officers who have 
been trained to recognize drivers under the influence of drugs. This is especially true in 
Europe, where several European countries (e.g., Sweden, Germany, and Belgium) have 

 
 
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enacted per se laws for driving under the influence of drugs. These laws stipulate urinalysis 
as the preliminary screening test and require a blood test if the urine is positive for drugs. 
Under these laws, any level of a prohibited drug detected in the blood is considered evidence 
of driving under the influence.  
Companies that offer blood analyzers for drugs of abuse include Siemens Syva and Viva 
Drug Testing Systems line, Thermo Fisher’s Indiko fully automated line, and Abbott’s 
Architect line. 
Oral 
Alfa-Scientific offers: (1) The Oral-view Saliva Multi-Drug of Abuse Test is a rapid lateral 
flow test that can simultaneously detect up to 8 drugs in human saliva. This test is CE marked 
and can be sold in Europe. In the United States, this test can be used for forensic use only; 
(2) The Oral-View Saliva Alcohol Test is FDA cleared and CLIA waived. It is a rapid lateral-
flow immunoassay test strip for the detection of alcohol in saliva 
1 Step Detect Associates offers Oralert, which is a 10-minute test for the detection of 
marijuana, cocaine, opiates, methamphetamine, amphetamines, and  PCP in saliva. 1 Step 
Detect Associates also offers Alco-Screen for the detection of alcohol in saliva, and for 
approximating blood alcohol concentration using a saliva sample. 
Confirm Biosciences offers Salivaconfirm, a CE-marked oral-fluid multi-drug test. In the 
United States, it is available for forensic use only.  Salivaconfirm tests for 6 drugs, while 
Salivaconfirm Premium has an 11-drug panel. Also, the company offers alcohol screening. 
Two products are available: Saliva Alcohol Test and Breath Alcohol Test 
Oasis Diagnostics Corporation has developed a unique proprietary range of oral fluid 
products, which includes: the SaliChek roadside drugs of abuse testing system, the VerOFy 
oral fluid rapid test platform, and the VersiSAL split sample saliva / oral fluid collection 
device. SaliChek is a hand-held reading device that provides electronic readout and hard-
copy printout of results generated from specially designed immunochromatographic (ICT) 
test strips in the VerOFy Rapid Saliva Testing Platform Device.  SaliChek incorporates a 
Pocket-PC with photographic and long-term data storage capabilities.  The reader is being 
configured to accept standardized saliva-based ICT strips in the VerOFy format.  The 
VerOFy Rapid Test Platform is an enabling technology for rapid point-of-care diagnosis 
using saliva specimens. The VerOFy technology was originally developed for roadside drug-

 
 
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of-abuse testing, but may be applied to a multitude of diseases, disease states, or biomarkers 
for use in any setting where immediate results are required. 
OraSure Technologies offers several oral fluid-based testing products, including: 
• Intercept Oral Fluid Drug Test 
• Q.E.D. Saliva Alcohol Test 
Jant Pharmacal offers a variety of tests, including the Accustrip CLIA Waived Saliva Alcohol 
Test Strip and the Accutest Breath Alcohol Detector. 
Hair 
Confirm Biosciences offers Hairconfirm, a hair follicle multi-drug test. The sample is 
collected at home and then sent to the company’s laboratory using a pre-paid shipping 
envelope included in the kit. This product line includes five products: HairConfirm, 
HairConfirm express, HairConfirm with Prescription Drugs, Hairconfirm Business, and 
Hairconfirm Business with Prescription Drugs. Psychemedics offers several hair drugs of 
abuse testing products. The company offers a test for alcohol using hair. This test measures 
average alcohol consumption over a period of approximately three months, indicates the level 
of alcohol use during that time period and can provide a behavioral indication of excessive 
use.  
 
 

 
 
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Saliva Testing  
Thanks to the pandemic, saliva testing has advanced and opened new opportunities for testing 
various diseases. One of the biggest obstacles to testing patients has been the invasive blood 
draw. Many patients are uncomfortable with needles, and there is an increased risk for 
healthcare workers.  
Saliva collection and testing are simple, inexpensive, and minimally uncomfortable for the 
patient. Additionally, as demonstrated during the pandemic, saliva testing was successfully 
used for COVID-19 testing and has the potential to be used for a variety of diseases, including 
diabetes and cancer.  
Salignostics offers SaliStick, the first rapid saliva-based pregnancy test. The test is based on 
the company’s proprietary technology, which detects the pregnancy hormone β-hCG. The 
test uses a lateral flow immunoassay platform.  Abingdon Health will distribute the test in 
the EU.  
 

 
 
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Breath Test Advances 
A major part of the success of POC testing relies on developing tests that use patient-friendly 
sampling techniques.  Sampling has been a major hurdle for non-laboratory test systems.  
Throughout the world, the invasive nature of blood sample collection has long been seen as 
a hindrance to patient self-testing and also decentralized testing by professionals.  For this 
reason, there has been considerable interest in developing breath-based devices as well as 
assays using urine, hair, sweat and saliva samples.  
 A growing demand for quick and easy methods for the primary diagnosis of diseases, such 
as asthma, chronic obstructive pulmonary disease, and cancer, is contributing to the attraction 
of breath-based testing devices. In addition, the rising adoption of breath analyzers in 
smoking cessation programs to detect carbon monoxide in the exhaled air is augmenting the 
market growth.  
In clinical medicine, the urea breath test has long been used to detect Helicobacter pylori (H. 
pylori).  This bacterium, found in the gastrointestinal system, is a main cause of ulcers in 
these areas.  H. pylori produces an enzyme called urease, which breaks urea down into 
ammonia and carbon dioxide. Patients swallow a tablet containing urea. The amount of 
carbon dioxide exhaled is measured to detect H. pylori in the stomach.  Breath-based testing 
has the potential to be used to research a range of lung diseases.  
The concept of testing odors and exhaled breath is not new.  Hippocrates recognized the link 
between odors and disease processes, such as breath smelling of rotten apples in diabetes, 
urine odor in kidney failure, and a sewer smell in lung abscess.  That is what breathalyzers 
do when they measure small volatile molecules. Diseases such as lung or breast cancers, liver 
disease, gastrointestinal problems, and many others could potentially be diagnosed through 
trace chemicals in exhaled breath.   
A leader in breath testing, Menssana Research markets the FDA-cleared Heartsbreath that 
identifies methylated alkanes, chemicals that are produced when the body is rejecting a newly 
transplanted heart, and a breath test for asthma that measures nitric oxide, a marker of airway 
inflammation.  Menssana Research is developing BreathLink, a cloud application for the 
collection, concentration and analysis of volatile organic compounds in human breath.  It is 
used with the Breathscanner, a mobile point-of-care system that can be used anywhere in the 
world with an Internet connection.  The BreathX technology is a personal testing system that 
can be used at home or in the clinic. The test is indicated for breast cancer, lung cancer, and 

 
 
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pulmonary tuberculosis. These tests are available in the EU and are currently in progress for 
the FDA app. 
The patient simply breathes into it for two minutes.  Less than ten minutes later, the system 
identifies markers of oxidative stress and disease using proprietary algorithms on servers in 
a central laboratory. All data is sent and received with defense-level encryption.  
A clinical initiative, led by NYU Langone Medical Center, aims to determine the 
effectiveness of a breath test in identifying volatile organic compounds in human breath that 
are biomarkers of chronic obstructive pulmonary disease. The study employs patented 
technology developed by Menssana Research.  
Bedfont Scientific Limited has developed a line of handheld analyzers and reports it has over 
2,000 customers throughout the world healthcare and industrial markets.  The analyzers are 
marketed by a network of 40 distributors in North and South America, Europe, Australia, 
Japan, the Middle East, and the Far East.  The Smokerlyzer is a device that can aid parents 
in testing their kids for cigarette and marijuana use.  Bedfont states the device has been in 
use for the last 20 years in clinical research and in quit-smoking clinics, and, more recently, 
by professional counselors in high schools across the U.S. Bedfont offers the device to 
consumers as a personal breath tester for $59.99.  
Bedfont’s Gastrolyzer2 is a portable, hand-held Breath Hydrogen Monitor designed to aid in 
the diagnosis of gastrointestinal disorders caused by bacterial infection.  ToxCO+ is a Breath 
Carbon Monoxide Monitor designed as a compact, portable instrument for the diagnosis of 
carbon monoxide poisoning by paramedics in the field and in hospital emergency units. It 
can be used to screen for poisoning without the need for blood tests.  NOxBOX+, Inhaled 
NO Therapy Monitor, provides real-time monitoring of nitric oxide (NO/NO2).   
A single exhaled breath contains hundreds, if not thousands, of volatile organic compounds, 
some of which may be specific biomarkers of disease. Numerous researchers are now 
exploring this possibility in the hopes of developing non-invasive, easy-to-use, and cost-
effective POC breath tests that rapidly detect a variety of diseases.  The table below lists 
some molecules that medical research has linked to various health conditions. Breath analysis 
offers the promise of a truly revolutionary new tool for improving healthcare without 
incurring high new costs, since expensive reagents or consumables are not required.  
Advances in breath-detection equipment have sparked renewed interest in breath testing.  
Tuberculosis detection is estimated to experience considerable growth and appear as the 

 
 
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fastest-growing category in this market.  The development in this category is because of the 
increasing incidence of tuberculosis and the rising demand for quick and non-invasive 
screening devices.  
Table 4-12: Selected Disease Markers in Exhaled Breath 
Disease 
Marker 
Asthma 
nitric oxide 
Breast cancer 
alkanes, formaldehyde 
Diabetes 
acetone 
Liver function 
Carbonyl sulfide 
Organ rejection 
ammonia 
Schizophrenia 
carbon disulfide 
Tuberculosis 
hydrogen peroxide 
Source: Kalorama Information 

 
 
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Micro-Hospital Opportunities 
There is an opportunity opening in clinical laboratories due to the growth in the number of 
micro-hospitals. Micro-hospitals feature 8 to 10 inpatient beds (but can have as many as 25 
beds), and range from 15,000 to 50,000 square feet, whereas full-service hospitals are 
100,000 square feet or more. At a cost of $7 million to $30 million, micro-hospitals are 
significantly less expensive than large hospitals to bring to market. 
For patients, micro-hospitals offer 24-hour care that cannot be found at health care clinics 
inside drugstores or at urgent care clinics. By offering emergency rooms and overnight beds, 
micro-hospitals can treat gastrointestinal pain, broken bones, minor trauma and other 
illnesses for patients who require only a one- or two-night stay. 
Short patient stays are consistent with the trend toward reducing the number and length of 
hospital visits, in keeping with insurance companies' preferences for managing care. The 
American Hospital Association says that from 2012 to 2014, hospital inpatient admissions 
dropped from 34.4 million to 33.1 million, while outpatient hospital visits grew from 674.9 
million to 693.1 million. 
Micro-hospitals are typically located in urban and suburban areas. Designed to fill coverage 
gaps, micro-hospitals sometimes meet the needs of Medicaid patients and the underserved, 
but more often provide convenient locations for well-insured patients who already use the 
system for outpatient care. Micro-hospitals tend to fill the gap between urgent care centers 
and full-service hospitals.  
These new entities offer opportunities for outside clinical labs. Independent labs might be 
used more often when faster test results are needed or are in closer proximity. There are also 
more opportunities for clinical labs to establish working relationships with micro-hospitals 
that are not affiliated with large health systems.  
Emerus is the first and largest operator of micro-hospitals. Its hospitals are organized around 
the patient-and-family concept. Emerus has 28 facilities nationwide and has served over 4 
million patients. It has another 25 facilities in development.  
Emerus opened three new neighborhood hospitals in the Philadelphia suburbs in 2025. New 
facilities are also being built in Las Vegas and San Antonio.  
. 

 
 
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Sila Realty Trust announced the completion of a healthcare acquisition that includes micro-
hospitals. They are located in Arizona and Texas.  
Nutex Health is a micro-hospital opened in Green Bay, WI. The facility is putting emphasis 
on personalized patient care. The new facility is owned by Nutex Health, which operates a 
nationwide network of micro-hospitals. 
There are more than 100 micro or neighborhood hospitals in the U.S. In the U.S., micro-
hospitals are expected to grow at a CAGR of 8.1% from 2025-2032. Europe is the second-
largest market for micro-hospitals. Growth of micro-hospitals will be influenced by finances, 
regulations and approvals. The micro-hospitals will need to meet the CMS minimum census 
requirements and demonstrate consistent growth.  

 
 
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Climate Change and Infectious Disease 
Emerging infectious diseases seem to be a recurring theme in global health, and it is no 
different in 2026.  New pathogens continue to evolve and outpace human defenses. Scientists 
are observing a shift in the geographic spread of infectious diseases. Whether climate change 
is man-made or a natural occurrence, infectious diseases are appearing well outside where 
they are expected, in months when they are not expected, and at levels of intensity not 
anticipated.  
Globalization, migration and urbanization are driving the spread of infectious diseases, but 
higher temperatures and more extreme weather events have also influenced the range and 
intensity of infectious diseases.  
Researchers agree that it is hard to predict the impact of climate deviations on disease 
patterns. Additionally, surveillance programs are underfunded and inconsistent, based on 
immediate need. For example, in 1999, when West Nile arrived, there was public outcry over 
lapsed mosquito surveillance and a surge of new funding. As the threat subsided, there was 
a return to the status quo. Then, 20 years later, Zika comes in, and everybody wonders why 
we are not ready for this. So, the scenario begins again with an uptick in surveillance 
programs and increased funding.  
Infections transmitted through water, food, or vectors such as mosquitoes and ticks are highly 
sensitive to weather and climate conditions. The warmer, wetter, and more variable 
conditions brought by climate change are therefore making it easier to transmit diseases such 
as malaria, dengue fever, chikungunya, yellow fever, Zika virus, West Nile virus, and Lyme 
disease in many parts of the world. 
To be better prepared, improved surveillance and better communication among hospitals and 
local health authorities are needed to improve readiness for outbreaks. Pathogens such as 
Zika, Lyme disease, or V parahaemolyticus are on the move. Early warning systems and 
prevention are key to protecting the population. 
Climate change is expected to alter the incidence, prevalence, and distribution of infectious 
diseases worldwide. Clinical labs will continue to be an important participant in the early 
warning system by developing real-time surveillance systems and rapid POC tests that inform 
them and make them more robust. 

 
 
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Kickback Schemes 
Fraud and abuse remain persistent issues in the healthcare system, including ongoing 
kickback arrangements and improper referral practices. In recent years, enforcement activity 
has continued to highlight schemes involving clinical laboratories, telemedicine, durable 
medical equipment, and pharmacy services. Many of these cases involve attempts to disguise 
payments through consulting agreements, marketing contracts, or investment structures that 
obscure the underlying financial relationships. The clinical laboratory sector has been 
particularly affected, with multiple cases involving payments to physicians or intermediaries 
in exchange for test referrals. Earlier enforcement actions included allegations against 
physicians and laboratory operators who used recruiters or third parties to channel payments 
tied to testing volumes. Large multistate investigations have also uncovered coordinated 
schemes involving genetic testing, telemedicine services, and billing for unnecessary 
procedures. 
More recent cases in 2024 and 2025 have continued to follow similar patterns, including 
arrangements where laboratory marketers and physicians were accused of structuring 
payments as consulting fees to encourage referrals. Additional enforcement actions have 
targeted pharmacy and durable medical equipment providers, as well as telemarketing-driven 
schemes that generated fraudulent orders for Medicare beneficiaries. In 2025, federal 
authorities announced multiple large-scale enforcement actions involving hundreds of 
individuals and billions of dollars in alleged fraudulent claims across Medicare, Medicaid, 
and private insurers. These cases included a range of activities such as unnecessary diagnostic 
testing, false billing, prescription-related kickbacks, and improper use of telemedicine to 
generate orders for laboratory tests and other services. 
The continued focus on fraud and abuse is directly impacting clinical laboratories and 
diagnostics companies. Organizations are placing greater emphasis on compliance programs, 
internal audits, and documentation of physician relationships to reduce legal and financial 
risk. Laboratories are also becoming more cautious in their use of third-party marketers and 
referral networks, as these arrangements have been a frequent source of enforcement actions. 
In addition, billing practices and test utilization are under closer review, with increased 
attention to medical necessity and proper coding. These pressures are contributing to a more 
disciplined operating environment, in which growth strategies are increasingly tied to 
transparent business practices and regulatory compliance. Overall, fraud schemes in 
healthcare continue to evolve in response to regulatory oversight, often becoming more 

 
 
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complex and involving multiple entities across different segments of the industry, 
underscoring the need for continued vigilance and strong compliance across the diagnostics 
sector. 

 
 
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Early Sepsis Detection 
Sepsis occurs when the body's response to these chemicals is out of balance, triggering 
changes that can damage multiple organ systems. If sepsis progresses to septic shock, blood 
pressure drops dramatically. This may lead to death. 
Formerly known as blood poisoning, sepsis is a syndrome characterized by an overwhelming 
systemic patient response to infection, which can rapidly lead to organ failure and ultimately 
death. It is the major cause of morbidity and death in intensive care patients. Sepsis syndrome 
is the leading cause of death in United States hospitals, and its incidence has increased 
consistently over the past 20 years. Responsible for over 350,000 deaths and affecting 2.5 
million inpatients annually, sepsis is one of the world’s fastest-growing healthcare problems. 
In the United States alone, the economic impact of sepsis is estimated to be in excess of $62 
billion. 
Worldwide, there are approximately 49.5 million cases of sepsis and 11 million deaths. In 
Spain, the incidence is 212 cases per 100,000 inhabitants per year, with mortality rates 
ranging from 15% to 50% 
The diagnosis of sepsis is challenging because it is a heterogeneous condition with different 
etiologies. Blood and diagnostic tests are used to identify the source and location of the 
infection. The presence of inflammatory markers is used to indicate infection. Blood and 
urine 
cultures 
help 
identify 
the 
pathogens 
and 
distinguish 
infections 
SI 
RS from non-infectious SIRS.  
There is evidence that early antibiotic treatment for sepsis improves patient survival. 
Beckman Coulter introduced its Early Sepsis Indicator which identifies sepsis patients with 
proven accuracy, providing the opportunity for clinicians to institute treatment when 
antibiotics are most effective.  
Point-of-care testing is also a useful tool for sepsis diagnosis by accurately distinguishing an 
immune response to infection from an inflammatory response to non-infectious disease.  
Several analyzers have been introduced to the market, including Siemens’ RAPIDPoint 500, 
Roche’s cobas b 221, and ILs GEM Premier 5000. Portable devices have also been 
introduced, including Nova Biomedical’s StatStrip Lactate and Abbott’s iSTAT.  

 
 
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Beckman Coulter Diagnostics and Diazyme Laboratories received FDA clearance to market 
a new procalcitonin (PCT) assay for sepsis detection.  The company reported it is the first 
homogenous PCT assay for use on current Beckman Coulter AU models 480, 680 and 5800 
chemistry analyzers. 
Cytovale offers IntelliSep Sepsis Test. The test aids in the rapid diagnosis of sepsis in adults 
in about 10 minutes.  
Inflammatix offers the TriVerity Acute Infection and Sepsis Test. The test includes the 
Myrna instrument and the TriVerity Test. The test results are available in about 30 minutes.  
Cepheid markets the Xpert Xpress GBS (Group B Streptococcus) dual target molecular test. 
The test is a next-generation test that utilizes new dual targets in regions of the GBS genome 
to improve sensitivity and bacterial strain identification.  The test is designed for use on the 
GeneXpert system.  
The leading cause of newborn infection is GBS, and it is hoped that the test will help decrease 
early-onset sepsis in newborns due to GBS.  The test can return results within 30 minutes.  
Abionic offers the IVD Capsule PSP for the rapid detection of sepsis. The IVD Capsule PSP 
runs on the abioSCOPE a nanofluidics platform that measures pancreatic stone protein, an 
emerging sepsis biomarker. 
 

 
 
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Medical Diagnostics and 3D Printing 
Manufacturers are utilizing 3D printing to customize and improve diagnostics. For example, 
3D-printed microfluidic devices are enabling faster, more portable testing. These devices can 
be customized to detect infectious diseases, monitor chronic conditions, and/or perform 
genetic and biochemical assays using very small sample sizes, with a quick turnaround time.  
3D printing also supports the development of innovative biosensors and diagnostic tools 
tailored to specific individuals or disease-specific needs. As technology evolves, it may play 
a significant role in point-of-care diagnostics in remote or resource-limited regions.  
Personalized and POC medicine will likely benefit significantly from the integration of 3D 
printing and medical diagnostics. 

 
 
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Staffing Shortages 
The healthcare staffing crisis has intensified over the last few years. Staffing shortages in 
healthcare are a major concern. The U.S. alone could face a shortage of 124,000 physicians 
by 2034. Staffing shortages are one of the biggest challenges facing the health care system.  
There are several concerns that have contributed to the increasing staff shortage problem, 
including:  
• Burnout – heightened by the pandemic 
• Early retirements due to stress and disillusioned by the trajectory of the profession 
• Aging population – increasing number of elderly requiring more care 
• Lack of nursing faculty 
The U.S. is not alone in this issue. There are staffing shortages of healthcare workers 
worldwide. The WHO predicts a shortage of 15 million healthcare workers by 2030. The 
worst shortages are expected in Africa, the Mediterranean, and the Middle East.  
The crisis in healthcare staffing will not be a quick fix. The industry needs to consider long-
term strategies and a committed investment in healthcare education.  
To combat staffing shortages, the healthcare industry needs to identify and address major 
drivers, including expanding education and training capacity. Every year, thousands of 
qualified applicants are turned away due to the lack of faculty, clinical sites, and federal 
funding for residency positions. There also needs to be an improvement in nurse-to-patient 
ratios, with flexible scheduling and safe working environments. Understaffed ratios create 
unsafe environments for both patients and healthcare workers. With the anticipated increase 
in demand from the aging population, decisive steps will be needed to address this issue.  
 
 

 
 
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Tariff Effects on the IVD Industry 
Tariffs have become an increasingly important, still-evolving factor shaping the global IVD 
market, with broad implications for cost structures, supply chains, innovation, and market 
access. Because the industry is highly globalized and dependent on cross-border sourcing of 
reagents, components, and finished systems, even modest tariff changes can have immediate 
downstream effects. While IVD products have historically benefited from relatively low 
trade barriers due to their role in healthcare, recent geopolitical tensions, shifting trade 
policies, export controls, and government efforts to strengthen domestic manufacturing have 
introduced greater uncertainty and complexity.  
The most direct impact is rising manufacturing costs, particularly for molecular diagnostics, 
POC platforms, and genetic testing systems that rely heavily on specialized materials, 
electronics, and single-source components, as well as for high-volume consumables such as 
reagents, cartridges, and test kits, where cost increases can compound over time. These added 
costs are often difficult to absorb, especially for smaller companies, and are frequently passed 
through the value chain, contributing to higher instrument and test pricing and potential 
pressure on reimbursement. At the same time, tariffs are disrupting established supply chains, 
forcing companies to reassess sourcing strategies, qualify alternative suppliers, and 
increasingly shift toward regional or in-country manufacturing to reduce exposure and 
improve supply security.  
In response, IVD manufacturers are actively implementing mitigation strategies, including 
dual-sourcing of critical components, diversifying supplier networks, and expanding 
localized manufacturing hubs across the U.S., Europe, and Asia. Many are also redesigning 
assays and platforms to reduce dependence on tariff-sensitive inputs, while adopting “make-
versus-buy” strategies and forming closer partnerships with key suppliers to secure access to 
essential materials. Operationally, companies are adjusting logistics through pre-emptive 
inventory builds, alternative shipping routes, and selective stockpiling to buffer against 
disruptions, although these measures can increase working capital requirements. 
 These adjustments can introduce delays in product launches, add regulatory burden due to 
revalidation requirements when components or manufacturing sites change, and create short-
term operational inefficiencies, while also diverting resources from research and 
development and potentially slowing innovation cycles. The impact is not uniform across the 
IVD landscape; segments such as molecular diagnostics and advanced POC testing remain 

 
 
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more exposed due to their reliance on complex, globally sourced inputs, while more 
established areas like routine chemistry and parts of histology tend to be less sensitive.  
Tariffs are also interacting with healthcare economics, as laboratories facing fixed or 
constrained reimbursement become more selective in adopting new tests, often favoring 
high-throughput, multiplexed, or workflow-efficient solutions that deliver clearer economic 
value. Despite near-term margin pressure in some cases, these dynamics are driving longer-
term structural changes, with companies prioritizing supply chain resilience over pure cost 
efficiency and building more regionally balanced operating models. While the full impact 
remains somewhat uncertain and continues to evolve, tariffs are now a structural 
consideration in IVD market planning through the remainder of the decade, shaping not only 
cost structures but also where products are made, how quickly they reach the market, and 
which technologies ultimately gain adoption, with companies that successfully balance cost 
control, supply chain resilience, and continued innovation better positioned to navigate this 
increasingly complex global trade environment. 

 
 
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Targeted Testing  
The targeted testing market, often referred to as panel-based or syndromic testing, continues 
to grow and has strong long-term potential. These tests enable the simultaneous detection of 
multiple pathogens and, increasingly, antimicrobial resistance markers from a single 
specimen, delivering faster and more clinically actionable results than traditional methods. 
Their value is driven by speed, streamlined workflows, improved diagnostic confidence, and 
earlier treatment decisions. While COVID-19 created a temporary surge in demand, the 
market has transitioned into a post-pandemic phase characterized by more normalized testing 
volumes, broader clinical adoption across multiple disease areas, and generally steady growth 
in the mid- to high-single-digit range, with variability by segment and geography. 
Respiratory panels remain a major revenue contributor, driven by seasonal testing patterns 
and continued demand for multiplex detection of viruses such as influenza, RSV, and SARS-
CoV-2. Molecular syndromic respiratory panels represent the dominant share of this 
segment, while rapid antigen and point-of-care molecular tests play an important 
complementary role in decentralized settings. Key players include Roche, Cepheid, Abbott, 
and QuidelOrtho. 
Non-respiratory panels represent an expanding portion of the market and are increasingly 
central to growth. These include gastrointestinal infections, bloodstream infections, 
meningitis/encephalitis, sexually transmitted infections, and antimicrobial resistance panels, 
along with broader applications in oncology, genetic testing, and transplant diagnostics. 
Molecular technologies dominate most infectious disease panels, while oncology and genetic 
panels are increasingly driven by next-generation sequencing and other advanced molecular 
methods. Key players include bioMérieux, Diasorin, Abbott, Roche, and Siemens 
Healthineers, among others. 
End-user demand remains heavily concentrated in hospitals, particularly in central 
laboratories and emergency departments, where rapid, comprehensive results support acute 
care decision-making. Emergency departments continue to drive high volumes of respiratory 
and bloodstream infection panel testing, while urgent care and outpatient settings are 
increasingly adopting smaller, faster panels and point-of-care formats as connectivity and 
ease of use improve. Growth is also supported by antimicrobial stewardship programs, which 
are driving adoption of panels that combine pathogen identification with resistance markers 
to guide targeted therapy. At the same time, laboratories are placing greater emphasis on 
cost-effectiveness and appropriate utilization, focusing panel use in high-impact clinical 

 
 
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scenarios such as sepsis, ICU care, and immunocompromised patients. The concept of panel-
based testing is expanding beyond infectious diseases into oncology and genetic testing, 
where multi-marker panels and liquid biopsy approaches are increasingly integrated into 
routine clinical practice. 

 
 
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Chapter 5: Point-of-Care (POC) Tests 
Scope 
Point-of-care (POC) testing in the in vitro diagnostics (IVD) market has a broad and 
expanding scope, driven by technological innovation, decentralization of healthcare, 
and the push for faster clinical decision-making. There are general synonyms, including 
near-patient testing, bedside testing, decentralized testing, and rapid testing. Generally, 
POC and rapid testing are the terms that are used most often globally. However, near-
patient testing is the preferred term in Europe.  
The products in this area are generally rapid tests, with results available within 1 hour.  
The two general categories in POC testing are Professional POC and OTC Self-Testing 
POC. Home collection methods are also discussed.  
Market segments highlighted: 
• Colon cancer screening 
• Diabetes testing 
• Infectious disease testing 
• Lipid testing 
• Pregnancy/Fertility testing 
These segments include revenues for diagnostic systems, consumables, and service 
maintenance. However, POC testing for these applications is covered in a separate 
chapter on that topic in this report. Direct-to-consumer tests are excluded from the 
market estimates but are covered in Kalorama Information’s Direct to Consumer 
Testing Market. 
 

 
 
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Overview and Trends 
The point-of-care market contributes significantly to the value and revenue of the IVD 
industry. Advances in miniaturization, connectivity, and assay performance over the past 
several years have expanded the range of testing that can be performed outside the central 
laboratory. Globally, the increasing prevalence of chronic and infectious diseases, along with 
the need for faster clinical decision-making, has driven demand for rapid diagnostic results. 
Early detection and timely treatment remain the main goals across all areas of diagnostics, 
and POC testing plays an increasingly critical role in achieving them. 
Among IVD segments, POC diagnostics is one of the fastest-growing areas. The COVID-19 
pandemic accelerated adoption by driving demand for rapid, accessible testing and by 
advancing molecular, antigen, and digital diagnostic technologies. As a result, POC testing 
is now widely viewed as a core extension of traditional laboratory services rather than a niche 
alternative. 
Innovation is expected to expand the capabilities of POC testing, particularly in decentralized 
and consumer-focused settings. New systems are more sophisticated, offering improved 
analytical performance, faster turnaround times, and enhanced connectivity. These 
developments offer broader use in managing both acute and chronic conditions, including 
infectious diseases, cardiovascular disorders, and metabolic conditions. 
POC testing has grown steadily over the past two decades, driven by the need for immediate 
diagnostic information in a variety of care settings. Technologies that have contributed to 
this growth include microfluidics, biosensors, lab-on-a-chip systems, and compact molecular 
platforms. Increasing integration with digital health tools, including smartphones and cloud-
based data systems, is further shaping the POC landscape by enabling real-time data sharing 
and remote clinical oversight. 
Decentralized testing, defined as diagnostic testing performed outside the central laboratory, 
is now a defining feature of modern healthcare delivery. Rapid tests, which often deliver 
results in less than an hour, are widely used in physician offices, urgent care centers, retail 
clinics, emergency settings, and increasingly at home. Testing is performed not only by 
laboratory professionals, but also by physicians, nurses, pharmacists, and patients, depending 
on the complexity of the test. 

 
 
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The menu of POC tests continues to expand beyond traditional glucose and pregnancy testing 
to include assays such as HbA1c, cardiac markers including BNP, coagulation markers such 
as D-dimer, inflammatory markers such as C-reactive protein, and whole-blood lactate. 
Molecular POC testing has also advanced, with systems now available for respiratory 
infections, sexually transmitted infections, and other acute conditions. These platforms 
deliver fast, actionable results when timing is critical and are being used closer to the patient. 
Regulatory pathways are contributing to this expansion, with a growing number of devices 
obtaining CLIA-waived status in the United States and equivalent approvals in other regions. 
At the same time, many decentralized testing sites continue to use moderately complex 
systems to expand their diagnostic capabilities. Improvements in instrumentation and assay 
design now allow some POC systems to deliver quantitative, laboratory-quality results with 
automated data transfer to electronic medical records and remote care platforms. 
In developing regions, POC diagnostics remain especially important due to limited access to 
centralized laboratories. Basic tests for glucose, hemoglobin, and infectious diseases provide 
significant clinical value. The increasing availability of portable and smartphone-enabled 
devices is expected to further expand access, although adoption may be constrained by 
infrastructure and resource limitations in some areas. 
The continued growth of POC testing is driven by broader healthcare trends, including 
provider consolidation, the expansion of outpatient and retail care models, the increasing use 
of electronic medical records, and a stronger emphasis on outcome-based care. Diagnostic 
tests are playing an increasingly important role in guiding therapeutic decisions, particularly 
as treatment strategies become more personalized. As a result, test adoption is driven by 
clinical performance, impact on patient outcomes, and overall cost-effectiveness rather than 
price alone. 
Future success in POC testing will depend not only on analytical performance but also on the 
ability to deliver more value through connectivity, clinical decision support, and integration 
into care pathways. This is already evident in areas such as diabetes management, where 
connected glucose-monitoring systems enable ongoing patient engagement and physician 
oversight. As the test menu expands to include more complex conditions such as cancer and 
cardiovascular disease, the need for integrated interpretation and clinical support will become 
even more important. 
 

 
 
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Despite its advantages, POC testing still faces challenges compared to centralized laboratory 
testing, including quality control, training requirements, and variability in performance 
across settings. Nevertheless, the number and scope of POC tests continue to expand. Since 
the early 1990s, the number of CLIA-waived analytes and systems has increased 
substantially, now encompassing a broad range of infectious-disease, metabolic, and drug-
testing applications. 
The POC diagnostics market is expected to continue growing, driven by the need to improve 
efficiency in acute care, reduce hospital stays, and support faster clinical decision-making. 
As healthcare delivery shifts toward decentralized and patient-centered models, POC testing 
will play an increasingly central role in diagnosis, monitoring, and disease management 
across multiple clinical settings. 

 
 
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POC Industry Drivers 
There are many benefits in providing POC and rapid IVD testing. One of the key benefits 
and market drivers for the POC testing market is the ability to have rapid results that can be 
used immediately for patient treatment decisions. While this is a major benefit of POC 
testing, many other factors are also driving the growth of this market. Factors driving the 
development of POC tests include: 
Patient-focused drivers 
• Rapid results can be used immediately for patient treatment decisions in physicians’ 
offices and clinics. 
• Demand for faster turnaround times for critical test results in hospital locations such 
as emergency departments and intensive care units. 
• Less sample volume (neonatal, pediatric, ICU benefit) 
• Varied samples besides blood 
Medical/Healthcare-related drivers 
• Introduction of POC tests for new targets such as additional infectious diseases and 
other new analytes, which previously could not be tested in the POC setting. 
Introduction of new therapies that require rapid feedback with diagnostic tests. 
• Growth of precision healthcare and precision medicine, and the need for rapid tests 
to support this. 
• Optimization of drug treatments 
Technology drivers 
• Advances in miniaturization, microfluidics, molecular, and other technologies have 
made it possible to expand the numbers and types of tests that can be performed in 
POC settings. 
• Nanotechnology has gained attention in the POC arena, offering unique opportunities 
for the advancement of POC devices 

 
 
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• Health apps for mobile devices are pushing the development of POC devices 
Economic drivers 
• Growth in specialty clinics, retail clinics, and other decentralized locations for patient 
care. 
•  Economic factors driving the need to reduce the length of patient stays in hospitals, 
reduce backlog in areas such as emergency departments, as patients wait for test 
results, etc. 
• Reduce postoperative care time 
Other drivers 
• Need for robust but also simple diagnostic tools for military applications outside of 
military hospitals. 
•  Need for disaster preparedness. 
• Need for robust but also simple diagnostic tools for developing countries 
• Decrease inappropriate use of drugs 
• Need for pandemic preparedness 
• Expansion in remote areas where healthcare is limited 

 
 
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POC Industry Challenges 
There are at least five challenges for the POC market. Those include: 
•  Cost of tests 
• Accuracy  
• Specificity and sensitivity of tests 
• Lack of trust by healthcare professionals 
• Lack of awareness in POC rapid testing 
Of these concerns, accuracy has been the key challenge. Advancements in POC technology 
have allayed some concerns, demonstrating improved accuracy and greater consistency. 
Home testing has come to the forefront during the pandemic, but it also raises some concerns, 
including: 
• User error 
• Lower accuracy  
• Reduced sensitivity and specificity 
• Indiscriminate testing by end-users causes more concern for healthcare providers 
• Unauthorized tests on the market 

 
 
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Regulatory Challenges 
Even though POC testing is often performed by non-laboratory personnel, the clinical 
laboratory typically retains primary responsibility for oversight, governance, and quality 
assurance of these programs. This includes establishing and enforcing standardized 
procedures for specimen collection and labeling, operator training and competency, 
documentation, quality control, proficiency testing, and infection control. Strong laboratory 
oversight is essential to ensure consistent test performance, accurate results, and compliance 
with regulatory requirements. The College of American Pathologists (CAP) maintains an 
extensive set of accreditation checklists that apply to POC testing, including dedicated point-
of-care requirements as well as broader laboratory general and all-common checklist 
elements that collectively govern areas such as personnel qualifications, calibration and 
validation, quality management, results reporting, safety, and instrument performance. While 
the exact number of checklist items evolves with periodic updates, CAP’s framework remains 
one of the most comprehensive for managing decentralized testing environments. 
Concerns about the rapid growth of waived testing sites, many operating outside traditional 
laboratory structures, have persisted, particularly regarding variability in training, oversight, 
and quality practices. Organizations such as COLA have responded by strengthening 
accreditation requirements for waived testing, including more explicit expectations for staff 
competency assessment, documentation, and quality practices, even in low-complexity 
settings. This reflects a broader industry shift toward increased scrutiny of waived testing as 
test menus expand and clinical reliance on rapid results grows. Additionally, the expansion 
of POC testing has increased the importance of device connectivity and data management, 
with many programs now relying on middleware and informatics systems to automatically 
transmit results into the LIS and electronic medical record, reduce transcription errors, and 
monitor QC performance and operator compliance in real time. Laboratories are also placing 
greater emphasis on ongoing competency assessment due to high operator turnover in 
decentralized settings, using standardized training programs and system-based controls to 
ensure only qualified personnel perform testing. 
The use of blood glucose meters has been a key example of the regulatory and clinical 
challenges in POC testing, particularly regarding “off-label” use. When devices are used 
outside their FDA-cleared intended use, such as in critically ill patients when not specifically 
indicated, they may be subject to higher regulatory requirements under CLIA, effectively 
treating them as non-waived testing. Over the past decade, regulatory agencies, including the 

 
 
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U.S. Food and Drug Administration, have issued more stringent performance expectations 
for glucose monitoring systems, especially in hospital settings. Rather than broadly 
reclassifying all glucose meters as non-waived, the regulatory approach has focused on 
tightening accuracy standards and encouraging manufacturers to obtain specific clearances 
for use in critically ill populations. While this initially created confusion among healthcare 
providers, more recent guidance and improved device performance have helped clarify 
appropriate use in both ICU and non-ICU settings. In parallel, laboratories are taking a more 
active role in evaluating which tests are appropriate for decentralized use based on clinical 
impact, risk, and cost, while also implementing continuous quality monitoring programs that 
track QC failures, error rates, and turnaround times. Increasing attention is also being paid to 
utilization management and reimbursement, as POC testing, while clinically valuable, often 
carries a higher per-test cost than central laboratory testing and must be justified by improved 
patient care and workflow efficiency. 

 
 
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Professional POC 
Outside of glucose testing, professional point-of-care has been successful on a number of 
fronts. The 2025 professional POC market, including glucose, is estimated at $13.5 billion.  
The POC professional market will grow at 4.4% annually, reaching $16.8 billion in 2030.   
The fastest growing segments in the professional POC market include: 
• Hematology– 5.2% 
•  HbA1c – 8.4% 
• Infectious disease – 5.4% 
• Fecal occult blood testing – 5.4% 
 
 
 

 
 
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Table 5-1: Worldwide Professional POC Test Sales, by Category, 2025 -2030 ($ million)  
 
[Cardiac Markers; Cholesterol; Coagulation; Critical Care POC; Drugs of Abuse; Fecal Occult Blood; Fertility; 
Glucose; HbA1c POC; Hematology; Infectious Diseases; Urinalysis; Others] 
 Category 
2025 
% Mkt 
2030 
% Mkt 
CAGR 
Fecal Occult Blood 
3,057 
23% 
3,988 
24% 
5% 
Infectious Diseases 
2,720 
20% 
3,542 
21% 
5% 
Glucose 
2,272 
17% 
2,640 
16% 
3% 
Critical Care POC 
1,074 
8% 
1,176 
7% 
2% 
Hematology 
876 
6% 
1,127 
7% 
5% 
Coagulation 
805 
6% 
892 
5% 
2% 
Cardiac Markers 
751 
6% 
895 
5% 
4% 
HbA1c POC 
615 
5% 
925 
6% 
8% 
Drugs of Abuse 
506 
4% 
556 
3% 
2% 
Cholesterol 
278 
2% 
335 
2% 
4% 
Urinalysis 
181 
1% 
209 
1% 
3% 
Fertility 
170 
1% 
175 
1% 
1% 
Others1 
232 
2% 
291 
2% 
5% 
 Total 
13,537 
100% 
16,751 
100% 
4% 
Note: ¹ FSH, TSH, cancer, etc.  
Source: Kalorama Information 
Point-of-care tests were growing rapidly before the COVID-19 pandemic, but test 
manufacturers have stepped up the development of reliable POC tests to answer the call for 
rapid and easy-to-use devices to facilitate testing outside the laboratory. This has helped to 
spotlight the ease and quality of all FDA-cleared POC tests.  

 
 
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Throughout 2022, demand for POC products continued despite a significant decrease in 
COVID-19 tests compared with the prior year. This continued into the subsequent years of 
2023, 2024, 2025 and continuing into 2026.  
With lower device costs and improved data systems, point-of-care testing is becoming a 
practical and cost-effective alternative to traditional lab testing across clinics, hospitals, and 
home care settings. 
As the number of POC tests and devices continues to grow, it’s unrealistic to expect users to 
learn and manage a wide range of systems. That’s why there’s been a strong push over the 
past decade toward multipurpose platforms that can run both chemistry and immunoassay 
tests on a single system. Simple strip-based rapid tests can’t meet every near-patient need, 
and many physicians are looking to expand the range of testing they offer in their offices. 
This is driving demand for small, easy-to-use, and easy-to-maintain systems for clinics and 
smaller labs. Advanced technologies like microarrays and lab-on-a-chip platforms are well-
positioned to meet that need. 
A major barrier to increased POC use by professionals, especially outside the hospital, is a 
lack of correlation with lab-based tests. The growing prevalence of health networks, which 
comprise hospitals, clinics, and physician offices, increases the need to standardize test 
results across locations. For example, a cholesterol test result needs to correlate across 
multiple sites within the health network, regardless of whether the test was administered via 
a portable device in the physician’s office, a semi-automated device in the clinic, or on a 
hospital’s fully automated analyzer in the core laboratory. 
Physician office testing (POL) is primarily a phenomenon of the U.S. U.S. statistics indicate 
there are approximately 120,000 in-office labs. It represents roughly 65% of the global POL 
market and has demonstrated slightly above-average growth in recent years, at around 4%. 
The physician lab market includes a variety of institutions beyond physician practices, such 
as specialty and multispecialty clinics; other primary care and urgent care clinics; and 
outpatient clinics not located in or associated with a hospital or outpatient surgical services. 
Most European cities have small lab and pharmacy-based test services readily available. 
Physician office testing is not developed in Japan. In emerging markets, physician office 
testing serves the needs of the middle class. 
More tests and technologies have been adapted to serve the needs of physician offices and 
home testing. It is estimated that U.S. physicians see 2.5 million patients per day. In 60% - 

 
 
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70% of those visits, the physician needs to order diagnostic tests to guide treatment or to 
monitor the patient. In larger physician practices, these tests are performed on site in a 
physician's office lab. 
Tests used in physician office labs are clinical tools for disease screening, the diagnosis of 
common infectious diseases (e.g., strep, flu, mono, H. pylori, RSV), or routine monitoring 
tests for patients with common chronic diseases such as diabetes, cholesterol and colon 
cancer.  
The United States remains the largest single market for IVD and point-of-care testing, and it 
has played a major role in shaping how rapid tests are developed and introduced. Many new 
POC products are launched first in the U.S., often working through CLIA waiver pathways 
before expanding into international markets, where regulatory approaches frequently follow 
similar models. While the focus on cost control and preventive care contributes to testing 
closer to the patient, the higher per-test cost of decentralized testing can limit adoption. In 
some cases, large healthcare systems and payers continue to favor centralized laboratory 
testing, as it allows them to leverage existing infrastructure and reduce overall costs. 
In the U.S., COLA (the Commission on Office Laboratory Accreditation, www.cola.org) 
accredits nearly 8,000 medical laboratories and provides education programs and standards 
that enable clinical laboratories to meet U.S. CLIA and other regulatory requirements.  
The following table presents a small selection of announced innovations in general 
professional POC testing platforms and tools. It demonstrates the efforts underway to make 
POC testing more accessible to physician offices, clinics and in-hospital testing. 

 
 
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Table 5-2: Selected Professional POC Test Innovations (excluding COVID-19 testing) 
Company 
Location 
Area 
Details 
Abbott 
US 
Platform 
iSTAT 
Acon Laboratories 
US 
urine 
Mission U120 Ultra Urine Analyzer 
Ativa Medical 
US 
platform 
Ativa Analyzer "micro-lab": microfluidics-based 
hematology/chemistry 
DiaSys Diagnostics GmbH 
Germany 
platform 
InnovaStar; photo-/turbidimetric HbA1c, glucose, 
hemoglobin 
platform 
SensoStar; glucose & lactate 
DiaSys Diagnostics India 
India 
platform 
QDx InstaLab, all routine laboratory tests 
EKF Diagnostics 
UK 
ketones 
STAT-Site M β-HB, ketones strip & reader 
Loop Medical (formerly 
Qloudlab) 
Switzerland 
sample prep 
Needle-free blood collection 
Luoxis Diagnostics Inc. 
(Aytu Biopharma) 
US 
biosensor 
RedoxSYS Diagnostic System, oxidative stress 
Polymedco (LSI Medience) 
US 
Analyzer 
Pathfast hs-cTn 
Radisens Diagnostics 
Ireland 
platform 
Gemini all-in-one: immunoassay, biochemistry, 
hematology 
Roche Diagnostics 
US 
platform 
cobas b 101, POL and clinic 
Samsung Healthcare 
Korea 
platform 
Samsung LABGEOIB10, chemistry & immunoassays 
U Washington 
US 
app 
BiliCam app, phone-linked newborn bilirubin test 
vantix DIAGNOSTICS 
US 
biosensor 
vantix POC system, chemistry, immunochemistry, 
hematology 
Source: Kalorama Information, company reports 
 
 

 
 
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B&E Biotechnology offers the i-Check handheld blood gas electrolyte analyzer.  The product 
offers microfluidic and electrochemical detection technologies in a single-use cartridge.  
PixCell Medical offers direct capillary sampling for its HemoScreen 5-part differential CBC 
analyzer for POC use with venous and capillary blood. This allows collection of a sample 
directly from the finger, without an intermediate tube. 
Ad Astra Diagnostics markets its QScout rapid hematology system, which provides POC 
WBC counts and the neutrophil-to-lymphocyte ratio, and differentiates the number and 
percentage of five types of mature WBCs, as well as immature granulocytes.  
Sebia provides its Capillarys 2 DBS automated instrument. The product is intended for 
detecting normal and abnormal hemoglobin in blood from newborns. The analysis is 
performed by capillary electrophoresis.  
Genalyte offers its TSH immunoassay performed on a silicon chip.  
Visby Medical markets its POC respiratory Health Test. The test is a rapid PCR test that 
detects and differentiates infection caused by influenza A&B, and SARS-CoV-2  

 
 
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OTC Self Testing 
The market for POC self-tests is estimated at $23 billion in 2025, with glucose testing 
accounting for the majority share of the market (29% self, 54.8% continuous).  The total OTC 
self-testing segment is expected to grow 7.0% annually, reaching $32.1 billion by 2030. 
Table 5-3: Worldwide POC Self-Test Sales, by Category, 2025-2030($ million)  
 
[Cholesterol; Coagulation; Drugs of Abuse; Fecal Occult Blood; Glucose, Continuous; Glucose, Self;  
H. pylori; HIV; Other Infectious Disease (inc. COVID-19); Pregnancy; Urinalysis; Other (TSH, Allergy, 
Autoimmune, etc.)] 
 Category 
2025 
% Mkt 
2030 
% Mkt 
CAGR 
Glucose, Continuous 
12,458 
54.7% 
20,600 
64.2% 
11% 
Glucose, Self 
6,693 
29.4% 
7,020 
21.9% 
1% 
Other Infectious Disease (inc. COVID-19) 
1,904 
8.4% 
2,502 
7.8% 
6% 
Pregnancy 
970 
4.3% 
1,030 
3.2% 
1% 
Fecal Occult Blood 
431 
1.9% 
562 
1.8% 
5% 
Coagulation 
90 
0.4% 
95 
0.3% 
1% 
Drugs of Abuse 
37 
0.2% 
43 
0.1% 
3% 
Urinalysis 
33 
0.1% 
38 
0.1% 
3% 
HIV 
20 
0.1% 
24 
0.1% 
4% 
Cholesterol 
16 
0.1% 
17 
0.1% 
1% 
H. pylori 
6 
0.0% 
7 
0.0% 
3% 
Other (TSH, Allergy, Autoimmune, etc) 
135 
0.6% 
171 
0.5% 
5% 
 Total 
22,793 
100% 
32,109 
100% 
7% 
Source: Kalorama Information 
 
 

 
 
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There are several aspects that are driving the OTC/self-testing POC market in 2025, 
including: 
• As with professional testing, the COVID-19 pandemic contributed to a large increase 
in POC self-testing for other infectious diseases, namely COVID-19 as more at-home 
COVID-19 tests entered the market and continue to fuel new growth opportunities.  
• At-home testing is surging, both in home collection and in other segments of the POC 
OTC IVD market.  
• Additionally, the continued uptake of CGM contributed the lion's share of revenues 
for 2025 (55%) and will likely grow to 64% by 2030. throughout the forecast period. 

 
 
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Pregnancy/Fertility Tests 
The pregnancy and fertility tests market are dominated by sales generated in the OTC POC 
segment, accounting for 85% of total sales, compared to professional tests with 15%. 
Table 5-4: POC Pregnancy and Fertility Test Market Distribution, by End User, 2025 (%)  
 
[OTC, PRO] 
End User 
Distribution 
OTC 
85% 
PRO 
15% 
Total 
100% 
Source: Kalorama Information 
North America will remain the largest market for rapid pregnancy test kits in 2025, 
accounting for almost half of global revenues. Demand for rapid kits will continue to grow 
in the developing countries of the Asia Pacific, the Middle East, and Africa. 
Table 5-5: Pregnancy/Fertility POC Test Sales Distribution, by Global Region, 2025 (%) 
 
[Europe; Japan; United States; Rest of World] 
 Region 
% Mkt 
United States 
45% 
Europe 
31% 
Japan 
7% 
RoW 
17% 
Total 
100% 
Source: Kalorama Information 

 
 
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Rapid pregnancy tests are also used in hospital settings and health clinics. A pregnancy test 
is performed in hospital emergency departments when a woman may be slated for an 
emergency surgery or another intervention where it is important to know if she is pregnant. 
Early detection of pregnancy is also important for caregivers in order to avoid certain 
medications and procedures that could harm a fetus.  
The pregnancy hormone hCG can be detected in urine or blood after implantation, which 
occurs six to twelve days after fertilization. Quantitative blood tests can detect hCG levels as 
low as 1 mIU/mL, while urine test strips have published detection thresholds of 10 mIU/mL 
to 100 mIU/mL, depending on the brand. Therefore, blood-based tests can detect pregnancy 
approximately two to eight days earlier than commonly available urine-based tests. 
Most commercially available rapid pregnancy test immunoassays are used with urine and 
serum, but not whole blood. In light of the critical need for reliable early pregnancy detection, 
several whole-blood rapid pregnancy tests have been commercialized. 
NowDiagnostics Inc. markets the CE-marked and FDA CLIA-waived AdexusDx human 
chorionic gonadotropin point-of-care test. It uses a single drop of capillary or whole blood. 
Abbott Laboratories offers the i-STAT Total β-hCG test cartridge, a whole-blood, 
quantitative, handheld pregnancy test for patient testing. 
Sekisui offers the OSOM Ultra hCG Test, which provides qualitative hCG results in 3-5 
minutes with high accuracy. The OSOM Ultra hCG Combo Test detects hCG B-core 
fragments, reducing the interference when testing urine samples from later stages of 
pregnancy. 
bioMérieux offers two ranges of rapid tests for pregnancy and fertility. The VIKA fertility 
panel and Bionexia hCG Urine and Bionexia hCG Combo panels. 
Salignostics offers SaliStick, the first rapid saliva-based pregnancy test. The test is based on 
the company’s proprietary technology, which detects the pregnancy hormone β-hCG. The 
test uses a lateral flow immunoassay platform.  Abingdon Health will distribute the test in 
the EU. The test is available in Europe, South Africa, and Israel. The company has completed 
an initial 510(k) Q-submission for SaliStick to the FDA.  

 
 
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Colon Cancer Screening 
POC testing as preventative medicine is not a new concept, but amid all the controversy 
surrounding cancer screening, there is evidence that self-tests have increased colon cancer 
screening. 
Routine colorectal cancer screening is something that tens of millions of people in developed 
countries go through every few years. Almost all developed countries have cancer screening 
programs that offer free colon cancer screening tests. After the age of 45, patients are 
encouraged to have a colonoscopy every 5-10 years. Between these colonoscopies, they can 
use non-invasive tests that can sometimes determine the presence of cancer or even 
precancers. Currently, three main types of tests are used: fecal occult blood tests (FOBT), 
fecal immunochemical tests (FIT), and stool DNA tests (sDNA). 
Of these three, fecal occult blood tests are used the most frequently, probably because they 
are inexpensive. The main problem with this test is its high false-positive rate and low 
precancer detection rate. Another major drawback is poor patient compliance because FOBT 
requires three stool samples and shipping them to a laboratory. The FIT overcomes many of 
these limitations. It requires only one sample, and several devices allow the user to run the 
test at home. These tests are gaining in popularity over the standard guaiac FOB test. 
Exact Sciences and Beckman Coulter generate the largest share (84%) of sales in the 
segment. Because screening for colon cancer represents a potentially huge number of medical 
laboratory tests each year, many biotech companies have developed FIT test kits that patients 
can use at home. Therefore, numerous other products are available in lateral-flow-style 
cassettes. 
Helena Laboratories’ Colocare test is an easy-to-use paper sheet placed in the toilet bowl 
with a stool sample. If it turns blue, the user should consult a physician. The test is distributed 
by Thermo Fisher Scientific.  
Colorectal cancer screening has traditionally relied on a combination of structural exams and 
noninvasive stool-based testing, with colonoscopy and fecal occult blood testing (FOBT) or 
fecal immunochemical testing (FIT) remaining the most widely used approaches. Screening 
recommendations have evolved over time, and the U.S. Preventive Services Task Force now 
recommends that average-risk adults begin screening at age 45 and continue through age 75 
using a range of acceptable options, including annual FIT, stool DNA-FIT testing at defined 

 
 
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intervals, CT colonography, flexible sigmoidoscopy, and colonoscopy every 10 years. All of 
these methods have been shown to reduce colorectal cancer mortality by detecting early-
stage cancers and precancerous lesions. 
Among noninvasive options, Exact Sciences’ stool-based Cologuard test has become a 
widely adopted screening tool, detecting abnormal DNA and hemoglobin shed into stool 
from cancerous and precancerous lesions. Newer versions, including next-generation 
multitarget stool DNA tests, are being developed to improve sensitivity and specificity. 
Additional innovation includes RNA-based stool testing such as ColoSense from 
Geneoscopy, as well as growing interest in blood-based screening, highlighted by Guardant 
Health’s Shield test, which offers a noninvasive alternative for patients who may be reluctant 
to use stool-based methods. 
At the same time, FIT- and FOBT-based assays from companies such as Sekisui Diagnostics, 
Hemosure, and Aidian continue to play an important role due to their low cost, ease of use, 
and suitability for large-scale screening programs, with ongoing improvements in 
automation, digital readers, and connectivity. The market continues to shift toward 
noninvasive, patient-friendly testing strategies to improve compliance, while colonoscopy 
remains the gold standard for definitive diagnosis and intervention. 
 
 

 
 
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Table 5-6: Selected POC Colon Cancer Tests 
Company 
Details 
Beckman Coulter 
Hemocult ICT 
Biohit Oyj 
ColonView 
Enterix 
InSure One FIT 
Exact Sciences 
Cologuard 
Geneoscopy 
ColoSense 
Helena Labs 
Colocare 
Hemosure 
Hemosure One-Step FIT 
Jant Pharmacal 
Accutest iFOBT 
Orion Diagnostica (Aidian) 
QuikRead go iFOBT cassette test 
Polymedco 
OC-Light S FIT 
ScheBo-Biotech AG 
ScheBo-2in1 Quick Test 
Sekisui Diagnostics 
OSOM iFOB 
Source: Kalorama Information 
With an increasing prevalence of colon cancer cases across the major countries, a number of 
new screening tests are either in development or have come to market. This may help address 
the technical and procedural limitations of currently available colon cancer screening tests 
and drive the anticipated expansion of this test segment. 
The market for in-vitro colorectal cancer screening tests using fecal occult blood in various 
forms is expected to grow over the next five years, increasing from an estimated $3.5 billion 
in 2025 to $4.6 billion in 2030 (5.5% annual growth). Proven outcomes, increased 
competition and advertising of testing are driving this successful category. 

 
 
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Table 5-7: Colon Cancer POC Test Sales Distribution, by Global Region, 2025 (%) 
 
[Europe; Japan; United States; Rest of World] 
Region 
% Mkt 
United States 
56% 
Europe 
28% 
Japan 
5% 
RoW 
11% 
Total 
100% 
Source: Kalorama Information 

 
 
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Lipid Testing 
Lipid testing, and cholesterol in particular, is recognized as a risk marker for cardiac disease. 
On the other side of the coin, it has been shown that even people without elevated lipid levels 
may suffer from heart disease. Nevertheless, despite the controversy surrounding this test, 
physicians continue to include it in a routine workup. Most tests are run on automated clinical 
lab instruments, but there is a steady demand for cholesterol testing among physicians.  
The world market for POC cholesterol testing is estimated at $294 million in 2025 and, with 
3.7% annual growth, will reach $352 million in 2030.  Despite the high incidence of elevated 
cholesterol, the self-test market has not evolved as expected, largely due to a barrier: people 
are reluctant to accept finger-pricking to obtain test results.  This may change in the future as 
technological advancements in specimen collection that are not blood-based enter the market.  
Europe and the U.S. share the market about evenly, with 42% and 39%, respectively, in 2025. 
Japan accounted for 5% of the share, and the ROW accounted for the remaining 14%. 
Table 5-8: Lipid POC Test Sales Distribution, by Global Region, 2025 (%) 
 
[Europe; Japan; United States; Rest of World] 
 Region 
% Mkt 
Europe 
42% 
United States 
39% 
Japan 
5% 
RoW 
14% 
Total  
100% 
Source: Kalorama Information 
The market leader is the Abbott LDx. The analyzer is included in the CLIA waived test list 
and is certified by the Cholesterol Reference Method Laboratory Method Network program 
and Lipid Standardization Program. 

 
 
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Roche Diagnostics historically offered point-of-care cholesterol testing through products 
such as Accu-Chek InstantPlus and the Reflotron system. The Accu-Chek InstantPlus 
cholesterol and triglyceride tests used reflectance photometry for quantitative lipid 
measurements with optional data management capabilities, while the Reflotron functioned 
as a self-calibrating desktop analyzer designed for near-patient testing in physician offices. 
The Reflotron platform supported quantitative measurement of multiple routine chemistry 
parameters with results available within two to three minutes. By 2026, however, both Accu-
Chek InstantPlus lipid testing and Reflotron chemistry testing are considered mature systems, 
with Roche’s current near-patient focus centered on glucose and HbA1c rather than lipid 
panels. 
The United States remains the largest single market for IVD and point-of-care testing and 
continues to play a leading role in the development and introduction of rapid tests. Many new 
POC products are still launched first in the U.S., often pursuing CLIA waiver status to enable 
use in decentralized settings before expanding into international markets. While other regions 
are strengthening their own regulatory frameworks, U.S. approval and commercialization 
pathways continue to influence global product strategies. 
However, healthcare delivery is shifting toward preventive care, faster clinical decision-
making, and more testing outside the hospital, all of which support the growth of near-patient 
testing. The higher per-test cost of decentralized testing, compared with high-volume central 
lab testing, can still limit broader adoption. Large health systems and payers continue to 
balance these costs against clinical value and workflow efficiency, and, in many cases, still 
rely on centralized laboratories, where existing infrastructure and economies of scale help 
control overall costs. 

 
 
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Drugs of Abuse Testing 
Healthcare professionals use drug tests as part of a comprehensive evaluation of individuals 
to reach a correct decision regarding the individuals’ actions, behaviors or performances. The 
main focus in 2025 for DOA testing is critical care.  
They can also be used in the identification of high-risk populations, including those with 
histories of substance abuse or treatment of mood, anxiety, and/or attention deficit disorders, 
or in emergency situations.   
Only tests for a clinical purpose are considered in Kalorama’s traditional IVD analysis.  
Point-of-Care drugs of abuse testing is estimated at $543 million and is anticipated to grow 
at 2% over the next five years.  It is anticipated that drug testing technology will become 
increasingly sensitive and easier to use, leading to more innovative and effective testing for 
drugs of abuse. The move from urine testing to oral fluid testing reduces privacy concerns 
and mitigates some of the issues associated with urine testing. In the future, drug testing 
practices must include identification of a larger number of drugs, including newly emerging 
drugs of abuse, and testing must become less expensive and more resistant to adulteration. 
Table 5-9: POC Drugs of Abuse Test Sales Distribution, by Setting, 2025 (%) 
 
[Criminal Justice; Critical Care - Traditional POC; Employment Screening] 
 Setting 
% Mkt 
Employment Screening 
47% 
Critical Care - Traditional POC 
31% 
Criminal Justice 
22% 
Total 
100% 
Source: Kalorama Information 
Products 
There is a wide range of drug-of-abuse testing products on the market in central laboratory, 
POC, and home-use settings, utilizing multiple specimen types including urine, oral fluid, 
blood, and hair. Urine and oral fluid testing remain the most commonly used formats due to 

 
 
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ease of collection and established regulatory frameworks, with oral fluid gaining increased 
traction in workplace and roadside testing because it is less invasive, more difficult to 
adulterate, and better reflects recent drug use. A large portion of POC and rapid screening 
assays are CLIA-waived, reflecting their relatively simple immunoassay-based design and 
suitability for use outside traditional laboratory environments; however, confirmatory testing 
using more advanced methods such as mass spectrometry remains within high-complexity 
laboratory settings. In addition, certain products are designated for forensic use only, 
particularly in workplace or legal testing environments where strict chain-of-custody and 
documentation requirements apply. Increasingly, rapid testing is being paired with digital 
readers and connectivity solutions that improve result interpretation, reduce user subjectivity, 
and enable automatic transmission of results into reporting systems for compliance and 
recordkeeping. 
Thermo Fisher Scientific has continued to expand capabilities in this segment with updates 
to its TruNarc handheld narcotics analyzer, which uses Raman spectroscopy to identify illicit 
substances in the field. Recent updates have expanded its detection library to include 
additional synthetic opioids, including multiple fentanyl analogs and highly potent 
compounds such as carfentanil. These handheld systems are increasingly used by law 
enforcement and first responders, reflecting a broader trend toward rapid, on-site drug-
identification technologies that operate alongside traditional laboratory workflows. At the 
same time, centralized laboratories are expanding the use of highly sensitive confirmatory 
testing methods to keep pace with emerging synthetic drugs, while hair testing continues to 
serve a niche role in detecting longer-term drug use. The drugs-of-abuse testing market 
continues to evolve through a combination of expanded test menus, improved detection 
technologies, and an increased emphasis on compliance, connectivity, and real-time 
decision-making. 
 
 
 

 
 
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Table 5-10: Drugs of Abuse Tests on the Market 
Company 
Location 
Type 
Description 
Target 
1 Step Detect 
Associates 
US 
oral 
OrAlert 
amp, coc, meth, opi, pcp, thc 
Alco-Screen 
etoh 
urine 
DTx cassette 
amp, bar, coc, meth, opi, thc, etc. 
DTx Dip test single tests 
amp, bar, bup, bzo, coc, mdma, meth, mtd, 
opi, pcp, thc 
one-step lateral flow assay 
for smokers 
nic 
Specimen Validity Test (SVT) 
for adulterants 
assesses creatinine, nitrite, glutaraldehyde, 
pH, specific gravity, oxidants/pyridinium 
chlorochromate 
Abbott 
Toxicology 
US 
urine 
SEFRIA Fentanyl urine drug 
screening test 
fen 
Abbott 
Toxicology  
US 
oral 
DDS2 Mobile Test System 
amp, bzo, coc, meth, mtd, opi, thc 
urine 
iCassette 
amp, bar, bzo, coc, mdma, opi, oxy, pcp, 
ppx, tca, thc 
iCup DS IScreen Dip Card 
amp, coc, meth, opi, thc 
E-Z Split Key Cup 
amp, bar, bzo, bup, coc, mdma, meth, mop, 
mtd, opi, oxy, pcp, ppx, tca, thc 
First Check Home Drug Tests 
amp, bar, bzo, coc, mdma, meth, mtd, opi, 
oxy, pcp, tca, thc 
Accutech, LLC 
US 
urine 
QuikScreen 5, 7, and 12 
amp, coc, opi, pcp, thc + mdma, meth + 
bar, bzo, oxy, pcp, tca 
Alfa Scientific 
US 
oral 
Oral-view Saliva Multi-Drug 
of Abuse Test 
amp, bzo, coc, mdma, meth, mtd, opi, pcp, 
thc 
Oral-view Saliva Alcohol Test 
etoh 
urine 
Instant-view Multi-drug test 
amp, bar, bzo, coc, meth, opi, oxy, thc 

 
 
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Company 
Location 
Type 
Description 
Target 
American Bio 
Medica 
US 
urine 
RapidTOX, RapidONE, 
RapidTOX Cup, RapidTOX 
Cup II 
amp, bar, bup, bzo, coc, mdma, meth, mtd, 
opi, oxy, pcp, ppx, tca, thc 
Bioscan 
Screening 
Systems 
US 
urine 
Professional Premium 
Marijuana Urine Test 
k2, thc 
Confirm 
Biosciences 
US 
hair 
Hairconfirm and Hairconfirm 
with Prescription Drugs 
amp, coc, mdma, meth, opi, pcp, thc + hyd, 
oxy, hym 
oral 
Salivaconfirm 6-drug panel; 
Salivaconfirm Premium 11-
drug panel 
amp, bzo, coc, mdma, opi, thc + bar, bup, 
etoh, fen, k2, meth, mtd, oxy, pcp 
oral 
Saliva and Breath Alcohol 
tests 
etoh 
Healgen 
Scientific 
 
urine 
Multipanel DOA Urine 
Testing Cups 
amp, bar, bup, bzo, coc, eddp, mdma, mtd, 
meth, mop, opi, oxy, pcp, ppx, tca, thc 
Jant Pharmacal 
US 
oral/ 
urine 
Accustrip and Accutest panel 
cups 
amp, bar, bzo, coc, etoh, mdma, meth, 
mtd, nic, opi, oxy, pcp, tca, thc 
Mossman 
Associates 
US 
urine 
NicCheck I 
cot, nic 
Nymox 
Pharmaceutical 
Corp 
US 
urine 
NicAlert 
immunochomatographic 
assay 
cot 
Phamatech 
US 
urine 
Quickscreen multipanel dip 
card 
amp, coc, mdma, meth, opi, thc 
Polymed 
Therapeutics 
US 
urine 
rapid urine drug of abuse 
tests 
amp, bar, bup, bzo, coc, cot, eddp, fen, ket, 
mdma, meth, mop, mtd, mtq, opi, oxy, pcp, 
ppx, tca, thc 
Princeton 
BioMeditech 
US 
urine 
Accusign tests 
amp, bar, bup, bzo, caf, coc, cot, etoh, 
meth, mtd, nic, opi, oxy, pcp, tca, thc 
Randox 
Laboratories 
UK 
urine 
RX series analyzers; 
dedicated for urine drug 
screening 
amp, bar, bzo, coc, eddp, etoh, mdma, mtd, 
opi, thc 
Siemens 
Healthineers 
Germany 
blood/ 
urine 
Syva Emit II Plus assays 
6am, amp, bar, bup, bzo, coc, etoh, lsd, 
mdma, mtd, mtq, opi, pcp, ppx, thc 

 
 
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Company 
Location 
Type 
Description 
Target 
Thermo Fisher 
US 
blood 
Indiko analyzer 
6am, amp, bar, bup, bzo, coc, cot, eddp, 
etoh, mdma, meth, mop, mtd, opi, oxy, 
pcp, ppx, thc 
Note: 6am=6-acetylmorphine (heroin), ace=acetaminophen, amp=amphetamines, bar=barbiturates, caf=caffeine, coc=cocaine, 
cot=cotinine (nicotine metabolite), eddp=methadone metabolite, etoh=ethanol (alcohol), fen=fentanyl, hyd=hydrocodone, 
hym=hydromorphone, k2=spice (synthetic marijuana), ket=ketamine, lsd=lysergic acid diethylamide, mdma=ecstasy, 
meth=methamphetamine, mop=morphine, mtd=methadone, mtq=methaqualone, nic=nicotine, opi=opiates, oxy=oxycodone, 
pcp=phencyclidine, ppx=propoxyphene, sal=salicylate (aspirin), tca=tricyclic antidepressants, thc=marijuana 
Source: Kalorama Information 
Urine testing has long been the most widely used method in drugs-of-abuse testing due to its 
non-invasive collection, relatively low cost, and well-established regulatory acceptance. 
Urine drug testing is commonly used for initial screening in POC settings and hospital 
laboratories, particularly in emergency medicine where rapid identification of drug classes 
such as opioids and benzodiazepines can guide treatment decisions. In these settings, assay 
cutoffs are often designed to detect clinically relevant or higher concentrations of drugs, 
aligning with the needs of acute care rather than forensic sensitivity. 
Blood testing, while more invasive and costly, plays a critical role in forensic and legal 
contexts because it more closely reflects active impairment. In regions with zero-tolerance 
or, per se, drug-driving laws, including parts of Europe, urine screening is often followed by 
confirmatory blood testing, leading to increased demand for toxicology analysis in forensic 
laboratories. At the same time, oral fluid testing has gained significant traction as a less 
invasive alternative that better reflects recent drug use compared to urine and is more difficult 
to adulterate, making it increasingly accepted in workplace and roadside testing programs. 
Regulatory momentum has supported this shift, with updates from agencies such as the U.S. 
Department of Transportation allowing oral fluid testing as an alternative to urine in regulated 
workplace programs. 
Hair testing continues to serve a niche role, particularly in workplace and forensic settings, 
due to its resistance to adulteration and its ability to detect drug use over an extended window 
of up to several months. However, it is less useful for identifying recent use because drugs 
take several days to incorporate into hair. Oral fluid testing, while convenient and 
increasingly accepted, still presents analytical challenges due to lower drug concentrations 
and variability in detection windows, though improvements in assay sensitivity are helping 
address these limitations. 

 
 
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OraSure Technologies was an early leader in oral fluid testing with its Intercept system, 
which helped establish laboratory-based oral fluid drug testing, though product availability 
and branding have since evolved. Companies such as BTNX and Hangzhou AllTest Biotech 
have expanded rapid lateral flow testing options, including test strips for emerging drugs such 
as fentanyl and xylazine, reflecting the ongoing need to address the opioid crisis and the rise 
of synthetic and adulterant compounds. QuidelOrtho has also expanded its laboratory-based 
menus to include assays such as fentanyl testing on its clinical chemistry platforms. 
The drugs-of-abuse testing landscape is evolving to address a broader and more complex 
range of substances, including synthetic opioids, novel psychoactive substances, and 
adulterants that may not be reliably detected by traditional immunoassays. This has increased 
reliance on high-sensitivity confirmatory testing in centralized laboratories and has driven 
more frequent updates to screening panels. There is also growing use of testing data for real-
time public health surveillance to monitor regional drug trends and detect emerging threats, 
particularly in response to the opioid crisis.  Laboratories are also integrating drug testing 
more closely into routine clinical workflows through automation and informatics, while 
placing greater emphasis on result interpretation, as the presence of a drug does not always 
correlate directly with impairment or clinical effect. The market continues to move toward a 
more flexible, multi-matrix testing approach supported by both rapid screening technologies 
and advanced laboratory-based methods. 
Table 5-11: Drugs of Abuse POC Test Sales Distribution, by Global Region, 2025 (%) 
 
[Europe; Japan; United States; Rest of World] 
Region 
% Mkt 
United States 
49% 
Europe 
29% 
Japan 
7% 
RoW 
15% 
Total 
100% 
Source: Kalorama Information 
 

 
 
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Rapid and POC Infectious Disease Testing 
The primary goal of rapid, point-of-care infectious disease testing is to detect pathogens 
quickly and guide appropriate clinical management, including antimicrobial use. While 
infectious diseases are often associated with developing regions, they remain a significant 
source of morbidity and mortality in developed markets such as the United States and Europe, 
particularly with seasonal outbreaks, hospital-acquired infections, and emerging pathogens. 
Factors including global travel, migration, antimicrobial resistance, and co-infections 
continue to increase the need for rapid, accessible diagnostics and sustained public health 
vigilance. Traditional centralized laboratory testing, while highly sensitive and 
comprehensive, can fall short in situations requiring immediate decision-making, mass 
screening, or decentralized care delivery. 
The demand for rapid and accurate infectious disease diagnostics has grown, particularly 
those that can deliver actionable results during the patient visit. Rapid testing improves 
clinical workflow, provides timely treatment decisions, and helps reduce unnecessary 
isolation or inappropriate antimicrobial use. In addition, delays associated with centralized 
testing can lead to loss of follow-up, reinforcing the value of near-patient testing. 
Historically, many POC assays have been based on immunoassay formats due to their low 
cost, simplicity, and speed; however, these tests can have lower sensitivity compared to 
molecular methods, and negative results in certain clinical scenarios may still require 
confirmation. 
More recently, there has been a significant shift toward molecular POC testing, with compact 
platforms using PCR and isothermal amplification technologies such as LAMP delivering 
higher sensitivity and specificity in near-patient settings. These systems are increasingly 
designed for ease of use, minimal hands-on time, and integration with digital health 
platforms, making them suitable for decentralized environments including clinics, 
pharmacies, and urgent care settings. At the same time, advances in biosensors and 
microfluidics are continuing to push the boundaries of rapid diagnostics. A key trend is the 
expansion of multiplex and syndromic testing, allowing simultaneous detection of multiple 
pathogens from a single sample, which is particularly valuable in settings where symptoms 
overlap, such as respiratory or gastrointestinal infections. There is also increasing use of 
testing outside traditional healthcare environments, including retail clinics and at-home 
settings, offered by simplified workflows and user-friendly designs. 

 
 
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While true POC antimicrobial susceptibility testing remains limited, progress is being made 
with emerging rapid phenotypic and genotypic approaches that aim to shorten time to 
targeted therapy. In centralized laboratories, technologies such as MALDI-based 
identification and rapid molecular panels have already reduced turnaround times significantly 
compared to traditional culture-based workflows. At the same time, greater connectivity of 
POC devices is enabling real-time transmission of results into electronic medical records and 
public health systems, providing faster clinical decisions and improved outbreak 
surveillance. Rapid diagnostics are also playing an increasing role in antimicrobial 
stewardship programs by helping clinicians distinguish between viral and bacterial infections 
and reduce unnecessary antibiotic use. 
Infectious disease diagnostics will remain a critical and evolving segment of the IVD market. 
Continued emergence of new pathogens, seasonal viral variants, vector-borne diseases, and 
healthcare-associated infections such as MRSA will continue to demand faster, more 
accurate, and increasingly decentralized testing solutions. Looking ahead, next-generation 
technologies, including CRISPR-based diagnostics and advanced biosensors, are expected to 
further expand the capabilities of POC testing by combining high sensitivity with rapid 
turnaround times in decentralized settings. 
 
 

 
 
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Table 5-12: Innovations in Molecular POC Infectious Disease Diagnostics 
Company 
Location 
Area 
Description 
Abacus Diagnostica Oy 
(Uniogen) 
Finland 
HAI 
GenomEra CDX MRSA/SA mecA and mecC detection 
from blood culture and plate sample 
GenomEra CDX Norovirus detection and differentiation 
of genogroups I and II 
Abbott 
US 
HAI 
C. difficile cartridge for Alere i 
Hepatitis 
Alere Determine HBsAg; HBV surface antigen test, 
whole blood or serum/plasma from fingerstick or 
venous blood 
HIV 
Alere Determine HIV-1/2 AG/AB Combo 
Alere Determine HIV-1/2; one-step serum/plasma or 
two-step whole blood in 15 minutes 
Other 
Influenza A & B assay for ID NOW 
Strep A assay for ID NOW 
RSV rapid molecular test for ID NOW 
Sexual health 
Chlamydia trachomatis and Neisseria gonorrhea 
cartridges for ID NOW 
 Abbott  Syphilis TP 
Tuberculosis 
Abbott TB LAM Ag Test; detects lipoarabinomanna 
(LAM) antigen in urine in 25 minutes 
bioMérieux 
France 
Sepsis 
BioFire FILMARRAY Blood Culture Identification (BCID) 
panel 
Becton-Dickinson 
US 
HAI 
parasite panel (Giardia and Entamoeba) for BD MAX 
platform 
Carbapenem-resistance and CRE panels 
Other 
Veritor and Veritor Plus analyzers with flu, RSA and 
Strep A applications 
Sexual health 
vaginal panel for BD MAX (bacterial vaginosis, 
trichomoniasis, vulvovaginal candidiasis) 
STD panel for BD MAX; CT/NG/TV 

 
 
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Company 
Location 
Area 
Description 
CT, HPV, and NG assays for BD Viper LT 
Cepheid 
US 
HAI 
Xpert MRSA NxG 
Xpert vanA (vancomycin resistance; vanA/B in EU) 
Xpert C. difficile 
Xpert Norovirus 
Xpert Carba-R 
Hepatitis 
Xpert HBV and HCV viral load assays 
HIV 
Xpert HIV-1 Viral Load 
Xpert HIV-1 Qual 
Other 
Xpert Xpress Flu + RSV 
Xpert Streptococcus Group A 
Xpert EV (enteroviral meningitis) 
Xpert assays for pertussis, gastrointestinal pathogens 
Sexual health 
Xpert TV for testing symptomatic and asymptomatic 
men 
CLIA-waived Xpert vaginitis/vaginosis 
CLIA-waived Xpert CT/NG 
CLIA-waived Xpert HPV 
Tropical disease 
Xpert Ebola assay 
Tuberculosis 
Xpert MTB/RIF; M. tuberculosis and rifampicin 
resistance 
Chembio Diagnostics 
US 
Hepatitis 
Collaboration with FIND to develop and test rapid HCV 
core antigen diagnostic 
HIV 
DPP HIV-Syphilis assay 
Tropical disease 
DPP Micro Reader and DPP Zika assay 
DPP Zika/Chikungunya/Dengue IgG/IgM assay 

 
 
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Company 
Location 
Area 
Description 
Oral fluid/saliva test for malaria 
Collaborations with FIND and Massachusetts General 
Hospital for febrile illness diagnostics 
DNA Electronics 
UK 
Sepsis 
LiDia Bloodstream Infection (BSI) panel 
DxNA 
US 
HAI 
MRSA/SA test for GeneSTAT platform 
Eiken Chemical 
Japan 
Tuberculosis 
collaboration with FIND and HUMAN GmbH to develop 
LAMP-based TB diagnostic 
Fio Corporation 
Canada 
Tropical disease 
Malaria assay for Deki Reader 
Corgenix ReLASV rapid antigen test for Lassa virus 
adapted for Deki Reader 
Corgenix ReEBOV rapid antigen test for Ebola virus, 
conducted on Deki Reader 
genedrive 
UK 
Hepatitis 
Genedrive HCV ID Kit; hepatitis C from plasma in 90 
minutes 
HIV 
Genedrive HIV assay 
Sexual health 
STI+ for Genedrive platform; CT/NG/HSV 
Tuberculosis 
Genedrive MTB/RIF test 
£1.1 million grant from Innovate UK for further 
development of Genedrive MTF/RIF 
Greiner BioOne 
Austria 
HAI 
Superbug CR for Genspeed R2; detects over 70 
carbapenemase variants 
VanABC plus for Genspeed R2; single-tube multiplex for 
vancomycin resistance genes vanA/B/C 
Hain Lifescience 
Germany 
Tuberculosis 
GenoType MTBDRplus; detects MTB complex and drug 
resistance genes in five hours 
Hema Diagnostic 
Systems 
US 
Hepatitis 
RAPID 1-2-3 HEMA EXPRESS Hepatitis B HBsAg test 
RAPID 1-2-3 HEMA EXPRESS Hepatitis C (HCV) test 
RAPID 1-2-3 HEMA CASSETTE Hepatitis B test 
RAPID 1-2-3 HEMA CASSETTE Hepatitis C (HCV) test 

 
 
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Company 
Location 
Area 
Description 
HIV 
Rapid 1-2-3 HEMA EXPRESS HIV P24Ab assay 
Sepsis 
Rapid 1-2-3 HEMA SEPSIS 
Tropical disease 
Rapid 1-2-3 HEMA Cassette Malaria PF, PF/PV 
Tuberculosis 
Rapid 1-2-3 HEMA EXPRESS TB-XT rapid lateral flow 
immunochromatography test 
Hibergene Diagnostics 
Ireland 
HAI 
C. difficile assay for HG SWIFT platform 
Other 
HG Mycoplasma pneumoniæ for HG SWIFT platform 
HG Meningococcus for HG SWIFT; for bacterial 
meningitis diagnosis from whole blood, CSF, and 
nasopharyngeal swab 
HG Pneumo/Meningo Combo; for Neisseria meningitidis 
and Streptococcus pneumoniæ from CSF 
RSV 1/2 for HG SWIFT 
Influenza A/B for HG Swift 
InSilixa 
US 
HIV 
HIV diagnostic and drug resistance genotyping assays 
J Mitra & Co Pvt Ltd 
India 
Tropical disease 
Advantage Chikungunya IgM Card 
MedMira Inc 
Canada 
Hepatitis 
Multiplo HIV/HCV, Multiplo HBc/HIV/HCV 
Tuberculosis 
$1.1M SBIR grant for POC test for antibiotic-resistant 
MTB 
Meridian Bioscience 
US 
HAI 
C. difficile assay for illumigene 
Other 
Babesia, Campylobacter, and EHEC assays for illumigene 
Sexual health 
HSV-1 and HSV-2 assays for illumigene 
CT/NG assay for illumigene 
Tropical disease 
Malaria assay for illumigene 
Molbio Diagnostics 
India 
Hepatitis 
Truenat HBV Viral Load 
Truenat HCV Viral Load 

 
 
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Company 
Location 
Area 
Description 
HIV 
Truenat HIV Viral Load qPCR test 
Other 
Truenat H1N1 qPCR test 
Truenat Salmonella qPCR test 
Sexual health 
Truenat HPV qPCR test 
Truenat Chlamydia qPCR test 
Truenat Gonorrhea qPCR test 
Truenat Trichomonas qPCR test 
Tropical disease 
Truenat Malaria (P. falciparum) qPCR test 
Truenat Chikungunya qPCR test 
Truenat Dengue qPCR test 
Tuberculosis 
Truenat TB resistance qPCR test 
MP Biomedicals 
US 
Hepatitis 
FASTSURE HCV DNA Rapid Test 
Tuberculosis 
FASTSURE TB DNA Rapid Test 
Nanōmix 
US 
Sepsis 
Sepsis panel for eLab platform 
QIAGEN 
Netherlands 
Tuberculosis 
Fourth generation QuantiFERON-TB tuberculosis ELISA 
QuantuMDx 
UK 
HIV 
Q-POC HIV assay 
Sexual health 
CT/NG, other STI assays for Q-POC 
Tropical disease 
Q-POC malaria assay 
Tuberculosis 
Tuberculosis and multiple drug-resistant TB assays for 
Q-POC 
QuidelOrtho 
US 
HAI 
C. diff, MRSA, Van 
AmpliVue C. difficile assay 
HIV 
HIV viral load  
Other 
Flu, RSV, and Strep A assays for Sophia FIA platform 

 
 
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Company 
Location 
Area 
Description 
Lyme FIA for human IgM and IgG antibodies to Borrelia 
burgdorferi, for Sofia platform 
RSV, GI, and transplant infection  
AmpliVue Bordetella pertussis assay 
Sepsis 
bloodstream infection  
Sexual health 
STD, HSV/VZV/syphilis, and vaginitis  
GBS, TV, HSV 1 & 2 AmpliVue cassettes 
 
Trichomonas assay for Solana 
Tuberculosis 
RSV, GI, TB, and transplant infection  
Reagena 
Finland 
Other 
Reagena PC PUUMALA IgM 
Rheonix 
US 
HIV 
Rheonix CARD HIV assay 
Sepsis 
Rheonix CARD sepsis panel 
Sexual health 
Rheonix CARD HPV panel 
Rheonix CARD STI panel; CT/NG/TV and syphilis 
Tropical disease 
Rheonix CARD Zika assay 
Roche 
Switzerland 
Hepatitis 
LINEAR ARRAY Hepatitis C Virus Genotyping Test for 
AMPLICOR system 
HIV 
MPX, multiplex assay for HIV-1 groups M and O, HIV-2, 
HBV, and HCV 
Other 
cobas Liat Streptococcus A and influenza assays 
Sexual health 
cobas TV/MG assay 
cobas CT/NG assay 
cobas HPV assay 
Tropical disease 
Zika assay for cobas 6800/8800 

 
 
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Company 
Location 
Area 
Description 
Tuberculosis 
Mycobacterium assays for M. tuberculosis, M. avium, 
and M. intracellular, and for drug resistance 
RPS Diagnostics 
US 
Respiratory 
FebriDx  
Seegene 
Korea 
Other 
respiratory panel, flu, multiplex pneumonia, MERS CoV 
PCR reagents 
gastrointestinal panel PCR reagents 
Sepsis 
Magicplex Sepsis qPCR test 
Tuberculosis 
MTB and multiple drug-resistant tuberculosis PCR 
reagents 
T2 Biosystems 
US 
Sepsis 
T2Bacteria Panel for sepsis-causing pathogens 
Ustar Biotechnologies 
China 
Hepatitis 
HCV cartridge for proprietary isothermal platform 
Sexual health 
cartridge based isothermal NAAT for C. trachomatis 
Tuberculosis 
EasyNAT isothermal diagnostic for M. tuberculosis 
Veredus Laboratories 
Singapore 
Other 
VereFlu for VerePLEX Biosystem; 10 influenza A 
subtypes and IFV B 
Tropical disease 
VereFever, for Chikungunya, Dengue, malaria, Zika, et 
al. 
Tuberculosis 
VereMTB; detects and differentiates ten 
Mycobacterium species, detects rifampicin and isoniazid 
resistance 
Source: Kalorama Information 
Products 
Rapid tests are available for a diverse range of disease pathogens like HIV, gonorrhea, 
syphilis, chlamydia, herpes, hepatitis, human papillomavirus, Groups A and B Streptococcus, 
M. tuberculosis, RSV, influenza, Legionella, mononucleosis, M. pneumoniæ, E. coli, H. 
pylori, Cryptosporidium, Giardia, C. difficile, S. aureus, Candida, rotavirus, and bacterial 
meningitis. 

 
 
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The availability of tests produced and offered in developing and developed countries are 
going to vary, as the prevalence of different illnesses will vary from region to region. 
Developed countries require tests primarily for respiratory infections; developing countries 
would like reliable tests for malaria and STDs. Both geographies can use reliable HIV tests. 
There is one difference: those to be used in developing countries have to be much more 
reliable than those used elsewhere because there is rarely a lab nearby to confirm negative 
results. 
MeMed markets its MeMed BV test on whole blood samples at the POC. The MeMed Key 
analyzer can distinguish between bacterial and viral infections in 15 minutes. 
Table 5-13: POC Infectious Disease Test Summary by Disease and Technology  
Disease / Pathogen 
Technology 
Chagas disease 
Immunochromatographic test 
Chlamydia, gonorrhea 
NAAT 
COVID-19, Influenza, RSV 
Antigen / molecular (home & office) 
Dengue (NS1 antigen) 
Antigen test 
HIV, HBV, HCV, EBV, TORCH-H, MMRV, Lyme 
Single / multiplex panels 
Leptospirosis 
IgM ELISA 
Malaria, Zika, Rotavirus, Helicobacter, Gonorrhoeae 
Antigen / antibody 
S. pneumoniae, L. pneumophila 
Urine antigen test 
Schistosomiasis 
Antibody ELISA 
Syphilis 
Lateral flow antibody; multiplex panels 
Trichomoniasis 
MDx multiplex panels 
Tuberculosis 
Molecular 
Typhoid, Cholera 
Stool immunochromatographic test 
Visceral leishmaniasis 
Lateral-flow strip 
Source: Kalorama Information 

 
 
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HIV and Hepatitis Testing and Monitoring 
The highest volumes of molecular infectious disease tests are for HIV, hepatitis and CT/NG. 
Hepatitis and HIV treatment involves recurrent quantitative molecular testing to determine 
viral load levels and the effectiveness of implemented therapy.  
OraSure has established a strong position in HIV self-testing with its OraQuick HIV Self-
Test, which has seen broad adoption in developing markets and plays an important role in 
expanding access to screening. The test received World Health Organization prequalification, 
supporting its use in global health programs and procurement by international funding 
organizations. OraQuick is widely recognized for its ease of use and reliability, offering high 
specificity and strong overall performance for antibody-based detection, although it does not 
match the early detection capability of laboratory-based fourth-generation assays. Overall, 
the product has contributed significantly to increasing HIV testing rates by making screening 
more accessible in community and home settings. 
Atomo Diagnostics has developed the AtomoRapid HIV 1/2 test, a lateral flow immunoassay 
that integrates sample collection and testing into a single device for professional and self-
testing use. The test delivers results in approximately 15 minutes and has demonstrated high 
sensitivity and specificity in clinical studies. It has been CE marked and deployed across a 
range of international markets. Atomo has partnered with Access Bio to commercialize the 
test in professional settings under the CareStart brand in selected regions, and with Owen 
Mumford to distribute a version under its Simplitude brand. While the test is designed for 
ease of use in decentralized and home settings, results are read visually, with digital support 
tools available in some programs. 
Encouraged by OraSure’s lead in HIV self-testing, Chembio Diagnostics developed its SURE 
CHECK HIV 1/2 Assay, for which it was awarded CE approval as a self-test. The test is a 
variation of Chembio’s professional use blood based POC HIV tests that is endorsed by the 
WHO and several other international aid agencies. Chembio also produces the CE-marked 
Dual Path Platform HIV/Syphilis test, a rapid immunochromatographic test that can 
simultaneously detect antibodies from HIV types 1 and 2 and/or Treponema pallidum in 15 
to 30 minutes from fingerstick or venous whole blood, serum, or plasma. 
STDCheck markets the OTC test for HIV 1/2, HSV 1/2, hepatitis A/B/C, gonorrhea, 
chlamydia, and syphilis. WholeHealth Products provides its HIV 1&2 Rapid Diagnostic Test, 
oral fluid home test. 

 
 
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Cepheid offers qualitative HIV and HIV viral load assays for its GeneXpert system, 
producing results in 90 minutes with one-minute hands-on time. The system, by its self-
contained nature, requires no liquid waste management. 
Roche offers its cobas Plasma Separation Card, a simple and stable device for the collection 
of plasma for HIV viral load testing, with Roche’s cobas AmpliPrep, cobas TaqMan, and 
cobas 6800/8800 HIV tests. The device requires only a small volume of blood taken the 
patient’s fingertip and can be transported with the need for cold storage, making the Plasma 
Separation Card ideal for use in remote areas and those of extreme temperature and humidity. 
Roche is also working on a multiplex assay that detects not only HIV-1 subgroups M and O 
and HIV-2, but also hepatitis B and C viruses, in a single test. The company offers a CE-
marked test for chronic hepatitis C patients designed to determine the genotype (GT1-GT6) 
of the virus affecting them. 
OraSure’s OraQuick HCV rapid antibody test was the first hepatitis diagnostic of its kind to 
be granted a CLIA waiver. The immunochromatic strip-based assay delivers test results for 
multiple HCV genotypes in fingerstick or venous whole blood in 20 minutes with 98% 
accuracy. 
Other hepatitis diagnostics on the market include Abbott’s Determine HBsAg for hepatitis B 
surface antigen, Cepheid’s Xpert HBV and HCV Viral Load cartridges, Hema Diagnostic 
Systems’ Rapid 1-2-3 HEMA Express and Cassette HBV and HCV assays, and MedMira’s 
Multiplo assays for hepatitis and HIV. MolBio Diagnostics currently offers a Truenat HBV 
viral load assay for its Truelab platform and has a similar test for hepatitis C in development.  
Abbott offers the Determine Rapid HIV-1/2 and  Determine HBsAG2 test for use with serum, 
plasma or whole blood for the detection of Hepatitis B surface antigen. 
Chembio’s DPP HIV-Syphilis System is a single-use, 15-minute screening test for the 
simultaneous detection of antibodies to HIV types 1 and 2 and the bacteria that cause syphilis, 
Treponema pallidum. It uses a 10-microliter fingerstick sample of whole blood, venous 
whole blood, or plasma. The test is highly sensitive and specific, includes a built-in 
procedural control, can be stored at room temperature, and has a shelf life of up to 24 months. 
binx health offers the Sassy Little Box program to enable access to HIV and sexually 
transmitted infection testing in the Birmingham, Alabama region. The Sassy Little Box, 
which consists of self-collection materials and easy-to-follow instructions, is distributed to 
local partnerships and can be used without visiting a clinic. 

 
 
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Abbott markets its HPV test that is run on the company’s Alinity m system.  The test is 
approved for fast HPV detection and for use in routine cervical cancer screening. It can also 
be used in combination with a Pap test, providing information on five risk groups covering 
the 14 different cancer-causing genotypes of the virus.  
Cepheid  has a CLIA waiver for Xpert HCV. This is the only molecular test in the US to 
detect hepatitis C RNA directly from human capillary whole blood.  
bioLytical provides its 1-minute INSTI Multiplex HIV and Syphilis Test in Australia.  
Tuberculosis 
Diagnosing tuberculosis through conventional means is a lengthy and arduous task; it 
requires a combination of chest x-rays, growth of Mycobacterium tuberculosis in culture, 
sputum smear microscopy, interferon-γ assay, and the Mandel-Mantoux tuberculin skin test. 
The last two are rather inconvenient in developing regions, and sputum smear microscopy 
can be troublesome in HIV patients, children, and patients with low pathogen load. Drug 
resistance can only be assessed through bacterial culture, which can take six weeks and can 
be very costly. Efforts to develop a better solution have been underway for years and have 
been funded by organizations like the Foundation for Innovative New Diagnostics (FIND), 
Innovate UK, and the Bill & Melinda Gates Foundation. The most promising tests will 
deliver rapid results with high sensitivity and specificity, but at an affordable cost. 
The current generation of decentralized molecular TB diagnostics is largely represented by 
the Cepheid GeneXpert system and its Xpert MTB/RIF assay, which detect TB and 
rifampicin resistance in sputum samples. Placed in sub-Saharan Africa, India and Southeast 
Asia, GeneXpert systems have provided reference and district labs with rapid, high-
sensitivity TB and first-line drug resistance testing. Other tests include the Oxford 
Immunotec TSPOT TB test and the QIAGEN TB test. 
genedrive plc offers a tuberculosis diagnostic assay for its CE-marked Genedrive molecular 
POC platform. The test detects M. tuberculosis complex (MTBC) and rifampicin resistance, 
providing results in 45-60 minutes.  
MP Diagnostics FASTSURE TB DNA Rapid Test is a qualitative isothermal assay kit for 
detection of M. tuberculosis DNA from human sputum samples; it handles extraction, 
amplification and hybridization, and detection in less than two and a half hours. The test has 

 
 
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been shown to have sensitivity and specificity of 82.45% and 100%, respectively, and 
detected positive results in 60% of samples previously found negative by microscopy. The 
cross-contamination-proof assay is CE-marked and available outside the United States. 
Other CE- or FDA-approved TB diagnostic offerings include QIAGEN’s fourth-generation 
QuantiFERON-TB ELISA, MTB and multiple drug-resistant TB detection reagents from 
Seegene, and the MTBDRplus line-probe assay from Hain Lifescience. When using sputum 
samples, Hain’s product has sensitivities of 97.7% and 95.4% for detecting resistance to 
rifampicin and isoniazid, respectively, and specificities of 91.9% and 89%, respectively; 
however, it is less effective in detecting resistance to ofloxacin and amikacin. 
Tropical and Neglected Diseases 
In recent years, outbreaks in regions such as Brazil, Central and West Africa, and parts of 
Asia have reinforced the need for more advanced diagnostics for infectious diseases prevalent 
in developing regions. High-profile diseases in this category include malaria, Ebola, and Zika 
virus, as well as chikungunya, dengue, West Nile virus, leishmaniasis, Chagas disease, and 
trypanosomiasis. These infections continue to drive demand for rapid, decentralized 
diagnostic solutions for use in resource-limited settings and during outbreaks, with growing 
influence from global health organizations such as the World Health Organization and 
funding bodies like the Global Fund and FIND, which play a major role in shaping 
procurement and deployment strategies. 
Chagas disease, caused by Trypanosoma cruzi, remains a significant public health concern 
in Latin America, with increasing recognition in non-endemic regions, including the United 
States, due to migration and alternative transmission routes such as blood transfusion, organ 
transplantation, and congenital infection. Efforts to expand access to screening have led to 
the development of rapid diagnostic tests suitable for decentralized use. Companies such as 
InBios International have introduced antibody-based rapid tests that can deliver results in 
approximately 20 minutes, providing screening initiatives in clinics and field settings. These 
tests improve access but are generally used as initial screens and often require confirmatory 
laboratory testing. Laboratory-based serological assays from companies including Abbott 
and QuidelOrtho continue to play a key role in blood donor screening and clinical 
diagnostics, with the newer integration of Chagas assays into automated immunoassay 
platforms such as the VITROS systems reflecting a gradual shift toward broader clinical use 
beyond transfusion safety. 

 
 
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Ebola diagnostics have historically relied on emergency and outbreak-driven pathways, with 
rapid antigen tests and molecular assays used during active outbreaks. While earlier 
emergency use authorizations enabled rapid deployment of tests from multiple 
manufacturers, the market today is more episodic, with diagnostics being scaled up primarily 
in response to outbreaks rather than maintained as routine high-volume testing. Molecular 
platforms such as Cepheid’s GeneXpert system have played an important role in outbreak 
response due to their ability to deliver rapid, sensitive results in decentralized settings. 
Collaborations between diagnostics companies and regional public health organizations have 
been critical in expanding access. Chembio Diagnostics, working with Brazil’s Oswaldo 
Cruz Foundation (Fiocruz/Bio-Manguinhos), developed and deployed its DPP platform for 
diseases including Zika, HIV, dengue, and leishmaniasis. Although the company has 
undergone structural changes, the DPP technology continues to be used in certain public 
health programs through local partnerships. 
Several companies have pursued molecular and multiplex diagnostics for tropical and vector-
borne diseases, including Roche and Veredus Laboratories. Platforms such as VerePLEX and 
its VereFever panel are designed to detect multiple pathogens associated with febrile illness 
in a single assay, supporting outbreak response and targeted surveillance, although adoption 
remains more limited than that of larger syndromic panel platforms. This reflects a broader 
trend toward multiplex testing for febrile illness, allowing clinicians to differentiate between 
multiple potential causes of infection in a single test, which is particularly important in 
regions where co-circulating pathogens are common. 
Rapid testing formats play a critical role in these markets due to cost and accessibility 
advantages, while molecular diagnostics are gradually expanding as platforms become more 
portable, battery-operated, and easier to use in field settings. These mobile molecular systems 
are helping bridge the gap between centralized laboratory testing and true POC use in remote 
environments. In addition, diagnostics are increasingly being integrated into surveillance and 
outbreak preparedness systems, enabling real-time tracking of disease spread and supporting 
faster public health responses. 
Diagnostics for tropical and emerging infectious diseases remain highly dependent on public 
health priorities, funding cycles, and outbreak dynamics. The market continues to move 
toward a combination of low-cost rapid tests for broad screening and more advanced 
molecular platforms for confirmation and surveillance, with growing interest in next-

 
 
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generation technologies such as CRISPR-based diagnostics and advanced biosensors that aim 
to deliver high sensitivity in decentralized settings. 
Respiratory Diseases 
Improving the treatment of respiratory illnesses in primary health care facilities requires 
rapid, accurate pathogen diagnosis, and many such facilities are turning to rapid PCR-based 
assays that have been shown to be more accurate than their rapid antigen counterparts. Some 
are even CLIA-waived, allowing clinicians to use them in the office rather than sending 
samples to centralized labs, making for faster, more reliable diagnoses that lead to better 
treatment. 
Respiratory molecular IVD multiplex panels detect multiple respiratory pathogens, typically 
from nasopharyngeal or nasal swabs. These tests use multiplex PCR technology and are 
designed to deliver high sensitivity, with results available in approximately 30 to 90 minutes. 
They are primarily used in emergency rooms, inpatient wards, and intensive care units. The 
mechanism of action involves amplification and detection of viral and/or bacterial DNA or 
RNA targets. Molecular multiplex respiratory panels represent the largest and most mature 
segment of the respiratory panel-based testing market and routinely include three or more in 
a single run. 
Sekisui Diagnostics markets the OSOM Ultra Flu A & B Test, a rapid lateral-flow 
immunoassay that delivers results in approximately 10–15 minutes. In addition, Sekisui 
distributes a cassette-based, CLIA-waived molecular influenza A & B assay originally 
developed by Mesa Biotech. This molecular test is marketed by Sekisui under the Silaris Flu 
A & B Test name and runs on the Accula platform, enabling rapid near-patient molecular 
influenza testing. 
RPS Diagnostics markets its FebriDx test, which is offered in the EU and other CE mark 
countries. The FebriDx is a rapid, accurate POC test that provides clinicians with a 10-minute 
assessment of the body's immune response to an acute respiratory infection from a blood 
sample. This test aids in the differentiation of viral and bacterial ARI through rapid detection 
of both Myxovirus resistance protein A and C-reactive protein.  
Randox Laboratories offers the Vivalytic POC analyzer, which has been instrumental in 
coronavirus testing. The Vivalytic platform is capable of both Hi-Plex and Lo-Plex testing.  

 
 
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Genomtec provides its POC respiratory disease test -  the Genomtec ID Respiratory 5-Plex 
molecular diagnostic panel. The test is designed to detect influenza A and B, RSV, 
Mycoplasma pneumonia, and Chlamydophila pneumonia.  The tests are run on the 
company’s portable Genomtec ID Analyzer, with results available in 25 minutes.  
Visby Medical offers its respiratory panel test. The test is designed for point-of-care but can 
also be used in laboratories. The test is an RT-PCR assay that simultaneously detects and 
differentiates between SARS-CoV-2, influenza A and influenza B viral RNA.  
 bioMérieux offers its BIOFIRE SPOTFIRE Respiratory Panel. The SPOTFIRE System is 
designed to be run on the SPOTFIRE R Panel. The panel detects upper respiratory infections 
such as SARS-CoV-2, influenzas A & B, RSV and rhinovirus.  
iHealth  markets the company’s 3-in-1 COVID-19/Flu A&B /rapid Test Kit for self-testing 
at home. The test provides results within 15 minutes, and is the first OTC rapid antigen test 
for COVID-19 and influenza A & B in the U.S.  
Wondfo USA offers its WELLlife COVID-19/Influenza A&B Home Test. The test provides 
a 3 in 1 result in only 10 minutes. It is suitable for treating individuals aged 2 and older within 
the first 5 days of symptom onset.  
WatmindUSA offers its SpeedySwab COVID-+ FLU A&B Self-Test for use at the point of 
care and OTC. The test provides results within 15 minutes and is designed for individuals 
aged 2 and older.   
Healgen markets its POC COVID-19/Flu A&B Ag Combo Rapid Test Cassette, a lateral flow 
assay for the qualitative detection and differentiation of SARS-CoV-2 and flu A&B 
nucleocapsid protein antigens.  
bioMérieux provides a CLIA waiver for its BIOFIRE SPOTFIRE respiratory/sore throat 
panel mini.  The product is a multiplex PCR test that detects five of the most common viral 
and bacterial causes of respiratory or sore throat infections in about 15 minutes.  
FDA granted Nano-Ditech EUA for its Flu/COVID Dual POC test. The test is designed for 
the detection and differentiation of SARS-CoV-2, influenza and influenza B antigens.  
QIAGEN offers its QIAstat-Dx Respiratory Panel Mini. Results are available within one 
hour.  

 
 
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Sepsis and Nosocomial Disease 
Diagnosing sepsis is particularly challenging in its early stages, when timely intervention is 
most critical, because its clinical presentation of fever, respiratory distress, and circulatory 
instability which overlaps with many other acute conditions. As a result, recent advances in 
sepsis diagnostics have focused on improving speed and accuracy through pathogen 
detection, resistance profiling, and host-response biomarkers associated with bloodstream 
infections. 
Multiplex molecular panels have become central to rapid organism identification following 
blood culture positivity. bioMérieux’s BIOFIRE BCID2 panel provides broad detection of 
sepsis-related bacterial and fungal pathogens, along with key antimicrobial resistance 
markers, enabling actionable results in approximately 1 hour. Roche’s cobas eplex blood 
culture identification panels similarly support rapid identification and resistance gene 
detection, reflecting the continued evolution of syndromic testing in microbiology 
laboratories. 
Direct-from-blood diagnostic approaches have also gained attention by eliminating the need 
for prior blood culture. T2 Biosystems’ T2Candida and T2Bacteria panels use a magnetic 
resonance-based platform to detect fungal and bacterial pathogens directly from whole blood, 
allowing earlier identification of causative organisms in patients with suspected sepsis. 
Host--response and biomarker-based diagnostics are expanding the clinical toolkit. Beckman 
Coulter’s Access procalcitonin assay is widely used to support assessment of infection 
severity and risk of progression to severe sepsis or septic shock. Newer approaches focus on 
immune response profiling rather than pathogen detection alone. Cytovale’s IntelliSep test 
evaluates biophysical changes in immune cells to aid rapid sepsis diagnosis in emergency 
settings, delivering results in approximately ten minutes. Inflammatix’s TriVerity system 
combines gene expression analysis with an integrated instrument platform to distinguish 
bacterial from viral infections and assess sepsis risk in about 30 minutes. 
Emerging technologies continue to push toward faster, culture-free detection. Deepull 
Diagnostics is developing the UllCORE bloodstream infection test, a molecular platform 
designed to identify a broad range of pathogens directly from whole blood in roughly one 
hour, although it remains in advanced development and regulatory review as of 2026. 
Despite these advances, many sepsis diagnostic solutions still rely on centralized laboratory 
infrastructure and molecular workflows. Ongoing innovation focuses on simplifying testing, 

 
 
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reducing turnaround times, and expanding point-of-care capabilities, including integrating 
compact platforms and host-response diagnostics to enable earlier clinical decision-making 
and improved patient outcomes. 
Sexual Health 
Chlamydia and gonorrhea testing has largely transitioned to molecular methods due to the 
invasiveness and lower sensitivity of culture-based approaches and the limited clinical utility 
of serology. Nucleic acid amplification tests now dominate the market, offering high 
sensitivity, rapid turnaround times, and the ability to use non-invasive specimens such as 
urine and vaginal swabs. 
Becton Dickinson offers a broad portfolio of molecular STI diagnostics across its BD MAX 
and BD Viper platforms. The BD MAX system supports assays for chlamydia and gonorrhea 
as well as a vaginitis panel that detects bacterial vaginosis, vulvovaginal candidiasis, and 
Trichomonas vaginalis. The BD Viper system continues to support established ProbeTec 
assays for chlamydia, gonorrhea, and trichomoniasis. HPV testing is addressed separately 
through BD’s Onclarity assay on the COR system. 
QuidelOrtho provides molecular and near-point-of-care STI testing through its AmpliVue 
and Solana platforms. AmpliVue assays detect Group B Streptococcus and herpes simplex 
virus, while the Solana system offers rapid Trichomonas testing via isothermal amplification. 
The company previously developed the Savanna platform as a cartridge-based multiplex 
PCR system intended for point-of-care testing across sexually transmitted infections and 
women’s health applications; however, in 2025, QuidelOrtho announced it would 
discontinue further development of the platform and shift its molecular diagnostics strategy 
toward next-generation ultra-fast PCR technologies. As a result, Savanna is no longer 
considered an active emerging point-of-care platform in the STI diagnostics market. 
Cepheid is a major player in POC molecular STI testing with its Xpert CT/NG assay on the 
GeneXpert platform, delivering results in approximately 90 minutes. The company has also 
expanded its women’s health menu with the Xpert Xpress MVP panel, which detects 
bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis from a single sample. 
Point-of-care molecular testing has advanced significantly with the introduction of rapid, 
CLIA-waived systems. binx health’s io platform provides chlamydia and gonorrhea results 
in about 30 minutes directly at the point of care. Visby Medical has further extended access 

 
 
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with a fully self-contained, at-home molecular test for chlamydia, gonorrhea, and 
trichomoniasis that delivers results in approximately 30 minutes. 
Centralized high-throughput molecular testing remains important, with QIAGEN’s 
NeuMoDx systems providing fully automated PCR-based detection of chlamydia and 
gonorrhea in laboratory settings. Additional specialized systems, such as Bosch’s Vivalytic 
platform, provide multiplex detection of organisms, including Mycoplasma genitalium and 
Ureaplasma species. 
Beyond pathogen detection, serological and biomarker-based assays are important in STI 
management. Bio-Rad’s BioPlex 2200 system provides multiplex syphilis testing, while 
consumer diagnostics expand access to screening. NOWDiagnostics’ First To Know test 
represents the first FDA-authorized over-the-counter rapid syphilis test for home use, 
delivering results from a fingerstick sample in approximately 15 minutes. 
Roche offers its cobas liat sexually transmitted infection multiplex assay panels. The panels, 
which include tests for chlamydia, gonorrhea, and mycoplasma genitalium, will be identified 
from a single sample.  The cobas liat CT, NG, and MG STI assays further expand and 
complement the company's portfolio of solutions for point-of-care diagnostics. 
Visby Medical markets its OTC molecular test for chlamydia, gonorrhea and trichomoniasis. 
The test can be purchased without a prescription and provides results in 30 minutes. This is 
the first test for chlamydia, gonorrhea and trichomoniasis that can be performed entirely at 
home.  
Waters offers one of the most comprehensive at-home Cervical Cancer screening tool HPV 
in the U.S. The FDA-cleared Onclarity HPV Self Collection Kit with extended genotyping 
for at-home use expands access to cervical cancer screening.  The kit is tested with the BD 
Onclarity HPV Assay and processed on the BD COR System.  
Lyme Disease 
QuidelOrtho markets its POC Sofia Lyme FIA for the rapid differential detection of human 
IgM and IgG antibodies to Borrelia burgdorferi serum and plasma specimens. 

 
 
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Reagena offers the ReaScan CXCL13, a new diagnostic tool for rapid Lyme disease testing. 
ReaScan CXCL13 is an immunochromatographic rapid test for the detection of chemokine 
CCXCL13 in human cerebrospinal fluid. Results are available in 20 minutes. 
The table below displays a selection of molecular POC diagnostic tests for infectious diseases 
that have emerged in recent years.  
COVID-19 
The U.S. Food and Drug Administration continues to evaluate and transition COVID-19 
diagnostics from emergency use authorization to traditional clearance pathways, with a clear 
shift toward multiplex respiratory testing. The COVID-19 testing market has evolved into a 
broader respiratory diagnostics segment, in which combination tests for SARS-CoV-2, 
influenza A/B, and RSV are now widely available in laboratory, point-of-care, and at-home 
settings. This reflects ongoing clinical demand to differentiate respiratory pathogens with 
overlapping symptoms using a single test. A number of rapid antigen and molecular 
multiplex assays have entered the market, including products from companies such as Pfizer 
(Lucira), Visby Medical, and Aptitude Medical Systems, offering increasingly portable, user-
friendly formats with turnaround times of approximately 15 to 30 minutes. 
Molecular point-of-care systems have continued to gain traction, with platforms such as 
Nuclein’s DASH system providing rapid PCR-based detection of SARS-CoV-2 and 
influenza at the POC, and ongoing menu expansion into additional respiratory and infectious 
disease targets. High-throughput laboratory systems, including Hologic’s Panther platform 
with the Aptima SARS-CoV-2 assay, are important for centralized testing, particularly in 
hospital and reference laboratory settings. Rapid antigen testing also remains widely used, 
particularly in home and decentralized settings, with ongoing product introductions and 
incremental performance improvements. 
The market has matured significantly since the peak of the pandemic, with reduced overall 
testing volumes and consolidation among manufacturers. New product development is now 
focused less on standalone COVID-19 tests and more on multiplex panels and improved 
usability, including integration with digital reporting and connectivity tools. A key trend is 
the continued expansion of respiratory multiplex panels beyond COVID-19 and influenza to 
include RSV and, in some cases, broader pathogen menus, positioning testing as 
comprehensive respiratory panel diagnostics rather than single-pathogen detection. Demand 
has also become more seasonal, with testing volumes increasing during peak respiratory 

 
 
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illness periods as healthcare providers use multiplex testing to guide patient management and 
isolation decisions more efficiently. For additional information on the multiplex market, see 
Kalorama Information’s Worldwide IVD Panel-Based Testing: Respiratory/Non-
Respiratory, 2020-2030. 
There is also a growing adoption of at-home molecular testing, expanding beyond traditional 
antigen-based formats and bringing higher-sensitivity testing into the home environment. 
Connectivity and digital health integration are also becoming more important, with many 
systems linking results to mobile applications, telehealth platforms, and public health 
reporting systems. Manufacturers continue to focus on reducing turnaround times and 
simplifying workflows, with many newer platforms offering true sample-to-answer testing 
with minimal user intervention, making them increasingly practical for decentralized settings 
such as clinics, pharmacies, and home use. Overall, the respiratory diagnostics market in 
2025–2026 reflects a transition from emergency-driven COVID-19 testing to a more stable, 
multiplex-driven system that integrates rapid, molecular, and connected testing solutions 
across care settings. 

 
 
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Market Size and Growth 
The world market for rapid infectious disease tests is estimated at $4.8 billion in 2025. With 
a 7.2% CAGR, this is expected to reach $6.8 billion in 2030. COVID-19 testing has leveled 
off and now reflects a market that is not dominated by COVID-19 testing, but still contributes 
19% of the market. The tests most commonly performed are influenza, HIV, STDs, hepatitis, 
Strep A, and respiratory viruses, which showed the most gains. 
Traditionally, one of the largest segments within POC infectious disease diagnostics is 
influenza testing and the overall value of the sector is influenced by the demand for tests 
during the influenza season.  Overall, rapid testing for respiratory represents the largest group 
of test sales – consisting of influenza, COVID-19, and other respiratory – 54% total market 
share. 
Point-of-Care OTC and Professional Use Immunoassays 
The POC market includes the following segments: 
• patient self-testing / OTC products 
•  rapid tests used in a professional setting—POL, home care, clinic, etc. 
•  rapid tests performed in the hospital 
This market analysis estimates IVD company sales of POC tests, including those in the home 
or OTC market and those used by professionals in hospitals, POLs, clinics, etc.  It is beyond 
the scope of this report to separate POC tests run in the hospital from those in physician 
offices and other patient care sites.  These two segments are pooled as a professional POC.   
The analysis does not include workplace and criminal justice POC tests and services for drug 
abuse testing, which generate approximately $1.2 billion in sales (2025), with more than half 
of those sales generated in the United States.   
This chapter covers OTC immunoassays and those performed by professionals in hospitals, 
physician office labs and clinics.  Blood glucose testing is covered in Chapter 5, infectious 
disease immunoassays are discussed in Chapter 11 and POC tests for routine chemistries are 
discussed in Chapter 5.   

 
 
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In 2025, the U.S. market accounts for 45%, the European market accounts for approximately 
31% of the worldwide market, Japan represents 5% and the ROW accounts for the remaining 
19% of the market.  Despite market growth outside the U.S., the country remains the largest 
market for POC immunoassays. 
Table 5-14: Global POC Immunoassay Sales Distribution, by Region, 2025 (%) 
 
[Europe; Japan; United States; Rest of World] 
 Region 
% Mkt 
United States  
45% 
Europe 
31% 
Japan 
5% 
RoW 
19% 
Total 
100% 
Source: Kalorama Information 
The global market for all POC immunoassay tests (OTC and professional tests) is estimated 
at $6.5 billion in 2025, with an average annual growth rate of 3.2%. The global market for 
POC immunoassays is expected to reach $7.6 billion by 2030.  
Growth in the global POC immunoassay market will be driven by: 
• OraSure Technologies' sales of the most successful saliva-based OTC tests. 
• HbA1c sales will show strong performance through the forecast period of 8.5% 
CAGR to support growth in the professional sector  
• The most widely used patient self-tests are for pregnancy and ovulation. 
• Manufacturers anticipated consumer acceptance of tests for occult blood, cholesterol, 
HIV, coagulation/PT and H. pylori.   
• Online test services have proliferated for cholesterol, HbA1c and infectious diseases. 
The consumer buys a kit, sends the sample to a lab and then receives a test result 
(home-based collection, lab processed).  

 
 
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• Outside North America, consumers will find OTC tests for a wider range of analytes, 
including allergens, TSH, and FSH. 
Worldwide, there has historically been a perception that POC tests are more expensive than 
centralized laboratory testing and that results generated outside the core lab may not always 
be fully integrated into the patient’s longitudinal medical record. While cost per test is often 
higher for POC assays, this view has evolved as healthcare systems increasingly recognize 
the value of faster turnaround times, improved clinical decision-making, reduced length of 
stay, and more efficient patient throughput. Concerns about loss of results to the historical 
record have also diminished significantly, as most modern POC systems now incorporate 
connectivity solutions that transmit results directly into laboratory and hospital information 
systems and, increasingly, into broader digital health and telehealth platforms. 
Earlier concerns about poor correlation between POC and laboratory-based testing have 
improved, although variability can still exist depending on the analyte and clinical context. 
For many commonly used assays, including blood gases, glucose, and cardiac markers, 
correlation with central laboratory systems has strengthened due to advances in technology, 
calibration, and standardization. However, differences in sample type, methodology, and 
clinical use still require careful validation and, in some cases, institution-specific correlation 
protocols. 
From a technical standpoint, data communication is now largely well established. Most major 
POC system manufacturers provide integrated data management platforms that support 
connectivity, operator management, quality control tracking, and regulatory compliance. 
Many health systems have implemented centralized POC governance programs, typically led 
by the laboratory, to oversee device selection, training, competency assessment, and 
standardization across multiple care settings. 
Market acceptance, however, remains influenced by operational factors. Device 
maintenance, quality-control requirements, operator training, and oversight remain primary 
challenges, particularly in decentralized environments involving non-laboratory personnel. 
Operator error and workflow variability remain real-world issues despite technological 
improvements, reinforcing the need for ongoing training and system safeguards such as 
operator lockouts and automated QC checks. Newer technologies are addressing these 
barriers. Advances in microfluidics and lab-on-a-chip designs are moving toward simplified, 
sample-to-result workflows with minimal user intervention, incorporating built-in 
calibration, internal quality checks, and connectivity. 

 
 
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Adoption of next-generation POC systems is increasingly tied to demonstrating clear clinical 
and economic value. While the technology continues to advance, broader uptake depends on 
reimbursement, workflow integration, and the ability to show measurable improvements in 
patient outcomes and operational efficiency. POC testing continues to evolve toward a more 
connected, standardized, and value-driven model that offers decentralized care while 
maintaining laboratory-level quality oversight. 
The market for POC tests is highly diversified and, in many instances, a different set of 
companies is active in each sub-segment. A review of POC company revenues is provided in 
Chapter 5. 
 
 

 
 
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Table 5-15: Global POC Immunoassay Test Sales, by Test Category, 2025-2030 ($ million)  
 
[OTC/Self Tests (Drugs of Abuse; H. pylori; HIV; Infectious Disease/COVID-19; Pregnancy/Ovulation; 
Other) and Professional POC (Cardiac Markers; Drugs of Abuse; HbA1c; Infectious Disease/COVID-19; 
Pregnancy; Other)] 
Test Category 
2025 
Mkt % 
2030 
Mkt % 
CAGR 
OTC/Self Tests 
Pregnancy/Ovulation 
970 
32% 
1,030 
27% 
1% 
Drugs of Abuse 
37 
1% 
43 
1% 
3% 
HIV 
20 
1% 
24 
1% 
4% 
H. pylori 
6 
0% 
7 
0% 
3% 
Other Infectious Disease  
(inc. COVID-19) 
1,876 
61% 
2,468 
65% 
6% 
Other* 
168 
5% 
209 
6% 
4% 
OTC/Self Total 
3,077 
100% 
3781 
100% 
4% 
 
 
 
 
 
 
Test Category 
2025 
Mkt % 
2030 
Mkt % 
CAGR 
Professional POC 
Infectious Disease 
953 
28% 
747 
20% 
-5% 
Cardiac Markers 
751 
22% 
895 
24% 
4% 
HbA1c 
615 
18% 
925 
24% 
9% 
Drugs of Abuse 
506 
15% 
556 
15% 
2% 
Pregnancy 
170 
5% 
175 
5% 
1% 
Other** 
413 
12% 
500 
13% 
4% 
Professional POC Total 
3,408 
100% 
3,798 
100% 
2% 
Note: * Other = UA, FSH, TSH, etc. 
Note: ** Other = TSH, PSA, FSH, cancer, etc. 
Note: Percentages may not add to 100% due to rounding. 
Source: Kalorama Information 

 
 
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The latest trend to overcome reticence for self-testing is direct-to-consumer marketing of lab 
tests in public venues such as malls and supermarkets.  This is primarily a phenomenon of 
North America. COVID-19 has influenced the uptake of self-testing.  Elsewhere in the world, 
many community labs provide tests requested by consumers.  Currently, there are over 2,000 
walk-in medical clinics in the U.S. in drug and big-box stores and supermarkets, including 
CVS, Walgreens, Target, and Kroger. 
Collaborations between the hospital and retail world are proliferating.  The line between 
hospital and retail clinic continues to blur, with a new partnership between one of the nation’s 
most prominent health systems and one of its most popular merchants. 
Some pioneering U.S. hospitals are forming partnerships with retail clinics to further their 
reach. Some are finding other alternatives to emulate the convenience and affordability of a 
retail clinic, whether through renting space in a Walmart, starting their own clinic chains, or 
offering primary care at more convenient hours. 
A selection of immunoassays developed for self-testing is presented below.  Of particular 
interest are the variety of new tests that appeal to special interest groups, such as sleep apnea 
screening, breast milk assessment, and pregnancy evaluation. This is not a complete list, as 
new self-test immunoassays for various tests are entering the market regularly.  

 
 
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Table 5-16: Selected Self-Test Immunoassay Innovations 
Company 
Location 
Area 
Details 
AESKU. Diagnostics 
Germany 
calcium 
Test4D LFIA POCT for calcium, thyroid markers 
Biomerica 
U.S. 
microalbumin 
Fortel Microalbumin Screening, urine 
Fertility Focus 
UK 
LH 
OvuSense Fertility Monitoring Device, saliva  
Happy Vitals 
U.S. 
nutrition 
DTC home testing kit for breast milk 
HealthTab 
Canada 
wellness 
pharmacy-based on-site, 21 routine markers  
NanoSpeed Diagnostics 
U.S. 
calcium 
Test4D LFIA POCT for calcium, thyroid markers 
NanoSpeed Diagnostics 
U.S. 
vit D 
Test4D LFIA POCT for 25-hydroxyvitamin D 
NuSomnea 
U.S. 
apnea 
Easy Peezy Pee Test, sleep apnea, urine  
Purity Laboratories 
U.S. 
vit D 
Vitamin D blood spot test, home test sent to lab  
Source: Kalorama Information 
This group of offerings spans consumer wellness testing, femtech devices, early-stage POCT 
platforms, and legacy rapid assays, with relatively few representing fully validated, regulated 
clinical diagnostics. Many entries reflect the continued convergence of home testing, 
pharmacy-based screening, and early biomarker quantification technologies, rather than 
traditional IVD pathways. 
Pregnancy Testing 
The most widely used professional and patient self-tests (OTC) for women’s health are for 
pregnancy and ovulation. The professional sector comprises tests used in hospitals, 
physicians' offices, and clinics.  In 2025, the professional sector generated $170 million in 
sales and, with an average revenue increase of < 1%, will reach $175 million in 2030.  The 
market leader in the professional sector is QuidelOrtho, with a reported share of half the U.S. 
market.  Other players include Meridian Biosciences, Trinity Biotech, bioMérieux and many 
more. 
The OTC sector for pregnancy and ovulation (LH) includes tests available in pharmacies and 
other retail establishments.  This POC test segment is mature and highly competitive.  In 

 
 
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2025, this sector generated $970 million in sales and, with a 1.2% increase in revenue, will 
total $1,030 million in 2030.  At least 20 companies are active in the largest self-test segment, 
except for glucose self-testing. 
The top vendors are: Swiss Precision Diagnostics (SPD), Church & Dwight and QuidelOrtho. 
Furthermore, all major pharmacy chains sell their own home-brand test kits, manufactured 
by leaders and other OEMs.  These private brands sell for half the price of brand-name kits, 
typically $5-$10 versus $10-$15. 
Innovation in this mature market comes from the introduction of digital test devices. SPD’s 
Clearblue digital pregnancy test with Conception Indicator rapid pregnancy test also 
indicates an approximate date of conception.  If the test is positive, “Pregnant” will be 
indicated in words on the display along with the Conception Indicator result. This is displayed 
as an estimate of how many weeks have occurred since conception: 1-2 weeks, 2-3 weeks, 
or 3+ weeks.  Digital tests retail for approximately $1 above other brand-name pregnancy 
tests.  
Rapid pregnancy tests are also used in hospital settings and health clinics.  A pregnancy test 
is performed in hospital emergency departments when a woman may be slated for an 
emergency surgery or another intervention where it is important to know if she is pregnant.  
Early detection of pregnancy is also important for caregivers in order to avoid certain 
medications and procedures that could harm a fetus.   
The pregnancy hormone hCG can be detected in urine or blood after implantation, which 
occurs 6 to 12 days after fertilization.  Quantitative blood tests can detect hCG levels as low 
as 1 mIU/mL, while urine test strips have published detection thresholds of 10 mIU/mL to 
100 mIU/mL, depending on the brand.  Therefore, blood-based tests can detect pregnancy 
approximately two to eight days earlier than commonly available urine-based tests. 
Most commercially available rapid pregnancy test immunoassays are validated for use with 
urine and serum, but not whole blood.  In light of the critical need for reliable early pregnancy 
detection, several whole-blood rapid pregnancy tests have been commercialized. 
Now Diagnostics Inc. markets the CE-marked and FDA CLIA-waived AdexusDx human 
chorionic gonadotropin (hCG) point-of-care test.  It uses a single drop of capillary or whole 
blood. 

 
 
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Abbott Laboratories’ i-STAT Total β-hCG test cartridge is a whole-blood, quantitative, 
handheld pregnancy test available for patient testing. 
Sekisui launched the OSOM Ultra hCG Test which provides qualitative hCG results in 3-5 
minutes with highly accurate results. The OSOM Ultra hCG Combo Test detects hCG B-core 
fragments, reducing the interference when testing urine samples from later stages of 
pregnancy. 
bioMérieux offers two ranges of rapid tests for pregnancy and fertility. The VIKA fertility 
panel and Bionexia hCG Urine and Bionexia hCG Combo panels. 
Actim Oy offers the Actim PROM to detect premature rupture of fetal membranes. Actim 
PROM identifies even the smallest rupture, and it can be used on all pregnant women, even 
those with bleeding. The results are available in five minutes. 
Salignostics offers SaliStick, the first rapid saliva-based pregnancy test. The test is based on 
the company’s proprietary technology, which detects the pregnancy hormone β-hCG. The 
test uses a lateral flow immunoassay platform.  Abingdon Health will distribute the test in 
the EU.  
Cardiovascular Diagnostics 
Despite improvements in treatment and increased public awareness about prevention, 
cardiovascular disease (CVD) is still the leading cause of death worldwide. CVD causes half 
of all deaths in several developed countries and is the major cause of adult death in many 
developing countries.  More importantly, many cardiovascular events aren't fatal but may be 
sufficiently debilitating to seriously affect functional ability.  The World Health Organization 
(WHO) estimates that 25% to 30% of the cardiovascular disease burden arises from disabling 
sequelae of stroke or other forms of heart disease.  
Cardiovascular diagnostics are used in a number of situations and POC tests play an 
important role in both of these areas of medicine.  Physicians use cardiac markers in two 
ways: to diagnose a cardiac event in a hospital emergency room or to evaluate the risk of a 
cardiovascular event occurring. 
The majority of cardiovascular diagnostics are performed in the laboratory on a variety of 
systems, including POC devices, specialized coagulation and immunoassay instrumentation, 

 
 
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chemistry/immunoassay workstations, and molecular test systems.  High-volume analytes 
such as acute myocardial infarction enzymes, cholesterol, HDL, LDL, hsCRP, BNP, and 
homocysteine are available for use on chemistry/immunoassay workstations.   
The most commonly used acute-care cardiac tests at the POC are troponins and BNP.  Many 
of these tests, though designed for use outside the main laboratory, are used for rapid testing 
inside the lab.  Problems associated with quality control and training non-laboratory staff 
have scared off many would-be users.  To avoid these issues, many hospitals have installed 
rapid testing systems in laboratories or established dedicated POC testing teams. 
In the global POC cardiac markers test market, Roche is the market leader with about 23% 
Siemens Healthineers is second with 22%, QuidelOrtho with approximately 18% market 
share, and Abbott is fourth with 17%.  Others include Response Biomedical, a small company 
that develops, manufactures and markets rapid on-site diagnostic tests for use with its RAMP 
System for clinical and environmental applications.  The RAMP System consists of a 
portable fluorescent reader and single-use, disposable test cartridges.  
An aging population, combined with technological advancements, is fueling this growth as 
health care providers seek ways to meet demand for high levels of service more cost-
effectively.  Approximately 2.6 million people die of CVD each year in the seven leading 
countries: France, Germany, Italy, Japan, Spain, the UK, and the U.S.  Thus, the market for 
CVD tests is concentrated in the developed world.  One can therefore expect that these 
countries account for about 85% of product sales, with the ROW accounting for the 
remaining 12%.  The U.S. and Canada markets make up 45%, European countries 37% and 
Japan 6%.   
A burgeoning middle class in Latin America, India, Asia Pacific, and the Middle East 
accounts for about 10%-12% of the market, with the rest of the world accounting for the 
remaining share.  From 2025 to 2030, no significant change in the geographic breakdown of 
cardiac IVDs is anticipated.   
Drugs of Abuse/Therapeutic Drug Monitoring 
Medical tests for toxicology and drugs of abuse are usually done as a panel on overdose and 
trauma patients brought into emergency and include: a screen for alcohol, acetaminophen, 
salicylates, tricyclic antidepressants and individual tests for amitriptyline, amphetamines, 

 
 
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barbiturates, benzodiazepines, cannabinoids, cocaine and metabolites, antidepressants, LSD, 
methadone, methamphetamine, morphine, opiates and PCP.   
These same tests are available to consumers who want to test friends and family members 
for drug use.  They are also used for workplace drug screening and criminal justice markets.  
This market analysis does not include workplace and criminal justice applications of POC 
drug abuse tests, but these are included in table 2-1 to provide some sense of the marketplace.   
In the past few years, there has been an increasing transition from instrumented screening for 
drugs to testing with disposable devices.  The leader in instrumented tests is Siemens 
Healthineers’ Syva products.  
Kalorama estimates the market for POC drug tests performed by professionals for medical 
purposes and for home testing was $506 million and $37 million, respectively, in 2025.  Close 
to 49% of the market is held in the U.S.  In the U.S., all major drugstore chains and retail 
outlets such as Walmart now offer urine test kits that can detect marijuana, cocaine, ecstasy 
and a variety of other drugs.  
The first generation of LF drug-testing kits used a urine sample.  More saliva drug tests have 
come to market.  They continue to gain market acceptance because saliva is less invasive 
than urine. The leading companies for saliva drug tests are Branan Medical, Interleukin 
Genetics, Quest, OraSure Technologies and Abbott. 
Therefore, Kalorama estimates that drugs of abuse testing using POC devices (professional 
and OTC) will grow to $543 million in 2030, with the major growth coming from developed 
nations. 
 
 

 
 
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Table 5-17: Infectious Disease POC Test Demand, by Type, 2025 (%) 
 
[C. difficile; COVID-19; E. coli; H. pylori; Hepatitis; HIV; Home Test/OTC; Influenza; Malaria; Other 
respiratory; STD; Others] 
Type 
Demand 
COVID-19 
18.8% 
 Influenza  
18.7% 
Other respiratory 
16.7% 
 STD   
7.7% 
 HIV   
6.1% 
 Hepatitis   
6.1% 
C. difficile 
4.3% 
 Malaria   
4.2% 
 E. coli   
2.2% 
H. pylori 
2.0% 
 Home Test/OTC   
0.9% 
 Others   
12.3% 
Total 
100% 
Source: Kalorama Information 
In 2025, the U.S. holds about 45% of this market, primarily because POC testing in Europe 
is underdeveloped. Furthermore, tests used in developing countries are often purchased under 
government programs at discounted prices, which limits growth in RoW markets.  

 
 
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Table 5-18: Infectious Disease POC Test Sales Distribution, by Global Region, 2025 (%) 
 
[Europe; Japan; United States; Rest of World] 
 Region 
% Mkt 
United States 
45% 
Europe 
31% 
Japan 
5% 
RoW 
19% 
Total 
100% 
Source: Kalorama Information 
The market leader in all POC testing is Abbott, with approximately 30% market share in 
2025. Dexcom commands 12.8% and Roche holds 6.5%. This is a very fluid market that 
changes with the severity and type of infectious diseases that are present. There are about 
50+ companies that offer infectious disease testing in 2025.   

 
 
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Diabetes Testing – Blood Glucose Monitoring 
Diabetes continues to pose a major global health threat, with incidence and complications 
increasing at alarming rates. According to the International Diabetes Foundation, 
approximately 589 million people worldwide were living with diabetes as of 2025. This 
number is expected to surge, with diabetes-related deaths projected to rise within the next 
decade. WHO now refers to the condition as a global diabetes epidemic. 
The burden is especially evident in Europe, where the International Diabetes Federation 
(IDF) reported that 65 million adults had diabetes in 2025. This number is forecasted to reach 
67 million by 2030, reflecting steady growth driven by aging populations, sedentary 
lifestyles, and poor dietary habits. 
In the United States, diabetes remains a leading cause of death. According to the American 
Diabetes Association, the disease is directly responsible for more than 102,000 deaths 
annually and contributes to over 282,000 deaths each year. 
The IDF Diabetes Atlas provides a stark view of the escalating crisis. By 2025, diabetes is 
expected to affect 11% of the world’s adult population, driven in large part by the adoption 
of unhealthy lifestyles in developing countries. Currently, about 7 million new cases of 
diabetes are diagnosed each year. The number of people living with diabetes globally has 
ballooned from 30 million two decades ago to 589 million today, and the trajectory shows 
no sign of slowing. 
This growing epidemic presents significant economic and healthcare challenges. The IDF 
estimates that global diabetes-related healthcare expenditures exceed $1 trillion annually. 
Even more concerning is the estimated 252 million people who remain undiagnosed—many 
living in low- and middle-income countries with limited access to adequate care. These 
individuals are at elevated risk of severe complications, including cardiovascular disease, 
kidney failure, blindness, and limb amputations. 
Geographically, the burden of diabetes is uneven but widespread. China leads the world in 
the total number of people affected, with cases projected to rise from 148 million in 2024 to 
151 million by 2045. However, the highest prevalence rates are observed in the Western 
Pacific region, particularly in Tokelau, Micronesia, and the Marshall Islands, where over a 
third of adults are affected. 

 
 
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In the Middle East and North Africa (MENA) region, countries such as Kuwait, Saudi Arabia, 
and Qatar rank among the top 10 globally for diabetes prevalence. Collectively, over 34.6 
million people in the MENA region have diabetes, accounting for 10.9% of the global 
diabetic population. Treating these patients places a heavy burden on regional healthcare 
systems, with annual costs exceeding $12 billion. 
Table 5-19: Glucose POC Test Sales Distribution, by Global Region, 2025 (%) 
 
[Europe; Japan; United States; Rest of World] 
 Region 
% Mkt 
United States 
45% 
Europe 
30% 
Japan 
3% 
RoW 
22% 
Total 
100% 
Source: Kalorama Information 
Low-cost test strips for all the major players are available on a myriad of web-based vendors, 
including eBay, Amazon, and others. It is estimated that these and other direct-to-consumer 
channels for all meter brands own about 25% of the market. 

 
 
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Figure 5-1: POC Glucose Testing Market Growth, by Category, 2025-2030 (%) 
 
[Continuous; HbA1c POC, Professional; OTC; Professional] 
 
Source: Kalorama Information 
Kalorama anticipates that with increased testing in emerging markets, increased HbA1c and 
increased continuous glucose monitoring segment, along with intensive government 
programs that alert the public to the urgency of being screened for diabetes, the market for 
POC blood glucose testing will be worth $23.3 billion in 2025 and will maintain demand to 
reach $32.9 billion by 2030. 
IT to Aid Diabetes Management 
People with diabetes, especially children and adolescents, often find it difficult to control 
their blood glucose level on a daily basis. There are quite a few factors for diabetics to 
consider when monitoring and regulating glucose levels: diet and exercise, how much insulin 
is necessary, the time since the last dose, current glucose levels, and past glucose levels; it’s 
quite a bit to manage. 

 
 
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One solution to help make these important decisions is glucose-testing meters linked to 
sophisticated algorithms, either on a computer or on a mobile phone. Glucose monitors are 
considered Class III medical devices by the FDA, which requires the highest amount of 
regulatory scrutiny. However, the agency loosened restrictions on software that displays 
glucose monitor data on mobile devices and smartwatches. Now the software simply has to 
be registered with the FDA and will not require prior marketing approval. Part of the reason 
for this is that do-it-yourself free applications had appeared and were used without adverse 
events. 
Thus, the newest generation of glucose meters differentiate themselves by providing a long-
sought value-added feature. They are interactive and provide more information than just a 
glucose result, thus allowing patients to participate in tight glucose control. Some of the 
features include glycemic variability score, a tool often used to show how often blood sugar 
changes over a period of time and how intense these fluctuations are. Mealtime tagging 
before and after meals provides more useful information when analyzing glucose readings. 
Meters alert users when their blood glucose result falls within their pre- and post-meal target 
ranges, encouraging tighter control. These tools give a complete picture of the effectiveness 
of drug therapy, as well as how exercise and food portions affect blood glucose and energy 
levels. 
The table below presents a selection of apps and glucose-management information 
technology tools announced in the past few years. 

 
 
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Table 5-20: Selected Apps and Glucose Management IT 
Company 
Location 
Type 
Details 
Abbott 
US 
app 
diasend (Sweden) connected app for Abbott's FreeStyle Libre 
Biomedtrics, Inc. 
US 
app 
ditto Glucose Data System, meter connect to phone app 
DexCom 
US 
app 
Dexcom’s Apple Watch app & G5 CGM System 
diasend (Sweden) connected app for G7 CGM System 
Asante Solutions' pump data with DexCom mobile app 
Diasend AB 
Sweden 
app 
diasend Connected Apps 
Entra Health Systems 
US 
glucose mgmt 
MyHealthPoint, online portal, glucose mgmt 
Glytec 
US 
glucose mgmt 
eCMS, Glucommander glucose management IT 
iHealth Lab Inc. 
US 
app 
iHealth Align & iHealth Gluco-Smart app 
LabStyle Innovations 
Israel 
app 
Dario app on iOS 
Medtronic Inc. 
US 
glucose mgmt 
Sugar.IQ smart diabetes assistant, with IBM Watson Health 
app 
Medtronic MiniMed Connect meter to pump on iOS/Android 
Tactio Health Group 
Canada 
app 
TactioDiabetes, a diabetes management app 
Tandem Diabetes Care 
US 
app 
t:simulator app insulin pump connect 
TelCare Inc. 
US 
glucose mgmt 
TelCare BGM automatic connect to glucose mgmt team 
Source: company reports, Kalorama Information 
Diabetes Market Analysis 
The POC glucose testing market remains highly competitive, with companies continually 
introducing features to differentiate their products. Beyond alternate-site testing on forearms, 
thighs, and other locations, modern meters now focus on enhanced usability, with larger 
screens, tactile buttons, and voice-assisted functions. High-end devices integrate glucose 

 
 
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management programs, nutrition guidance, alerts, and connectivity features to help users 
interpret results and take proactive steps in managing their condition. Despite these advances 
in user experience and support tools, the underlying testing technology, such as enzyme strips 
and electrochemical detection, has changed very little since the earliest meters. In clinical 
practice, debates continue over the interpretation of results, as critical value cutoffs vary 
widely across institutions. 
The lure of this large market attracts more and more new products, innovations, and new 
vendors.  In 2025, it is estimated that more than 50 companies worldwide market a glucose 
meter, and more than 100 companies participate in the glucose market overall. The table 
below summarizes the market for diabetes testing outside the central laboratory.  
Table 5-21: Global Diabetes Sales, by Test Category, 2025-2030 ($ million) 
 
[Glucose OTC; Glucose, continuous; HbA1c Lab; HbA1c POC] 
Test Category 
2025 
% Market 
2030 
% Market 
CAGR 
Glucose, continuous 
12,458 
53% 
20,600 
63% 
10.6% 
Glucose OTC 
6,693 
29% 
7,020 
21% 
1.0% 
Glucose Professional 
2,272 
10% 
2,640 
8% 
3.0% 
HbA1c POC 
615 
3% 
925 
3% 
8.5% 
Subtotal 
22,038 
94% 
31,185 
95% 
7.2% 
HbA1c Lab 
1,342 
6% 
1,700 
5% 
4.8% 
Total 
23,380 
100% 
32,885 
100% 
7.1% 
Source: Kalorama Information 
Kalorama anticipates that, with increased testing in emerging markets and intensive 
government programs that alert the public to the urgency of screening for diabetes, the market 
for POC blood glucose testing will grow.  The glucose OTC self-testing portion of this market 
accounts for roughly $6.7 billion in 2025 and, with 1.3% CAGR, will reach an estimated $7.0 
billion in 2030. This conservative projection of the self-testing market is due to pricing 
strategies that continue to reduce the cost of meters and strips. Further, European payers 
continue to restrict support for glucose testing for non-insulin-dependent diabetics. In 

 
 
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emerging countries, expansion of the market is driven by government-sponsored programs 
that negotiate the lowest price possible. 
Professional BGM in hospitals, physician offices and other test venues continues its presence 
and occupies some 10% of the market for POC glucose testing. The world market for 
professional BGM is estimated at $2.3 billion in 2025 and will reach $2.6 billion in 2030, 
representing 2.6% CAGR.  
The continuous blood glucose monitoring segment reached $12.5 billion in 2025 and will see 
the strongest growth in glucose monitoring, reaching $20.6 billion in 2030 with a CAGR of 
10.6% for the forecast period.  
POC Glucose Competitors 
Three companies (Abbott, Dexcom, and Roche) account for over 65% of the glucose-
monitoring diagnostic segment.    
Table 5-22: Top Three POC Test Vendors, by Glucose Test Revenues, 2025 ($ million) 
Company 
Sales 
Abbott 
7,998 
Dexcom 
4,662 
Roche 
1,577 
Source: Kalorama Information, company reports 
Blood Glucose Self-Testing 
The self-testing market for blood glucose is more dynamic than its professional counterpart 
and will continue to expand due to demographic factors. The aging of the population in most 
developed countries, new criteria for the diagnosis of diabetes that emphasize lower glucose 
thresholds, and expansion of monitoring technologies into emerging market populations will 
all contribute to a growing market. 
Although multinational companies dominate the market, the enormous market potential 
continues to attract new entrants with traditional-type devices and device innovation. The 

 
 
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major companies market their share of innovations, including small sample sizes, talking 
meters, smartphone apps, integrated lancing devices, and large, numbered display screens.  
Table 5-23: Selected Glucose Self-Test Meter Innovations 
Company 
Location 
Details 
Abbott  
US 
FreeStyle Precision Neo 
ACON Labs 
US 
On Call Express/On Call Plus glucose meter  
Ascensia Diabetes Care 
US 
CONTOUR NEXT ONE/PLUS ONE & CONTOUR diabetes app 
CONTOUR Next EZ, advanced biosensor 
iHealth Lab Inc. 
US 
iHealth Gluco+ Wireless Smart Glucose -Monitoring System 
DarioHealth 
Israel 
Dario, cloud-based, diabetes management meter & app 
LifeScan Inc. 
US 
OneTouch Verio Flexmeter with ColorSure technology 
Teledoc Health Diabetes 
Management 
US 
Livongo glucose meter with pedometer, cloud connection 
Trividia Health 
US 
TRUE METRIX self-monitoring blood glucose system 
TRUE METRIX AIR with phone connection 
Philosys 
Korea 
Gmate SMART blood glucose monitoring system with app 
Prodigy Diabetes Care 
US 
Prodigy Autocode talking meter 
Smart Glucose Meter Corp 
US 
Smart Meter iglucose glucometer  
Source: company reports, Kalorama Information 
Non-invasive Testing Devices 
The expected increase in demand for glucose testing products has renewed interest in 
noninvasive testing devices that do not require a blood sample. Of interest are new efforts to 
commercialize transdermal devices, saliva, contact lens, and breath-based systems. 
Conventional techniques for measuring glucose still involve a fingerstick blood sample, 
which can cause pain and discomfort for the patient. As a result, some patients are reluctant 

 
 
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to test. Also, noninvasive devices make testing as simple as wearing a watch or putting a 
finger into a device.  
Many companies have attempted to develop non-invasive technologies for glucose 
monitoring, but commercial success has remained limited. One of the earliest and most well-
known examples was the GlucoWatch, introduced in the early 2000s, which ultimately faced 
technical challenges related to accuracy, reliability, and user comfort. 
Efforts to reduce the burden of traditional fingerstick testing have continued, with a range of 
devices designed to improve convenience and patient compliance. While fully non-invasive 
glucose monitoring has yet to achieve widespread adoption, minimally invasive continuous 
glucose monitoring systems have gained strong traction in the market. 
Additional non-invasive tools have been developed to support diabetes management. For 
example, TRIGOcare’s Neuropad is a simple, patch-based test that assesses sweat function 
as an indicator of diabetic peripheral neuropathy. The test is primarily used as a screening 
tool rather than for glucose monitoring or disease classification. 
Table 5-24: Selected Noninvasive Glucose Monitoring Devices 
Company 
Location 
Details 
Gentag 
US 
smartphone NFC-based wearable for type 2 diabetes (dev) 
GlucoTrack DF-F 
Israel 
GlucoTrack DF-F non-invasive blood glucose 
Integrity Applications 
Israel 
GlucoTrack earlobe sensor 
Inow Labs 
US 
Radiofrquency-based glucose detection 
Movano 
US 
Non-invasive RF-based glucose sensing ring 
NovioSense BV 
Netherlands 
NovioScience tear glucose biosensor (dev) 
Source: Kalorama Information, company reports 
Continuous Glucose Monitoring 
Continuous glucose monitoring (CGM) is considered the most significant breakthrough in 
diabetes management in the past 40 years. CGM augments glucose meter use in diabetes 

 
 
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management by automatically linking to an implanted insulin pump that delivers insulin 
according to algorithms customized for each person. In the long term, the investment is in 
non-invasive and implanted glucose-testing products.  
The major companies in this segment, Abbott, Medtronic, and Dexcom, are working with 
multiple generation devices to offer closed-loop continuous glucose monitoring (CGM) 
systems that involve a meter (sensor), transmitter, and insulin pump.   These companies 
compete in an exciting, emerging test segment. However, the number of companies offering 
CGM devices has increased. 
Kalorama estimates that in 2025, continuous blood glucose systems generated product sales 
of approximately $12,579 million, compared with approximately $100 million in 2008.   
Abbott has been an integral participant in this market, demonstrating year-on-year growth. 
The diabetes segment generated $6,805 million in 2024 and climbed to $8,098 million in 
2025.   
The unmet demand for this type of system is also illustrated by Dexcom’s revenue track 
record.  The company’s first-generation SEVEN continuous blood glucose monitor system 
was launched in March 2006.  Since then, Dexcom has invested in numerous product 
improvements and worked with insurance companies to secure reimbursement.  Dexcom’s 
product sales were $2.2 million in 2006 and estimated at $4.705 million in 2025.   
Dexcom marketed its next-generation Dexcom G7 CGM System in 2023. The system is 
available to Medicare beneficiaries. The Dexcom G7 sports many new features, including a 
smaller, all-in-one unit that warms up faster than any other CGM on the market. In March 
2023, the FDA cleared Abbott’s FreeStyle Libre 2 and 3 sensors for integration with 
automated insulin delivery systems.  
Abbott offers the FreeStyle Libre 3 Reader. The FreeStyle Libre 3 Reader is a small handheld 
device that displays real-time glucose readings directly from a small sensor.  
Medtronic offers its MiniMed 780G with Simplera Sync. The new product is a disposable, 
all-in-one CGM that requires no fingerstick. The MiniMed 780G with Simplera Sync sensor 
will be available in Europe in the summer of 2024.  
Dexcom provides the Dexcom ONE+ in Spain, Belgium, and Poland. The Dexcom ONE+ 
replaces the previous-generation Dexcom ONE sensor with a more accurate design.  

 
 
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Dexcom offers its Stelo, an over-the-counter CGM that provides insights to a user’s 
smartphone. The product is the first glucose biosensor that doesn’t require a prescription.  
Dexcom announced that its Dexcom G7 connects directly to an Apple Watch.  Dexcom G7 
was the first CGM available directly to the Apple Watch. 
Abbott markets two over-the-counter CGM systems. The Lingo is a biowearable for 
consumers aged 18 and older that will track glucose levels and provide personalized insights 
and customized coaching. The Libre Rio is designed for people over 18  with Type 2 diabetes 
who do not use insulin and manage their diabetes through lifestyle modifications. The Libre 
Rio is the first OTC CGM system with a measurement of 40-400 mg/dL.  
Abbott entered into a partnership with Medtronic to collaborate on an integrated continuous 
glucose monitoring system based on Abbott’s FreeStyle Libre technology. The collaboration 
is intended to enable connectivity between Libre CGM sensors and Medtronic’s automated 
insulin-delivery systems and smart insulin-pen platforms, supporting greater interoperability 
across diabetes-management devices. As of 2026, the partnership remains active, with 
integrated 
system 
development 
progressing 
toward 
regulatory 
clearance 
and 
commercialization. 
Abbott’s Freestyle Libre 2 and 3 systems are approved for use during medical imaging.  
Roche has announced plans to expand its manufacturing operations in Indianapolis, which 
serves as its North American diagnostics headquarters. The company is investing several 
hundred million dollars to increase production capacity for its diabetes care portfolio and to 
support future growth, with the project expected to continue through the end of the decade. 
The facility is a major global hub for Roche’s Accu-Chek products and produces billions of 
test strips each year. While the expansion supports broader diabetes technologies, Roche’s 
current focus remains centered on established glucose monitoring products rather than large-
scale continuous glucose monitoring manufacturing. 
 
 

 
 
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Table 5-25: Selected Continuous Blood Glucose System Developments 
Company 
Location 
Details 
Abbott Diabetes Care 
US 
FreeStyle cont gluc with Insulet pump 
FreeStyle Libre Flash Glucose Monitoring System 
FreeStyle Libre View 
Ascensia Diabetes Care 
US 
CONTOUR NEXT LINK  
Becton Dickinson 
US 
Diabetes delivery/infusion technologies 
Bigfoot Biomedical 
(Abbott) 
US 
Bigfoot Uniity smart pen-cap dosing system  to work with  FreeStyle Libre 2 
Debiotech SA 
Switzerland 
artificial pancreas with Swiss partners 
waterproof JewelPUMP, patch pump and glucose meter 
DexCom, Inc. 
US 
DexCom G67 Mobile CGM System for adults & children 
G7 for pediatric use 
Glucosense Diagnostics 
UK 
laser sensor noninvasive glucose monitor 
Hong Kong Polytechnic 
University 
Hong Kong 
glucose biosensor smart textile 
Insulet Corporation 
US 
OmniPod Insulin Management System, new PDM 
Medtronic Inc. 
US 
MiniMed 780G pump with Enlite, insulin suspend 
Guardian Connect app and CGM system 
Nemaura Medical 
UK 
sugarBEAT CGM System body worn sensor patch 
Nightscout 
US 
Nightscout (CGM in the Cloud), an open source, DIY project 
NovioSense BV 
Netherlands 
glucose measurement in tears 
Senseonics 
US 
Eversense 3 implantable CGM system 
Tandem Diabetes Care 
US 
t:connect Diabetes Management app compatible with major meters 
TelCare Inc. 
US 
Telcare Total Diabetes Management Solution 

 
 
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Company 
Location 
Details 
U Virginia 
US 
phone-controlled artificial pancreas technology 
Verily/Google 
US 
contact lens with Novartis Alcon eye care (paused) 
diabetes management app with Sanofi 
wristband glucose monitor 
Source: Kalorama Information, company reports 
Blood Glucose Testing by Professionals 
Hospital glucose meters share the same strip technology as OTC meters, but the hospital 
models have much more sophisticated data management capabilities.  Shorter hospital stays 
and increased ambulatory services limit demand for bedside glucose testing.  However, there 
is a growing demand for continuous glucose monitoring in intensive care units.   The 
objective of these systems is to ensure tight glucose control (TGC) in critical care patients.  
There are probably more than 500 papers on TGC in ICUs published.  Some say TGC is 
good, others say it’s not so good, and others say there is a need to be more cautious.  
Nevertheless, the prevailing consensus is to proceed with TGC, on the belief that it will lead 
to improved outcomes.  
Information from the FDA indicates that the agency has reservations about using POC 
devices to treat critical care patients, with new FDA guidelines to be issued in the near future. 
Particularly controversial has been the whole area of point-of-care glucose testing in the ICU 
because of one of its major uses – TGC. 
The major issue is whether POC glucose meters are sufficiently accurate to meet TGC 
requirements.  For this reason, the FDA requires manufacturers to include a notice stating 
that the devices have not been evaluated in critically ill patients. 
Major vendors have added connectivity and other critical-care analytes to their systems 
intended for use in hospitals. According to Nova Biomedical, StatStrip is the world’s most 
extensively studied and best understood glucose test.  After seven years of extensive studies 
and significant field use, StatStrip Glucose systems were cleared by the FDA as safe and 
effective for use with all patients in all professional healthcare settings, including intensive 
and critical care.  The device was tested with a wide array of medical conditions, including 

 
 
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cardiopulmonary disease, endocrine disorders, malignancies, obstetric or gynecologic issues, 
renal disease, surgery, and trauma. Moreover, this device can use arterial or venous whole 
blood obtained from hospitalized patients of all ages, including neonates, children, and 
adults.  
Table 5-26: Selected Innovations in Hospital-based Glucose Monitoring 
Company 
Location 
Details 
Abbott Diagnostics 
US 
FreeStyle Optium Neo Blood Glucose and Ketone 
FreeStyle Precision Pro Blood Glucose and β-ketone 
DexCom, Inc. 
US 
DexCom   CGM 
ForaCare Suisse AG 
Switzerland 
FORA COMFORT pro GD40 blood, Hct control 
GlySure Limited 
UK 
continuous intravascular glucose monitoring system for acute care 
Nipro Diagnostics 
US 
TRUE METRIX PRO Professional Monitoring blood glucose system 
Nova Biomedical 
US 
StatStrip Glucose Hospital Meter System, ICU 
Nova Biomedical 
US 
StatStrip Xpress Glucose Hospital Meter System 
Roche Diagnostics 
US 
ACCU-CHEK meters with meter-level wireless technology 
Source: Kalorama Information, company reports 
Diabetes Testing – Glycated Hemoglobin 
Hemoglobin A1c (HbA1c) is an essential component to both the diagnosis and management 
of patients with diabetes mellitus. HbA1c is a specific glycated hemoglobin that is modified 
at the N-terminal valine residue of each β-chain of hemoglobin A. The landmark Diabetes 
Control and Complications Trial, a major clinical study conducted from 1983 to 1993 and 
funded by the National Institute of Diabetes and Digestive and Kidney Diseases, showed that 
keeping blood glucose levels as close to normal as possible slows the onset and progression 
of the eye, kidney, and nerve damage caused by diabetes. 

 
 
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As a result, measuring A1c has become an integral component of the standard of care for 
patients with diabetes, and there are a variety of methods to do so. HbA1c methods fall into 
two broad categories: those that use molecular charge (ion-exchange high-performance liquid 
chromatography [HPLC], and electrophoresis) and those that use molecular structure 
(immunoassay and affinity chromatography). Nearly all HbA1c measurements are performed 
using these methods, though point-of-care devices are also widely used. 
This overwhelming growth in the number of diabetics, worldwide and the recognition that 
they may have some difficulty in managing their disease have spurred incredible research 
into new tests and a concerted effort to promote glycated hemoglobin (HbA1c) that measures 
glucose control in diabetics with type 1 diabetes and tests that can detect the first symptoms 
of diabetes. Therefore, the most common markers for monitoring patients with diabetes are 
glucose and HbA1c, but additional markers, such as glycated human serum albumin (HSA), 
have been identified that could address the glycation gap and bridge the time scales of 
glycemia between transient and 2–3-month measurements. 
HbA1c has been used since the 1990s to measure long-term glycemic control in people with 
diabetes, but glucose was the primary test for diagnosing the disease. New research has 
included the HbA1c test as a diabetes screening tool, as well as for patient monitoring, and 
especially in combination with a fasting blood glucose (FBG). 
There has been a shift toward immunoassays and point-of-care tests because they are simple 
to use and widely available, especially in settings where technologies such as HPLC, 
electrophoresis, and chromatography are not readily accessible. These tests offer several 
advantages, including the ability to be performed at any time of day without fasting. HbA1c 
levels are also more stable than fasting plasma glucose and provide a better picture of a 
patient’s average blood glucose over the past two to three months. 
The market for HbA1c test devices in this report refers to immunoassay and point-of-care 
devices. Laboratory testing devices account for the majority share of the market in 2025, 
about 69% while the global market for point-of-care testing devices totaled approximately 
32%.  

 
 
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Table 5-27: Global HbA1c Test Sales Market and Distribution, by Setting, 2025-2030 ($ million)  
 
[HbA1c Lab; HbA1c POC] 
Setting 
2025 
% Market 
2030 
% Market 
CAGR 
HbA1c POC 
615 
31% 
925 
35% 
8.5% 
HbA1c Lab 
1,342 
69% 
1,700 
65% 
4.8% 
Total 
1,957 
100% 
2,625 
100% 
6.0% 
Source: Kalorama Information 
The laboratory setting has been the gold standard for HbA1c testing in the past, but with the 
advent of new technology and increased demand, we are seeing a growing shift toward POC 
testing. This move is happening across the board and HbA1c testing is no exception. 
Moreover, POC test devices have contributed significantly to the growth of the overall 
diagnostics market over the past 10 years. More diagnostic manufacturers have pursued 
CLIA waiver status for their POC devices and CE Mark for POC or self-use. POC testing 
appears to be headed for an even bigger role in diagnosis and monitoring of patient care, 
especially since new technologies are enabling POC devices to produce quantitative, lab-
quality test results that can be automatically transferred to an information system, a remote 
caregiver service for consultation, or an electronic medical record.  
Professional HbA1c testing is done through the core laboratory or point-of-care testing. At 
least 35+ companies offer lab-based and POC HbA1c tests using immunoassay methods. Of 
particular interest is the migration of the HbA1c test to mass spectrometry. Also, Sysmex 
Corp. markets an automated HbA1c test on its XN-9000, HbA1c hematology analyzer. 
Accurex Biomedical offers the Accurex XpressA1 Analyzer. The device is a handheld 
HbA1c meter with lab-like accuracy. The system uses boronate affinity chromatography. 
Results are available in five minutes. The product is CE marked and FDA cleared. 
Abbott offers the Afinion 2 HbA1c assay an immediate POC test. The test is CLIA-waived 
and provides reliable, high-quality results in three minutes. The HbA1c Test cartridge 
contains all reagents necessary for the measurement of glycated hemoglobin. The assay is 
run on the Alere Afinion AS100 Analyzer.  The Afinion 2 analyzer is a compact, rapid, multi-
assay platform that streamlines and simplifies the delivery of actionable, accurate 

 
 
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measurements of hemoglobin A1c (HbA1c) and the albumin-to-creatinine ratio (ACR) at the 
point of care.  The Afinion 2 platform also offers all-in-one connectivity to laboratory and 
hospital information systems. 
Menarini offers the Hb9210 Premier, which uses the borate affinity method. The product 
features a user-friendly touchscreen with adaptive software. The Premier HB9210 Resolution 
is an ion-exchange HPLC analyzer featuring automated quantitative hemoglobin A2, F and 
for the detection of common and rare Hb variants. 
Bio-Rad Variant II Hemoglobin Testing System offers automated high-volume HbA1c, and 
B-thalassemia testing coupled with clinical data management software for accuracy and ease 
of use. 
Convergent Technologies sells the POC HbA1c Analyzer, a portable device for use in a 
physician’s office or a small clinic laboratory. The immunoassay-based test requires only 
1μL of whole blood, and the results are displayed in NGSP and IFCC formats along with the 
eAG values. The time to result is only six minutes. 
DiaSys markets the InnovaStar. It is an automated POCT analyzer. It measures up to four 
tests (glucose, hemoglobin, HbA1c, and CRP) from one sample.  
Diazyme offers the SMART HbA1c Analyzer and Assay kit, designed for the quantitative 
determination of stable HbA1c in whole-blood samples. The system is CLIA-waived and is 
CE marked.  
Drawbridge Health offers the OneDraw A1c Needle-Free Test System. The system consists 
of the OneDraw blood collection device and the OneDraw A1C test. Blood is collected from 
the upper arm onto filter paper within the collection device. Samples are sent to the laboratory 
for the quantitative measurement of HbA1c 
EKF Diagnostics’ CE-marked, semi-automatic Quo-Lab and fully automatic Quo-Test 
HbA1c analyzers are compact point-of-care analyzers combining market leading accuracy 
with easy and affordable patient testing. Both use patented boronate fluorescence quenching 
technology to measure HbA1c from a 4 µL sample of venous or finger-prick blood. The 
instruments are designed specifically to meet the needs of clinics and laboratories in 
emerging economies, where diabetes is an increasingly large public health issue, and is ideal 
for GP surgeries, diabetes clinics and laboratories. 

 
 
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HemoCue provides the HbA1c 501 System, which is a fully automated POCT system. This 
system is CE marked and is not available in the US.  
OSANG Healthcare offers the CloverA1c Plus and the CloverA1c. The Clover A1c measures 
HbA1c by using spectrophotometry. The system features boronate affinity chromatography, 
a one-step measurement and quick test results. It uses capillary or venous blood. The 
CloverA1c Plus is the newest addition to HbA1c measurement. The new system features a 
touch color screen, a wider screen, and quick test results.  
Roche offers the Tina-quant HbA1cDx Gen. 3 assay as an aid in diagnosing diabetes.  The 
test is run on the cobas series clinical chemistry analyzers.  Due to the reagent's high 
specificity, this test is not affected by interference from common hemoglobin variants such 
as HbS, HbE, HbC, and HbD. 
Siemens offers the DCA Vantage. It is a diagnostic solution for diabetes management, 
allowing physicians and other clinicians to perform CLIA-waived HbA1c testing; retrieve an 
instrument-calculated, estimated average glucose (eAG) value; and test albumin and 
creatinine levels to also determine the albumin-to-creatinine (A:C) ratio. The DCA Vantage 
provides physicians with insight into patients' glucose management and allows them to screen 
at-risk diabetic patients for kidney disease. The instrument also features connectivity and 
security functions for transmitting and managing test results.  
PTS offers the A1CNow+ system, which is designed for professionals. The system is CLIA-
waived, FDA-cleared, and CE-marked. It is an easy-to-use, portable product that produces 
results in five minutes.  
Pointe Scientific Hemoglobin A1c uses the immunoturbidimetric method in liquid form. It is 
intended for the quantitative determination of HbA1c. The product is CE marked.  
Tosoh Bioscience offers the Tosoh Automated Glycohemoglobin Analyzer HLC-723 GR01 
for HbA1c testing.  The analyzer is designed for both diabetes diagnosis and long-term 
glucose monitoring. Results are available in 50 seconds, and it uses Tosoh‘s non-porous ion-
exchange HPLC technology. The analyzer is compact with high throughput.  
Transasia Biomedical offers the Hb-Vario, which is an HPLC platform for HbA1c testing 
with HbA2/F flagging. The product produces results in 3.5 minutes and is a compact 
benchtop model.  

 
 
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Trinity introduced the Tri-STAT, a new POC HbA1c device that can test three samples 
simultaneously and provide results in 10 minutes.  The Tri-STAT 2 offers HbA1c results 
within minutes using boronate affinity technology.  
The self-testing portion is also driven by the availability of mail-in, home-collected sample 
lab services. These lab services offer diabetics, an essential value-added component of test 
interpretation and physician consultation without leaving home.  
In self-testing for HbA1c, ARKRAY (Kyoto, Japan) offers the ADAMS Hybrid AH-8280, 
A1c & glucose meter in Japan. 
PTS Diagnostics offers the A1CNow Self Check designed for diabetes patients who need to 
check their HbA1c levels four times per year. Physicians recommend this product for 
diabetes patients whose treatment plans have changed or who are struggling to meet glycemic 
goals. The test is administered quarterly at home. 
DTI Labs offers the AccuBase A1c Home Mail-in Test Kit, which is FDA-cleared for OTC, 
CLIA-waived use. It is a non-fasting, fingerstick, whole-blood, mail-in, aqueous-transfer 
technology test.  It is considered highly accurate and very reliable, with over 20 years of 
industry success. 
Now, at least 20 companies offer lab-based and POC HbA1c tests using immunoassay 
methods. Of particular interest is the possible migration of the HbA1c test to mass 
spectrometry. Also, Sysmex Corp. received FDA clearance to market an automated HbA1c 
test on its XN-9000, HbA1c hematology analyzer. 
Kalorama estimates that the world market for HbA1c testing lab-based and at the point-of-
care by professionals is valued at $2.0 billion in 2025 and with 5.9% annual growth will reach 
$2.6 billion by 2030. The POC segment occupies about 32% of the total hemoglobin A1c 
testing market ($622 million) and with a CAGR of 8.2% will reach $922 million in 2030. 
The increasing adoption and introduction of systems is notable.  Because lab-based tests are 
about half the price of the POC version, this segment actually will grow much faster related 
to the number of tests performed. 
Kalorama was not able to estimate the market share by geographic distribution for POC 
HbA1c tests with certainty but developed countries collectively account for at least 80% of 
the total HbA1c testing market. What is certain is that the entire market for HbA1c tests will 
grow by at least 6% annually over the next five years. 

 
 
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Table 5-28: Selected POC HbA1c Devices 
Company 
Location 
Area 
Details 
Abbott Diagnostic 
US 
chem 
ARCHITECT hemoglobin A1c 
Afinion 2 HbA1c assay 
Beckman Coulter/Danaher 
US 
chem 
Hemoglobin A1c assay 
Bio-Rad 
US 
Prof  
Variant II 
EKF Diagnostics 
UK 
prof POC 
Quo-Lab HbA1c analyzer 
DiaSpect Tm handheld hemoglobin analyzer 
ERBA Diagnostics, Inc. 
US 
chem 
Hb-Vario, Hgb A1c/A2, HPLC automated 
Home Access Health 
US 
DTC 
Home Access A1c test 
Quantimetrix Corp 
US 
QC 
Dropper A1c Diabetes Control 
Randox Laboratories 
UK 
QC 
Acusera HbA1c control 
Roche Diagnostics 
US 
immuno 
cobas Integra 800 Tina-quant HbA1cDx 
Sebia 
France 
chem 
CAPILLARYS 2 Flex Piercing, Hgb electrophoresis 
Sekisui Diagnostics 
US 
chem 
HbA1c assay 
Siemens Healthineers 
US 
chem 
DCA HbA1c test, diabetes diagnosis 
Sysmex Corp 
Japan 
hemato 
Sysmex XN-9000 HbA1c automated track 
Tosoh Corp 
Japan 
HPLC 
Tosoh HPLC HbA1c, diabetes diagnosis 
chem 
HbA1c on AIA immunoanalyzers 
Source: Kalorama Information, company reports 
 
 

 
 
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Genes and Other Markers of Diabetes 
Diabetes is not generally considered an inherited disease, yet it can run in families. Research 
has shown that about 80% of people with type 1 diabetes have no family members with the 
disease. The remaining 20% have at least one family member with diabetes. 
Yet, some people are born more likely to get diabetes than others; they inherit a 
predisposition to the disease, and then something in the environment triggers it. 
Environmental risk factors such as diet, viral infection and others are thought to act as either 
initiators or accelerators of beta cell autoimmunity. Therefore, the onset of type 1 diabetes is 
attributed to both an inherited risk and external triggers. The hunt for these genetic and 
environmental risk factors is ongoing. 
Physicians sometimes screen for autoantibodies to insulin or beta cells. The antibodies 
indicate a very high risk for developing type 1 diabetes and can be present up to eight years 
before symptoms develop. According to the American Diabetes Association, four 
autoantibodies are markers of beta cell autoimmunity in type 1 diabetes: islet cell antibodies 
(ICA, against cytoplasmic proteins in the beta cell), antibodies to glutamic acid 
decarboxylase (GAD-65), insulin autoantibodies (IAA), and IA-2A antibodies to protein 
tyrosine phosphatase. Autoantibodies against GAD-65 are found in 80% of patients with type 
1 diabetes at clinical presentation. 
Presence of ICA and IA-2A at diagnosis for type 1 diabetes ranges from 69%-90% and 54%-
75%, respectively. IAA prevalence correlates inversely with age at onset of diabetes; it is 
usually the first marker in young children at risk for diabetes and is found in approximately 
70% of young children at the time of diagnosis. There is some evidence that these 
autoantibodies may be present several years before a patient develops the symptoms of 
diabetes, but there does not appear to be a trend to screen children thought to be at risk.  
Immunoassays for these proteins are not part of the routine workup for people with diabetes; 
they are used when an individual appears not to respond to insulin therapy as expected and 
in clinical research. For this reason, there is not enough data to estimate the market for these 
tests with certainty. The same goes for the various genetic markers discussed below. 
Some 18 regions of the genome have been linked with influencing type 1 diabetes risk. These 
regions, each of which may contain several genes, have been labeled IDDM1 to IDDM18. 

 
 
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The most studied is IDDM1, which contains the HLA genes that encode immune response 
proteins. HLA genes encode molecules that are crucial to the immune system. These 
molecules display short chains of amino acids on the cell surface, allowing immune cells to 
analyze them. When the immune cells find an inappropriate chain, they begin attacking. 
Without HLA genes, immune cells would not find the chains of viruses, bacteria, or tumor 
cells. On the other hand, inheriting certain HLA gene variants increases the probability that 
immune cells will attack the body's healthy cells. This is how IDDM1 contributes to the 
immune attack on beta cells and thus to type 1 diabetes. 
Variations in HLA genes are an important genetic risk factor, but they alone do not account 
for the disease and other genes are involved. There are two other non-HLA genes that have 
been identified thus far. One of these non-HLA genes, IDDM2, is the insulin gene, and the 
other non-HLA gene maps close to CTLA4, which has a regulatory role in the immune 
response.  
With rising obesity levels, it is sometimes difficult for doctors to distinguish between type 1 
diabetes, which requires treatment with insulin injections, and type 2 diabetes, which can be 
controlled through diet and weight loss. Genetics may provide some clues and options 
Micro ribonucleic acids (miRNAs) carry snippets of genetic information across cells and are 
regularly released into the bloodstream, and in diabetes, the levels of some of these miRNAs 
in the circulation change, and a blood test could detect these variations, years, maybe 
decades, before symptoms develop. 
An international team of scientists, led by researchers at Imperial College London (UK), has 
identified a miRNA linked to the pancreas. The scientists reported that a particular molecule, 
called miR-375, is released by the very cells in the pancreas that produce insulin. These cells 
normally contain high levels of miR-375, which helps control cell growth. In type 1 diabetes, 
it is released into the bloodstream in large quantities as soon as the cells begin to die.  
Adiponectin, a protein hormone produced and secreted exclusively by adipocytes, regulates 
the metabolism of lipids and glucose and influences the response to insulin. Higher levels of 
adiponectin are associated with increased insulin sensitivity, thereby reducing diabetes risk. 
Adiponectin also has anti-inflammatory effects on the cells lining the walls of blood vessels. 
Therefore, low levels of adiponectin can be indicative of insulin resistance leading to type 2 
diabetes and cardiovascular disease (CVD). Low adiponectin levels have also been correlated 
with increased likelihood of a woman developing gestational diabetes in pregnancy. 

 
 
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Obesity is associated with the risk of developing type-2 diabetes, nonalcoholic fatty liver 
disease, cardiovascular disease and cancer. However, it has been increasingly recognized that 
obesity is not a homogeneous condition, and about 25 to 40 percent of obese individuals can 
actually maintain a healthy status with no apparent signs of health complications. 
Researchers at the University of Hawaii Cancer Center have discovered a panel of markers 
that helps identify if a person is pre-diabetic by measuring the fatty acids in their blood. The 
levels of these fatty acids can change up to 10 years before the individuals are diagnosed with 
diabetes. This discovery, they explain, may allow physicians to warn patients years before 
the onset of diabetes, therefore allowing them to change their lifestyle patterns, potentially 
avoiding the diagnosis of a chronic disease.  
Table 5-29: Selected POC Diabetes Monitoring Tests 
Company 
Location 
Details 
Gentag 
US 
Insudex, type 1 diabetes autoantibodies, POC cartridge 
glycosylated fibronectin, preeclampsia and gestational diabetes 
Diazyme Laboratories 
US 
SMART Cystatin C POC test kit 
Epinex Diagnostics 
US 
G1A Diabetes Monitoring Index, glycated albumin 
NeuroMetrix 
US 
DPNCheck nerve conduction test for diabetic peripheral neuropathy 
Nirmidas Biotech 
US 
pGOLD Slides with islet cell-targeting autoantibodies 
XRGenomics Ltd 
UK 
RNA profiling for prediabetes/diabetes risk 
Source: Kalorama Information, company reports 

 
 
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The Major POC Test Players 
The market for POC tests is highly diversified and, for the most part, a different set of 
companies is active in each subsegment. POC testing by professionals is dominated 
worldwide by the vendors of glucose testing devices: Roche Diagnostics, Dexcom, Abbott 
Diagnostics and Ascensia. 
Table 5-30: POC Test Revenues of Selected IVD Companies, 2025 ($ million) 
Company 
Est. 
Target Markets 
Abbott Diagnostics 
10,891 
immunoassays, critical care, cardiac, DAU, infectious diseases, DofA. diabetes 
Dexcom 
4,662 
diabetes CGM 
Exact Sciences 
2,531 
fecal occult testing 
Roche Diagnostics 
2,352 
troponin T, critical care, coagulation, UA 
Beckman Coulter/Danaher 
1,266 
cancer markers, rapid tests, fecal occult 
Medtronic 
1,040 
diabetes CGM 
Siemens Healthcare 
940 
cardiac markers, critical care, UA, coagulation, DofA 
Ascensia 
677 
diabetes 
Radiometer/Danaher 
619 
chemistries 
QuidelOrtho 
602 
infectious diseases, cardiac markers, pregnancy/fertility 
Sysmex 
504 
blood chemistries, electrolyte, UA 
Becton Dickinson 
279 
infectious diseases rapid tests 
Source: Kalorama Information, company reports 
POC vendors Roche Diagnostics, Siemens Healthineers, Beckman Coulter, Dexcom, Exact 
Sciences, and Abbott hold significant positions in niched segments with at least 40 - 60 other 
companies offering a wide range of POC tests, worldwide. 

 
 
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Abbott is the clear leader in POC testing with tests and devices for cardiac markers, diabetes, 
HbA1c, lipids, infectious diseases, drugs of abuse, and blood and electrolyte testing. 
Roche offers a number of solutions for diagnostic testing by healthcare professionals outside 
the central lab, including PT/INR testing and anticoagulation management tools, glucose 
testing, blood gas/electrolytes testing for critical care and respiratory therapy, cholesterol 
testing and urinalysis. These are sold under the CoaguChek, AccuChek and cobas brand 
names. Physicians have been using Roche’s CoaguChek instruments for POC PT/INR 
(Prothrombin Time/International Normalized Ratio) testing since 1994. 
Siemens Healthineers offers several products. The company is a major participant in POC 
testing for blood and electrolytes, rapid coagulation, rapid cardiac markers, drugs of abuse, 
and urinalysis tests. Siemens Healthineers offers a large menu of critical care options for use 
in ICU, NICU, operating room, emergency department, laboratory, and respiratory. The 
product menu includes: RAPIDLab 1200 and RAPIDLab 248/348 Systems, RAPIDPoint 
400/405 Systems and RAPIDPoint 340/350 Blood Gas Systems. In addition to a broad line 
of blood gas instruments, the CE Marked and FDA RAPIDPoint 500 Analyzer, a cartridge-
based critical care system, provides testing for lactate, blood gas, electrolytes, metabolites, 
and CO-oximetry. 
Dexcom is a leader in the POC CGM arena.  The company has been increasing revenues year 
on year, driven by the growing use of CGM. 
Exact Sciences continues to grow its colon cancer testing. It is anticipated that the company 
will continue to post large gains in the future due to its product offerings. 
 Beckman Coulter participates in several POC testing segments and has a leading market 
share in POC blood and electrolytes testing, colon cancer screening/FOB testing, infectious 
disease and cancer testing markets. 
QuidelOrtho’s rapid diagnostics products test for flu, RSV, FOB, strep A, pregnancy, 
bacterial vaginosis, infectious mononucleosis, H. pylori, and Chlamydia. During the COVID 
event, Quidel offered numerous products including a 25-minute molecular test that runs on 
the Solana platform, QuickVue to detect SARS viral antigen, and a 15-minute MultiAntigen 
Respiratory Panel. The company also offers the Sofia and Solana analyzers. The merger of 
Quidel and Ortho Clinical provided added combined revenue in POC.  

 
 
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Ascensia Diabetes Care is a top provider in the glucose testing market. The company has 
recently entered the CGM segment, which will help to increase revenues in the coming years.  
At least 20 companies are active in pregnancy and ovulation (LH) testing. The top vendors 
are SPD, Church & Dwight, bioMérieux, Meridian and others. Further, all major pharmacy 
chains sell their own home-brand test kits, manufactured by leaders and other OEMs. This 
test segment continues to perform at an average annual growth rate of 2%-3 %. 
The hospital market for POC coagulation tests is made up of activated coagulation time 
(ACT) tests run on patients receiving heparin during cardiovascular and other surgeries and 
PT/INR tests for patients taking warfarin (Coumadin) anticoagulant. Manufacturers of 
commercially available analyzers for ACT testing include Array Medical, Roche 
Diagnostics, International Technidyne Corp., Helena Laboratories, and Medtronic.  No one 
company dominates the market.  These companies also sell PT/INR tests and devices.   
More robust is the market for PT/INR testing by professionals in physician offices, clinics 
and community care. In fact, there is a growing trend to integrate retail clinics with 
pharmacists to adjust warfarin dosages as needed. The leader is Roche Diagnostics.  
Point-of-care PT/INR self-testing for patients on warfarin is a well-established segment, 
although overall growth has slowed as newer anticoagulants reduce the need for routine 
monitoring. Roche Diagnostics has been a leading player in this market since the 1990s with 
its CoaguChek systems, which have seen strong adoption in Europe, particularly in Germany. 
In the United States, home PT/INR testing has expanded more gradually, supported by 
physician-managed programs and reimbursement policies. 
Earlier systems from companies such as International Technidyne and HemoSense played a 
role in developing the market but are no longer widely used. Today, Roche’s CoaguChek 
platforms remain among the most recognized options, allowing patients to perform 
fingerstick testing at home and share results with healthcare providers through connected 
data systems. While home testing offers convenience and reduces the need for venous blood 
draws, the overall market is now more stable than it was during periods of high growth, 
reflecting a broader shift in anticoagulation therapy. 
New biosensor-based and microfluidic technologies continue to be explored to simplify and 
standardize point-of-care coagulation testing. While earlier development efforts from 
companies such as Microvisk highlighted the potential of these approaches, the current 
market remains dominated by established PT/INR systems. Ongoing innovation focuses on 

 
 
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improving ease of use, consistency, and connectivity rather than introducing entirely new 
platform technologies for routine clinical use. 
Gaining acceptance are rapid tests for cholesterol and other lipids. These are used by 
physician offices and clinics to monitor people at risk of cardiac events. The market leaders 
are Roche's AccuChek and Reflotron products and Abbott's LDX system. 
CholesTrak was FDA-cleared for professional use in 1991 and was introduced to the over-
the-counter market for consumer use in 1994. CholesTrak was formally known as Advanced 
Care and originally promoted by Johnson & Johnson. AccuTech acquired cholesterol in 1999 
from a failed company called ChemTrak, which had manufactured the product for Johnson 
& Johnson. AccuTech then reintroduced the product to the POC market in its current form, 
a palm-sized, non-instrumented cassette cholesterol test system called the CholesTrak.  
Polymer Technology Systems offers the PTS Lipid Panel Test Strips for use with the 
CardioChek device. The lipid panel test strips are dry-phase strips constructed in a plastic 
holder that holds chemically treated membranes. The lipid panel test strips are for in vitro 
diagnostic use with the CardioChek reflectance photometers. Lipid measurements assess 
cholesterol, HDL cholesterol, and triglycerides in whole blood. 
OraSure Technologies has pioneered self-testing for HIV. The company’s products include 
rapid tests for detecting antibodies to HIV and HCV at the point of care, and testing solutions 
for detecting various drugs of abuse. The company’s lead product is the OraQuick In-Home 
HIV Test, the first rapid HIV test approved by the U.S. Food and Drug Administration for 
sale to the consumer over-the-counter market in the U.S. OraSure Technologies claims to be 
the leading supplier of oral-fluid testing solutions for drugs of abuse and for the detection of 
antibodies to HIV in the professional POC market. The OraQuick HCV test is the first and 
only FDA-approved, CLIA-waived point-of-care test for detecting HCV infection in at-risk 
individuals. 
OraSure Technologies received a U.S. Food and Drug Administration (FDA) Emergency Use 
Authorization (EUA) for its OraQuick Ebola Rapid Antigen Test for use with fingerstick and 
venous whole blood. This test has been authorized by FDA under an EUA for use by 
laboratories and facilities adequately equipped, trained, and capable of testing for Ebola 
infection (including treatment centers and public health clinics). 
As for the remainder of self-tests on the market – H. pylori, vaginitis, TSH. FSH, etc., just 
about any company involved in the immunoassay industry has a POC strip test for sale. 

 
 
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In hospitals, the trend towards more ambulatory procedures and decreased hospital days per 
patient means that the acuity of the patient mix has increased. Thus, critical care testing 
devices that previously ran only blood gases and electrolytes now have added glucose, 
lactate, other metabolites, hemoglobin and ACT to the menu. Abbott Diagnostics’ i-STAT is 
the clear leader in the market for handheld critical care test systems, now offering glucose 
testing along with other critical care tests. Critical care tests are performed on hospitalized 
patients only and most decentralized critical care testing is done on small lab-type analyzers 
marketed by Roche Diagnostics, Siemens Healthineers, Radiometer/Danaher, Nova 
Biomedical and Instrumentation Laboratory (Werfen). 
Cardiac markers (BNP, CK-MB, myoglobin and troponin I/T) are showing steady demand 
in the hospital sector. The leaders are Abbott Diagnostics’ i-STAT, Biosite and Siemens 
Healthineers STRATUS. Cardiac markers for decentralized testing are also available from 
Roche Diagnostics (cobas h232) Radiometer/Danaher (AQT 90) and PHC Group (Pathfast 
system), There are also at least another 20 companies that sell test strips for all or one of the 
marker panels. 
 
 
  

 
 
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Chapter 6: The Core Lab 
Scope 
The core laboratory concept integrates multiple diagnostic disciplines—including 
clinical hematology, chemistry, immunochemistry, toxicology, and coagulation—into a 
single, automated, and contiguous workflow. This model has evolved significantly due 
to advances in instrument interconnectivity and laboratory information technology 
systems, enabling seamless integration of diverse testing methodologies. However, the 
most compelling driver behind this evolution remains the urgent need to reduce the 
escalating costs associated with laboratory operations. 
While large institutions may still manage molecular diagnostics and specialized tests as 
separate entities, many smaller hospital laboratories and regional systems are shifting 
toward a fully integrated core lab model. These smaller labs are increasingly investing 
not only in multifunctional instrumentation but also in automation and informatics to 
enhance operational efficiency. 
 
 

 
 
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Core Lab Overview and Trends 
The consolidation of routine testing across multiple disciplines within the core laboratory 
continues to expand. Over time, a broader range of analytes that were once run on specialized 
immunoassay systems are now run on integrated core lab platforms. These include tests such 
as D-dimer, vitamin D, HbA1c, BNP, hsCRP, cystatin C, procalcitonin, and a variety of 
infectious disease markers, with additional specialty assays increasingly incorporated where 
volumes support automation. As a result, traditional boundaries among chemistry, 
immunoassay, and certain aspects of hematology and serology have become less distinct, 
thereby supporting a more centralized and efficient workflow. While disciplines such as 
microbiology, blood banking, and pathology remain operationally separate, they are 
increasingly connected through shared automation, informatics, and data management 
systems, reinforcing the role of the core lab as a central hub in modern laboratory medicine. 
Several external forces are accelerating this transformation. Economic constraints, staffing 
shortages, and the constant expansion of test menus are pushing laboratories to adopt more 
efficient models. Currently, over 80 immunoassays are available on many core lab analyzers, 
and with continued automation, it is increasingly feasible that most routine manual tests will 
become fully automated in the near future. 
In response to these pressures, even smaller hospitals are embracing core lab systems that 
consolidate chemistry and immunoassay testing. A new generation of compact, tabletop 
analyzers now offers multianalyte testing capabilities previously reserved for larger 
platforms. These systems are being developed with seamless connectivity to laboratory 
information systems (LIS) and centralized lab tracks, allowing labs of all sizes to achieve 
higher throughput, better resource utilization, and improved turnaround times. 
The core lab model is no longer just a strategy for high-volume reference centers—it is 
becoming the operational backbone for labs across the healthcare spectrum. 
Some of the tests added to core lab instruments over the past few years are shown below. 
 

 
 
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 Table 6-1: Selected Analytes for the Core Lab 
Company 
Location 
Area 
Details 
SCIEX Pte Ltd. 
U.S. 
Vitamin D 
SCIEX Vitamin D 200M kit for Topaz LC-MS 
Abbott Diagnostics 
U.S. 
sepsis 
ARCHITECT BRAHMS PCT (procalcitonin) 
Beckman Coulter/Danaher 
U.S. 
reproductive 
Access Sensitive Estradiol 
Beckman Coulter/Danaher 
U.S. 
reproductive 
Access AMH (anti-Müllerian hormone) assay 
Beckman Coulter/Danaher 
U.S. 
cardiac 
High-sensitivity troponin assay 
Beckman Coulter/Danaher 
U.S. 
sepsis 
Procalcitonin assay 
Beckman Coulter/Danaher 
U.S. 
endocrine 
Access TSH assay 
Diazyme Laboratories 
U.S. 
sepsis 
Procalcitonin assay 
Diazyme Laboratories 
U.S. 
diabetes 
Direct HbAc1 assay, enzymatic on-board lysis 
Diazyme Laboratories 
U.S. 
Vitamin B 
Vitamin B12 and Folate assays 
EKF Diagnostics 
UK 
ketones 
β-Hydroxybutyrate LiquiColor Reagent, automated 
analyzers 
EKF Diagnostics 
U.S. 
diabetes 
Quo-Lab and Quo-Test HbA1c analyzers 
MedTest Dx 
U.S. 
Vitamin D 
25-OH vitamin D assay for Mindray BS-480 Chemistry 
Analyzer 
QuidelOrtho  
U.S. 
diabetes 
VITROS C-peptide reagents & calibrators 
QuidelOrtho 
U.S. 
diabetes 
EKF’s β-Hydroxybutyrate assay for ketoacidosis 
QuidelOrtho 
U.S. 
sepsis 
BRAHMS PCT for VITROS 
QuidelOrtho 
U.S. 
diabetes 
VITROS Insulin reagent & calibrators 
QuidelOrtho 
U.S. 
kidney 
VITROS NephroCheck Assay; TIMP-2 and IGFB-7 
Randox Laboratories 
UK 
diabetes 
Adiponectin biomarker assay 
Randox Laboratories 
UK 
wellness 
sLDL (small dense LDL) Cholesterol assay 
Roche 
Switzerland 
coagulation 
cobas t 411 analyzer 

 
 
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Company 
Location 
Area 
Details 
Roche 
Switzerland 
Vitamin D 
Elecsys Vitamin D total II assay 
Roche 
Switzerland 
reproductive 
Elecsys AMH assay 
Sekisui Diagnostics 
U.S. 
coagulation 
Coapresta 3000 (CP3000) instrument 
Siemens 
Germany 
cardiac 
ADVIA Centaur Intact High-Sensitivity Troponin I assay 
Siemens 
Germany 
endocrine 
ADVIA Centaur iPTH (intact parathyroid hormone) assay 
Siemens 
Germany 
endocrine 
ADVIA Centaur Testosterone II assay 
Sysmex Corp 
Japan 
coagulation 
Revohem FVIII Chromogenic 
Sysmex Corp 
Japan 
coagulation 
Revohem PT reagent for prothrombin time 
Tosoh Corp. 
Japan 
cardiac 
ST AIA-PACK cTnI 3rd-Gen cardiac troponin 
Tosoh Corp. 
Japan 
vitamin D 
ST AIA-PACK 25-OH Vitamin D assay 
Tosoh Corp. 
Japan 
cardiac 
ST AIA-PACK Homocysteine 
Tosoh Corp. 
Japan 
diabetes 
HbA1c on AIA immunoanalyzers 
Tosoh Corp. 
Japan 
diabetes 
Tosoh HPLC HbA1c, diabetes diagnosis 
Source, company reports, Kalorama Information 
Of particular interest is the migration of advanced technologies to the core lab. With clinical 
market clearance for the Bruker MALDI Typer and bioMérieux’s VITEK MS, it is not too 
far-fetched to see microbiology and other tests on mass spectrometry come to the core lab. 
This eventuality is supported by a preanalytical sample preparation system that can decap 
and process screw cap tubes used to transport cytology and microbiology samples, as well as 
traditional blood tubes.  
Already, mass spectrometry specialist Sciex has introduced an HbA1c test, and the company 
also offers a mass spec kit for vitamin D. Newomics Inc. was awarded the CE Mark for its 
IVD-MS Kit for 25-OH-vitamin D2/D3 on a Sciex mass spec system.  Other tests are bound 
to follow; stay tuned. A more detailed discussion of the role mass spectrometry plays in 
diagnostics is presented in Chapter 7 Immunoassays. 

 
 
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The importance of HbA1c in monitoring diabetic glucose management has been advanced 
with the market clearance of this test for diabetes diagnosis as well as disease monitoring. 
More importantly, major quality control companies offer  HbA1c control products in an effort 
to standardize test results. 
High-sensitivity troponin (hsTroponin) testing has become the method of choice for triage of 
acute cardiac disease in emergency room patients. In the past few years, a number of these 
tests have been added to the traditional cardiac marker panel: BNP, myoglobin, and troponin. 
Lipid profile and cholesterol testing have gained importance, driven by growing awareness 
of the risks of heart attack and a greater realization among individuals of the need to control 
their cholesterol levels. Overall growth in the testing volumes is driven by factors such as an 
aging population and a growing number of people at risk of cardiovascular disease, including 
those with hypertension, diabetes mellitus, and abdominal obesity. Thus, lipid profile tests 
are becoming increasingly evident in the core lab. 
Vitamin D deficiency has been linked to various diseases, including cancers, cardiovascular 
disease, diabetes, osteoporosis, multiple sclerosis, Alzheimer's disease, and all-cause 
mortality. This new understanding of the importance of vitamin D levels has driven an 
increase in the number of physician requests for total 25-Hydroxy vitamin D tests in the 
United States and worldwide.  
For esoteric immunoassays, microplate-based ELISA assays are commonly used to process 
tests that are not available on automated platforms. With the ongoing consolidation among 
laboratories, however, the demand for esoteric immunoassays is reaching volumes that 
require automation. Therefore, ELISA system manufacturers have automated the test 
process, from stand-alone washers and readers to fully automated workstations and solutions, 
to meet a clinical laboratory’s assay and throughput requirements. 

 
 
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Connectivity 
Adopting the new generation of connectivity standards is an opportunity that should not be 
missed. Laboratories owe it not only to the general public, but also to the hundreds of highly 
qualified volunteers who have contributed thousands of hours to define the industry’s best-
ever standards, all for the common good of improving patient healthcare. 
The LOINC Terminology Service provides features based on the HL7 FHIR standard. The 
update consists of support for multiple versions of LOINC across CodeSystem, ConceptMap 
and ValueSet resources and inclusion of LOINC concept translations and alternate names as 
FHIR designations.  
LOINC marketed version 2.74 includes new, edited, and newly mapped concepts across 
laboratory, clinical, and other domains. It features a streamlined file structure. 
LOINC marketed the 2.78 version, which included 1,589 new concepts and 1,416 edits to 
existing LOINCs.  
In February 2025, LOINC offered the 2.8 Hotfix, which was designed to correct issues with 
the 2.79 version and add terms accidentally omitted.  
IICC members include Abbott Diagnostics, Beckman Coulter, Becton Dickinson, 
bioMérieux, Data Innovations, Orchard Software, QuidelOrtho, Roche Diagnostics, Siemens 
Healthineers, and Systelab Technologies, S.A. 

 
 
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Overview of Chemistry Tests 
The new look of chemistry may center on the core lab, but clinical chemistry remains one of 
the most important areas in lab medicine. Routine clinical chemistry comprises 30 to 40 tests, 
including substrates, metabolites, electrolytes, blood gases, enzymes, urinalysis, and lipids, 
and can be divided into tests performed for routine patient investigation and rapid-response 
tests used to monitor unstable hospitalized patients. Esoteric tests for renal clearance, liver 
function and metabolic status also feature in this segment. 
Some chemistries are used in the routine medical checkup. Clinical chemistries are among 
the classic routine tests run as a first pass to a diagnosis, along with the hematology complete 
blood count (CBC) and urinalysis. Thus, the chem 7 (glucose, BUN, cholesterol, 
electrolytes), urinalysis and the CBC are among the most common tests performed. Long 
eclipsed in apparent importance by molecular tests and esoteric immunoassays, several 
chemistries are making a mark in patient management. 
A basic metabolic panel (BMP) includes 8 tests - sodium, potassium, chloride, bicarbonate, 
blood urea nitrogen (BUN), creatinine, glucose, and calcium. A more comprehensive 
metabolic panel could include 14 tests: a BMP plus total protein, albumin, alkaline 
phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and 
bilirubin. They provide physicians with an overall appraisal of a patient’s wellness. 
Abnormal values in any one of these tests would signal further investigation. 
Clinical chemistries are performed using serum or plasma on analyzers with varying levels 
of automation, depending on the test volume at a particular test site. The market for routine 
clinical chemistries can be segmented into high and low-volume users. High-volume users 
are found in large urban and regional hospitals and private laboratories. Low-volume users 
are found in non-laboratory test sites within the hospital, physician office labs, small and 
medium-sized hospitals, and community laboratories. 
This mature industry is continually seeking to reinvent itself by improving test processes and 
menus. Trends in clinical chemistries over the next 5-10 years include: 
• new emerging tests, including markers for metabolic and cell pathways 
• a reorganization of testing procedures 
• emphasis on increasing whole blood analysis 

 
 
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• workstation consolidation 
• expansion of automated solutions 
Lab Automation 
Laboratory automation is the use of technology to streamline or replace manual operation of 
equipment and processes. Automated solutions can be applied to the majority of lab 
procedures—from simple capping and decapping of sample bottles to high-throughput 
screening. 
The goal is to automate or minimize manual work previously performed by medical 
technologists, including sorting tubes, decapping, centrifuging, loading analyzers, and 
prepping and sorting materials for storage, while optimizing workflow and the electronic 
transfer of test results to a lab information system and/or electronic medical record. 
Sometimes, a core lab is highly automated, with a preanalytical sample-preparation station 
that sorts and prepares samples for transport to the appropriate analyzer along an automated 
track. Other times, preanalytical sample preparation is simply automated in a central location 
where samples are logged in and then are manually transported to analyzers, all located in 
the same room. In each case, the heart of the system is a lab information system with 
intelligent software that controls all activities.  
Automation has long been regarded as an important means for clinical laboratories to achieve 
greater efficiency, accuracy, standardization, and test quality. Lab consolidation increases 
the number of samples processed in one facility and with increasing competition and 
demands for higher levels of performance, the need for automation has become more and 
more essential, even among smaller labs that have been resistant to automating. Meanwhile, 
the development of new generations of automated stand-alone and benchtop equipment has 
made lab automation a more and more viable option for labs of all sizes. 
One of the most popular automation solutions has been the pre-analytical sample-preparation 
station. This is because the preanalytical phase accounts for more than half of all laboratory 
costs and has been shown to be a source of laboratory errors due to specimen mislabeling, 
misidentification, mis-sorting, improper routing, and decanting. While Beckman 
Colter/Danaher has been a pioneer in this area, other major IVD vendors now offer a variety 

 
 
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of automation preanalytical solutions, including Bio-Rad Laboratories, Abbott Diagnostics, 
Siemens Healthineers, Roche Diagnostics, and others. 
The major automation companies that partner with IVD companies to provide customized 
automation solutions include: Tecan Group, Copan, Kiestra, Hitachi High Technologies, and 
others. The next logical step is to incorporate a variety of molecular tests in the core lab. It is 
likely that, with this level of amalgamation, the lineup of red-, lavender-, green-, gray-, and 
blue-stoppered tubes would eventually become generic, with all tubes the same color. In fact, 
this trend is already in progress.  
 

 
 
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Market Analysis 
The remainder of this chapter discusses the market for lab-based and POC chemistries. 
Routine lab-based clinical chemistry testing comprises 30 to 40 tests, including substrates, 
metabolites, electrolytes, blood gases, enzymes, urinalysis, and lipids. Traditionally included 
in clinical chemistry analysis are data for rapid-response analytes that are also run on lab-
based systems, including blood gases, electrolytes, glucose, urea, creatinine, lactate, and 
ionized calcium, which are measured using either whole blood or serum, either in a laboratory 
or as point-of-care tests. 
The global market for clinical chemistry is estimated at $11.0 billion in 2025. Overall, this 
test segment is projected to grow by 3.9% per year, reaching nearly $13.3 billion by 2030. 
Table 6-2: Global Lab-based Clinical Chemistry Sales, by Test Category, 2025-2030 ($ million)  
 
[Blood Gases; General Chemistries; Urinalysis] 
Clinical Chemistry 
2025 
% Mkt 
2030 
% Mkt 
CAGR 
General Chemistries 
8,645 
79% 
10,650 
80% 
4.3% 
Blood Gases 
 1,195  
11% 
 1,388  
10% 
3.0% 
Urinalysis 
  1,138  
10% 
 1,270  
10% 
2.2% 
Total 
10,978 
100% 
13,308 
100% 
3.9% 
Note: Includes all lab chemistries, electrolytes, enzymes, and lipids run on chemistry analyzers; excludes POC. 
Source: Kalorama Information 
 

 
 
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Table 6-3: Global Clinical Chemistry Sales Distribution, by Region, 2025 (%) 
 
[Asia Pacific; Europe; North America; Rest of World] 
Region 
% Mkt 
North America  
39% 
Europe 
33% 
Asia Pacific 
16% 
RoW 
12% 
Total 
100% 
Source: Kalorama Information 
Intense provider consolidation in the United States, the commoditization of most chemistry 
offerings, and increasing price pressures have pushed the cost per test for routine chemistries 
to just about the lowest possible level. The average 2%-4% annual growth in this segment is 
driven by new tests in lipid analysis, proteins, hormones, and enzymes used to test for 
diabetes, cardiovascular disease, cancer, and other acute and chronic conditions. 
In developed countries (North America, Western Europe, and Japan), almost all routine 
electrolyte estimations are performed on automated general chemistry analyzers, while in the 
developing world, 70% are run on dedicated instruments. The major players for clinical 
chemistry analyzers and reagents are shown below. 

 
 
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Table 6-4: Selected Major Clinical Chemistry Companies, by Sales, 2025 ($ million, estimated) 
Company 
Clinical Chemistry Revenues 
Beckman Coulter/Danaher 
1,855  
Roche Diagnostics 
1,311  
Werfen 
970  
Abbott Laboratories 
911  
Siemens Healthineers 
758  
QuidelOrtho 
596  
Radiometer/Danaher 
429  
Sysmex 
304  
Others 
5,392  
Total 
12,526  
Note: Sales include combined laboratory and POC 
Source: Kalorama Information 
In addition, serving European and emerging markets are local companies such as Eiken 
Chemical, Menarini Diagnostics (Florence, Italy), Dr. Bruno Lange GmbH (Berlin, 
Germany), Biochemical Systems (Arezzo, Italy), Transasia Bio-Medicals Ltd (Maharashtra, 
India) and Snijders Scientific (Tilburg, Netherlands) market small tabletop instruments that 
run a wide chemistry test menu on both serum and whole blood. 
Despite intense competition and a modest growth potential, the market for chemistry systems 
is in constant renewal. A selection of innovations in clinical chemistry analyzers is listed 
below. 

 
 
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Table 6-5: Selected Clinical Chemistry Innovations 
Company 
Location 
Details 
Beckman Coulter/Danaher 
U.S. 
AU5800 automated chemistry system 
Carolina Liquid Chemistries 
U.S. 
CLC1600 High Throughput Chemistry Analyzer 
Carolina Liquid Chemistries 
U.S. 
CLC 800 Clinical Chemistry Analyzer Mid-Volume Labs 
Diatron 
Hungary 
Pictus 700, fully automated chemistry analyzer 
EKF Diagnostics 
UK 
Altair 240 clinical chemistry analyzer 
ERBA Diagnostics 
Germany 
ERBA Automated Chemistry Analyzer XL-400 
ERBA Diagnostics, Inc. 
Germany 
Chemistry Analyzer XL-400 
Horiba Medical 
Japan 
Pentra C400 
Mindray/MedTest Dx 
China 
Mindray BS-480 analyzer, chemistry & drugs of abuse reagents 
QuidelOrtho 
U.S. 
VITROS XT 3400 reads pair of tests on one Micro Slide 
Randox Laboratories 
UK 
RX imola, chemistry analyzer 
Sekisui Diagnostics 
U.S. 
SK500 Chemistry System, SEKURE reagents, mid volume labs 
Source: Kalorama Information 
Rapid Response Systems 
Systems designed for rapid-response testing are used both in central laboratories and at the 
point of care. Many of these systems use whole blood, which helps eliminate the need for 
centrifugation and speeds up turnaround time. This is especially important for time-sensitive 
testing, although not all rapid testing platforms rely exclusively on whole blood. The major 
and emerging players in whole blood analysis systems used both inside and outside the lab 
are outlined in the following table. 

 
 
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Table 6-6: Selected Major Whole Blood Chemistry Analyzers  
Analyzer 
AVL, Indianapolis, IN 
Awareness Technologies, Inc., Palm City, FL 
Diagnostics/International Technidyne/Diametrics, St Paul, MN 
Instrumentation Laboratory, Lexington, MA 
i-STAT/ Abbott, East Windsor, NJ 
Nova Biomedical, Waltham, MA 
Radiometer, Westlake, OH 
Scil Diagnostics, Martinsried, Germany 
Siemens Healthineers, Tarrytown, NY 
Transasia Bio-Medicals, Mumbai, India 
Source: Kalorama Information 
Critical Care Analysis 
Blood gas/electrolyte and critical care testing are among the more mature areas of the lab; 
however, with increased acuity of the inpatient population, these critical care systems have 
become increasingly important. Critical care chemistries are highly time-sensitive diagnostic 
tests, such as blood gas, electrolyte, and metabolite analysis. In some cases, a sample is sent 
to the lab for testing and increasingly portable systems are used at the bedside. 
These analyzers are primarily used in the emergency room, operating room, cardiac 
monitoring area and any location where time-critical diagnostic testing is performed within 
the hospital setting. They are also used in routine laboratories for stat testing. 
In 2025, rapid-response tests or POC critical-care testing accounted for $1,119 million in 
sales revenue. This segment is currently growing at 1.8% annually as more hospitals are 

 
 
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moving these time-critical tests closer to the patient. The market is expected to expand to an 
estimated $1,225 million in 2030. 
Blood gas analysis, more specifically arterial blood gas (ABG) analysis, is a standard clinical 
diagnostic test that measures a patient’s blood gases; oxygen and carbon dioxide levels 
constitute a delicate balance within the human body. Arterial blood pH is included in these 
measurements because dissolved carbon dioxide helps balance the acidity or alkalinity of the 
respiratory system. Similarly, bicarbonate balances pH in the renal system. Bicarbonate also 
functions as an indicator of metabolic balance. 
Other parameters that can be tested in conjunction include electrolytes and metabolites. 
Blood gas analysis can not only assess a patient’s health status but also diagnose respiratory, 
renal, or metabolic diseases that affect the normal balance of blood gases. 
In critical care medicine, blood gas analysis is combined with other critical care analytes, 
including bilirubin for neonates, glucose, BUN, creatinine, calcium, ionized calcium, 
magnesium, lactate, pH, hemoglobin, and hematocrit. Blood gases, oximetry and a cardiac 
marker panel are added for patients with chest pain. The most advanced critical care test 
devices include various cartridge combinations of gases, electrolytes, and others, depending 
on the patient care situation. These may be used for POC testing in intensive care units, 
emergency rooms, ambulances, and other acute-care settings, as well as in laboratories. 
Handheld devices include Abbott/i-STAT; Opti Medical; Medica Corp. EASY systems; 
LifeHealth IRMA TruPoint Blood Analysis System; and Alere Epoc (now Siemens 
Healthineers). The leader in this field is Abbott’s i-STAT, which has gained market share 
through a continuous menu expansion that includes basic chemistries, blood gases, 
electrolytes, coagulation, hematology, and cardiac markers. Abbott has reported that more 
than 50,000 i-STAT handhelds are used by health care professionals in a variety of high-
acuity settings worldwide–including in more than 1,800 hospitals. More than 50 million test 
cartridges are produced annually.  
Small portable lab-style systems include: Instrumentation Laboratory’s Gem Premier 
systems; Roche Diagnostics cobas b 123 POC System; Radiometer ABL800 FLEX Blood 
Gas Analyzers; Nova Biomedical StatProfile pHOx Ultra; and Siemens Healthineers 
RAPIDLab 1200 Blood Gas Systems and RAPIDpoint systems.  
The major traditional players in blood gases are Radiometer/Danaher, Instrumentation 
Laboratory/Werfen, Siemens Healthineers, Roche Diagnostics and Nova Biomedical.  

 
 
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These companies and others are focusing on expanding the test menu to support more 
efficient on-site critical care diagnostics. They are also commercializing instruments with 
minimal or no maintenance, multi-test cassettes, remote instrument management for 
maintenance and quality control and automatic transfer of test results to an information 
system. These features are necessary for easier market penetration for POC usage, but also 
for use in core laboratories for stat and evening and night shifts.  
Neonatal jaundice has generally been measured using non-invasive transcutaneous bilirubin 
measurement with transdermal devices. In the past few years, total bilirubin testing has been 
added to critical care analyzers. For example, Instrumentation Laboratory offers what it 
claims is the first-ever, rapid point-of-care, laboratory-quality blood test for measuring total 
bilirubin in newborns. The tBili test is performed on the company's automated GEM Premier 
4000 critical care analyzer, providing on-the-spot results in 90 seconds. Similarly, Siemens 
Healthcare has been awarded the CE Mark for a total bilirubin test on its RAPIDPoint 405 
system. 
Werfen offers the GEM Premier 7000 with IQM 3 Blood gas testing system for POC.  The 
product represents a breakthrough in blood gas testing due to its ability to detect hemolysis 
as the POC.  
 In this test segment, the division between POC and lab-based systems is blurred because the 
instruments can be and are used in multiple test settings. Nevertheless, Kalorama has 
estimated the use of critical care testing inside and outside the lab. 
In 2025, the world market for blood gas, electrolyte and POC critical care instruments is 
$2,314 million ($1,195 million lab; $1,119 million POC). Performance in critical care POC 
has been slow. Expect annual growth of 2.4%, driven primarily by the lab-based sector 
(3.0%). 

 
 
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Table 6-7: Blood Gas, Electrolyte, and Critical Care Instrument Market, by End User, 2025 and 2030 ($ million) 
 
[Lab-based; POC-based] 
End User Category 
2025 
2030 
CAGR (%) 
Lab-based 
1,195 
1,388 
3.0% 
POC-based 
1,119 
1,225 
1.8% 
Total 
2,314 
2,613 
2.4% 
Source: Kalorama Information 
The market leader for blood gas analyzers (for all critical care, not just gases, including POC) 
shifted slightly, bringing Siemens Healthineers' market share to 20%. Radiometer increased 
its market share to 19%, Abbott maintained its at 18%, Werfen at 9%, and Beckman Colter 
at 7%.    
Table 6-8: Blood Gas, Electrolyte, and Critical Care Market Leaders, 2025 (% distribution of total sales, 
including POC) 
Company 
% Mkt 
Siemens Healthineers 
20% 
Radiometer 
19% 
Abbott 
18% 
Werfen 
9% 
Beckman Coulter 
7% 
Others 
28% 
Total 
100% 
Source: Kalorama Information 
 

 
 
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Urinalysis 
Urinalysis consists of two separate elements: reading a strip test for chemical analysis of the 
sample and a microscopic examination of cellular elements. Urine sediment analysis is an 
important test used in diagnosing renal disease and urinary tract disorders. Clinical laboratory 
technologists use microscopes to classify, and measure formed elements in the urine 
sediment, including red blood cells, white blood cells, and bacteria. 
These procedures are usually done manually and are considered fairly low-tech and routine 
compared to other analysis groups. Since urinalysis samples come from a variety of 
collection sites: inpatient, nursing homes, physician offices, outpatient clinics, emergency 
departments at all times of the day and night, laboratories need a simple solution to manage 
high volumes as well as individual samples. In this era of cost pressures and scarce human 
resources, urinalysis was ripe for automation. Therefore, in the past few years, most 
laboratories have been upgrading to automated systems that read the urine strip and integrate 
the two steps.  
Further, image analysis from Iris International (now part of Danaher), Sysmex and ARKRAY 
provides a quantitative urine sediment test result that is necessary for initial disease 
assessment. 
Lab-based urinalysis systems are estimated at $1,138 million in 2025, reflecting steady sales.  
The market is expected to grow at a 2.2% annual growth rate, to reach $1,270 million in 
2030. Additionally, the POC UA market is valued at $214 million for 2025.  Key players 
include ARKRAY Inc., Beckman Coulter, Roche Diagnostics, Siemens Healthineers and 
Sysmex. 
Table 6-9: Urinalysis Market, by End User, 2025 and 2030 ($ million)  
 
[Lab-based, POC-based] 
End User Category 
2025 
2030 
CAGR (%) 
Lab-based 
1,138 
1,270 
2.2% 
POC-based 
214 
247 
2.9% 
Total 
1,352 
1,517 
2.3% 
Source: Kalorama Information 

 
 
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The market leader in 2025 is Sysmex, with 22% of the market share. Sysmex grabbed the 
market-leading position due to increasing demand for reagents in Asian markets. In the 
Americas and EMEA, Sysmex reported enhanced promotional efforts and increased product 
demand. Siemens Healthineers holds approximately 20% of the market and Roche holds 
18%, Beckman Coulter secured 13%, and ARKRAY held 8%.  Other market vendors share 
the remaining 19%. 
Table 6-10: Urinalysis Systems (including POC) Market Leaders, 2025 (% distribution of total sales, 
estimated)  
Company 
% Mkt 
Sysmex 
22% 
Siemens Healthineers 
20% 
Roche 
18% 
Beckman Coulter 
13% 
ARKRAY 
8% 
Others 
19% 
Total 
100% 
Source: Kalorama Information 
Urinalysis innovations include the addition of analytes other than traditional urinalysis 
parameters, automated instrumentations and apps for test management. A selection of these 
innovations is presented below. 

 
 
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Table 6-11: Selected Urinalysis Innovations 
Company 
Location 
Area 
Details 
Acon Laboratories 
U.S. 
instrument 
Mission U120 Ultra Urine Analyzer 
ARKRAY 
Japan 
instrument 
Urine Analyzer Aution Hybrid AU-4050 
Beckman Coulter 
US  
Instrument 
DXU Iris Workcell  
ERBA Diagnostics 
U.S. 
instrument 
Laura M, urine analyzer with microalbumin & creatinine 
ERBA Diagnostics 
U.S. 
instrument 
Laura XL, a fully automated urinalysis and sedimentation 
processor 
IRIS  
U.S. 
Instrument 
IChem line of analyzers (legacy brand) 
Macherey-Nagel 
Germany 
Instrument 
URYXXON Relax 
Roche 
U.S. 
Instrument 
Urisys 1100 
Siemens Healthineers 
U.S. 
instrument 
CLINITEK Novus Analyzer, dipstick cassette 
Siemens Healthineers 
U.S. 
connect 
CLINITEK Status Connect System, wireless 
Sysmex Corp 
Japan 
instrument 
Eiken's urinalysis strips with Sysmex's automated analyzers 
Sysmex Corp 
Japan 
instrument 
UD-10, complete analysis of urine in combination with the UF-
5000/4000 
Sysmex 
Japan 
Instrument 
UN-Series Automated urinalysis solution 
Source: company reports, Kalorama Information 
 

 
 
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The Commercial Outlook for Chemistry Tests 
The clinical chemistry market, though mature, continues to experience moderate growth, 
driven by technological innovation and evolving clinical needs. Emerging tests are being 
rapidly integrated into modern chemistry analyzers. Examples include homocysteine, anti-
CCP, tumor markers, procalcitonin, autoimmune markers (e.g., ANAs), allergy testing, B-
type natriuretic peptide (BNP), high-sensitivity C-reactive protein (hsCRP), and hemoglobin 
A1c. These additions expand diagnostic capabilities and support broader clinical decision-
making. 
Instrumentation is also becoming increasingly automated. Leading vendors are investing 
heavily in next-generation systems designed to streamline workflow, increase throughput, 
and reduce labor costs, all in response to the industry's push for operational efficiency. AI is 
being used in analyzers to boost accuracy and efficiency.  
A major contributor to market growth is the increased use of whole-blood specimens on 
miniaturized platforms. These compact systems are utilized in core laboratories, critical care 
units, and point-of-care settings, offering fast turnaround times and greater flexibility for 
routine 
and 
urgent 
testing. 
Analytics 
support 
multi-omics 
integration 
with 
genomics/proteomics in IVD, especially in oncology and chronic disease.  
As hospitals consolidate testing into centralized core labs, analyzers that offer broad test 
menus and scalability are in high demand. This is particularly advantageous for both high- 
and medium-volume laboratories, which benefit from comprehensive, integrated solutions 
that support consolidation and improve overall lab efficiency. 
 

 
 
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Chapter 7: Immunoassays 
Scope 
The immunoassay IVD market covers diagnostic tests and systems that detect or 
quantify specific analytes such as proteins, hormones, pathogens, or antibodies based 
on the binding reaction between an antigen and an antibody. Included in this chapter 
are: 
• Thyroid function tests 
• Therapeutic drug monitoring 
• Vitamin D tests 
• Anemia tests 
• Toxicology and drugs of abuse testing 
• Allergy testing 
• Proteins 
• Tumor markers 
• Cardiac markers 
• Rheumatoid arthritis 
• GI testing 
• Transplant management 
• Women’s health 
• Alzheimer’s disease 
• Traumatic brain injury 
• Pregnancy and fertility testing 
The market is further divided into Professional use and POC OTC use. This chapter 
discusses all lab based and POC immunoassay categories except those for infectious 

 
 
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diseases, which are covered in Chapter 12 covering Blood Banking Services, and 
Chapter 11 covering Microbiology/Virology. 
For the purposes of this report, the following definitions apply: Drugs of abuse tests 
include those for: alcohol; illegal drugs such as cocaine and opiates; and prescription 
drugs such as barbiturates and benzodiazepines used for clinical purposes, not 
workplace testing. Cardiac marker tests include: CK-MB, myoglobin and troponin I/T. 
 
 

 
 
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Overview and Trends  
Immunoassays—tests based on the specific binding of antibodies to antigens—have played 
a transformative role in clinical laboratory medicine since their introduction in the mid-
1960s. Today, they remain indispensable for the diagnosis and monitoring of a wide array of 
diseases and conditions. Formats such as manual and automated enzyme immunoassays 
(EIAs), ELISAs, bead arrays, microarrays, and newer platforms leveraging mass 
spectrometry are widely used across all segments of lab medicine. 
Despite earlier predictions that molecular diagnostics would eclipse immunoassays, these 
tests have instead experienced a significant resurgence. Their relevance has expanded well 
beyond infectious disease and hormone testing to include assays for metabolic pathways, 
autoimmune conditions, gastrointestinal disorders, diabetes, and women’s health. 
The publication of the human genome in 2001 catapulted in vitro diagnostics, and 
immunoassays in particular, into a new and revitalized track—generally referred to as post-
genomic medicine.   Lab medicine in this post-genomic era involves tests based on protein 
and nucleic acid targets derived from human genome research.  Gene identification is the 
first step; the next step involves detecting the physiological elements—proteins, hormones, 
and enzymes —expressed by genes.  Immunoassays are used to test all of these entities.  
Proteins perform many important cellular functions, serve as targets for most drugs and 
therapies, and are often used as biomarkers for detecting and monitoring disease. 
Proteins, enzymes, coenzymes and a host of cellular elements are the major players in 
metabolic pathways that actually promote and predict the evolution of a disease.  The 
combination of genes, proteins, and pathways creates a comprehensive toolbox for modern 
post-genomic lab medicine. 
Immunoassay Technology Continues to Evolve 
One aspect of proteomic research is the discovery of markers that are implicated in various 
disease processes.  However, in many cases, the concentration of these new markers in both 
healthy and disease states is very low.  This is especially true in the case of cancer and 
neurological diseases such as Alzheimer’s disease and Parkinson’s disease.  While advanced 
techniques such as mass spectrometry are used in the search for new markers, they are not 
appropriate for routine testing in hospital laboratories.  

 
 
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New ultra-sensitive test methodologies are being developed to detect highly specific disease 
markers, many of which are present at nanomolar, picomolar, and femtomolar 
concentrations. 
ELISA remains a well-established and widely used immunoassay technique, particularly in 
laboratory settings. It is a solid-phase method typically performed in microtiter plates, where 
an antigen or antibody is immobilized in a test well. When a sample is added, the target 
analyte binds through a specific antigen–antibody interaction if present. After a washing step 
to remove unbound material, a detection antibody linked to an enzyme is introduced, 
allowing the reaction to be visualized through a measurable signal, most commonly 
colorimetric, but also fluorescence or chemiluminescence in some formats. While the 
sandwich format is widely used due to its sensitivity, other ELISA formats such as 
competitive and indirect assays are also employed. Although ELISA is a mature technology, 
it continues to play an important role in detecting low concentrations of analytes, even as 
more automated and high-throughput immunoassay systems expand in the core laboratory. 
There remains strong investment in new technologies that expand the capabilities of 
immunoassay-based testing. While major IVD companies are advancing next-generation 
systems, smaller specialized firms also play an important role in developing innovative 
approaches. These include multiplexing, microarrays, and biosensor-based platforms, all 
aimed at improving sensitivity, throughput, and ease of use. Additionally, techniques such as 
mass spectrometry are being used alongside immunoassays in certain applications. A key 
focus across these technologies is the ability to detect analytes at very low concentrations, 
enabling earlier and more precise disease detection.   
This ability to wash away nonspecifically bound materials makes the ELISA a powerful tool 
for measuring specific analytes within a crude preparation.  However, the process involves 
many steps and is not readily adapted to automated immunoanalyzers or core lab clinical 
workstations.  So … one can see the innovation in progress to enhance the delivery of ELISA 
testing with random access, arrays, digital and microfluidic techniques and automation.  
These enhanced ELISA systems improve the technology's versatility to support more 
efficient immunoassay processing. 
Veravas provides VeraBIND technology for ultra-sensitive assays and matrix-free sample 
analysis. The technology is bead-based and enables reliable biomarker detection. VeraBIND 
is designed for use in clinical diagnostics and research to improve workflows and enable 
more sensitive detection of low-abundance biomarkers. Once validated, it is compatible with 

 
 
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commercially available assays and can be run using any detection method, including ELISA, 
chemiluminescence, and mass spectrometry.  
With continuous investment from both large IVD companies and agile biotech startups, 
immunoassays are poised to remain a key platform in diagnostic medicine, meeting the 
growing demand for precision, sensitivity, and speed in detecting today's most complex 
diseases. 
 
 

 
 
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Table 7-1: Selected Immunoassay Technologies  
Company 
Location 
Area 
Details 
Aesku Diagnostics 
Germany 
ELISA 
HELMED 3 in 1 platform - IFA, ELISA, and BLOT 
ALPCO Diagnostics 
U.S. 
ELISA 
Euro Diagnostica’s ELISA 
Bio-Techne Corp 
U.S. 
multiplex 
Ella, new ProteinSimple Simple Plex platform  
Caprion BioSciences 
Canada 
mass spec 
CellCarta, gel-free, label-free mass spec platform  
Corgenix Medical Corp 
U.S. 
ELISA 
SkyLab 752 dual-pipette automated ELISA analyzer 
Cyvek, Inc. (Bio-Techne) 
U.S. 
multiplex 
CyPlex System multiplex test cartridge; Ella/Simple Plex 
Dynex Technologies 
U.S. 
automation 
DSX automated enzyme-linked immunosorbent assay; 
Agility EKLISA 
Enzo Clinical Labs 
U.S. 
EIA 
Diasorin's immunoassays, Liaison XL 
Fujirebio Diagnostics 
Japan 
EIA 
LUMIPULSE G1200, chemiluminescent EIA 
LUMIPULSE G B-Amyloid 
LUMIPULSE G B.R.A.H.M.S. PCT Assay 
Gold Standard Diagnostics  
U.S. 
ELISA 
200 ThunderBolt-Ready ELISA from 20 companies  
The Bolt 
Gyros AB 
Sweden 
nano 
Gyrolab immunoassays   
Immunovia 
Sweden 
array 
IMMray, antibody biomarker microarray  
InDevR, Inc. 
U.S. 
multiplex 
miPLEX translate single well ELISA to multiplexed 
InDevR, Inc. 
U.S. 
IT 
automate interpretation hemagglutination assays 
Indi Molecular 
U.S. 
tech 
protein catalyzed capture reagents (PCCs)  
INOVA Diagnostics, Inc. 
U.S. 
EIA 
BIO-FLASH, a rapid chemiluminescent analyzer 
Intel Corporation 
U.S. 
chip array 
silicon microarray chip real-time analysis in minutes 
Mindray Medical 
China 
EIA 
CL-2000i instrument and reagents 
Olink Bioscience 
Sweden 
immunoPCR 
Proseek Multiplex proteins, Fluidigm BioMark HD PCR  
OTraces, Inc. 
U.S. 
automation 
CDx Chemistry System, automated ELISA 
ProteinSimple 
U.S. 
multiplex 
Simple Plex platform with Bio-Techne proteins 

 
 
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Company 
Location 
Area 
Details 
Qualigen, Inc. 
U.S. 
EIA 
FastPack IP System, chemiluminescent immunoanalyzer 
Quanterix Corp 
U.S. 
digital ELISA 
Simoa HD-1 Analyzer, SR-X Ultra-Sensitive Biomarker 
Detection System 
Quidel Corp 
U.S. 
EIA 
Sofia fluorescent immunoassays  
Randox Laboratories 
UK 
multiplex 
Evidence Multistat Biochip Analyzer  
Response Biomedical 
Canada 
ELISA 
with Hangzhou Joinstar Biomedical (China) 
Singulex 
U.S. 
cell 
Sgx Clarity System, single cell counting 
Singulex 
U.S. 
automation 
Sgx Clarity Tecan’s Freedom EVO liquid handling  
Singulex 
U.S. 
EIA 
Erenna Immunoassay System 
SISCAPA Assay Technologies  
Canada 
mass spec 
SISCAPA SAT affinity-MS technology antibodies 
Somalogic 
U.S. 
aptamers 
SOMAmer aptamers & antibody reagent 
Somalogic 
U.S. 
multiplex 
SOMAscan assay proteomics platform  
T2 Biosystems 
U.S. 
biosensor 
T2MR miniaturized, magnetic resonance 
Theradiag 
France 
ELISA 
Theralis: xMAP, immunofluorescence, ELISA 
Theradiag 
France 
CLIA 
BioCLIA 1 200, nanoparticle chemiluminescence, 
automated 
Source: Kalorama Information 
Mass Spectrometry 
Mass spectrometry makes an important contribution to protein analysis.  Sequencing of the 
human genome has provided a picture of the human proteome as well as the genome.  An 
important step in immunodiagnostics is the ability to screen an individual's proteome using 
a standardized, quantitative tool.  Mass spec has been recognized as an ideal solution.  
Mass spectrometry quantifies molecules in a sample and offers high specificity and 
sensitivity compared to traditional techniques. It can be used for a variety of specimen types, 
including blood spots, serum, plasma, and breath.  

 
 
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Mass spectrometry in clinical laboratories has traditionally been viewed as complex, time-
intensive, and costly, thereby limiting its use to specialized applications. Early adoption 
focused on areas such as toxicology using GC-MS and later LC-MS/MS for assays where 
high specificity was required, and commercial immunoassays were not available. 
Today, mass spectrometry is more widely established in clinical laboratories, particularly in 
larger hospital and reference lab settings. Improvements in automation, system design, and 
workflow integration have made the technology more accessible, and the range of 
applications has expanded significantly. In addition to toxicology, mass spectrometry is now 
routinely used for therapeutic drug monitoring, endocrinology testing, vitamin analysis, and 
other specialized assays. Ongoing advances continue to improve ease of use and throughput, 
supporting broader adoption across the clinical lab environment.   
Compared to immunoassays, mass spec is sensitive enough to detect disease-specific proteins 
that have leaked into the blood flow.  Proteins released into body fluids by diseased tissue 
are the most relevant biomarkers, but their dilution in blood means they are present at very 
low levels that cannot normally be detected by immunoassays. 
Proprietary protein technology from Proteome Sciences plc has enabled the detection and 
quantification of very low-abundant disease-related proteins in body fluids that are 
undetectable by other methodologies.  The company reported that it has detected and 
quantified 41 phosphorylated peptides of the tau protein (an Alzheimer’s disease marker) in 
human cerebrospinal fluid using mass spectrometry. 
SISCAPA Assay Technologies developed a mass spec process for protein quantification, 
enabling panels of proteins to be measured across large numbers of samples with a very short 
turnaround time. Samples may be collected as Dried Blood Spots (DBS) and shipped at room 
temperature. The initial panel consists of proteins pertinent to cardiovascular function, 
inflammation, and muscle distress: Alpha-1-acid Glycoprotein, Cystatin C, C-Reactive 
Protein, Hemoglobin, Haptoglobin, Insulin-like Growth Factor 1, LPS Binding Protein, 
Mannose Binding Lectin, Myeloperoxidase, and Serum Amyloid A. 
Mass spec is an attractive alternative to ELISAs for clinical protein biomarker detection 
because of its multiplexing capabilities. Also, mass spec assays often have better specificity 
than immunoassays, providing greater confidence that the measured analyte is, in fact, the 
assay target.   

 
 
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VeriStrat, a multivariate serum protein test, is Biodesix’s first product developed with this 
technology. The commercially available test provides oncologists with information to help 
them select between erlotinib and single-agent chemotherapy for patients with advanced lung 
cancer. Tests are processed in Biodesix’s CLIA-certified laboratory and results are reported 
in less than 72 hours.  
Biodesix uses the MALDI-MS platform to generate spectra containing eight proteomic peaks 
that comprise the VeriStrat classifier.  Biodesix and Bruker are combining Biodesix’s 
platform technology, including Biodesix’s proprietary data analysis algorithms, and Bruker’s 
instruments, which form the basis for a clinical diagnostics platform. 
Even with the evolution of mass spec instrumentation for more routine analyses, it is still not 
as easy as running a clinical analyzer.  Therefore, Sciex has invested in developing its training 
solutions to provide more tailored support for less-experienced clinical users. 
Mass spectrometry has become an important tool in clinical laboratories, with early 
applications focused on toxicology and metabolic screening, including newborn screening. 
More recently, the adoption of MALDI-TOF systems from companies such as Bruker and 
bioMérieux has transformed clinical microbiology by enabling rapid identification of 
bacteria and fungi. 
The range of applications for mass spectrometry continues to expand, particularly in 
therapeutic drug monitoring, endocrinology, and specialized biomarker analysis. While 
research efforts are exploring its use in oncology, neurodegenerative diseases, and 
pregnancy-related conditions, many of these applications are still emerging rather than 
routine. 
There has also been ongoing interest in miniaturizing mass spectrometry systems to create 
more portable and user-friendly devices. However, most clinical use today remains centered 
on laboratory-based instruments, with portable systems still largely limited to research and 
niche applications rather than widespread clinical deployment. 
 The Ohio State University Badu Research Group developed a paper-based mass 
spectrometry immunoassay platform that uses stable and cleavable ionic probes as mass 
reporters.  The scientists report these probes make possible sensitive, interruptible, storable, 
and restorable on-demand detection. In addition, a new touch paper spray method was 
developed for on-chip, sensitive, and cost-effective analyte detection.  The paper contains 

 
 
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small synthetic chemical probes that carry a positive charge. It's these ionic probes that allow 
ultra-sensitive detection by a handheld mass spectrometer.   
Another emerging area of interest is the use of mass spectrometry for imaging tissue sections. 
This approach provides detailed molecular information that goes beyond what is available 
with traditional stain-based histology, offering the potential for deeper insight into disease 
processes. While improvements have been made, challenges such as acquisition time, 
workflow integration, and standardization continue to limit widespread clinical adoption. 
Even so, the ability to generate high-content molecular data directly from tissue makes this 
a promising technology for future use in pathology and translational research. 
Looking further into the future, it is expected that the trend toward increasing automation 
will ultimately result in the introduction of fully automated clinical analyzers using mass 
spectrometry-based detection, at which point mass spectrometry will become widely used by 
smaller clinical laboratories.  
It is beyond the scope of this research to evaluate the market for clinical mass spectrometry 
applications with certainty; however, Kalorama Information estimates the market at $1,032 
million in 2025, growing at 8.6% annually.   
The major mass spectroscopy system manufacturers include: Sciex/Danaher, Agilent 
Technologies, Bruker Corp., PerkinElmer, Shimadzu Corp., Thermo Fisher Scientific Sigma 
Aldrich and Waters Corp. The technology is used primarily in pharmaceutical research, 
biotechnology, industrial chemistry, environmental testing, and food and beverage testing.  
In clinical diagnostics, many LDTs based on mass spectrometry are currently addressing a 
range of analytes. 
For years Sciex/Danaher has been considered the top provider in this segment.  The company 
markets kits for steroids, vitamin D and metabolites, T3/T4, homocysteine, therapeutic drug 
monitoring, and inborn errors of metabolism, among others. In recent years, however, 
competition has increased in the space, including a recent surge in approvals, some examples 
of which are listed below. 
Waters markets the MassTrak system, which is CE Marked, for measuring the 
immunosuppressive drugs tacrolimus and everolimus. 
Thermo Fisher Scientific markets kits for pain management, drugs of abuse analysis, and 
endocrine analysis. 

 
 
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Shimadzu offers the MALDImini-1, the first compact MALDI digital ion-trap mass 
spectrometer. The MALDImini-1 fits in a space the size of a piece of paper, while allowing 
fast high-sensitivity measurements and detailed structural and qualitative analyses over a 
wide mass range, even with sub-microliter sample volumes. Shimadzu also offers Fraction 
Collector FRC-40 for high performance liquid chromatography. The FRC-40 incorporates 
improved fraction simulation to ensure pure fractions. Operators simply select the peaks of 
interest, and the software dynamically configures parameters that will collect them. 
SCIEX offers the TripleTOF 6600+ LC-MS System and Scanning SWATH Acquisition 
alongside data processing with OneOmnics in SCIEX Cloud. These products together enable 
precise large-scale quantification to drive the discovery of new biomarkers. SCIEX also 
offers the Micro-ESI 9030, an interface compatible with the Nexera Mikros Microflow 
LCMS that enables micro flowrate analysis with the LCMS-9030 Q-TOF system. 
PerkinElmer offers its GC Platform, an advanced automated gas chromatography headspace 
sampler and GC/mass spectrometry solution to help labs operations.  
Waters offers its MassTrak IVD  portfolio of LC-MS systems. The system, next-generation 
Xevo TQ Absolute IVE mass spec, is up to five times more sensitive for quantifying clinical 
analytes. 
Bruker offers the timsTOF Ultra Mass Spectrometer with Transformative Sensitivity. It 
incorporates  a  Captive Spray Ionization Ultra ion source. Additionally, Bruker markets the 
EVOQ DART-TQ+ system for chromatography-free triple-quadrupole mass spectrometry in 
POC analysis.  
Thermo Fisher markets the Thermo Scientific Orbitrap Astral mass spectrometer, which 
combines fast throughput, high sensitivity and deep proteome coverage. The  Astral analyzer 
complements Thermo Fisher’s Orbitrap MS platform.  
Shimadzu offers the new LCMS RX series of triple quadrupole mass spectrometry 
instruments. The CoreSpray improves heat distribution in the ionization source, enhancing 
data reliability. The IonFocus removes matrix contaminants. Shimadzu offers its MALDI 
EasyCare solution. The MALDI EasyCare Solution decreases downtime and makes it easier 
to perform routine upkeep on the MALDI-8000 Series TOF mass spectrometers 
SCIEX offers the SCIEX 7500+ System, one of the newest flagship instruments in the 
company’s mass spectrometry portfolio. The SCIEX 7500+ System is designed to deliver 

 
 
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exceptional sensitivity while maintaining high robustness and resilience to matrix effects, 
supporting reliable, high-throughput quantitative testing across demanding analytical 
applications. 
.  
 
 
 

 
 
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Table 7-2: Selected Innovation in Mass Spectrometry for Routine Analyses 
Company 
Location 
Area 
Details 
Agilent Technologies 
U.S. 
pregnancy 
mass spec for pregnancy complications 
Applied Proteomics  
U.S. 
cancer 
SimpliPro Colon 
Biodesix, Inc. 
U.S. 
cancer 
VeriStrat, a multivariate serum protein test 
Biodesix, Inc. 
U.S. 
IT 
ProTS, data analysis algorithms, and Bruker instruments  
BioMark Diagnostics  
Canada 
cancer 
acetylated form of the drug Amantadine, PGx 
Caprion Proteomics 
Canada 
instrument 
CellCarta, gel-free, label-free mass spec platform  
Matrix-Bio Inc. 
U.S. 
cancer 
VeraMarker metabolite assays pancreatic, liver, colon 
cancer 
Microsaic Systems 
UK 
miniature 
Microsaic 4000 MiD miniature mass spectrometer 
PerkinElmer 
U.S. 
instrument 
AxION iQT gas chromatography tandem mass 
spectrometer  
Proteome Sciences  
UK 
Alzheimer’s 
tau peptides and phosphopeptides in CSF 
Sciex 
U.S. 
instrument 
API 3200MD and 3200MD QTRAP LC/MS/MS  
Sciex 
U.S. 
instrument 
Citrine system 
Sciex 
U.S. 
transplant 
SCIEX IVD-MS Immunosuppressants kit  
Sciex 
U.S. 
vit D 
SCIEX IVD-MS Kit for 25-OH-vitamin D2/D3 
Sera Prognostics, Inc. 
U.S. 
pregnancy 
PreTRM, risk of preterm birth, Agilent technology  
Shimadzu 
Japan 
instrument 
MALIDmini-1 
SISCAPA Assay Technologies  
Canada 
technology 
SISCAPA SAT affinity-MS technology antibodies 
SISCAPA Assay Technologies  
Canada 
technology 
SISCAPA SAT antibodies with Agilent instrumentation 
Thermo Fisher Scientific 
U.S. 
cancer 
detect and track circulating biomarkers, mass spec 
University of Michigan 
U.S. 
cancer 
Mi-Prostate Score, early markers in urine 
Source Kalorama Information 

 
 
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Radioimmunoassays 
Radioimmunoassay (RIA) remains one of the most sensitive immunoassay methodologies, 
utilizing radioactive isotopes to quantify antigen-antibody interactions. This groundbreaking 
technique, developed by Rosalyn Yalow and Solomon A. Berson, transformed hormone 
testing and paved the way for modern endocrinology. Their early work on blood volume and 
iodine metabolism was followed by the application of RIA to hormone studies, most notably 
insulin, leading to their discovery that type 2 diabetes results from insulin resistance rather 
than insulin deficiency. 
Throughout the years, RIA was a cornerstone of laboratory testing for fertility, hormone 
levels, and endocrine disorders. However, it was time-consuming, labor-intensive, and 
required strict regulatory controls due to its use of radioactive materials. In a typical 
chemistry lab, RIAs were often run once or twice per week and took nearly a full day to 
complete—usually by a senior technologist. The advent and commercialization of enzyme 
immunoassays (EIAs) and ELISAs revolutionized lab workflows. These new methods 
eliminated radioactivity concerns, reduced processing time, and enabled random-access 
automation, with test results available in under an hour. This led many to believe RIA would 
become obsolete. This has not been the case. RIA has proven to be extremely precise and 
sensitive and thus, the technique is still used for infectious diseases, hormone analysis and 
oncology in some clinical labs worldwide. It is used particularly in Europe and emerging 
markets where EIA test kits and instrumentation are difficult to obtain.  
Kalorama estimates the 2025 market for RIAs is worth roughly 11% of the ‘other’ 
immunoassay market, which is valued at $3.0 billion. Beginning in the 14th Edition and 
continuing for the 15th Edition and beyond, RIA’s have been consolidated into the 
immunoassay chapter figures.  Major companies that still offer RIAs include: 
Danaher/Beckman Coulter, Bio-Rad Laboratories, Diasorin S.p.A., DRG International, Inc., 
MilliporeSigma, and MP Biomedicals, LLC.  
The immunoassay business of the next 5-10 years will see: 
• continued automation and commoditization of routine immunoassays—thyroid, 
anemia, proteins, fertility, therapeutic drug monitoring and drugs of abuse;  
•  more new assays and test categories—infectious diseases, cardiac markers, allergy, 
autoimmune, coagulation, bone and tumor markers; 

 
 
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•  menu expansion for more automatable and specialized assays, since labs want 
platforms that test for more tests and samples on a single platform; 
•  the migration of more immunoassays onto core lab workstations; 
•  the design of more sensitive, automated, homogeneous techniques; and  
•  the search for an ideal point-of-care platform. 

 
 
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Market Analysis 
The immunoassay market as a whole demonstrated growth in 2025. The global market for 
immunoassays (excluding those for infectious diseases and blood unit screening) is estimated 
at $14.3 billion.  By 2030, the market for immunoassays (excluding infectious diseases and 
blood screening) will reach $17.3 billion worldwide, with a CAGR of 3.9%. 
 
 

 
 
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Table 7-3: Global Lab-based Immunoassay Sales (excluding infectious disease and blood screening),  
by Analyte Type, 2025-2030 ($ million)  
 
[Allergy; Anemia; Autoimmune; Cardiac Markers; Diabetes/HbA1c; Drug of Abuse; Fertility; Proteins; 
Therapeutic Drugs; Thyroid; Tumor Markers; Vitamin D; Others] 
 Analyte Type 
2025 
% Mkt 
2030 
% Mkt 
CAGR 
Cardiac Markers 
1,867 
13% 
2,170 
12% 
3.1% 
Proteins 
1,862 
13% 
2,840 
16% 
8.8% 
Tumor Markers 
1,533 
11% 
1,685 
10% 
1.9% 
Diabetes/HbA1c 
1,342 
9% 
1,700 
10% 
4.8% 
Autoimmune 
955 
7% 
1,030 
6% 
1.5% 
Therapeutic Drugs 
775 
5% 
875 
5% 
2.5% 
Thyroid 
680 
5% 
730 
4% 
1.4% 
Allergy 
616 
4% 
652 
4% 
1.1% 
Anemia 
513 
4% 
527 
3% 
0.5% 
Fertility 
500 
4% 
525 
3% 
1.0% 
Drug of Abuse 
333 
2% 
353 
2% 
1.2% 
Vitamin D 
289 
2% 
290 
2% 
0.1% 
Others 
3,020 
21% 
3,943 
23% 
5.5% 
Total 
14,285 
100% 
17,320 
100% 
3.9% 
w/o HbA1c 
12,943 
-- 
15,620 
-- 
3.8% 
Note: Total percent may not add up due to rounding. 
Source: Kalorama Information 
The largest portion of the market (~74%-78%) is held in the more mature geographic 
segments of the world – North America (39%), Western Europe (32%) and Japan (5%).  
Emerging nations with stronger economies, such as those in Latin America and Africa, 
contribute to overall growth through the continued expansion of the market for routine 
immunoassays and some more esoteric tests.  

 
 
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Table 7-4: Global Immunoassay (excluding infectious disease and blood screening) Sales Distribution,  
by Region, 2025 (%)  
 
[Asia Pacific, Europe, Japan, North America, Rest of World] 
 Region 
% Mkt 
North America  
39% 
Europe 
32% 
Asia Pacific 
8% 
Japan 
5% 
RoW 
16% 
Total 
100% 
Source: Kalorama Information 
Markets in the Middle East, Saudi Arabia, Turkey, in particular, and Africa, led by S. Africa 
and Nigeria, are sparking the interest of competitors. These regions are looking to boost their 
diagnostics offerings. A once-emerging market, China, faces some uncertainties in growth 
due to a challenging healthcare environment, facing restructuring and government 
restrictions in response to cost savings initiatives. 
The commoditization of routine immunoassays and contractions in lab testing in the United 
States, Japan, and Western Europe has seen a decrease in the number of routine 
immunoassays performed.  In addition, the centralization of non-stat immunoassays on core 
lab analyzers (diabetes, thyroid, fertility, proteins, anemia, most infectious diseases), which 
make up 60% to 70% of immunoassays, has created pressure to decrease the cost per test.   
Nevertheless, immunoassay growth of about 3.9% in 2025 to 2030 derives primarily from 
testing in proteins due to the uptick of amyloid beta testing for Alzheimer’s disease, which 
has exploded on the scene at 8.8% CAGR, diabetes (HbA1c) expected at 4.8% CAGR, 
followed by cardiac markers (3.1% CAGR).  
In support of the use of immunoassays, a number of new quality control products have been 
commercialized.  The market for IVD quality control is estimated at $1,172 million for 2025. 

 
 
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Table 7-5: IVD Quality Control (immunoassay/molecular) Market, 2025 ($ million, estimated) 
Market 
2025 
IVD Quality Control Market 
$1,172 
Source: Kalorama Information 
The leading companies in third-party validated quality control products are Bio-Rad 
Laboratories, Thermo Fisher, and Randox Laboratories.   
Table 7-6: Selected Immunoassay Quality Control Products 
Company 
Location 
Details 
Bio-Rad Laboratories 
U.S. 
Lyphochek Whole Blood Immunosuppressant Control 
Lyphochek Anemia Control, Hypertension, Endocrine, Urine, Bone 
Bio-Rad Laboratories 
U.S. 
Liquichek Immunoassay Plus Control/Premium Control 
Bio-Rad Laboratories 
U.S. 
InteliQ Immunoassay Plus Control/Specialty Immunoassay Control 
Quanterix Corp 
U.S. 
Complete D 25-OH Vitamin D Control 
Randox Laboratories 
Ireland 
Acusera Aldolase & Ammonia Ethanol controls 
Randox Laboratories 
Ireland 
Acusera HbA1c, whole blood 
Randox Laboratories 
Ireland 
Acusera Immunoassay Premium Plus 
Randox Laboratories 
Ireland 
Acusera Liquid Tumor Marker Control 
Randox Laboratories 
Ireland 
Acusera Immunology CSF control 
Thermo Fisher 
U.S. 
MAS Omni-Core 
Thermo Fisher 
U.S. 
MAS Omni-IMMUNE Pro Max 
Thermo Fisher 
U.S. 
AcroMetrix 
ViveBio LLC 
U.S. 
Seracare QC products with ViveST sample 
Source: Kalorama Information 
 

 
 
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Table 7-7: Revenues of Leading Lab-based Immunoassay Vendors, 2024-2025 ($ million) 
Vendor 
2024 
2024 % Mkt 
2025 est 
2025 % est Mkt 
Roche 
5,904 
21.7% 
5,658 
20.3% 
Abbott 
3,674 
13.5% 
3,757 
13.5% 
Siemens 
2,122 
7.8% 
2,146 
7.7% 
Becton Dickinson 
1,250 
4.6% 
1,108 
4.0% 
Beckman Coulter 
1,704 
6.3% 
1,669 
6.0% 
Thermo Fisher 
1,229 
4.5% 
1,096 
3.9% 
QuidelOrtho 
1,278 
4.7% 
1,179 
4.2% 
Total 
17,161 
63.1% 
16,613 
59.6% 
Source: Kalorama Information 
The global market for immunoassays has been dominated by three top IVD companies, 
including Roche, Abbott Diagnostics, and Siemens Healthineers.  For the past few years, 
Roche Diagnostics has been very aggressive, displacing Abbott as the immunoassay leader. 
Roche has excelled in infectious diseases and in tests for women’s health, sepsis, vitamin D, 
and a number of cancer markers, all of which are higher-growth segments.   
Abbott’s strength lies in a broad menu of tests and assay systems and successful capture of 
at least 18% of the global market for infectious diseases (when combining its presence in 
POC infectious disease), primarily hepatitis and HIV tests, outside the United States, as 
compared to Roche with 9%, making Abbott the undisputed leader in microbiology 
immunoassays.  Abbott Diagnostics has also added the Galectin-3 assay, for use in 
conjunction with clinical evaluation to aid in assessing the prognosis of patients diagnosed 
with chronic heart failure, and the HbA1c test. 
The completed acquisition of Alere created a stronghold in POC and rapid testing 
immunoassays. The company had a substantial presence in the IVD immunoassay market 
before the acquisition, but Alere’s top POC immunoassay position helped to strengthen 
Abbott’s market share.  

 
 
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Only a few other companies can match the Roche and Abbott immunoassay test menus, 
including the third largest provider, Siemens Healthineers, with its Immulite products.  
Immulite is a dedicated immunoanalyzer, and although Siemens Healthineers has automated 
it, the company has focused on its chemiluminescence test menu within the ADVIA Centaur 
Immunoassay Systems line, originally from Bayer Diagnostics.   
Beckman Coulter's Access and Synchron systems provide a wide menu that is continuously 
enhanced by new tests. Beckman Coulter’s immunoassay menu consists of more than 60 tests 
for cancer detection, cardiac disease, thyroid function, reproductive endocrinology and 
women’s health. Beckman Coulter continues to add novel and proprietary tests from different 
sources including tests for: inhibin A, High Mobility Group Box 1 (septic shock), 
erythropoietin, cPAPPA (marker of plaque instability), placental growth factor (PIGF), 
soluble fts-like tyrosine kinase 1(sFlt-1), soluble CD40 ligand (sCD40L), preeclampsia, 
fertility hormones, CVD, autoimmune, inflammatory disease/ cytokines, and prenatal 
screening. 
bioMérieux's immunoassay product line includes more than 130 products: rapid single-dose 
tests, VIKIA; a high-throughput, fully automated microplate processor, DAVINCI; and 
automated multiparametric analyzers, VIDAS, miniVIDAS, and VIDIA.  bioMérieux has 
been working hard to establish a stronger presence in the immunoassay market. The VIDAS 
product range includes 99 tests covering a wide range of assays: identification and 
quantification of bacteria, viruses, and parasites; antibody measurements of the 
immunological response to an infection; various proteins circulating in the blood; markers 
for selected cardiovascular diseases and certain cancers; the inflammatory response; and 
hormonal dysfunction. 
bioMérieux offers the VIDAS C. difficile GDH, an innovative, qualitative assay for the 
automated detection of GDH, offering clinical laboratories a fully automated, standardized 
and cost-effective solution for C. difficile diagnosis and infection control.   
Other players include Becton Dickinson, Thermo Fisher and QuidelOrtho. There are also 
strong niche players such as Fujirebio, Tosoh, and Werfen. Diasorin has made a concerted 
effort to expand the test menu and distribution network, primarily in the U.S., India, China 
and emerging markets. Diasorin offers 122 available products, of which 31 are specialty tests. 

 
 
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Most of the tests included in the most mature immunoassay segment, such as thyroid, 
therapeutic drugs, and anemia, are part of the menu on clinical workstations discussed in 
Chapter 6. 

 
 
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Mature Assay Segment 
Thyroid Function 
Among the most mature immunoassays are those for thyroid disorders.  Thyroid tests include 
thyroid peroxidase autoantibodies (Anti-TPO), thyroglobulin autoantibodies (Anti-Tg), free 
and total triiodothyronine (T3), free and total thyroxine (T4), thyroid- stimulating hormone 
(TSH) and T-Uptake.  TSH is the thyroid function screen test and gatekeeper for almost all 
other thyroid function tests and makes up 50%-70% of the $680 million thyroid function test 
category in 2025.  With an estimated 1.4% annual growth, the market for thyroid markers 
will reach $730 million in 2030.  Growth in this test segment comes from esoteric thyroid 
function tests, such as TPO-Ab (Anti-Thyroperoxidase Autoantibodies) and TSH-R Ab (TSH 
Receptor Autoantibodies), many of which are performed by RIA. 
Genalyte markets its Thyroid Stimulating Hormone immunoassay, performed on the 
Maverick’s silicon chip.  
Therapeutic Drug Monitoring 
Therapeutic drug monitoring (TDM) is the measurement of a drug's serum concentration to 
ensure it remains within the therapeutic range. A drug's serum therapeutic range or index is 
the concentration range in which the drug is known to be effective while causing little or no 
toxic effects to the patient.  Therapeutic drug tests ($775 million in 2025) include digoxin, 
anti-asthmatics, anti-epileptics, anti-microbials and cyclosporine.  Here, digoxin occupies 
50%-60% of the test volume.  TDM testing is conducted primarily in the major developed 
markets, where Siemens Healthineers' products and Abbott Diagnostics are the leaders.  
Elsewhere, this market is mostly served by local manufacturers of ELISA tests.   
In recent years, therapeutic drug monitoring assays have been developed for newer 
anticonvulsant and related drugs. For example, ARK Diagnostics introduced the ARK 
Levetiracetam Assay, expanding immunoassay-based monitoring options for epilepsy 
management.  

 
 
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Vitamin D 
In the U.S. vitamin D testing is not recommend for most people, citing that there merely isn’t 
a good, practical reason to do so unless a patient in a high-risk category of people such as 
those with osteoporosis or other bone conditions, those with issues of fat absorption (e.g., 
Celiac disease, weight reduction surgery), or those who take medications that interfere with 
vitamin D activity (e.g., glucocorticoids, anticonvulsants).  That being said, U.S. doctors do 
conduct the testing, and Medicare stats indicate doctors have ordered over 12 million lab 
vitamin D tests for Medicare patients.  
Major suppliers in the vitamin D testing market include DiaSorin S.p.A., Immunodiagnostic 
Systems (IDS), Roche Diagnostics, and Abbott Diagnostics. Among the earliest companies 
to introduce automated vitamin D assays, Diasorin and IDS benefited from a rapid surge in 
clinical interest around 2009, when testing volumes expanded dramatically, often cited as 
increasing by 30%–50% year over year. Since that initial market expansion, automated 
vitamin D assays have become widely available and are now marketed by major IVD 
manufacturers, including Abbott Diagnostics, Danaher (Beckman Colter), bioMérieux, 
QuidelOrtho, Roche Diagnostics, Siemens Healthineers, and others. 
For several years, Diasorin was the first and major supplier of Vitamin D immunoassays.  
Diasorin received FDA clearance for the LIAISON 25-OH Vitamin D TOTAL assay in 2012. 
With increased demand for Vitamin D testing, most of the major IVD vendors market a test 
on their automated workstations.  This has eroded Diasorin’s market share. 
Nevertheless, Diasorin has invested in enhancing the test.  According to Diasorin, the 
LIAISON XL 1,25 Dihydroxyvitamin D Assay is the first extraction-free, fully automated 
1,25 dihydroxyvitamin D assay available with a time-to-first result of only 65 minutes.  

 
 
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Table 7-8: Selected Vitamin D Immunoassays  
Company 
Location 
Technology 
Details 
Aesku Diagnostics 
Germany 
ELISA 
Vitamin D ELISA  
ALPCO Diagnostics 
U.S. 
ELISA 
25-OH Vitamin D Total ELISA 
bioMérieux 
France 
EIA 
VIDAS 25 OH Vitamin D Total  
Boditech Med 
U.S. 
EIA 
Ichroma Vitamin D 
Carolina Liquid Chemistries 
U.S. 
EIA 
automated Vitamin D-direct assay  
Diasorin 
Italy 
EIA 
LIAISON XL 1,25 Dihydroxyvitamin D Assay  
Diazyme Laboratories 
U.S. 
EIA 
25-Hydroxy Vitamin D levels (D2 + D3 levels) 
Diazyme Laboratories 
U.S. 
EIA 
Vitamin D for Clinical Chemistry Analyzers 
Gold Standard Diagnostics  
U.S. 
ELISA 
Diasource's 25-OH Vitamin D, Total ELISA 
Immunodiagnostic Systems 
UK 
ELISA 
IDS-iSYS 1,25 VitDXp assay  
QuidelOrtho (QuidelOrtho) 
U.S. 
EIA 
VITROS 25-OH Vitamin D Total Assay 
Qualigen, Inc. 
U.S. 
rapid 
FastPack Vitamin D Immunoassay, 10-minute result 
Quantimetrix Corp.    
U.S. 
QC 
Complete D 25-OH Vitamin D Control 
Roche Diagnostics 
U.S. 
EIA 
Elecsys vitamin D Total  
SCIEX 
U.S. 
ELISA 
Vitamin D 200M Assay 
Sekisui Diagnostic 
Japan 
POC 
FastPack IP Vitamin D Immunoassay  
Siemens Healthineers 
U.S. 
EIA 
ADVIA Centaur Vitamin D Total Assay 
Tosoh Corp. 
Japan 
EIA 
ST AIA-PACK 25-OH Vitamin D assay  
Zivak Technologies 
Turkey 
HPLC 
automated Vitamin D2-D3 UHPLC analyzer 
Source: Kalorama Information 
 
 

 
 
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Qualigen markets the CE Marked and FDA-cleared FastPack Vitamin D Immunoassay for 
use on its FastPack System for the rapid determination of vitamin D status. FastPack Vitamin 
D test results are available in 10 minutes. 
NanoSpeed Diagnostics Inc. developed Test4D, a POCT device for the qualitative detection 
of 25-OH Vitamin D in human blood obtained via fingertip puncture. 
Kalorama estimates that the world market for vitamin D tests performed on automated 
instruments is approximately $289 million in 2025 and that testing will remain steady, 
reflecting a mature market environment and an increasing number of vendors, resulting in 
price sensitivity among buyers.  
Anemia 
The hematology complete blood count is the primary tool for anemia testing; immunoassays 
are used as follow-on tests to further analyze the source of the patient’s anemia.  Anemia 
markers B12/folate and ferritin just about share the segment in 2025. The anemia marker 
immunoassay market estimated revenues for 2025 totaled $513 million.  With an estimated 
0.5% annual growth, the world market for anemia marker immunoassays will reach $527 
million in 2030.  These are now part of the menu on most automated systems.  Other, more 
esoteric tests, such as erythropoietin, are run in ELISA format. There has not been a 
significant development in immunoassays for anemia primarily because the hematology CBC 
is the major test for anemia. Immunoassays are used to investigate cases where more 
intensive patient evaluation is required.  
DIESSE offers two tests for Vitamin B12 and Folate. These tests are available on the 
CHORUS systems as monotests. 
Toxicology/DAU 
In the hospital setting, tests for toxicology and drugs of abuse are usually done as a panel on 
trauma patients brought into emergency and include: a screen for alcohol, acetaminophen, 
salicylates, tricyclic antidepressants and individual tests for amitriptyline, amphetamines, 
barbiturates, benzodiazepines, cannabinoids, cocaine and metabolites, antidepressants, LSD, 
methadone, methamphetamine, morphine, opiates and PCP.  These same tests are used in the 
workplace screening and criminal justice markets.  The market for these analytes is primarily 

 
 
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served by home testing services.  These tests use hair and other noninvasive samples.  The 
market for toxicology and drugs of abuse tests for clinical medical purposes is estimated at 
$333 million in 2025.  This reflects a slight increase from the 2024 market. Excluding 
COVID-19 impact, the segment's maturity does not give credit to the growing market 
opportunity.  The recent attention of drug addiction and increased hiring trends in major 
markets has increased the opportunity and growth potential. 
The abuse of and addiction to opioids such as heroin, morphine, and prescription pain 
relievers such as Percocet (oxycodone) and Fentanyl is a serious global problem that affects 
the health, social, and economic welfare of all societies.  It is estimated that 68 million people 
abused opioids worldwide in 2025 
While much attention has focused on deaths from the overdose of these drugs, there is a 
growing problem associated with substance abuse by pregnant women and the subsequent 
addiction of newborns.  
There is no single standardized national protocol in the United States for drug screening in 
pregnant women, and practices vary across states and healthcare institutions. While clinical 
guidelines exist, hospitals and providers differ in how they implement screening, including 
whether to use targeted risk-based approaches or broader screening strategies for mothers 
and newborns. As a result, testing methods, consent practices, and referral pathways are not 
fully uniform across the healthcare system. 
Positive testing rates for prescription painkillers have risen dramatically over the past decade. 
The rates more than doubled for hydrocodone and hydromorphone and are up more than 70% 
for oxycodone. Pain is one of the most common reasons why people visit the doctor's office.  
Recently, overdose deaths from painkillers surpassed those from heroin and cocaine 
combined, according to U.S. federal data.  U.S. physicians who prescribe medication for 
chronic pain are often caught in a conundrum.  More and more patients are presenting with 
chronic pain, and at the same time, the black market for pain medicines such as oxycodone 
is increasing with alarm.  Patients are also mixing a number of non-prescribed medicines. So, 
some physicians fear they will be held responsible for painkiller-overdose-related deaths and 
accidents.  
In the past few years, there has been a growing shift from instrumented screening for DAU 
to testing with disposable devices, with Abbott as the market leader.  The leader in 

 
 
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instrumented tests is Siemens Healthineers EMIT products.  However just about every major 
immunoassay company offers tests for the basic drugs of abuse. 
Thermo Fisher announced the availability of the Thermo Scientific CEDIA Mitragynine 
(Kratom) Assay, its newest drugs of abuse test that includes supporting calibrators and 
controls. The CEDIA Mitragynine (Kratom) Assay can be run on commonly used clinical 
chemistry analyzers.  This test is for criminal justice and forensic use only.  Kratom is not 
currently classified as a controlled substance, but it is listed by the Drug Enforcement Agency 
(DEA) as a "drug of concern," since it can result in severe health effects or even death.  
Siemens Healthineers added fentanyl assay to its Atellica menu. The ARK Fentanyl Assay 
extends the detection window to provide the information clinicians need to triage their 
patients more appropriately. This is important because fentanyl absorption occurs at different 
rates depending upon the type of exposure, and during this time, a patient will typically face 
suppressed respiratory function and should be closely monitored. 
Many of BTNX’s rapid tests are lateral flow tests.  The company distributes its products 
under the Rapid Response brand.  The company provides single drug test strips for testing 
the presence of fentanyl and other drugs. The company also offers Xylazine Test Strips. 
Hangzhou AllTest Biotech markets the AllTest Xylazine and Fentanyl Rapid Test. These are 
lateral-flow rapid screening tests that can be performed at the POC. The test uses monoclonal 
antibodies to selectively detect specific drugs.  
Allergy 
Allergies represent the fifth leading chronic disease in the United States, with an estimated 
85 million Americans suffering from one or more allergy types.  Moreover, it is estimated 
that 30%- 40% of the world's population is now affected by one or more allergic conditions. 
This will increase demand for allergy and autoimmune testing. Additionally, fewer 
specialists are graduating in this area.  Early diagnosis and treatment of allergy have been 
shown to modify the course of the disease and help prevent subsequent development of other 
more serious conditions.  
However, most allergists in the U.S test using the skin test that is not part of this market 
assessment.  Serological allergy tests measure IgE and/or IgG immunoglobulin response to 
allergens. More patients are seen by family physicians that have little experience with skin 

 
 
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tests.  The market is expected to increase by roughly 1.1% annually from $616 million in 
2025 to $652 million in 2030.  At least half of the market for blood-based allergy tests is held 
in Western Europe.   
Allergy blood testing is recognized by the National Institutes of Health for managing patients 
with asthma.  IgG reactions to food have been implicated in a number of chronic diseases, 
including arthritis, irritable bowel syndrome, bronchitis, and depression.  
Allergies are often thought of as nothing more than a seasonal inconvenience; this is not 
always the case. Researchers have demonstrated a link between allergic diseases such as 
eczema, food allergy, otitis media, allergic rhinitis, and asthma.  More importantly, these 
diseases are recognized as steps in the Allergy March that generally start with eczema and 
end in asthma.  Allergy remains among the most common, yet often overlooked, chronic 
diseases according to the Asthma and Allergy Foundation of America.  
Statistics from the Global Allergy and Asthma European Network indicate that over 80 
million people are affected by some form of allergic disease in Europe.  Allergy affects more 
than 87 million Americans and is now the third most common chronic disease among 
children under 18 years old.  
Phadia (now part of Thermo Fisher), pioneered in vitro allergy testing and claims that seven 
out of ten allergy laboratory tests worldwide use Phadia’s ImmunoCap products.   
Food allergies are a serious condition, and peanut-free places and foods are now advertised 
with great frequency. Phadia has partnered with Quest diagnostics to increase the penetration 
of blood-based allergy testing in the U.S., where the skin test still occupies the major portion 
of the market. 
The major allergy IVD suppliers include Thermo Fisher Scientific’s Phadia ImmunoCAP 
platform, Siemens Healthineers’ 3gAllergy specific IgE assays, and Werfen’s HY·TEC 
allergy testing system (formerly Hycor). In addition, allergy immunoassays are available 
from a range of other manufacturers, including ALPCO, BioCheck, Biomerica, BMD France, 
DiaSys, and EUROIMMUN, which primarily serve regional and niche segments of the 
allergy diagnostics market.  
Immunodiagnostic Systems (IDS) offers a set of allergy tests on its IDS-iSYS 
immunoanalyzer.  PRO-LAB Inc. (Miami, FL) offers a test service to analyze allergens in 
vacuum cleaner dust. 

 
 
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HOB Biotech (Beijing, China) has established itself as a leading Chinese manufacturer of 
allergy immunoassays for Asian markets (Middle East, Southeast Asia, and South Asia), 
ranging from Line Immuno Assay (LIA) to Enzyme-linked immunosorbent assay (ELISA).  
Biomerica offers the Food Intolerance 14G Food Additives Test is a food allergen-specific 
ELISA kit intended for in vitro quantitative analysis of IgG antibodies to 14 unique food 
additive allergens in human serum.  
Others involved include AIBioTech and Omega Diagnostics, which offer Allergodip India, 
Allergodip LF IgE adapted for India.  Additionally, DST offers Fast CheckPOC. 
Thermo Fisher received FDA clearance to market the ImmunoCAP Specific IgE blood test 
for Ara h 6, part of a line of assays for detecting specific peanut allergen components.  
Thermo Fisher reported that results from Ara h 6 ImmunoCAP testing can aid specialists and 
other clinicians in better understanding patients' risk factors as part of tailored allergy 
treatment or management plans.  
Thermo Fisher markets its ImmunoCAP test, the ImmunoCAP IgE test, which is available to 
more patients in the U.S., and is available to patients at all Kroger Health The Little Clinic 
locations.  
Kenota Health offers its POC allergy test system. This is the first CLIA-waived IgE test 
available to allergy specialists in the office. 

 
 
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Growth Immunoassays 
The growth categories of immunoassays include tumor markers, cardiac markers, diabetes, 
autoimmune disease tests and tests for sepsis. 
Proteins 
Most protein testing for a wide class of entities, including complement components, transport 
proteins, and plasma proteins, generally falls under the heading of esoteric tests and is done 
by nephelometric methods or RIA.  These tests are used to diagnose a large number of 
metabolic, coagulation and malabsorption conditions.  Siemens Healthineers, Bio-Rad 
Laboratories and Beckman Coulter are the world leaders in this segment.  Roughly half of 
the market for these tests is in Europe, where there is a long tradition of in-depth protein 
analyses.   
The increased use of mass spectrometry to discover more precise biomarkers for the world's 
major diseases, such as diabetes, cancer, and cardiovascular diseases, has placed greater 
emphasis on protein analysis.  As part of the body’s immune response to cancer, antibodies 
are produced to fight cancer cells.  These antibodies are generated in the earliest stages of 
cancer.  Mass spectroscopy is one of the tools used to detect these early antibodies.  At this 
point in the research, protein patterns are emerging as a diagnostic tool.  As these proteins 
are better defined, they will, once validated, become part of the toolbox for specific diseases.   
One area of protein immunoassays includes amyloid beta testing, which is used to guide 
treatment of Alzheimer’s disease. Alzheimer’s disease protein immunoassays are highlighted 
in the growth immunoassay section.  
Thus, there is great expectation that, in the near future, protein analysis will emerge from the 
esoteric realm into that of the more routine.  The market for protein tests is estimated at 
$1,862 million in 2025 and, with an annual growth rate of 8.8%, will reach $2,840 million in 
2030. This market will be driven by amyloid beta testing for Alzheimer’s disease and 
dementia during the forecast period.  
Roche markets its Elecsys pTau217 assay. This blood-based test is intended to help identify 
amyloid pathology in individuals with cognitive impairment or dementia, offering a less 
invasive approach to Alzheimer’s disease evaluation than PET imaging or cerebrospinal fluid 

 
 
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testing. Roche is collaborating with Eli Lilly to support broader access to earlier Alzheimer’s 
diagnosis and to align diagnostic development with emerging disease-modifying therapies. 
 CNS/neurological proteins total 21% of the total protein immunoassay market, reaching an 
estimated $400 million. Most of this is from the advancements in Alzheimer's disease testing. 
There have been several approvals, and lab-developed tests are also growing in this arena. 
The main contributor is Roche followed by Fujirebio.  
It is anticipated that this area of protein immunoassays will continue to grow as more 
discoveries are made and technology advances.  
Figure 7-1: Other Proteins, by Percent of Total, 2025 (%) 
 
Source: Kalorama Information 
Tumor Markers 
Immunoassays measure antibodies produced by the body in response to cancer cells, which 
help prevent their growth. This early warning system has value in stratifying cancer types 

 
 
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and in monitoring disease progression and the effects of therapy.  However, most antibodies 
do not provide sufficient specificity.  
One cancer immunoassay continues to preoccupy science and medicine: PSA, prostate-
specific antigen, a protein made by the prostate. For decades, the PSA test has been used as 
a marker for the presence of prostate cancer in men.  High levels of PSA in the blood may 
indicate the presence of a prostate tumor. However, the PSA test is a nonspecific test for 
prostate cancer. That is, non-cancerous conditions such as an enlarged or inflamed prostate 
can cause elevations in PSA levels. And even when PSA levels rise above what has routinely 
been considered a trigger level (4.1 ng/ml in the blood), indicating the need for a needle 
biopsy to check prostate tissue for signs of cancer, less than half of those biopsies find 
cancerous cells.  In addition, up to 44% of PSA-triggered biopsies find non-lethal, indolent 
prostate cancer cells. Indolent prostate cancer is highly unlikely to shorten the lifespan of a 
man. However, treatment with surgery or radiation can carry a significant risk of side effects 
such as incontinence or sexual dysfunction. 
Immunoassays continue to play an essential role in cancer diagnostics.  The 2025 market for 
blood-based immunoassay cancer tests is estimated at $1,533 million and, with an annual 
growth of 1.9%, will reach $1,685 million in 2030.  This segment represents the third-largest 
immunoassay segment in this report.    
The major innovator in cancer immunoassays is Fujirebio, which has licensed its technology 
to other companies in order to make its tests readily available.  The company's existing 
CA125 biomarker is the current gold standard for monitoring ovarian cancer.  Fujirebio 
reported that a combination of biomarkers offers clinicians a diagnostic tool with higher 
sensitivity and specificity than CA125 or HE4 alone.  
Fujirebio’s lead test is an FDA-cleared and CE-marked test that combines HE4 and CA125 
with the Risk of Ovarian Malignancy Algorithm (ROMA).  The test is offered as a test service 
by Labcorp and other labs and is available on integrated analyzers from Abbott Diagnostics.  
Companies, including Abcodia (UK), and Roche Diagnostics (U.S.), market improvements 
for ovarian cancer diagnosis. 
Just about every major IVD company and ELISA system vendor offers the standard tumor 
marker tests.  Some 80% of the market for tumor markers is held in the U.S., Europe and 
Japan. 

 
 
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Alongside advances in molecular diagnostics and liquid biopsy, there is continued interest in 
developing new approaches to cancer testing. Mass spectrometry is being explored as a 
complementary tool, particularly in proteomic analysis and biomarker discovery, with some 
applications available through specialized testing services and others still in development. At 
the same time, there is a growing focus on assessing immune response to therapy, especially 
in immuno-oncology. This includes measuring T-cell activity and related biomarkers using 
a combination of immunoassays and other advanced techniques, supporting efforts to better 
understand treatment response and guiding patient management. 
The MasSpec Pen is a tool that rapidly and accurately identifies cancerous tissue during 
surgery. It is a handheld instrument that provides surgeons with information on which tissue 
to preserve or cut. This device is in development by scientists at the University of Texas at 
Austin.   
Scienion entered into a collaboration with IPA to develop UROfast, a rapid bladder cancer 
diagnostic platform. The collaboration is ongoing and designed to detect multiple biomarkers 
at the point of care.  
INEX Innovate, a Singapore-based diagnostic company, offers its lead ovarian cancer 
product, OvaCis Rapid Test. OvaCis is a POC test that differentiates benign from malignant 
ovarian cysts in the operating room. The test works by identifying a protein biomarker present 
in ovarian cysts to determine whether the cyst is benign or malignant within five minutes. 
The entire test provides results within 15 minutes.  The test allows surgeons to make fast, 
informed decisions about the patient's status.  
Promis Diagnostics offers EarlyTect BCD as a non-invasive, urine-based diagnostic for 
bladder cancer in patients with hematuria.  
Anbio offers its Anbio Lateral Flow Assay, which utilizes the immunochromatography 
principle to visually detect a specific biomarker in a sample. It can generate results in about 
20 minutes.  
 
 

 
 
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Table 7-9: Selected Tumor Marker Innovations  
Company 
Location 
Area 
Details 
Arrayit/Avant 
Diagnostics 
U.S. 
immune resp 
OvaDx cancer immune response 
Barts Cancer Institute 
UK 
pancreas 
LYVE1, REG1A, TFF1 early pancreatic cancer 
Binding Site (Thermo 
Fisher) 
UK 
immunoglobulin 
Freelite in 2017 Chinese Myeloma Guidelines  
Binding Site(Thermo 
Fisher) 
UK 
immunoglobulin 
Hevylite IgA, SPAPLUS Multiple Myeloma 
Biocare Medical 
U.S. 
p63 
AsymmetRx's (Acton, MA) p63 antibody, prostate  
BioLight Life Sciences 
Israel 
bladder 
CellDetect bladder cancer in urine, colorimetric cells 
BioNTech Diagnostics  
Germany 
immune resp 
PCRTyper, to monitor T cells immune response 
Euro Diagnostica AB 
Sweden 
endocrine 
NEOLISA CgA, ELISA neuroendocrine tumors 
Genalyte Inc. 
U.S. 
immune resp 
tumor antigen-associated autoantibodies, immune 
response 
Immunovia 
Sweden 
immune resp 
IMMray PanCan-d pancreatic cancer   
Integrated Diagnostics 
U.S. 
pan cancer 
multiple protein expression classifier 
Labcorp 
U.S. 
ovarian 
ROMA, Risk of Ovarian Malignancy Algorithm 
Minomic International 
Australia 
prostate 
MiStat MIL-38 marker prostate cancer in urine 
QuidelOrtho  
U.S. 
prostate 
VITROS Total PSA Assay II 
OTraces, Inc. 
U.S. 
prostate 
BC Sera Dx panel for breast, prostate 
Provista Diagnostics, Inc. 
U.S. 
breast 
proteomic breast cancer assay 
Quansys Biosciences  
U.S. 
EIA 
Q‐Plex Array, chemiluminescent assays  
Quanterix Corp 
U.S. 
digital ELISA 
digital Elisa cancer proteins 
Quest Diagnostics 
U.S. 
TDM 
tamoxifen drug metabolites in a blood specimen  
Randox Laboratories 
UK 
bowel 
bowel cancer antibodies, biochip array 
Roche Diagnostics 
U.S. 
ovarian 
Elecsys HE4 assay, ovarian cancer  
ScheBo-Biotech AG  
Germany 
FOB 
ScheBo · 2in1 Quick test, screen, M2-PK & iFOBT  

 
 
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Company 
Location 
Area 
Details 
Sequenta, Inc. 
U.S. 
T/B cells 
ClonoSIGHT MRD minimal residual disease, leukemia, 
lymphoma 
Siemens Healthineers 
U.S. 
liver 
ADVIA Centaur enhanced liver fibrosis (ELF) panel 
Sphingotec GmbH 
Germany 
breast 
sphingotest pro-NT, neurotensin breast cancer screen 
service 
Theranostics Health Inc. 
U.S. 
breast 
TheraLink HER Family Assay, signal transduction 
pathway, breast   
Tosoh 
Japan 
liver 
ST AIA-Pack PIVKA II, liver cancer marker  
Vigilant Biosciences 
U.S. 
oral fluid 
OncAlert Oral Cancer CD44/Total Protein 
VolitionRx 
Belgium 
nucleosomes 
NuQ Nucleosomics ELISA colon, prostate & ovarian 
cancer  
XEMA Corporate Group 
Russia 
ovarian 
XEMAtest Ovascreen, test strip, CA125 and HE4  
University of Texas  
US 
tissue 
MasSpec Pen to detect cancer by touch 
 Source: Kalorama Information 
Cardiac Markers 
The World Health Organization estimates that cardiovascular diseases, including those of the 
blood vessels supplying the heart muscle and the brain, are the leading cause of death 
globally. 
With the incidence of cardiovascular disease going through the roof, cardiac markers are in 
huge demand and a constant subject of research for improvement.  Cardiac biomarkers are 
substances that are released into the bloodstream when the heart is damaged or stressed. In 
patients with chronic heart failure, measurement of these biomarkers is used to help risk-
stratify, to assess treatment options, monitor progress, and guide in-hospital and post-
discharge care.  
Physicians use cardiac markers in two ways: to diagnose a cardiac event in a hospital 
emergency room or to evaluate the risk of a cardiovascular event.  The traditional markers, 
such as BNP, troponin, and myoglobin, are used in acute care, and tests such as cholesterol 
are used to evaluate risk.   

 
 
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The menu of biomarkers for cardiac risk is multidisciplinary and includes troponins (cTnI 
and cTnT), BNP, NT-proBNP, GFAP, H-FABP, LDH isoenzymes,  IMA, MPO, myoglobin, 
and sCD40L. Recent studies suggest that new biomarkers show promise for enhancing 
traditional methods of diagnosing and managing heart failure (HF). These biomarkers include 
cardiac troponin, Galectin-3, Copeptin, ST2 and MR-proADM. 
Recognizing the multifaceted nature of cardiac disease, a cardiac risk work-up generally 
includes a mix of lipid and inflammatory markers: cholesterol, HDL and LDL, homocysteine, 
fibrinogen, C-reactive protein, lipoprotein fractions, and D-Dimer Test. 
The lead acute care cardiac markers are troponin, BNP, and myoglobin.  Together, these tests 
account for about 75% of the segment, which is worth $1,867 million in 2025.  The market 
is expected to increase to $2,170 in 2030, representing 3.1% CAGR.   
An aging population, combined with technological advancements, is fueling this growth as 
health care providers seek ways to meet demand for high levels of service more cost-
effectively. 
Approximately 2.6 million people die of CVD each year in the seven leading countries: 
France, Germany, Italy, Japan, Spain, the UK, and the U.S.  Thus, the market for CVD tests 
is concentrated in the developed world.  One can therefore expect that these countries account 
for roughly 80% of product sales, with the ROW accounting for the remaining 20%.  The 
U.S. and Canada make up 45%, EU countries 27% and Japan 8%.   
 
 

 
 
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Table 7-10: Regional Cardiac Marker Immunoassay Market Share, by Country, 2025 (%) 
 
[EU Countries; Japan; Latin America; Middle East; North America; Rest of Asia Pacific; Rest of Europe; Rest 
of World] 
Region 
2025 
North America 
45% 
EU Countries 
27% 
Japan 
8% 
Rest of Asia Pacific 
7% 
Latin America 
4% 
Middle East 
4% 
Rest of Europe 
3% 
ROW 
2% 
Total 
100% 
Source: Kalorama Information 
A number of new and developing markers are in the works. It is possible that new cardiac 
panels will emerge, which combine markers of inflammation, ischemia, plaque instability 
and necrosis.  
At this time, troponin is attracting considerable attention.  Not too long ago, the debate was 
quite simple: troponin I or troponin T.  But the limitation of conventional troponin assays is 
their low sensitivity, so cardiac troponin (cTn) has been developed.  The process of necrosis 
is not immediate in response to ischemia, and once necrosis occurs, it usually takes 1–4 hours 
for cTn to increase in the circulation before becoming detectable in the blood. This timing 
varies due to differences in the analytical sensitivity of cTn assays. Physicians from the 
Department of Cardiology at University Hospital Basel (Basel, Switzerland) pioneered rapid 
diagnostic algorithms for acute myocardial infarction (AMI), most notably the 0/1-hour rule-
out and rule-in protocol using high-sensitivity cardiac troponin (hs-cTn). Their work 
demonstrated that measuring the absolute change in hs-cTn concentrations over one hour, 
rather than relying solely on a single cutoff value, allows clinicians to safely rule out AMI in 

 
 
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a substantial proportion of emergency department patients while rapidly identifying others 
who require immediate intervention. 
These findings fundamentally changed emergency cardiac care and have been incorporated 
into ESC and international clinical guidelines, significantly reducing time to diagnosis, 
length of stay in the emergency department, and unnecessary hospital admissions. 
High-sensitivity troponin assays are compatible with existing core laboratory immunoassay 
platforms, enabling laboratories to adopt the technology without major workflow disruption. 
In response to the clinical evidence, IVD manufacturers have commercialized multiple high-
sensitivity troponin assays that are now widely used in routine care. 
Currently available high-sensitivity troponin assays include: 
• Abbott Laboratories – ARCHITECT and Alinity hs-Troponin I, CE-marked and 
FDA-cleared, supporting 0/1-hour and 0/2-hour AMI algorithms 
• Roche Diagnostics – High-Sensitivity Troponin T, CE-marked and FDA-cleared, 
extensively validated in ESC rapid triage protocols 
• Siemens Healthineers – Atellica IM and ADVIA Centaur hs-Troponin I, CE-marked 
and FDA-cleared 
Earlier-generation assays such as Troponin I Ultra have largely been supplanted by true high-
sensitivity assays, which offer superior analytical precision at very low troponin 
concentrations and enable reliable detection of small dynamic changes over short time 
intervals. differences in patients’ physiology. 
Cardiac markers have been expanded with tests such as myeloperoxidase, brain natriuretic 
peptide (BNP), proBNP, becoming part of the acute care test menu and tests such as highly 
sensitive C-reactive protein, homocysteine, Fatty Acid Binding Protein, Glycogen 
Phosphorylase isoenzyme BB (GPBB), urinary albumin, S-100 protein and hemoglobin A1c 
are now part of the risk evaluation toolbox. 
Thus, the cardiac test toolbox may include C-reactive protein and N-terminal pro-B-type 
natriuretic peptide, which have been extensively studied in cardiovascular disease, and four 
analytes that have recently been identified as related to cardiovascular risk, including 
Cystatin C, Lp-PLA2, MR-proADM, and MR-proANP. 

 
 
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Biomarkers, MR-proADM, MR-proANP, and CT-proET1 measure inactive stable precursors 
of their respective peptide hormones. Adrenomedullin (ADM) is a hemodynamically active 
vasodilatory hormone.  Its precursor, MR-proADM, is elevated in chronic heart failure. Atrial 
Natriuretic Peptide (ANP) is a diuretic, natriuretic and vasodilatory peptide hormone 
produced in the upper chambers (atria) of the heart. MR-proANP could potentially be used 
for disease prognosis.  Endothelin-1 is a potent vasoconstrictor produced by vascular 
endothelial cells.  Thermo Fisher Scientific is developing a test for MR-proADM, MR-
proANP, and CT-proET1. 
There have been incremental improvements in heart disease detection. Novel markers such 
as ST2, galectin, PAPP-A and PGF, may improve the risk stratification and prognostic 
assessment.  Heart-type fatty acid-binding protein(h-FABP) was first noted as a marker of 
myocardial infarction in 1988.  Over the years, numerous studies have been relatively 
inconclusive in h-FABP’s ability to predict long-term mortality after acute coronary 
syndrome and to identify high-risk patients.  The marker faces an uphill battle in proving 
itself as a valuable addition to the acute care test menu that includes Troponin, BNP and 
myoglobin. 
Surfactant Protein-B (SP-B) is a lung-specific protein and a key functional component of the 
alveolus.  SP-B is present at very low concentrations in the serum of healthy people. It is 
released into the bloodstream following lung injury and is significantly elevated in primary 
and secondary lung disorders that mainly affect the lung parenchyma. This includes the 
alveolocapillary system, such as chronic obstructive pulmonary disease, acute respiratory 
distress syndrome and heart failure. Changes of lung disorders can be monitored by 
measuring levels of SP-B in the blood.   Roche Diagnostics acquired a license to develop 
tests for SP-B and suggests that, together with BNP or NT-proBNP) tests, SP-B helps to 
discriminate between cardiac and non-cardiac causes of dyspnea.  
The soluble β-galactoside-binding lectin, galectin-3, is elevated in a substantial portion of 
patients with heart failure, especially those with more severe disease and renal dysfunction.  
Increased levels of circulating galectin-3 may reflect the severity of active myocardial 
remodeling and adverse outcome as galectin-3 regulates fibrogenesis, inflammation, tissue 
repair, and cell proliferation. 
Galectin-3 has been implicated in a variety of biological processes important to the 
development and progression of heart failure. Higher levels of galectin-3 are associated with 
a more aggressive form of heart failure, which may make identification of high-risk patients 

 
 
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using galectin-3 testing an important part of patient care. Galectin-3 testing may help 
physicians identify patients at higher risk of death, hospitalization, or 30-day readmission.    
Critical Diagnostics markets the Presage ST2 Assay.  It is the only commercially available 
ST2 biomarker that has been CE Marked and cleared by the U.S. FDA for use in risk 
stratification of patients with chronic heart failure. ST2 is a member of the interleukin -1 
receptor family, whose expression in heart cells is upregulated in response to stress.  Large 
amounts of soluble sST2 result in adverse cardiac remodeling, heart failure, and premature 
death. Clinical studies have further shown that sST2 prognostic information is independent 
of, and adds value to, that of commonly used cardiac biomarkers.  
Coronary artery disease results when plaque grows in the arteries until blood flow to the heart 
is constricted and if enough plaque builds up, a piece could break off and block blood flow 
to the heart, which results in a heart attack or stroke.  Researchers at the University of 
Nebraska, while seeking clues to understand inflammatory conditions such as arthritis and 
alcoholic liver disease, focused on a molecule that is a strong indicator of inflammation. The 
molecule, known as malondialdehyde–acetaldehyde (MAA), also appeared to indicate the 
presence of coronary artery disease. The University of Nebraska Medical Center’s 
technology transfer office, UNeMed Corporation, is collaborating with several companies to 
translate the results into products that better account for a patient’s risk of heart attack.  The 
scientists hope the test could be used to definitively inform younger patients in their forties, 
thirties, or even their twenties, whether or not they will develop potentially fatal heart disease. 
The physicians suggest that even patients who are still teenagers could receive early warnings 
and begin taking preventive measures. 
Originally thought of as "a cholesterol-fueled, plumbing problem", atherosclerosis is now 
understood as a chronic inflammatory disease.  This shift has prompted a search for new 
biomarkers of inflammation that predict cardiovascular event risk. 
Radiometer’s POC AQT90 FLEX can simultaneously measure cardiac markers, coagulation 
markers, infection markers, and pregnancy markers, including troponin I, CKMB, 
myoglobin, NT-proBNP, CRP, βhCG, D-dimer, and troponin T.  In 2016, Radiometer added 
procalcitonin and creatinine to the test menu. 
The AQT90 FLEX PCT assay offers laboratory-quality, quantitative determination of 
procalcitonin in whole blood or plasma at the point of patient care.  Prehandling of whole 
blood samples is not required and results are available in less than 21 minutes. 

 
 
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Ani Biotech Oy offers the Biocard Troponin I test, which is a one-step 
immunochromatographic assay for the rapid detection of cardiac specific troponin I from 
patient whole blood samples. The company also offers myoglobin, MPO, hsCRP, 
quantitative reader, and CRP cardiac marker tests. 
Siemens Healthineers offers the Stratus CS analyzer for near-patient care quantitative cardiac 
marker testing from a whole blood sample in 14 minutes. The company also offers 
myoglobulin, CK-MB, and cardiac troponin I tests 

 
 
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Table 7-11: Selected Cardiac Marker Innovations 
Company 
Location 
Area 
Details 
Abbott Diagnostics 
U.S. 
galectin 
Architect galectin-3 on analyzers 
ALPCO Diagnostics 
U.S. 
RIA 
Cisbio Bioassays, Renin RIA, hypertension  
Beckman Coulter/Danaher 
U.S. 
troponin 
Access AccuTnI+3 troponin I 
Beckman Coulter/Danaher 
U.S. 
PAPP 
plasma protein-A (PAPP-A) 
Diasorin S.P.A 
Italy 
aldosterone 
Liaison Aldosterone, hypertension 
Diazyme Laboratories 
U.S. 
myoglobin 
Myoglobin latex-enhanced immunoturbidimetric  
DRG International 
U.S. 
renin 
DRG Renin  
GD Biosciences 
U.S. 
risk 
Cardiac PLUs early cardiac risk, asymptomatic  
HealthMed Holdings 
Qatar 
inflammation 
Myocardial Assessment Profile, inflammation 
Immunodiagnostic 
Systems 
UK 
renin 
IDS-iSYS Direct Renin 
Nanomix Inc. 
U.S. 
panel 
Omega-3 Cardiac Panel, cTnI, myoglobin, H-FABP 
Olink Bioscience 
Sweden 
panel 
Proseek Multiplex CVD II and CVD III panel, protein 
markers  
R&D Systems 
U.S. 
corin 
Quantikine Human Corin Immunoassay, atrial fib 
Randox Laboratories 
Ireland 
sPLA2 
Aterovax’s Phospholipase A2 (sPLA2), cardiac risk  
Randox Laboratories 
UK 
aspirin PGx 
automated urine 11dhTxB2 
Randox Laboratories 
UK 
H-FABP 
H-FABP assay, Heart-type Fatty Acid Binding Protein 
Singulex 
U.S. 
panel 
Sgx Clarity troponin, BNP, endothelin 
Sphingotek GmbH 
Germany 
panel 
sphingotest penKid and sphingotest bio-ADM 
Source: Kalorama Information 
 
 

 
 
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Cardiac biomarkers are substances that are released into the bloodstream when the heart is 
damaged or stressed. In patients with chronic heart failure, measurement of these biomarkers 
is used to help risk-stratify, assess treatment options, monitor progress, and guide in-hospital 
and post-discharge care.  
But the goal is to detect heart disease risk before events occur.  Screening comprised a 
standard examination of blood pressure, an electrocardiogram, an oral glucose tolerance test, 
a lung function assessment, and measurements of height, weight, waist, and hip 
circumference. 
Several research studies have shown that this systematic screening and repeated lifestyle 
intervention do not reduce the 10-year incidence of cardiovascular disease in the general 
population. There is a large unmet clinical need for biomarkers that can identify patients 
along the spectrum of heart failure progression from disease risk in apparently healthy 
individuals to symptomatic heart failure. 
Beckman Coulter markets the Access NT-proBNP assay for the assessment of heart failure 
in less than 11 minutes. The test is run on the Dxl 9000 Immunoassay Analyzer. The Access 
NT-proBNP assay helps to identify patients with acute heart failure.  
Autoimmune 
Autoimmune diseases occur when the immune system mistakenly recognizes the body's own 
proteins as foreign invaders and produces antibodies that attack healthy cells and tissues, 
leading to a variety of diseases.  
There are at least 80 clinically distinct autoimmune diseases, including insulin-dependent 
diabetes mellitus (type 1 diabetes), multiple sclerosis, systemic lupus erythematosus (SLE), 
rheumatoid arthritis, inflammatory bowel disease, psoriasis, uveitis, and autoimmune thyroid 
disease.  Autoimmune diseases collectively affect approximately 5% to 10% of the 
population of the developed world. 
NIH estimates up to 23.5 million Americans have an autoimmune disease. And in fact, of the 
50 million Americans living and coping with autoimmune disease (AD), more than 75 
percent of them are women.  In Europe, some 20 million people are thought to have an 
autoimmune disease. 

 
 
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Autoimmune diseases were perceived as a relatively small and esoteric segment of the in 
vitro diagnostic market. Recent scientific discoveries, however, are finding autoimmune 
characteristics in many of the more common diseases, such as arthritis, liver disease, 
atherosclerosis, celiac disease, diabetes, antiphospholipid syndrome, and vasculitis, among 
others.  
There are more than 80 different types of autoimmune disorders and diagnosis is a complex 
process. Focusing on the allergy and autoimmune markets provides important synergies as 
the diagnostics for these disease categories share commonalities such as platform, assay 
development and manufacturing, and also target the same end user and areas of the 
laboratory. 
In 2025, the market for immunoassay-based autoimmune disease marker test kits is estimated 
at $955 million worldwide and is projected to reach $1,030 million by 2030.  The leading 
companies are Werfen, Bio-Rad Laboratories and Thermo Fisher Scientific.  
But as common as autoimmune disease may seem, scientists face many diagnostic 
challenges.  The NIH (National Institutes of Health) reports that autoimmune disease 
medicine is not well defined, in spite of the fact that many people are affected. 
Autoimmune diseases include: 
•  multiple sclerosis 
•  juvenile diabetes 
•  rheumatoid arthritis 
•  scleroderma, lupus 
•  Sjogren's disease 
•  Graves' disease.   
This is a growing field of medicine that involves the use of many different analytes.  A 
positive ANA test is a screen for an autoimmune condition. Because manifestations of 
autoimmune disease can be very nonspecific, the diagnosis is often difficult.  Several 
different laboratory tests are used to identify autoimmune disease, including antinuclear 
antibodies, rheumatoid factors, erythrocyte sedimentation rates, or C-reactive protein and 
anticytoplasmic nuclear antibodies. 

 
 
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The ANA assay is the first test typically run if an autoimmune disease is suspected.  The 
immunofluorescence assay is the gold standard for ANA testing.  However, IFA, as it is 
currently practiced in many laboratories, is time- and labor-intensive and subject to 
interpretation, since ANA screening by IFA requires visual interpretation of the stained 
pattern under a microscope.  The test is performed by a specifically trained technician.  
Therefore, laboratories have increasingly been shifting to ELISA because it automates and 
standardizes the ANA test.  
Werfen has been an important contributor to the modernization of ANA testing using indirect 
immunofluorescence (IFA). Through its NOVA View automated IFA microscopy platform, 
the company has helped move ANA testing from a fully manual, reader-dependent process 
toward a semi-automated digital workflow. The system integrates slide scanning, image 
capture, pattern recognition support, and result archiving, improving throughput, 
consistency, and traceability while reducing inter-observer variability. As a result, automated 
IFA systems are increasingly used to support IFA’s role as the reference method for ANA 
testing and to help laboratories address ongoing staffing and efficiency challenges. 
At the same time, the market continues to see rapid growth in decentralized, automated 
autoimmune testing formats, particularly in rheumatology and plasma cell disorder 
assessment. Orgentec Diagnostika offers lateral flow assays for anti-mutated citrullinated 
vimentin and rheumatoid factor, supporting faster turnaround times and expanded testing 
outside high-complexity core laboratories. These assays complement automated laboratory 
testing by enabling quicker initial screening or follow-up in specific clinical settings. 
Similarly, Abingdon Health addresses unmet needs in plasma cell dyscrasia testing with 
Seralite-FLC, a rapid serum assay for free light chains (kappa and lambda). The test provides 
quantitative ratios in a shorter timeframe than traditional immunonephelometric methods, 
aligning with market demand for faster results, simplified workflows, and near-patient testing 
capability. 
The next step in automation is multiplex systems for the simultaneous measurement of 
autoantibodies based on microspheres beads coated with specific antigens and flow 
cytometry detection. These tests have been available since early 2000s.  Multiplex ANA tests 
usually detect the most common autoantibodies including: dsDNA, Chromatin, Ribosomal 
protein, SS-A (52 and 60), SS-B, Sm, Sm/RNP, RNP (A and 68), Scl-70, Jo-1 and 
Centromere B antibodies. With this method ANA screen reports show the actual levels of 
individual analytes. Here too, further confirmation can be made using the IFA method. 

 
 
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These multiplexed tests are closed system tests run on a company’s test kits run on a 
proprietary flow cytometer such as the Luminex xMAP system.  Inova Diagnostics (Werfen), 
Zeus Scientific, Bio-Rad Laboratories and Biomedical Diagnostics market the leading bead-
based multiplexed autoimmune tests.   
Thermo Fisher Scientific offers the ImmunoCAP IgE test, a widely used laboratory-based 
assay for allergy diagnostics. The company has expanded access to this testing in the United 
States through collaborations with retail health providers, including Kroger Health’s The 
Little Clinic, which offers allergy testing in select locations. These efforts aim to improve 
patient access to diagnostic testing outside traditional laboratory settings. 
Augurex Life Sciences markets  SPINEstat, a blood test that detects auto-antibodies to the 
14-3-3eta protein. This blood test will assist in the diagnosis of axial spondyloarthritis, which 
is a chronic inflammatory disease that causes persistent back pain.  

 
 
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Table 7-12: Selected Autoimmune Test Innovations 
Company 
Location 
Technology 
Details 
AliveDx 
US 
IFA 
LumiQ IFA 
Binding Site (Thermo Fisher) 
UK 
automation 
Optilite, automation for Freelite & Hevylite  
Binding Site 
UK 
EIA 
Optilite IgG, IgA, IgM, albumin, CSF & CSF/serum  
Biomerica 
U.S. 
PGx 
Thiopurine methyltransferase PGx, thiopurine drugs 
EUROIMMUN AG 
Germany 
IFA 
EUROPattern system ANA IFA IT 
Genalyte Inc. 
U.S. 
EIA 
Maverick diabetes & autoimmune assays 
HUMAN Diagnostics 
Germany 
ELISA 
HUMAN IMTEC, Phospholipid Screen ELISA 
Inova Diagnostics (Werfen) 
U.S. 
ELISA 
QUANTA Lite Calprotectin, fecal ELISA 
Inova Diagnostics (Werfen) 
U.S. 
EIA 
Quanta Flash extractable nuclear antigen tests 
Inova Diagnostics 
U.S. 
EIA 
Quanta Flash Beta-2 Glycoprotein1  
Inova Diagnostics 
U.S. 
digital IFA 
NOVA View, automated digital IFA microscope 
Inova Diagnostics 
U.S. 
automation 
NOVA Lite DAPI ANA Kit, automated 
Kronus Inc. 
U.S. 
ELISA 
Glutamic Acid Decarboxylase Autoantibody  
Miraca Life Sciences 
U.S. 
PGx 
Theradiag's (France) LISA TRACKER assays 
Orgentec Diagnostika (Sebia) 
Germany 
ELISA 
ELISA tests autoimmune liver diseases, automated 
Protagen Diagnostics 
Germany 
EIA 
SeroTag markers for autoimmune diseases 
Protagen Diagnostics 
Germany 
EIA 
SeroTag Multilisa BICD2, systemic sclerosis 
Protagen Diagnostics 
Germany 
EIA 
with Qiagen SeroTag autoimmune tests 
Theradiag 
France 
PGx 
10 LiSA TRACKER autoimmune CDX 
Source: Kalorama Information 
 
 

 
 
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Rheumatoid Arthritis 
The most prevalent autoimmune disease is rheumatoid arthritis (RA).  Rheumatoid arthritis 
occurs when, during inflammation, certain proteins are altered through a process known as 
citrullination. These modified proteins can induce an immune response in the body, whose 
antibodies can turn on themselves. Multiple studies have demonstrated that patients with 
rheumatoid arthritis are positive for rheumatoid factor and/or antibodies to citrullinated 
protein antigens from 2 to 10 years before symptoms appear.  
Approximately 350 million people worldwide have arthritis. Over 40 million people in the 
United States are affected by arthritis, including over a quarter of a million children. More 
than half of those with arthritis are under 65 years of age. 
Arthritis is a systemic disease and can significantly damage other parts of the body as well, 
resulting in infection, osteoporosis and cardiovascular disease, a leading cause of death for 
arthritis patients.  Rheumatoid arthritis is a particularly debilitative form of arthritis that, if 
left untreated, results in 70% of patients developing irreversible joint damage within 2 years 
of symptom onset. 
RA patients may experience difficulties with everyday tasks and restricted work options.  
Thus, RA has significant health economic implications. Early intervention gives immediate 
patient benefit and reduces healthcare costs. There are many obstacles in the diagnosis and 
monitoring of arthritis, including an incomplete understanding of disease pathogenesis, 
changes in physician behavior, and acceptance of costs by health insurers.  
The consensus in the medical community is that early and accurate stratification of patients 
with arthritis, followed by frequent monitoring and responsive therapeutic adjustments, is 
critical to improving clinical outcomes.  However, it can be difficult for a primary care 
physician to diagnose because the joint pain symptoms are common to other conditions.  The 
U.S. Centers for Disease Control and Prevention stated that, while the cause of RA remains 
unknown, it may result from a combination of genetic and environmental factors. Age and 
sex, genetics, smoking, oral contraception, and lack of exercise are some risk factors. 
Despite significant progress in the treatment of rheumatoid arthritis over the last 10 years, 
many patients remain partial responders and true remission is rarely achieved. A major goal 
is to develop precision tests for arthritis that can predict treatment response prior to initiating 
arthritis therapy. 

 
 
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Initiatives are underway, led by the American College of Rheumatology and the European 
League Against Rheumatism, to establish quantitative objective indicators of disease activity 
to assist in routine clinical practice and for outcome measures in clinical trials. 
By studying biological samples from RA patients, RA-MAP (www.ra-map.com) aims to 
develop an immunological toolkit to measure the immune status of healthy individuals and 
patients. 
The MATURA consortium is a UK-based stratified medicine research initiative focused on 
improving treatment selection for people with rheumatoid arthritis (RA). MATURA aims to 
identify biological and molecular predictors of treatment response, enabling patients to be 
allocated early in the disease course to therapies they are most likely to benefit from. 
The consortium is funded primarily by the Medical Research Council (MRC) and Versus 
Arthritis (formerly Arthritis Research UK). MATURA brings together a large collaborative 
network of academic research groups and industry partners, coordinated through Queen Mary 
University of London, with clinical and translational research activity spanning multiple UK 
centers. 
MATURA investigates genetic, transcriptomic, cellular, and protein biomarkers in blood and 
synovial tissue to understand why individual patients respond differently to disease-
modifying antirheumatic drugs, biologics, and targeted therapies. By linking molecular 
signatures to clinical outcomes, the consortium seeks to reduce trial-and-error prescribing, 
shorten time to disease control, and improve long-term outcomes in inflammatory arthritis. 
Overall, MATURA represents a major UK initiative in precision and stratified medicine for 
rheumatoid arthritis, providing a framework for biomarker-guided therapy selection and 
accelerating the translation of discovery science into clinically actionable diagnostics. 
A number of targeted drugs are used in the most severe cases, including anti-TNF-α agents 
(infliximab, etanercept, and adalimumab), treatments directed against IL1 (anakinra), a 
CTLA4-directed T-cell modulator (abatacept), and a monoclonal antibody against CD20 that 
serves as a B-cell modulator (rituximab). 
These emerging therapies offer great promise as well as challenges. They will likely be 
expensive and not uniformly effective. The need to identify biomarkers of treatment response 
and toxicity specific to the various agents will greatly enhance the ability to tailor treatment 
to individual RA patients. 

 
 
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Early diagnosis is a key to effective treatment options.  Tests that detect antibodies to 
citrullinated proteins are already being used to diagnose RA. 
Physicians commonly use a combination of clinical assessment, X-rays, and laboratory tests 
to help determine the risk of progression of structural damage. Serologic factors, including 
rheumatoid factor (RF), anti-CCP antibodies, and an elevated baseline erythrocyte 
sedimentation rate (ESR) or C-reactive protein (CRP) level, are associated with disease 
course.  None of these tests provides patient-specific information.  
The diagnosis of arthritis today is based on a scoring system for affected joints, symptom 
duration, general markers of inflammation, and the two specific markers, RF and anti-CCP.  
Research has shown that approximately one-third of RA patients are negative for the two 
serological markers that are predominantly used in the diagnosis of RA: rheumatoid factor 
(RF) and anti-cyclic citrullinated peptides (CCP). While third-generation CCP assays (CCP 
3.0 and CCP 3.1) have increased sensitivity in early disease, some RA patients remain 
seronegative. 
Researchers at Hasselt University conducted a study to identify novel autoantibody markers 
to improve the diagnosis of seronegative and early-stage rheumatoid arthritis. The research 
addressed a key unmet need in RA diagnostics, as approximately one-third of RA patients 
test negative for established serological markers, including rheumatoid factor (RF) and anti-
citrullinated protein antibodies (anti-CCP). 
Investigators have identified several novel autoantibody biomarkers that may have diagnostic 
value in early rheumatoid arthritis, including in patients who are seronegative by 
conventional testing. In research settings, combining these emerging markers with 
established tests such as rheumatoid factor and anti-CCP has shown potential to improve 
overall diagnostic sensitivity compared with standard serology alone. 
Further work is underway to validate these findings in larger patient populations and to assess 
whether these biomarkers could also help predict disease progression or response to therapy. 
While these markers are still in the research and early translational stage, they highlight the 
potential of expanded autoantibody panels to address diagnostic gaps and support earlier 
identification of rheumatoid arthritis. 
A novel biomarker for rheumatoid arthritis has significant potential to help physicians better 
identify early-stage disease when treatment can often arrest further disease progression and 
disability.  Researchers found that elevated levels of the 14-3-3eta protein outperformed 

 
 
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conventional antibody testing, including rheumatoid factor alone and anti-citrullinated 
peptide antibodies alone, in identifying RA.  A test for 14-3-3eta protein is offered as a lab-
developed test by Quest diagnostics under a license from Augurex Life Sciences Corporation. 
Table 7-13: Selected Arthritis Immunoassay Innovations 
Company 
Location 
Details 
Aesku Diagnostics 
Germany 
AESKULISA MMP-3, marker for RA 
Augurex Life Sciences  
Canada 
14-3-3eta biomarkers for rheumatoid arthritis  
Exagen Diagnostics, Inc.  
U.S. 
Avise MTX, methotrexate resistance 
Gold Standard Diagnostics  
U.S. 
Axis-Shield’s Anti-CCP2  
Orgentec Diagnostika (Sebia) 
Germany 
Anti-MCV ELISA, autoantibodies mutated citrullinated vimentin  
Oxford University 
UK 
protein tenascin-C arthritis risk marker 
Quest Diagnostics 
U.S. 
RA panel: Augurex's 14-3-3eta, RF, anti CCP 
Siemens Healthineers 
U.S. 
Immulite anti-CCP IgG, arthritis 
Werfen 
U.S. 
rheumatoid arthritis autoantibodies 
Source: Kalorama Information 
The RA diagnostics market is evolving from single-analyte serology toward expanded 
autoantibody and biomarker panels that support earlier diagnosis, risk stratification, and 
therapy selection, particularly in seronegative and early RA populations. 
Gastrointestinal Disorders 
Inflammatory bowel diseases (IBD), including Crohn's disease, celiac disease, and ulcerative 
colitis, are chronic inflammatory conditions of the intestinal tract.  The conditions can be 
difficult to diagnose and manage clinically while consuming a substantial amount of 
healthcare resources in terms of physician time, procedures and medications. 
Inflammatory bowel diseases (IBD) affect approximately 1.6 million Americans, or 1 in 200 
people, with the incidence evenly split between ulcerative colitis and Crohn's disease.  An 

 
 
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estimated 2.5–3 million people in Europe are affected by IBD, with a direct healthcare cost 
of 4.6–5.6 billion Euros/year.  IBD affects men and women equally and can strike at any age.  
While both inflammatory bowel diseases have similar symptoms, including diarrhea, 
abdominal pain, weight loss, and fatigue, Crohn's disease can affect any part of the GI tract, 
whereas ulcerative colitis is limited to the colon. Although considerable progress has been 
made in IBD research, investigators do not yet know what causes IBD. There is currently no 
medical cure for ulcerative colitis or Crohn's disease. 
Current methods for the initial clinical diagnosis of colitis and Crohn’s remain challenging. 
Healthcare providers primarily rely on colonoscopies and biopsies.  The development of a 
stool-based diagnostic test for IBD provides a non-invasive, cost-effective alternative. 
Researchers have found that high levels of serologic markers of inflammation are present in 
the circulation of patients who go on to develop inflammatory bowel disease many years 
before symptoms appear. 
Calprotectin is released in large quantities by granulocytes during inflammatory processes 
and fecal calprotectin is an established marker of intestinal inflammation. The determination 
of calprotectin in stool is, therefore, ideal for the differentiation of inflammatory and 
functional gastrointestinal diseases. Monitoring fecal calprotectin concentrations in patients 
with inflammatory bowel syndrome is also a reliable tool for assessing the efficacy of TNFα 
blocker therapy.  Elevated levels are an early and reliable indicator of a relapse in IBD 
patients.  
Prometheus Laboratories suggests that a Calprotectin test, together with a TNFα blocker 
monitoring test, is a powerful toolbox for diagnostics and therapeutic control in IBD patients.  
This research was unable to quantify the market for GI tests with certainty. 
DiaSorin offers a range of gastrointestinal assays on its LIAISON platform, including tests 
for Helicobacter pylori and Clostridioides difficile GDH and toxins A/B, with additional 
assays supporting the detection of enteric pathogens such as enterohemorrhagic Escherichia 
coli. These tests are performed on fully automated immunoassay systems designed to support 
routine laboratory workflows. However, fully automated platforms for infectious disease and 
gastrointestinal testing are widely available across the industry, and similar capabilities are 
offered by multiple diagnostic companies. 

 
 
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Table 7-14: Selected Inflammatory Bowel Disease Test Innovations 
Company 
Location 
Details 
ALPCO Diagnostics 
U.S. 
Portfolio of stool-based gastroenterology assays 
Biohit Oyj 
Finland 
GastroPanel on Dynex ELISA systems 
Biomerica 
U.S. 
Transglutaminase IgA ELISA, celiac disease   
Biomerica 
U.S. 
Antigliadin IgA/IgG ELISA, celiac disease   
Euro Diagnostica AB (Svar Life Science) 
Sweden 
Wieslab Celiac hs Screen, gliadin, celiac disease 
Preventis GmbH 
Germany 
PreventID CalScreen, calprotectin in stool, IBD 
Prometheus Biosciences 
U.S. 
Anser IFX test, infliximab drug antibody  
Quanterix Corp 
U.S. 
TNF- and IL-6 concentration, Crohn's disease  
Randox Laboratories 
Ireland 
Biohit's GastroPanel, gastric disorders 
Theradiag 
France 
LIS TRACKER Certolizumab and Vedolizumab, IBD 
Source: Kalorama Information 
The GI and IBD diagnostics market continues to evolve toward non-invasive stool 
biomarkers, multiparametric serologic panels, and therapeutic drug monitoring to support 
precision management of chronic gastrointestinal disease, particularly IBD and celiac 
disease. 
Transplant Management 
Organ transplants have saved more than 2 million years of life in the United States over 25 
years. However, less than half of the people who needed a transplant in that time period got 
one, because of a shortage of donors. 
Nearly 48,149 organ transplants were performed in the United States in 2024. They routinely 
extend lives, but the success of these procedures remains limited by complications, including 
rejection of the new organ by the recipient’s immune system.  

 
 
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A major role for immunoassays in transplant medicine is to adjust anti-rejection drug dosage.  
More and more transplant patients are being treated with multi-drug regimens that include 
mycophenolic acid (MPA), and studies suggest that therapeutic drug monitoring of MPA 
levels is helpful in-patient management. Therefore, having the ability to efficiently monitor 
any combination of MPA, cyclosporine, tacrolimus and sirolimus therapy on one integrated 
instrument can help to ensure patients receive the optimal balance of therapy. This may not 
only save the transplanted organ but also the patient's life.  
Siemens Healthineers has offered an assay to monitor the dosage of immunosuppressant 
drugs given to transplant patients.  Siemens offered Mycophenolic Acid assay (MPAT) on 
the Dimension Integrated Chemistry Systems in the U.S.  According to Siemens, with this 
addition, the company became the first company to offer the consolidation of four fully 
automated immunosuppressant drug (ISD) assays on a single integrated chemistry system. 
The four ISD tests—mycophenolic acid, cyclosporine, tacrolimus and sirolimus—are the 
most commonly prescribed immunosuppressants used by physicians to prevent organ 
rejection.  
Elecsys Tacrolimus assay is intended to be used as an aid in the management of liver and 
kidney allograft patients receiving tacrolimus therapy.  Tacrolimus (TAC) is a post-
transplantation immunosuppressant drug used in patients for whom careful monitoring of 
TAC concentration is essential. 
Roche announced the availability of its CE-marked Elecsys Sirolimus and Everolimus 
immunosuppressive drug assays. These two assays complement the currently available 
Elecsys Tacrolimus and Cyclosporine assays, and with the mycophenolic acid (MPA) assay 
complete the Roche Diagnostics immunosuppressive drug monitoring portfolio. 
QIAGEN announced the commercial launch of the CE-marked QuantiFERON Monitor 
(QFM), a diagnostic for monitoring immune function in solid-organ transplant recipients.  In 
North America and other markets, QFM is available for research use as a marker of immune 
function in studies of immunosuppressive conditions, immune-modulating therapies, and 
recovery following transplantation. The test is used to assess patients' risk of both organ 
rejection and infections to determine the appropriate dosage of immunosuppressive drugs.  
QFM uses a combination of stimulants that specifically target different cell types involved in 
both the innate and adaptive immune systems to detect cell-mediated immune response, 
thereby providing qualitative and quantitative measurement of cell-mediated immune 

 
 
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function. Clinical studies are underway to investigate QFM's utility in transplantation for 
multiple organs (heart, lung, liver and kidney).  
This research was not able to quantify the market for the transplant immunoassays with 
certainty.   
Table 7-15: Selected Immunoassays for Transplant Medicine 
Company 
Location 
Details 
One Lambda (Thermo Fisher) 
U.S. 
LABScreen Multi antibody screening, HLA/HNA  
Oxford Immutec 
UK 
T-SPOT.PRT T reactive cells 
Plexision 
U.S. 
Pleximmune test liver transplant rejection 
Siemens Healthineers 
U.S. 
Mycophenolic Acid on Dimension Systems  
Thermo Fisher Scientific 
U.S. 
Thermo Scientific QMS Everolimus Assay Kit  
ViveBio LLC 
U.S. 
Renovar's markers rejection kidney transplant, urine 
Source: Kalorama Information 
Transplant diagnostics are increasingly moving beyond drug level monitoring and HLA 
antibody screening toward functional immune assays and noninvasive biomarkers, 
particularly urine- and cell-based tests aimed at earlier detection and risk stratification of 
rejection. 
Women’s Health 
Of particular interest is immunoassays related to women’s health and preeclampsia in 
particular. According to the Preeclampsia Foundation (www.preeclampsia.org) thousands of 
women and babies die or get very sick each year from preeclampsia, a disorder that occurs 
only during pregnancy and the postpartum period.  Preeclampsia is a cardiovascular disorder 
of late pregnancy.  Preeclampsia and related disorders such as HELLP syndrome and 
eclampsia are most often characterized by a rapid rise in blood pressure that can lead to 
seizure, stroke, multiple organ failure and death of the mother and/or baby. 

 
 
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Preeclampsia affects 10 million mothers worldwide every year and is associated with 
premature births and infant illness, including cerebral palsy, blindness, epilepsy, deafness, 
and lung conditions. It is estimated that preeclampsia costs the global health care system $3 
billion per year. Preeclampsia is estimated to affect 2%-8% of all pregnancies.  
Metabolomic Diagnostics offers PrePsia, a screening test that identifies women at increased 
risk of developing preeclampsia.  
In recognition of this important condition, several companies have taken up the challenge to 
provide diagnostic solutions.  This research was unable to quantify the market for 
preeclampsia and preterm birth tests with certainty. 
Revvity was awarded the CE Mark for the DELFIA Xpress PlGF Assay.   
The Anti-Müllerian Hormone (AMH) blood test has become a widely accepted biomarker of 
ovarian reserve, used by reproductive endocrinologists to estimate the remaining pool of 
recruitable follicles in the ovaries. AMH levels correlate with the quantity of ovarian follicles, 
providing clinically useful information about a woman’s potential response to ovarian 
stimulation. 
Unlike follicle-stimulating hormone (FSH) and estradiol, AMH levels are relatively stable 
throughout the menstrual cycle, allowing blood collection on any day. As a result, AMH is 
increasingly regarded as a more reliable and convenient indicator of ovarian reserve than 
traditional day-3 FSH or estradiol testing. Standardized automated AMH assays have further 
enabled routine clinical adoption, supporting consistent interpretation across laboratories and 
fertility clinics. 
Beyond assessing ovarian reserve, AMH testing is used to predict ovarian response to 
gonadotropin stimulation and to help guide treatment planning in assisted reproductive 
technologies (ART). AMH is therefore an important tool not only in fertility assessment but 
also in optimizing infertility treatment protocols. 
AMH assays are commonly used in conjunction with recombinant follicle-stimulating 
hormone (rFSH) therapies, including products marketed by Ferring Pharmaceuticals. AMH-
guided approaches enable individualized rFSH dosing, aiming to improve ovarian 
stimulation outcomes while reducing the risks of poor response or ovarian hyperstimulation 
syndrome (OHSS) in vitro fertilization (IVF) cycles. 

 
 
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Separately, in the area of maternal–fetal medicine, Thermo Fisher markets its B·R·A·H·M·S 
PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR immunoassays. These assays 
are used for the risk assessment and management of preeclampsia, representing the first 
FDA-cleared immunoassays for this indication in the U.S. Importantly, these biomarkers are 
distinct from AMH and address a different clinical need: placental dysfunction and 
hypertensive disorders of pregnancy, rather than fertility assessment. 
Circero Diagnostics offers its MyReceptiva endometriosis detection test. The test detects the 
presence of the BCL6 protein. The sample needs to be collected at the right time in the luteal 
phase of the menstrual cycle.  
For a more in-depth report see Kalorama Information’s Women’s Health Diagnostics 
Markets: Global Outlook and Forecast to 2030. 
Table 7-16: Selected Women’s Health Innovations 
Company 
Location 
Details 
Abbott 
U.S. 
Endoglin marker, preeclampsia 
Kellbenx Inc. 
U.S. 
fetal fibronectin, preterm birth  
Kellbenx Inc. 
U.S. 
interleukin panel, preterm birth screen 
Metabolomic Dx 
UK 
metabolite panel preeclampsia  
Revvity 
U.S. 
PreeclampsiaScreen | T1 screen panel  
Revvity 
U.S. 
DELFIA /AutoDELFIA  PlGF Assay, preeclampsia  
Pronota NV 
Belgium 
mid-gestation preeclampsia screening test 
Roche Diagnostics 
U.S. 
preeclampsia panel 
Sera Prognostics 
U.S. 
PreTRM, Proteomic Assessment of Preterm Risk  
Siemens Healthineers 
U.S. 
endometriosis panel 
Wistar Institute, The  
U.S. 
Adam 12 protein blood marker for ectopic pregnancy 
Source: Kalorama Information 
 

 
 
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AMH has evolved from a niche fertility marker into a routine component of modern 
reproductive medicine, supporting ovarian reserve assessment and more individualized 
treatment planning. At the same time, advances in placental biomarkers, such as PlGF and 
sFlt-1, are expanding the role of biomarker-guided decision-making in women’s health, 
particularly in the management of conditions like preeclampsia. 
Alzheimer’s Disease and Multiple Sclerosis 
According to the Alzheimer's Association, it is estimated that over 6.5 million people in the 
United States suffer from Alzheimer's disease. Over 500,000 patients are diagnosed annually, 
with nearly one-in-nine older Americans affected by the disease. Alzheimer's disease is the 
third leading cause of death in the United States. The cost of unpaid care in the United States 
is estimated at over $400 billion annually. Alzheimer's expenditures in the United States are 
expected to exceed $1.5 trillion by 2050. There is no cure or effective treatment for 
Alzheimer's disease.  
An estimated 59 million people worldwide had dementia in 2023, compared with 35 million 
in 2009, according to a report released by Alzheimer's Disease International. This is expected 
to increase to 152 million in 2050, a 204% increase.  The group said if there are no major 
medical advances, the number of people with dementia will likely double every 20 years.   
About 60% of people with dementia live in developing nations and by 2050, nearly half of 
all those with the disease will live in Asia, according to Alzheimer's Disease International. 
Alzheimer Europe (www.alzheimer-europe.org) reports that some 10 million people are 
afflicted with some form of dementia, including Alzheimer’s disease.  Worldwide, about 59 
million individuals have the disease, and according to the World Health Organization, the 
number will double every 20 years to 116.4 million people with Alzheimer's by 2050. 
Age-related diseases, such as dementia and Alzheimer’s, could bankrupt Western medicine 
by 2050.  Therefore, the search for new solutions, such as earlier and more specific diagnosis, 
is required to help deliver care more effectively and efficiently. 
Definitive confirmation of Alzheimer’s disease has traditionally relied on neuropathological 
examination of brain tissue, which is typically performed after death. As a result, the disease 
has often gone unrecognized until it has progressed. More recently, advances in 
biomarkers—including blood-based tests, cerebrospinal fluid analysis, and imaging—are 

 
 
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making it possible to identify Alzheimer’s pathology earlier in the disease course. 
Researchers continue to focus on developing noninvasive, cost-effective markers that can 
support early detection and improve patient selection for prevention and treatment studies. 
Early detection of Alzheimer’s symptoms is critically important for people with the disease 
and for clinical studies seeking to slow or stop its progression. However, many diagnostic 
techniques can be costly or invasive. Saliva is simple to obtain and easy to transport and has 
been successfully used to help identify a variety of diseases and conditions. In addition, 
because multiple samples can be readily obtained, saliva testing is particularly useful for 
performing repeated assessments that span days, weeks, months or longer. 
There is a consensus that Alzheimer’s disease begins with changes in the brain that are 
happening while people are still cognitively normal, decades before memory and thinking 
problems begin, which then accelerate as the disease progresses.  There is no known cure for 
the disease.  The search for early markers has been expanded in light of the recent 
commercialization of therapeutics that appear to slow down the cognitive impairment of 
people with dementia and Alzheimer’s. 
Studies have revealed several potential protein biomarkers in cerebrospinal fluid (CSF).  Tau 
and Aβ are among the most promising. Meanwhile, most research on proteins and other types 
of biomarkers in the blood and saliva are easier and cheaper to collect than CSF.  It is beyond 
the scope of this research to evaluate the market for markers of Alzheimer’s disease other 
than traditional CSF-based markers with certainty.   
Roche is establishing the presence of degenerative diseases of the central nervous system, 
which is important when it comes to distinguishing age-related memory disorders from early-
stage dementia.  Deposits of β-amyloid peptides (1-42) and neurofibrillary tangles in the 
brain are the two earliest changes associated with the development of Alzheimer's disease 
and can be detected by different methods.  Biomarkers in the cerebrospinal fluid help 
clinicians detect Alzheimer’s disease, the most common form of dementia, from an earlier 
stage.  
Roche has established a leading position in cerebrospinal fluid–based testing for Alzheimer’s 
disease through its Elecsys immunoassay portfolio. The Elecsys β-Amyloid (1-42) CSF II, 
Phospho-Tau (181P) CSF, and Total-Tau CSF assays quantitatively measure hallmark 
proteins associated with amyloid plaque formation and tau pathology. These biomarkers can 
be evaluated individually or combined as ratios to improve the biological characterization of 

 
 
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Alzheimer’s disease in adults undergoing assessment for cognitive impairment. The assays 
use electrochemiluminescence technology and are performed on Roche’s Elecsys and cobas 
e immunoassay systems, enabling standardized, automated testing in clinical laboratories. 
Roche’s CSF assays have progressed from a breakthrough designation to full U.S. regulatory 
clearance, reflecting their clinical role in supporting the evaluation of Alzheimer’s disease 
and other dementias in symptomatic patients. When used together as biomarker ratios, these 
tests help clinicians assess the likelihood of underlying amyloid pathology and the risk of 
disease progression, rather than serving as standalone diagnostic or screening tools. 
Beyond CSF testing, the Alzheimer’s diagnostics market is rapidly expanding toward blood-
based biomarkers that offer less invasive assessment options. Fujirebio has advanced both 
CSF- and plasma-based assays targeting beta-amyloid peptides and phosphorylated tau, 
supporting earlier detection of amyloid pathology and facilitating broader clinical adoption 
of biomarker-guided evaluation. These assays are designed to identify disease-related 
changes earlier in the clinical course, when therapeutic intervention may be more effective. 
C2N Diagnostics has taken a laboratory-developed test approach with its PrecivityAD blood 
test, which assesses circulating biomarkers associated with brain amyloid status. This test is 
offered through a centralized clinical laboratory and reflects growing interest in proteomic 
and ratio-based blood assays as complements to imaging and CSF testing. 
Sysmex has focused on plasma amyloid beta measurement using its automated immunoassay 
platforms, positioning its assay as a tool to support the identification of amyloid accumulation 
in the brain. This approach aligns with industry efforts to transition Alzheimer’s testing from 
specialized procedures to high-throughput laboratory workflows. 
Quanterix has introduced a highly sensitive blood-based test that measures phosphorylated 
tau isoforms in plasma. Leveraging ultra-sensitive digital immunoassay technology, the test 
is intended to aid clinical evaluation of Alzheimer’s disease by detecting low-abundance 
biomarkers associated with neurodegeneration. 
At the same time, companies such as Revvity and Thermo Fisher Scientific remain primarily 
active in the discovery and translational research side of Alzheimer’s biomarker 
development, supplying antibodies, reagents, and platforms for exploring beta-amyloid and 
tau targets. These tools support biomarker discovery and validation rather than serving as 
fully regulated clinical diagnostics. 

 
 
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Overall, Alzheimer’s disease diagnostics are moving toward a multi-modal, biomarker-
driven model that integrates CSF assays, blood-based testing, and imaging. This evolution 
reflects the broader trend toward earlier, less invasive, and more scalable assessment of 
neurodegenerative disease biology in both clinical practice and drug development. 
The product helps identify the level of Aβ accumulation in the brain by measuring the ratio 
of Aβ peptides (1-42 and 1-40) in the blood using Sysmex’s HISCL-Series, which employs 
chemiluminescence enzyme immunoassay (CLEIA) as its measurement principle. Unlike 
conventional testing methods, the Product enables testing using blood, thereby reducing the 
physical, emotional, and financial burden on patients with suspected Aβ accumulation in the 
brain. Furthermore, the product is expected to contribute to early diagnosis and early 
determination of optimal treatment plans for patients. In addition, automated assays using the 
HISCL-Series—which require only 10 to 30 μL of blood (plasma) and have a measurement 
time of just 17 minutes—will also help improve the efficiency and standardization of testing, 
according to Sysmex executives. 
Sysmex offers an assay kit to detect amyloid-beta accumulation in the brain. The assays 
measure the level of Aβ accumulation to determine whether there is supporting evidence for 
a diagnosis of Alzheimer's disease.  
LifeLabs markets three blood-based Alzheimer’s disease biomarker tests to assess the risk of 
dementia or Alzheimer’s disease. The portfolio consists of: 
• APOE Test – a blood test for genetic factors 
• P-tau317 Test – a blood marker for diagnosing Alzheimer's disease 
• Beta-Amyloid 42/40 Ratio Plasma Test – a blood test that detects early signs of 
Alzheimer’s disease. 
In Europe, Roche offers its Elecsys pTau181 test to measure the phosphorylated Tau181 
protein. The test can be used to rule out Alzheimer’s disease.  
Multiple sclerosis affects more than 2.9 million people worldwide. Roche’s Elecsys 
Neurofilament Light Chain (NfL) test is a blood test designed to detect neuroaxonal damage 
associated with neuroinflammation. It is a quantitative immunoassay that measures 
neurofilament light chain protein concentrations in plasma. The test is CE marked and is 
performed on the cobas instruments. The test aims to deliver reliable insights into relapsing-
remitting multiple sclerosis.  

 
 
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Table 7-17: Selected Innovations for Alzheimer’s Disease Immunoassays 
Company 
Location 
Details 
Amprion 
U.S. 
cerebrospinal fluid, blood or urine 
Analytik Jena 
Germany 
hTAU total ELISA kit tau protein, Alzheimer’s, CSF 
Araclon Biotech SL 
Spain 
ABtest40 & ABtest42, early Alz markers, blood 
Fujirebio 
Japan 
Lumipulse G β-Amyloid Ratio (1-42/1/40) test 
Innovative Health Diagnostics 
France 
IHD-Amy blood test, Alzheimer’s disease 
NanoSomiX 
U.S. 
blood assay, p-tau 
Quanterix Corp 
U.S. 
Amyloid-beta 42 levels in blood, Alzheimer  
Roche 
Switzerland 
Elecsys β-Amyloid (1-42) CSF, Elecsys Phospho-Tau (181p) CSF and 
Elecsys(R) Total-Tau CSF immunoassays 
Spear Bio 
U.S. 
SPEAR UltraDetect BD-Tau 217 
Sysmex 
Japan 
Measurement using Automated Immunoassay System HISCL-
5000/HISCL-800 
Source: Kalorama Information 
Across Alzheimer’s diagnostics, the market is clearly stratified between established CSF-
based clinical assays, emerging blood-based laboratory tests, and research-stage biomarker 
technologies, with industry momentum shifting steadily toward scalable, minimally invasive 
blood testing while CSF biomarkers remain the biological reference standard. 
Traumatic Brain Injury 
Traumatic brain injuries (TBI), including concussions, are responsible for over 4.8 million 
emergency room visits per year. Most of these (40%) are concussions caused by a slip and 
fall. Traumatic brain injuries are seen in the sports world.  Worldwide, there are 
approximately 10 million people affected by TBI. The primary goal of testing is to detect 
changes in the brain that could help determine if the brain was injured.  

 
 
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Abbott offers its iSTAT TBI plasma test, the first rapid, handheld TBI blood test. Results are 
available in 15 minutes. The company is also working on a whole blood test, which would 
eliminate the need to separate plasma. 
A study was conducted at the UC San Francisco using the i-STAT Alinity portable blood 
analyzer with the ARCHITECT assay series to analyze the brain injuries on the day it 
happened. Results revealed that day-of-injury blood tests measuring the concentrations of the 
biomarkers glial fibrillary acidic protein (GFAP), which originates in glial cells, and 
ubiquitin C-terminal hydrolase L1 (UCH-L1), which originates in neurons, can predict the 
outcome of TBIs.  Abbott is pursuing FDA clearance under Breakthrough Designation for 
the TBI test on its Alinity and ARCHITECT core laboratory instruments.  
Bio-Techne offers the Simplex Assays that are run on the fully automated Ella platform. The 
test evaluates multiple biomarkers using the Simple Plex, which is a quantitative, 
multianalyte immunoassay platform. The results provide a potential profile for TBI.  
A Swiss startup, ABCDx, is developing biomarker panels, including TBICheck, for traumatic 
brain injuries. The device is small and lightweight, producing results in less than 30 minutes.  
BRAINbox is developing the first AI-enabled, multi-modality system for mild TBI. The 
BRAINbox test is a POC system that uses a multiplex fluorescent immunoassay for 
biomarkers, together with a tablet-based neurocognitive test, to diagnose mild TBIs.  
Abbott markets its rapid i-STAT TBI Plasma test, which runs on the Alinity I laboratory 
instrument. The test provides clinicians with a way to assess individuals with mild TBI, and 
yields results in about 18 minutes.  
Abbott also markets its i-STAT TBI test for use with whole blood. This will enable testing 
in a variety of healthcare settings, including on the sidelines of sporting events.  
bioMérieux offers its VIDAS TBI assay. The assay is a serum-based test to aid in the 
assessment of patients with mild traumatic brain injury, including concussion. The test 
measures the biomarkers GFAP and UCH-1, which enter the circulation following cellular 
injury.  

 
 
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Other Immunoassays 
This part of the chapter presents a list of selected immunoassay innovations.  The list 
presented here is a testament to the breadth and significance of immunoassays in diagnostics. 
In the past few years, emphasis on molecular assays has somewhat overshadowed the value 
of immunoassays, but this lab segment is extremely vibrant and dynamic.  
The other immunoassay segment is growing, posting revenues of $3,020 million in 2025. A 
beginning breakout of the segment features bone markers at 14% of the total, 
endocrine/adrenal immunoassays at 24%, and radioimmunoassays at 11%. The remaining 
other immunoassays are a variety of important immunoassays that are on or entering the 
market.  
Figure 7-2: Other Select Immunoassays, by Percent of Total Immunoassays, 2025 (%) 
 
[Bone Marker; Endocrine/Adrenal; Radioimmunoassays; Others] 
 
Source: Kalorama Information 

 
 
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Table 7-18: Selected Immunoassay Innovations 
Company 
Location 
Area 
Details 
Abbott Diagnostics 
U.S. 
asthma 
periostin and DPP4 asthma markers 
Abbott Diagnostics 
U.S. 
fertility 
ARCHITECT 2nd Generation Testosterone 
ALPCO Diagnostics 
U.S. 
cytokine 
STELLUX Chemi Human IL-6 ELISA  
ALPCO Diagnostics 
U.S. 
kidney 
PPR Diagnostics, N-Acetyl-ß-D-Glucosaminidase, kidney 
disease   
ArcticDx, Inc. 
Canada 
mac deg 
Vita Risk pharmacogenetic analysis, macular degeneration 
treatment 
Astute Medical, Inc. 
U.S. 
kidney 
NephroCheck Test, acute kidney injury, IGFBP7 & TIMP-2 
Bio-Rad Laboratories 
U.S. 
IT 
automated link VARIANT II TURBO hemoglobin & BioPlex 
2200  
Biomerica 
U.S. 
kidney 
Fortel Microalbumin Screening 
Calbiotech 
U.S. 
iron met 
Hepcidin immunoassays are widely used in 
research/translational iron studies. 
Caprion Proteomics 
Canada 
Parkinson 
CNS ProteoCarta, 142 cerebrospinal fluid proteins 
Cisbio Bioassays  
France 
fertility 
Estradiol, Cortisol and Testosterone radioimmunoassays 
Clinical Research 
U.S. 
metabolic 
Mercodia AB's metabolic disorder antibodies 
Diazyme Laboratories 
U.S. 
ferritin 
Ferritin Latex-Enhanced Immunoturbidimetric 
DRG International 
U.S. 
iron met 
DRG Hepcidin 25  
EKF Diagnostics  
UK 
kidney 
Soluble Tumor Necrosis Factor receptor 1 
EUROIMMUN AG 
Germany 
kidney 
Anti- PLA2R IFA blood test kidney disease 
Exagen Diagnostics, 
Inc.  
U.S. 
lupus 
Avise SLE panel, Lupus 
Immuno Concepts 
U.S. 
SLE 
IgG Anti-nDNA Fluorescent Test System 
Immunodiagnostic 
Systems 
UK 
endocrine 
IDS-iSYS Aldosterone  
Immunodiagnostic 
Systems 
UK 
endocrine 
Diametra manual immunoassays 

 
 
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Company 
Location 
Area 
Details 
Mercodia AB 
Sweden 
metabolic 
ELISA and antibodies for metabolic disorders 
Rowan University 
School  
U.S. 
psych 
neurodegenerative disease markers  
ScheBo-Biotech AG  
Germany 
pancreas 
ScheBo • Pancreas Elastase 1 Quick stool test  
Siemens Healthineers 
U.S. 
liver 
Enhanced Liver Fibrosis test  
Singulex 
U.S. 
inh dis 
Erenna mutant Huntington protein 
Thermo Fisher 
Germany 
Down's 
Free sshCG and PAPP-A Down's markers 
Tosoh 
Japan 
hormone 
ST AIA-PACK SHBG assay, sex binding hormone  
Venaxis, Inc. (Bioptix) 
U.S. 
appendicitis 
APPY1 Test and APPYReader, appendicitis  
Source: Kalorama Information 
. 

 
 
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Innovating POC 
There has been renewed interest in POC immunoassays related to miniaturization and digital 
technologies that allow the devices to provide lab quality quantitative test results. These 
advances have been applied primarily to tests for infectious diseases. This has been 
reinforced by the number of POC COVID-19 immunoassays that have become available 
during the pandemic.  The products for POC professional use are responding to the demand 
for fast and reliable solutions to screen and monitor patients for the most pressing medical 
conditions. 
 
 

 
 
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Table 7-19: Selected POC Test Innovations 
Company 
Location 
Target 
Details 
Abbott Diagnostics 
U.S. 
concussion 
i-STAT concussion test 
Abbott Diagnostics 
U.S. 
hCG 
i-STAT Total β-hCG, blood 
Abingdon Health 
UK 
autoimmune 
Seralite–FLC serum, kappa/lambda light chains 
BBInternational 
UK 
ngal 
Recombinant Human NGAL  
Becton Dickinson 
U.S. 
women 
Diabetomics preeclampsia on Veritor 
Biohit Oyj 
Finland 
celiac 
Celiac Quick Test 
Boditech Med 
Korea 
vit D 
ichromα Vitamin D  
Critical Diagnostics 
U.S. 
cardiac 
Aspect-LF ST2 test, heart failure risk 
Diazyme Laboratories 
U.S. 
cardiac 
SMART Point of Care chemistry system  
Diazyme Laboratories 
U.S. 
kidney 
SMART Cystatin C POC Test Kit 
Epinex Diagnostics 
U.S. 
kidney 
Epinex ACR, quantitative microalbumin, LF 
NanoSpeed Diagnostics 
Canada 
vit D 
Test4D, rapid vitamin D 
Neogen Corp 
U.S. 
DAU 
UltaSal, oral fluid drugs of abuse collection and test 
NOWDiagnostics 
U.S. 
hCG 
ADEXUSDx hCG rapid blood test 
Oasis Diagnostics 
U.S. 
cortisol 
cortisol in saliva rapid test 
Oasis Diagnostics 
U.S. 
Parkinson's 
saliva-based, rapid test Parkinson’s disease 
Omega Diagnostics   
UK 
allergy 
Allergodip India, Allergodip LF IgE adapted for India 
OPKO Diagnostics 
U.S. 
cancer 
Claros PSA and 4KScore Prostate Cancer, kallikrein 
OPKO Diagnostics 
U.S. 
Vit D 
Claros Vitamin D test 
Orgentek Diagnostika 
Germany 
arthritis 
lateral flow anti-MCV and rheumatoid factor 
Progenika Biopharma 
Spain 
endocrine 
AlphaKit QuickScreen, Alpha-1-Antitrypsin Deficiency  
PTS Diagnostics 
U.S. 
cotinine 
PTS Detect systems, cotinine tobacco detection 
Royal Philips 
Netherlands 
troponin 
Minicare I-20 system, biosensor 

 
 
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Company 
Location 
Target 
Details 
Sekisui Diagnostics 
U.S. 
FOB 
OSOM iFOB 
Sekisui Diagnostics 
U.S. 
hCG 
OSOM Ultra hCG Comb, serum or urine 
Trinity Biotech 
UK 
BNP 
Meritas point-of-care BNP (B-type natriuretic peptide) 
Trinity Biotech 
UK 
D-dimer 
Meritas D-dimer 
Trinity Biotech 
UK 
troponin 
Meritas, high sensitivity Troponin I (hsTnI) 
True Diagnostics 
U.S. 
PSA 
TrueDX PSA, finger stick blood 
True Diagnostics 
U.S. 
TSH 
TrueDX TSH test 
Source: Kalorama Information 
Tests are only one aspect of POC testing with immunoassays.  New platforms, many of which 
are still in development, illustrate the creativity underway to make POC testing easier and 
more efficient.  Included are saliva, digital and paper-based test platforms.  Manufacturers 
are also investing in critical connectivity tooled platforms. 

 
 
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Table 7-20: Selected POC Immunoassay Test Platforms 
Company 
Location 
Details 
BBInternational 
UK 
Novarum DX smartphone-based Reader 
Boditech Med 
Korea 
Ichromα II 
Cambridge Consultants 
UK 
XylemDx, paper-based tests with 3D printed microfluidics 
Fio Corporation 
Canada 
Deki Reader with Fionet connectivity, LF immunoassays 
LamdaGen 
U.S. 
LAuRA plasmonic ELISA, 20-minute multiplexed panels 
Nanomix Inc. 
U.S. 
Nanomix  eLab diagnostic platform 
Oasis Diagnostics 
U.S. 
VerOFy point-of-care testing platform  
Oasis Diagnostics 
U.S. 
VerOFy Point-of-Care Testing platform, saliva  
OPKO Diagnostics 
U.S. 
Claros 1 in-office analyzer, Sangia microfluidic cassette 
Sekisui Diagnostics 
U.S. 
Qualigen’ s FastPack IP System, POC immunoassays  
Silicon BioDevices 
U.S. 
instrument free chip with wireless connectivity 
Skannex AS 
Norway 
SkanFlexi and SkanSmart, LF test readers 
Trinity Biotech/Stago 
UK 
Meritas POC Analyzer, laser diode to detect immunofluorescence  
True Diagnostics 
U.S. 
TrueDX reader, tests, wireless & USB connection  
Source: Kalorama Information 

 
 
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The Commercial Outlook for Immunoassays 
 The global immunoassay market continues on a steady growth trajectory. While many 
immunoassay tests, such as ELISA and lateral flow assays, are mature and well-established, 
the market remains highly competitive and dynamic. The COVID-19 pandemic underscored 
the value of immunoassays, particularly for rapid point-of-care (POC) and at-home testing 
using lateral flow formats, highlighting their critical role in public health response.  
Prospects for growth in the immunoassay market are good in certain geographic regions 
worldwide (developing countries). Several factors are driving the growth of diagnostic 
testing, including lateral flow testing, in these markets.  One major factor is economics. There 
is a growing middle-class population that is increasingly insured in many countries in 
Southeast Asia and Latin America, and these patients are better able to pay for services.  
These and other factors will make these regions promising segments of the immunoassay 
market.  Many companies are targeting these markets, including major worldwide diagnostic 
companies and smaller companies established in those countries. Much of the growth in 
testing in these markets in the near future will be driven by existing technologies (including 
ELISA and lateral flow tests).  
However, all immunoassays will have to pass the test of medical research to prove their 
contribution to improved patient outcomes.  Increased knowledge of disease physiology from 
molecular biology and human genome studies will enhance the role of analytes in chronic 
conditions such as cardiovascular disease, autoimmune disorders, and diabetes.  The function 
of genes is measured by the presence of tangible products—proteins of every size and 
molecular structure.  Thus, immunoassays combined with DNA probe studies will have an 
important place in post-genomic medicine. 
For the point-of-care sector, the news is good and bad.  Since the early 1990s, patient self-
testing has grown in popularity.  Kits are available for pregnancy, blood pressure, drugs of 
abuse, H. pylori, blood glucose, cholesterol, cancer, and HI.  More are in development for 
heart attack monitors, and sexually transmitted disease tests, among others.  Predictions are 
that patient self-testing will skyrocket due to rising consumer expectations, technological 
innovations, and a surge in consumer activism in healthcare, especially with the growing 
acceptance of POC immunoassay testing.  Further, pharmacies, retail outlets, and the 
physician's office are establishing their position for patient wellness screening.  The 
expectation is that under these conditions, POC testing, both self and professional, will grow.  

 
 
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The current set of tests and technologies can't accommodate all the needs of the consumer 
and professional markets.  For consumers, many of the tests are blood-based, not a user-
friendly sample type.  Further, many times, people just don't want to know what is really 
wrong with them. There is also a barrier in consumer perception of costs - the thought that 
new tests and technologies are just too expensive.  Faster, more sensitive, more user-friendly, 
and less expensive tests may produce better market penetration. 
Again, in the development of COVID-19 immunoassays, there was a push to provide saliva-
based tests, which has spilled over into other areas, increasing acceptance, including cortisol 
analysis.  
After many years of little growth, the professional POC test market is picking up steam. In 
the past few years, demand for quicker test turnaround time has spurred the launch of nearly 
100 new POC tests and devices.   
As the cost of POC devices becomes more affordable and healthcare organizations have 
constructed data management infrastructures, point-of-care testing has also become an 
attractive operational and economical alternative to traditional laboratory-based testing in a 
variety of situations, including physician office testing, home care and in-hospital care. 
The other significant opportunity for growth in the immunoassay market lies in innovations 
that create new opportunities.  This includes both innovative new platforms, innovative 
technology and development of novel biomarkers. 
With the continued emphasis on earlier detection, personalized medicine and remote care, 
immunoassays will remain a relevant and foundational tool for diagnostics. 
 
 

 
 
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Chapter 8: Molecular Assays 
Scope 
The molecular assays market consists of all IVD diagnostic products and technologies 
that detect and/or quantify nucleic acids (RNA, DNA) to identify pathogens, genetic 
mutations, and other molecular targets. It encompasses oncology, inherited disease and 
thrombosis, depression and psychiatric disorders, prenatal and newborn testing, 
transplant diagnostics, and women’s health. 
The molecular diagnostics field has evolved into one of the fastest-growing and most 
transformative segments of the in vitro diagnostics (IVD) industry. Since the discovery of 
the DNA double helix in 1953, the journey from basic scientific understanding to practical 
clinical tools has spanned decades, culminating in today’s highly sophisticated molecular 
testing platforms. 
Focus on infectious diseases was maintained even in the early years of the last decade by 
companies that ventured into the molecular diagnostics sector, and commercial molecular 
assays were introduced for hepatitis and respiratory diseases, as covered in Chapter 11.  The 
blood banking sector became one of the key application areas during this period, as the high 
sensitivity offered by molecular diagnostics brought significant value to donor blood 
screening for pathogens of great concern, a topic covered in Chapter 12.  Currently, the use 
of molecular diagnostics methods is not limited to infectious diseases. Other disease 
segments where molecular assays have high demand include inherited diseases, coagulation, 
transplant medicine, prenatal and postnatal screening and cancer. 
 
 

 
 
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Overview 
Over the last 30 years, molecular tests have been used in just about every facet of laboratory 
medicine: infectious diseases, inherited diseases, coagulation, transplant medicine, prenatal 
and postnatal screening, and, of course in cancer.  Their contribution to patient care is quite 
remarkable.  The first generation of molecular testing tools includes basic, time-consuming, 
and labor-intensive techniques such as Southern blotting, DNA probes, pulsed-field gel 
electrophoresis, and capillary electrophoresis.  These techniques are still used; however, their 
influence in the evolution of molecular testing has been overshadowed by the power of PCR 
and other amplification techniques, sequencing, mass spectroscopy, microarrays, and 
biochips. 
Molecular diagnostics is a fast-evolving, dynamic field and one of the fastest-growing 
segments within the IVD market. It has become an indispensable tool in clinical medicine 
that touches all aspects of healthcare including treatment decisions in terms of identifying 
antimicrobial resistant (AMR) infections at the earliest, companion diagnostics assisting in 
the evaluation of suitability of various cancer treatment options, pharmacokinetics or patient 
metabolism of drugs for HIV, psychiatric conditions or blood thinners; cancer prognosis and 
therapy, organ matching, blood safety, and the diagnosis of latent and neonatal conditions. 
Rather than replacing other major IVD modalities such as immunodiagnostics, the molecular 
diagnostics market has expanded by meeting clinical needs that were unmet or never 
envisioned by other major testing disciplines. As they become more affordable, the 
displacement of other diagnostics, such as immunodiagnostics, has also occurred owing to 
the high sensitivity and unique insights that molecular diagnostic methods offer. Certain IVD 
segments have been, or are in the process of being, remade worldwide through the application 
of molecular methods, including blood screening, POC diagnostics, cytogenetics, and tissue 
typing.  
The primary growth drivers in the molecular diagnostics market overall are the continued 
discovery of genetic markers with proven clinical utility, the increasing adoption of 
genetically based diagnostic tests, and the expansion of reimbursement programs to include 
more approved diagnostic tests.  The most attractive growth areas are molecular tests for 
histological analyses, women’s health, infectious diseases, organ transplant testing and 
oncology. 
On the technology side, one of the major drivers in this market is technological advancements 
that lead to new tests and innovations.  Although PCR is one of the standard techniques for 

 
 
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amplification, the method is quite complex due to the need for repeated thermocycling and 
cooling, and it consumes more energy. As an alternative to PCR, isothermal nucleic acid 
amplification circumvents the need for repeated denaturation and cooling, as the 
amplification occurs under isothermal conditions. This greatly aids in the design of 
microfluidic chips for conducting molecular diagnostics. It is expected that the 
miniaturization of nucleic acid-based diagnostics will boost market growth. 
The key isothermal vendors are Eiken, Becton, Dickinson and Co., bioMérieux, and 
QuidelOrtho. 
The molecular diagnostics industry is also experiencing a rapid shift toward greater process 
automation and the integration of sample analysis into single miniaturized devices.  
Miniaturization enables reducing sample volume, allowing the end-user to automate and 
analyze the sample. 
Advancements in automation and information technology (IT) have created a new level of 
optimism in the molecular diagnostics market, as evidenced by research investments, 
university spin-offs, mergers, and acquisitions in the segment. The holy GRAIL for 
molecular testing is the ability to load an untreated sample onto a cartridge or cassette, push 
start, and then come back when the test is complete. The ‘sample-to-result’ table-top systems, 
which are fast entering the market, represent an important milestone towards achieving this 
goal. Some of the leading global companies offering such tabletop systems include Cepheid, 
QIAGEN, Hologic, and Roche. The investments by such leading companies and government 
agencies that partner with them are pushing the existing limits of automation and IT, 
facilitating fast advancement towards near-patient and point-of-care diagnostics solutions.  
Table-top systems are considered the prerequisite technological advancement to providing 
molecular testing in small laboratories and resource-limited test sites anywhere in the world. 
The market is moving beyond these systems and the next generation of sample-to-result 
molecular test instruments is focusing on bringing genetic medicine to a much broader 
audience. The commercialization of these platforms and tests are the next major development 
towards democratization of molecular diagnostics as they have the potential to improve the 
quality of healthcare by improving the affordability and accessibility to advanced diagnostic 
solutions even in remote areas where challenges of skilled manpower and infrastructure are 
acute. Government investments into academic research and initiatives to support startup 
companies in the field are also driving the growth of molecular diagnostics sector.  

 
 
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Significant changes in healthcare delivery herald a new era in diagnostic testing needs.  This 
new era requires on one hand very sophisticated, sensitive assays for disease detection, 
disease management and drug treatment decisions.  On the other hand, these tests should be 
user-friendly and very cost effective.  This bodes well for automated and user-friendly 
molecular test platforms. 
However, the contribution these tests can make to patient outcomes is hindered by significant 
barriers, including reimbursement issues, a lack of standardization across test platforms, and 
limited quality-control products and programs.  Also, molecular tests, especially for inherited 
diseases and some FISH analyses, are extremely complex.  The tests provide raw data, the 
interpretation of which sometimes baffles even the most experienced molecular biologists. 
The technologies used in the Human Genome Project have become tools that molecular 
pathologists routinely use to diagnose diseases in patients whose conditions had long 
remained a mystery.  This is good for patient care, but the evolution of sequencing and next-
generation sequencing-based tests has been so rapid that government agencies and payers are 
scrambling to address the regulatory, reimbursement, and ethical issues that accompany this 
new generation of tests.  
Only five years ago, it would have been almost inconceivable that hospital- and government-
funded programs would provide whole-genome and whole-exome sequencing for thousands, 
and even millions, of people.  The contribution that these programs are making to patient 
care is beyond measure at this time.  The potential is enormous.  New sequencing 
technologies are expanding the number of genes known to cause genetic disorders.  Gene 
identification is a first step toward the future development of targeted therapies, especially 
for cancer and rare diseases.  
But the market potential of a diagnostic is measured by its clinical utility - the ability of the 
test to lead to an improved patient outcome.  According to the American College of Medical 
Genetics and Genomics (www.acmg.net), there is great clinical value in genomic test 
information.  The data can help physicians determine a precise medical diagnosis, a 
disorder’s cause and prognosis, and inform preventive and treatment options.  
Coverage by Medicare and other payers for a molecular diagnostics product or test can be 
obtained by demonstrating its clinical utility, particularly how the test can improve patient 
outcomes. This involves generating clinical data that demonstrates the test's utility. This is in 
addition to tests that evaluate analytical validity or the accuracy, precision and reproducibility 

 
 
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of test results and clinical validity or how well test can determine the presence, absence or 
risk of disease. Definitive clinical utility is becoming a criterion for the market success of 
new molecular diagnostics, particularly in the case of high-priced advanced tests without 
comparable products on the market.  
Important factors considered by payers when determining the clinical utility of molecular 
diagnostics and associated testing services include impact on therapy, improved patient 
survival, and added life expectancy. This scope of clinical utility has benefited prognostic 
assays that provide therapeutic guidance and companion assays that identify patients eligible 
for co-labeled targeted therapies. Reimbursement eligibility is important for the growth of 
the molecular cancer diagnostics market, as evidenced by the rapid growth of the non-
invasive prenatal testing (NIPT) segment of the molecular diagnostics market, which saw 
rapid growth after one of its tests received coverage in 2016.  
Table 8-1: Common Next Generation Molecular Test Traits 
Traits 
Reduced test time to minutes versus hours 
More test data leads to a better understanding of disease processes 
Easier to use and thus found in more clinical labs 
Automated sample to answer test procedures 
A variety instrument choice – from high throughput systems to tabletop low volume options 
Data analysis algorithms incorporated in testing system for sample to answer testing 
Source: Kalorama Information 
One of the major challenges facing molecular testing is getting stakeholders, including 
payers, physicians, researchers, and regulators, to work together to close the gap between 
research and clinical applicability.  Physician education is another area that could advance 
the use of molecular assays.   
The ensemble of these elements creates a dynamic, energetic, and fast-moving environment 
for new tests and companies, requiring vendors to adapt quickly to the changing market.  This 

 
 
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chapter provides an overview of the market for molecular tests across the key market 
segments. 
Molecular medicine transformed the entire spectrum of disease management, from assuring 
the early detection of disease, to defining the prognosis of disease evolution, and to predicting 
a patient's response to specific therapies.  This applies to a number of chronic conditions 
cardiovascular diseases, diabetes, cancer, psychiatric disorders and drug therapy.  

 
 
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Sample Preparation and Quality Control 
The generation of high-quality genomic data depends on starting material that contains 
adequate quantity and integrity of genomic DNA. To achieve the accuracy and 
reproducibility required for clinical-grade sequencing, laboratories follow established best 
practices in sample collection, stabilization, nucleic acid extraction, and library preparation. 
Each step in this workflow directly influences downstream sequencing performance, data 
quality, and interpretability. 
Nucleic acid extraction from solid tissue samples is a relatively mature and well-standardized 
segment of the genomics workflow. Established vendors such as QIAGEN, Macherey-Nagel, 
PreAnalytiX, and Greiner Bio-One offer broad portfolios of extraction kits, collection 
devices, and automation-compatible consumables. In tissue-based workflows, cells are lysed 
and genomic DNA is purified through established chemical and mechanical processes that 
efficiently separate nucleic acids from proteins, lipids, and cellular debris. 
In contrast, nucleic acid extraction from blood-based samples presents additional technical 
challenges. Many clinically relevant next-generation sequencing targets in blood are present 
at very low concentrations, including circulating tumor cells (CTCs), circulating fetal cells, 
and cell-free DNA (cfDNA) such as circulating tumor DNA (ctDNA) or circulating fetal 
DNA. These analytes are often fragmented, diluted by background genomic DNA, and 
susceptible to degradation during collection and processing. 
As a result, blood-based genomic testing places greater emphasis on pre-analytical controls, 
including specialized blood-collection tubes, rapid plasma separation, and extraction 
chemistries optimized for short, low-abundance DNA fragments. These requirements have 
driven continued innovation in liquid biopsy workflows, distinguishing them from more 
traditional tissue-based extraction methods despite sharing common downstream sequencing 
and bioinformatics pipelines. 
For blood samples, centrifugation is used to create a plasma sample from whole blood, 
though white blood cells remain and contamination with gDNA remains possible without 
proper sample collection. Formaldehyde is a common stabilizing agent for blood samples 
that preserves blood cells and reduces gDNA in plasma but can damage nucleic acids. Streck 
Cell-Free DNA blood collection tubes (BCTs) are increasingly used as a formaldehyde-free 
option for preserving cell-free DNA in blood samples. The product also removes the need 
for immediate centrifugation to plasma and remains stable for plasma preparation for up to 

 
 
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14 days and for CTC isolation for up to 4 days at ambient conditions. Common methods for 
extracting cfDNA from plasma include spin columns, silica- or magnetic-bead-based 
methods, phenol/chloroform extraction, and alkaline salts. However, recovery rates for these 
methods are low due to losses from binding, washing, and elution. Without improvements in 
extraction efficiency from plasma, serum or urine, larger blood draws will be necessary or 
clinical NGS will have to compensate through enrichment and library preparation from 
recovered content and improved sequencing sensitivity.  
Challenges in library preparation can limit the adoption of NGS in clinical labs, especially in 
POC settings. In the case of targeted sequencing, libraries or templates are limited to a group 
of genes or only one locus to identify key variants for clinical decision-making, which is 
relatively easier compared to broader genome or exome sequencing for clinical purposes, 
which tends to be much more complex and needs to be handled by specialty labs experienced 
in more complex library preparation procedures. The following product developments are 
expected to assist more routine clinical performance of library preparation for targeted 
sequencing: customized and packaged probe sets for targeted enrichment; automation and 
engineering improvements to sequencers and other workflow instruments that reduce hands-
on requirements; and single-molecule sequencing methods.  
Direct detection or single-molecule sequencing platforms can simplify sequencing runs by 
eliminating the need for amplification with tissue samples. Pacific Biosciences’ SMRT 
sequencing technology is complemented by automatable SMRTbell Template Prep Kits. 
SMRTbell templates use hairpin adapters that serve as common primer-binding sites between 
fragments. The template design further reduces sequencing bias that is already mitigated by 
the removal of amplification in SMRT workflows. Similarly, nanopore sequencing 
technologies, such as those marketed by Oxford Nanopore Technologies, eliminate the need 
for amplification in library preparation.  
Automation is an important trend as it can offer better precision and reproducibility. Illumina 
has standardized NGS assay workflows that couple TruSight panels with library preparation 
kits automated under a sequencer platform such as the MiSeqDx. Illumina’s automated 
microfluidic library preparation assays are available only for research use, but, together with 
panels potentially developed from TruSight research assays, they could form a reliable, 
hands-off solution for routine clinical sequencing.  
Microfluidic and liquid-handling systems are also being employed to automate library 
preparation. The Illumina NeoPrep system and the DNA Electronics developmental 

 
 
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Pathogen Capture System (PCS) are examples of automated microfluidics systems for 
automated target capture and library preparation. Liquid handling systems that can be used 
for NGS target capture and library preparation include Agilent Technologies NGS 
Workstations, Takara Bio Apollo 324, Revvity Sciclone G3 Workstation, and Tecan 
Freedom EVO. Automated or robotic liquid-handling systems are appropriate for larger labs 
and will lead to clinical adoption of sequencing. Benchtop liquid-handling systems or 
microfluidic sample-preparation systems are suitable for clinical sequencing in hospitals and 
smaller labs.  
Microarrays and in situ hybridization (ISH) segments are shifting toward nucleic acid 
amplification (NAATs) and NGS platforms in developed markets, while growth for these 
platforms is mainly in emerging markets. Another emerging platform within the molecular 
diagnostics market is isothermal nucleic acid amplification (iNAAT) technologies; the 
demand for which is mainly in the developed markets. Even though the POC potentials of 
the platform are promising for emerging markets, costs are still considered high to promote 
large-scale adoption in emerging markets 
QIAGEN launched the QIAseq cfDNA All-in-One Kit, the first dedicated solution for liquid 
biopsy analysis that combines cell-free DNA extraction and library preparation on any NGS 
platform. The kit integrates with QIAGEN's PAXgene Blood cfDNA Tube for the collection 
and stabilization of blood samples, as well as with QIAGEN's bioinformatics workflow for 
cfDNA, creating a streamlined testing solution that enables faster, more convenient, and more 
reliable analysis of cfDNA from sample collection to result.  
AcroMetrix, offered by Thermo Fisher Scientific, was one of the first offerings in molecular 
QC products.  QIAGEN was the first company to routinize nucleic acid extraction and 
preparation in the 1990s.  The company claims to still dominate the market but as seen in 
Table 8-2 below, there are more and more companies entering this market.  Some have 
specialized products; others are for general use.  Unfortunately for clinical labs, the majority 
of these products are for research use only.  Market-cleared kits, reagents, and instruments 
are still largely lacking, and filling this gap is essential for the routine use of molecular 
testing. 
In the same vein, appropriate sample collection and transport tools are essential to maintain 
nucleic acid integrity and contamination control while a sample is in route from the sampling 
site to the testing lab.  The travel route may involve very short distances (even to the same 
building) to thousands of miles and days.   

 
 
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PreAnalytiX is a joint venture of QIAGEN and blood tube manufacturer Becton Dickinson.  
The products are marketed by QIAGEN.  It is beyond the scope of this research to report the 
revenues generated from the sale of sample transport and nucleic acid extraction 
(preparation) with certainty. 
Streck offers its Cell-Free DNA BCT, which recently received FDA De Novo clearance by 
the U.S. Food and Drug Administration. When paired with the Guardant360 CDx, it has 
quickly become the industry standard for maintaining cell-free DNA samples and limiting 
pre-analytical variation. 
 
 

 
 
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Table 8-2: Selected Molecular Test Sample Preparation and QC Innovations 
Company 
Location 
Area 
Target 
Details 
10X Genomics 
U.S. 
smpl prep 
sequencing 
Chromium System 
Agena Bioscience 
U.S. 
QC 
mass spec 
 iPLEX reference standards  
Asuragen 
U.S. 
smpl 
integrity 
FFPE 
SuraSeq DNA Quantitative Functional Index, DNA QC  
Becton Dickinson 
U.S. 
smpl prep 
sequencing 
CLiC System 
Biotype Diagnostic 
Germany 
smpl 
enrich 
micro 
Sampletype DNA extraction from sperm, skin, swabs, 
blood 
CareDx (Revvity) 
U.S. 
QC 
cfDNA 
Horizon's cell-free DNA QC - organ transplant  
CareDx (Revvity) 
U.S. 
QC 
transplant 
Horizon Diagnostics standards, transplant, sequencing 
Diasorin 
Italy 
smpl prep 
DNA 
ELITe STAR, PCR ready elutes  
DxTerity 
Diagnostics 
U.S. 
smpl 
transport 
RNA 
DxCollect MCD RNA stabilized in blood  
Fluidigm(Standard 
BioTools) 
U.S. 
smpl prep 
sequencing 
Library Prep IFCs, mRNA 
IncellDx 
U.S. 
smpl prep 
liquid biopsy 
IncellPrep Liquid Biopsy cell suspension: FFPE 
Seegene 
Korea 
smpl prep 
DNA 
Diasorin's DNA extraction technology 
SeraCare Life 
Sciences 
U.S. 
QC 
ctDNA 
cell-free circulating tumor DNA (ctDNA), NGS 
SeraCare Life 
Sciences 
U.S. 
QC 
coag 
ACCURUN 611oagulation gene markers  
SeraCare Life 
Sciences 
U.S. 
QC 
HPV 
ACCURUN HPV mRNA positive  
SeraCare Life 
Sciences 
U.S. 
QC 
micro 
AccuSpan viral molecular linearity panels  
SeraCare Life 
Sciences 
U.S. 
QC 
prenate 
Non-Invasive Prenatal Testing reference materials  
SeraCare Life 
Sciences 
U.S. 
QC 
STD 
ACCURUN 841 CT/GC Negative  

 
 
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Company 
Location 
Area 
Target 
Details 
Thermo Fisher 
Scientific 
U.S. 
QC 
cancer 
AcroMetrix Oncology Hotspot Control, oncology NGS 
Source: Kalorama Information 
Next-generation sequencing for hereditary genetic diseases and oncology is rapidly growing.  
At present, there are no widely accepted genomic standards or quantitative performance 
metrics for confidence in variant calling.  These are needed to achieve the confidence in 
measurement results expected for sound, reproducible research and regulated applications in 
the clinic.   
The promise of DNA sequencing via NGS alone has already attracted many companies, 
researchers, and investors.  Recent significant efforts in automation and miniaturization have 
led to a further uptick in the adoption of automated systems across the range of sample-
preparation areas.   
Quality control products for genomic molecular tests are a complicated matter.  Many regions 
of the genome cannot be confidently sequenced and accurately variant called with current 
whole-genome and exome sequencing methods.  Groups, including the NIST (National 
Institute of Standards and Technology, an agency of the U.S. Department of Commerce), are 
working on NGS quality control.  This is vital for ensuring successful and accurate NGS test 
results take their place in routine testing.  Further, external quality assurance (EQA), as is 
available in all other IVD test segments, will play an important role in enabling labs to 
benchmark this new technology, assess data accuracy, and facilitate high-quality reporting. 

 
 
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Molecular Evolution 
The way molecular testing has evolved is interesting.  Testing for infectious diseases is 
growing by leaps and bounds with a continuous stream of new market cleared tests and 
technologies. This is evident amid the recent COVID-19 pandemic.  Other molecular tests, 
such as those discussed in this chapter, have had difficulty with market clearance and 
reimbursement.  The result, most tests in this segment are offered by lab services or through 
company-sponsored accredited labs.  At the same time, a number of technologies are poised 
to make their mark in genomic diagnostics. 
Digital PCR is a new approach to nucleic acid detection and quantification that uses 
molecular counting. It offers an alternative to conventional real-time quantitative PCR for 
absolute quantification and rare-allele detection. Digital PCR works by partitioning a sample 
of DNA or cDNA into many individual, parallel PCR reactions; some of these reactions 
contain the target molecule (positive) while others do not (negative).  A single molecule can 
be amplified a million-fold or more. During amplification, dye-labeled probes are used to 
detect sequence-specific targets.  The strength of color generated is proportional to the 
amount of DNA present. 
The market for digital PCR is poised for growth over the next several years, led by established 
life science tool vendors such as Standard BioTools, Thermo Fisher Scientific (Ion Torrent), 
and Bio-Rad Laboratories. 
Exosome Sequencing 
Exosomes are messengers released by all cells into biofluids, such as plasma/serum, urine, 
cerebrospinal fluid and saliva. Exosomes contain RNA, including mRNA, microRNA, 
lncRNA and other RNA species, as well as DNA and proteins, from their cell of origin.  They 
can serve as rich sources of proteomic and genomic markers of tissue dysfunction.  Biofluid 
exosomes are particularly useful for differential molecular profiling because they are present 
not only in primary and metastatic cancer but also in inflammatory, metabolic, 
cardiovascular, neurodegenerative and other disease processes.  
The information in these particles is extremely stable and the focus of intense interest in the 
scientific community for the diagnosis and treatment of cancer, immunological disorders, 
newborn diseases of metabolism, preterm birth, diseases of the central nervous system, 

 
 
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Alzheimer’s disease, autoimmune disorders and other medical conditions.  The aim is to 
identify the genetic changes that trigger the disease’s onset; however, the mutations found to 
date do not adequately explain the origin or recurrence of the disease. 
Exosomes carry nucleic acids and proteins from their host cells and are widely considered to 
be essential for biomarker discovery for precision healthcare diagnostics.  Tumor cells, for 
instance, release exosomes which contain tumor-specific RNAs that can be isolated more 
easily from biofluids such as blood and urine than from biopsies.  
It is expected that exosome-based tests in routine genomic diagnostics will provide an 
alternative to tissue biopsies and create new opportunities in molecular testing, especially for 
cancer liquid biopsy analysis.   
Exosome Diagnostics (ExoDx) is widely recognized as one of the most advanced commercial 
players in exosome-based diagnostics. Its technology platform uses urine and other biofluids 
as a liquid biopsy source and is designed to isolate and analyze exosomal RNA (exoRNA), 
with complementary workflows that can also incorporate cell-free DNA (cfDNA) analysis. 
ExoDx’s approach enables interrogation of tumor- and tissue-derived molecular signals 
without the need for invasive sampling, positioning exosomes as a distinct, information-rich 
class of analytes within liquid biopsy. 
ExoDx has established collaborations with academic medical centers, research consortia, 
advocacy organizations, and government-supported research initiatives to explore both the 
biological relevance and clinical utility of exosome-derived biomarkers across oncology and 
other disease areas. Its most visible commercial application to date has been in noninvasive 
cancer risk stratification, reflecting the company’s focus on translating exosome biology into 
clinically actionable tests rather than remaining purely research-facing. 
More broadly, a growing ecosystem of companies is developing exosome-related tools, 
assays, and services, including Aethlon Medical, Caris Life Sciences, Cell Guidance 
Systems, Bio-Techne, QIAGEN, and specialized exosome reagent and service providers such 
as Exosome Sciences. In addition, most major molecular diagnostics and life science 
companies are actively investigating the diagnostic and monitoring potential of extracellular 
vesicles as part of longer-term R&D strategies. 
 

 
 
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Despite this activity, exosome-based diagnostics remain at an early stage of market 
development. Outside a limited number of clinically deployed tests, most offerings today are 
delivered as laboratory-developed tests or research services, with significant work still 
underway to standardize isolation methods, analytical workflows, and clinical validation 
frameworks. 
Separately, iGene Laboratory offers FetalExome, a whole exome sequencing–based 
laboratory test intended for use in pregnancies with suspected genetic complexity, such as 
unexplained fetal anomalies. The test analyzes fetal genetic material to support diagnosis in 
high-risk prenatal cases and is delivered as a specialized clinical sequencing service rather 
than a kit-based IVD. 
Table 8-3: Selected Exosome Test Innovations 
Company 
Location 
Area 
Details 
Agilent Technologies 
U.S. 
sample prep 
SureSelectQXT Reagent Kit, sample prep for exosome 
sequencing 
Agilent Technologies 
U.S. 
cancer 
exome sequencing oral cancer patients 
Ambry Genetics 
U.S. 
newborn 
ExomeNext: neonatal, pediatric and adult onset  
Athena 
Diagnostics/Quest 
U.S. 
psych 
Personalis’ proprietary ACE Exome, neurological in children  
Caris Life Sciences 
U.S. 
cancer 
Carisome TOP platform, blood-based exosomes 
ExoDx 
U.S. 
cancer 
plasma/urine-based liquid biopsies, exosomal RNA  
ExoDx 
U.S. 
cancer 
exosome RNA in CSF for brain cancer 
ExoDx 
U.S. 
general 
multiplexed sequencing, mRNA, blood and urine exosome  
Labcorp 
U.S. 
pediatric 
ExomeReveal, whole exome seq pediatric diseases 
Labcorp 
U.S. 
sequencing 
ExomeReveal, a whole exome sequencing 
Thermo Fisher Scientific 
U.S. 
general 
Ion AmpliSeq Exome Kit, CNVs on Ion Proton  
Thermo Fisher Scientific 
U.S. 
general 
Ion AmpliSeq Exome Kit  
QIAGEN 
Netherlands 
sample prep 
Exosome-based clinical tests, sample prep 
Source: Kalorama Information 

 
 
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Exosome diagnostics represent a high-potential yet emerging segment of liquid biopsy, with 
early commercial traction driven by service-based models and targeted clinical use cases, 
while broader adoption will depend on continued standardization, regulatory clarity, and 
demonstration of incremental clinical value beyond cfDNA alone. 
Liquid Biopsy 
The topic of liquid biopsy as a complement to tumor histology and circulating tumor cells is 
discussed in Chapter 13; here, Kalorama provides a brief discussion highlighting the 
importance of this emerging technology in patient care and the role of molecular tools.  
Minimally invasive ‘liquid biopsies’ of tumor cells and tumor DNA from the bloodstream 
can enable earlier primary and secondary diagnosis compared to solid tumor biopsies, as well 
as the detection of metastasis and/or residual disease, and real-time monitoring of treatment 
effectiveness that is not practical with solid tumor biopsy methods.  
Circulating tumor DNA is a small piece of mutated DNA that tumor cells release into the 
bloodstream.   
Cell-free DNA can be applied more broadly than ctDNA. cfDNA will determine the standard 
of care in oncology, transplant medicine and cardiovascular disease. This field is emerging 
as one of the most promising and exciting areas of medicine and has already made a huge 
impact on prenatal care. 
It’s been known for many years that dying cells, including tumor cells, shed DNA into the 
bloodstream.  Since the mid-1990s, Dr. Dennis Lo and his team at the Chinese University of 
Hong Kong have been researching the detection of circulating nucleic acids in plasma and 
serum.  He explained the future of this new technology at a plenary session of the American 
Association for Clinical Chemistry's annual meeting in July 2005.   
In the 1960s and 1970s, circulating DNA was found in cancer patients, but until the advent 
of PCR, the technology for further study was limited.  More recently, next-generation 
sequencing technology made it possible to detect and quantify cell free and cancer-specific 
DNA in plasma by the identification and chromosomal location of billions of specific DNA 
fragments present in blood. 
Researchers of circulating free nucleic acids have extended the reach of this technology 
beyond DNA to RNA, miRNA and exomes.  Although just emerging, it is anticipated that 

 
 
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circulating nucleic acids may emerge as a prominent technology in future molecular 
diagnostics, and so it has – first in prenatal fetal testing for genetic abnormalities and now as 
the basis of the liquid biopsy in cancer. 
Cell free DNA has already brought advances to prenatal diagnostics that allows physicians 
to screen for gene mutations noninvasively and avoid amniocentesis.  More importantly, 
NIPT (noninvasive prenatal testing) using NGS can detect these mutations in the first 
trimester of pregnancy.  NIPT has provided the proof of principle that is being applied to 
cancer management.  
Most currently available cfDNA assays are LDTs. Asymptomatic detection and initial 
profiling of tumors could be achieved through more cost-effective ctDNA detection, 
potentially followed by CTC testing to better determine cancer stage. Either cfDNA or CTCs 
could be used for tumor profiling, with CTCs offering a more comprehensive analytical 
resource for determining intracellular cancer mechanisms. CtDNA could be used for routine 
patient monitoring, with its relative level monitored to determine disease progression or 
remission. Halted remission or cancer recurrence could prompt CTC analyses to inform the 
selection of new therapies. Liquid biopsies may ultimately become the standard sample type 
for custom panels that incorporate both CTCs and ctDNA.  
A variation of sorts on CTCs is circulating tumor DNA. Circulating tumor DNA is a 
promising biomarker with applications for many cancers.  An international team of 
researchers used digital PCR-based technologies to analyze blood samples from 640 patients 
with various cancers and detected ctDNA in the blood of more than 75% of patients with 
advanced cancers (including pancreatic, ovarian, colorectal, bladder, and breast).  They also 
found that ctDNA was often present in patients without detectable circulating tumor cells. 
They found that ctDNA was detected in 73%, 57%, 48%, and 50% of patients with colorectal 
cancer, gastroesophageal cancer, pancreatic cancer, and breast adenocarcinoma, respectively.   
Studies of ctDNA are also especially important in lung cancer.  In response to the increasing 
availability of targeted therapies for non-small-cell-lung cancer (NSCLC), clinical guidelines 
recommend molecular testing of relevant genes to identify candidates for targeted therapy.  
However, an estimated one-third of NSCLC patients lack adequate tissue samples for 
molecular testing and therefore cannot be considered for the new targeted treatments.  
Noninvasive ctDNA testing has become popular as an alternative. 

 
 
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These technologies complement each other and once fully validated, they are poised to 
revolutionize cancer diagnosis, drug choice, and recurrence testing.  This approach is still in 
the early stages of development but is the subject of much research.  Researchers at the 
University of Cambridge and the Cancer Research UK Cambridge Institute published a 
proof-of-principle study in the New England Journal of Medicine suggesting that circulating 
cell-free DNA can serve as a blood-based marker for monitoring metastatic breast cancer in 
women undergoing treatment.  They used targeted and/or whole-genome sequencing to find 
characteristic somatic mutations in metastatic breast tumors.  They then tested for the 
presence or absence of these alterations in cell-free DNA in each woman's blood over the 
course of her treatment, assessing how well this technique detected metastatic disease and 
tracked treatment response and progression.  They found that the technique compared 
favorably with conventional imaging-based tests for metastatic breast cancer and with other 
blood-based methods for detecting the disease, such as cancer antigen testing and analyses 
aimed at capturing intact tumor cells in blood samples. 
Special blood tubes for cfDNA analyses are: Cell-Free DNA BCT tubes manufactured by 
Streck, Inc., and the K3EDTA tubes from BD Vacutainer.  They prevent increases in 
background gDNA levels caused by temperature fluctuations or agitation that can occur 
during blood sample storage, shipping and processing.  These special blood-collection tubes 
provide a method for obtaining high-quality stabilized samples for rare DNA target detection 
and determining accurate cfDNA concentrations. 
There are a number of novel applications for genomic testing. Eleven percent of Americans 
age 12 and over are reported to be taking an antidepressant drug in the CDC's National Health 
and Nutrition Examination Survey (NHANES).  Research shows that antidepressant drugs in 
the U.S., Canada and a number of European countries carry the highest-level warning for risk 
of suicide, but doctors have not been able to determine which patients may be at risk for 
suicide.  
Genetic factors are known to influence susceptibility to nicotine dependence, affecting both 
the intensity of addiction and an individual’s response to smoking cessation interventions. 
Variants in genes involved in nicotine metabolism, neurotransmitter signaling, and reward 
pathways have been associated with differences in smoking behavior, quit success, and 
response to pharmacologic therapies such as nicotine replacement, bupropion, or varenicline. 
BioRealm has been developing the SmokeScreen genotyping array, a research-use platform 
designed to support studies examining the genetic architecture of nicotine dependence and 

 
 
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tobacco use behaviors. The array is intended for population and translational research, 
enabling investigators to explore genetic variants associated with addiction risk, smoking 
intensity, and treatment response, rather than serving as a direct-to-consumer or clinical 
diagnostic test. 
In a related area of addiction research, the National Institutes of Health is actively studying 
the genetic and biological underpinnings of alcohol use disorder. Through large-scale 
genomics initiatives and longitudinal cohort studies, NIH-supported researchers aim to better 
understand how genetic variation contributes to alcohol dependence, disease progression, 
and treatment outcomes. While this work may eventually inform risk stratification and 
personalized intervention strategies, it is important to note that these efforts are currently 
focused on research and discovery, rather than the near-term development of a standalone 
clinical genetic test for alcoholism risk. 
The diagnostics industry has rallied to support CTCs, ctDNA, and cell-free DNA testing by 
providing sample-preparation reagents and quality-control materials.  When one considers 
that just a few years ago Veridex was practically alone in this space, the speed with which 
and the depth of product development have grown is a testament to the unmet need for 
noninvasive diagnostics in cancer, particularly, but in all facets of medicine 
Nucleix offers its real-time PCR-based Bladder EpiCheck test for qualitative detection of 15 
DNA methylation patterns associated with transitional cell carcinoma.  
  
 

 
 
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Table 8-4: Selected Liquid Biopsy Innovations 
Company 
Location 
Area 
Details 
Angle plc 
UK 
capture 
Parsortix cell separation 
Angle plc 
UK 
analysis 
cancer detection: ovarian, c, br 
ApoCell 
U.S. 
capture 
ApoStream technology 
CareDx (Revvity) 
U.S. 
QC 
 cell-free DNA QC - organ transplant 
Caris Life Sciences 
U.S. 
Analysis 
Caris Assure Molecular profiling assay 
Clearbridge BioMedics 
Singapore 
capture 
ClearCell FX System, automated CTChip 
Cure Forward 
U.S. 
IT 
patient access to CTC test from Cynvenio Biosystems 
Cynvenio Biosystems 
(LungLife AI) 
U.S. 
analysis 
Liquid Biopsy DNA in CTC & ctDNA 
Cynvenio Biosystems 
(LungLife AI) 
U.S. 
analysis 
ClearID Breast Cancer recurrence monitoring, CTC 
Cynvenio Biosystems 
(LungLife AI) 
U.S. 
capture 
ClearID SCORE, CTC 
Epic Sciences 
U.S. 
analysis 
metastatic bladder cancers, CTC 
Epic Sciences 
U.S. 
analysis 
high-definition CTC microscopy 
Exosome Diagnostics 
U.S. 
analysis 
prostate cancer predictive score, ExoDx Prostate 
Fluxion Biosciences 
U.S. 
cell enrich 
IsoFlux NGS assay kits 
Fluxion Biosciences 
U.S. 
cell enrich 
IsoFlux System NGS sample prep 
Fluxion Biosciences 
U.S. 
cell enrich 
IsoFlux EMT, epithelial 
Genomic Health (Exact 
Sciences) 
U.S. 
analysis 
line of liquid biopsy tests 
Guardant Health 
U.S. 
analysis 
Guardant360 biopsy-free cancer, CTC 
Horizon Discovery 
(Revvity) 
UK 
QC 
standards for circulating DNA tests 
IncellDx 
U.S. 
smpl prep 
IncellPrep Liquid Biopsy cell suspension: FFPE 
Inivata ( NeoGenomic 
Health) 
UK 
analysis 
with Biodesix, Tam-Seq lung cancer, cfDNA 

 
 
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Company 
Location 
Area 
Details 
Inivata 
UK 
analysis 
TAm-Seq, cell free DNA: sequencing 
Kindstar Global 
China 
analysis 
Advanced Cell CTCscope, ISH 
Life Technologies/ 
Thermo Fisher 
U.S. 
smpl prep 
Cynvenio's LiquidBiopsy with Ion Chef & AmpliSeq 
Cancer Hotspot 
MDxHealth 
Belgium 
analysis 
DNA methylation markers, liquid biopsy test for bladder 
cancer 
Menarini Diagnostics 
Italy 
cancer 
GluCyte, liquid biopsy processing & analysis 
ProKyma Technologies 
UK 
capture 
KymaSep POC CTC isolation 
QIAGEN 
Netherlands 
smpl enrich 
AdnaGen's enrichment and molecular analysis 
QIAGEN 
Netherlands 
analysis 
AdnaTest Breast Cancer/ Prostate Cancer relapse 
monitor 
QIAGEN 
Netherlands 
analysis 
therascreen EGFR RGQ Plasma PCR, cfDNA 
QIAGEN Hanover 
Germany 
analysis 
AdnaTest Cancer kits, RNA PCR 
Rarecells Diagnostics 
France 
analysis 
ISET test, cell sizing 
RareCyte 
U.S. 
analysis 
AccuCyteSystem, CTC microscopy 
Roche Diagnostics 
U.S. 
analysis 
cell-free DNA (cfDNA) technology 
ScreenCell 
France 
capture 
ScreenCell MB, DNA or RNA extraction from CTCs 
SeraCare Life Sciences 
U.S. 
QC 
cell-free circulating tumor DNA (ctDNA), NGS 
Silicon Biosystems 
Italy 
analysis 
DEPArray, CTC molecular characterization 
SRI International 
U.S. 
capture 
FASTcell, cancer specific cell markers, CTC cytometry 
Streck 
U.S. 
QC 
Cell-Free DNA BCT 
Swift Biosciences (IDT) 
U.S. 
analysis 
 Accel-Amplicon panel with Fluxion IsoFlux 
Sysmex Inostics 
Germany 
analysis 
BEAMing: digital PCR and flow cytometry for CTCs 
Sysmex Inostics 
Germany 
analysis 
OncoBEAM companion tests, CTC 
Veridex 
U.S. 
cell enrich 
Cellsearch with Asuragen's SuraSeq panels 
Veridex 
U.S. 
analysis 
PD-L1 immune marker 
Source: Kalorama Information 

 
 
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Caris Life Sciences offers its Caris Assure Liquid Biopsy Assay. The assay is a blood-based 
molecular profiling assay that uses circulating nucleic acids sequencing to analyze the 
cfDNA (Whole Exome) and cfRNA (Whole Transcriptome) of 22,000 genes.  
Bio-Rad markets its Celselect Slides which offer an improved method of enumeration of 
CTCs in liquid biopsies. The Celselect Slides are designed to be used with Bio-Rad’s Genesis 
Cell Isolation System for use in genomics, digital PCR or stained on-slide for 
immunofluorescent applications.  
Metabolomic Profiling 
The Human Metabolome Database (HMDB, www.hmdb.ca) is a free electronic database 
containing detailed information on small-molecule metabolites found in the human body.  
The database is designed to contain or link three kinds of data: 1) chemical data, 2) clinical 
data, and 3) molecular biology/biochemistry data.  The database contains 220,945 metabolite 
entries, including both water-soluble and lipid-soluble metabolites, as well as metabolites 
that are considered abundant and relatively rare.  Additionally, 8,610 protein sequences are 
linked to these metabolite entries.  
Research into the human metabolome is uncovering important linkages between genes, 
metabolites  and diseases.  Further, researchers are gaining a better understanding of the 
genetic underpinnings of complex diseases and drug responses through metabolic pathways. 
For example, scientists at the Wellcome Trust Sanger Institute (WTSI) have linked over 145 
genetic regions with more than 400 molecules involved in metabolism in human blood.  The 
goal was to create an Atlas of the Metabolome that could be used to target the development 
of drugs and clinical laboratory tests.  The Atlas is an open-access database that allows 
researchers to easily search through the findings. 
The WTSI researchers identified 90 new genetic associations, tripling the number of known 
genetic associations with metabolites. In the case of the already-known metabolites, they 
were able to link the molecule to gene function. Additionally, the researchers were able to 
map genes to their likely substrates or products. This allowed them to further link these 
metabolites to conditions, such as hypertension, cardiovascular disease, and diabetes.   
The leading company in this area is Metabolon, Inc. The company is dedicated to metabolic 
pathway analysis for biomarker discovery and the development of follow-on diagnostic tests.  

 
 
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Metabolon reported that its metabolytics business has conducted more than 5,400 
collaborative studies with over 1,300 clients to identify diseases, discover biomarkers, and 
better understand complex biological processes.  Tests are run in Metabolon’s in-house CLIA 
laboratory. 
Metabolon’s biomarker discovery platform has already been used to identify biomarkers for 
a number of diseases. These biomarkers are being incorporated into clinical diagnostic tests 
in the following areas: prostate cancer, bladder cancer, kidney cancer, nephrotoxicity of 
chemotherapy drugs and diabetes/insulin resistance. 
Metabolon offers its new SmartPanel portfolio. Metabolon states that its Microbiome 
SmartPanel demystifies the gut microbiome by zeroing in on biologically relevant microbial 
and host-derived metabolites, as well as xenobiotic molecules, to reveal deep insights into 
microbiome function and its impact on host health. The proprietary Heliogram visualization 
tool allows users to explore 13 microbiome pathways to rapidly assess the impact of 
therapeutic interventions on the host microbiome. In addition, the on-demand access to 
Metabolon’s comprehensive pathway knowledge base gives seamless access to expertly 
curated, microbiome-relevant disease associations and biological themes. 
Metabolon markets its Bile Acids and Short Chain Fatty Acids Targeted Panels, which 
measure microbially derived metabolites of biological significance to identify biomarkers.  
The Bile Acids Panel measures 21 metabolites and the Short Chain Fatty Acids Panel 
measures nine metabolites 
Other major players in the metabolomics market include Thermo Fisher Scientific, Danaher 
Corporation, Shimadzu Corporation, Waters Corporation, Agilent Technologies, and Bruker 
Corporation. 
Researchers from the Norwegian University of Science and Technology have found that 
pregnant women with preeclampsia have a metabolic profile that is distinct from that of 
healthy pregnant women and women who are not pregnant.  By comparing the serum and 
urine metabolomes of pregnant women with and without preeclampsia, they identified 9 urine 
metabolites that distinguished women with preeclampsia from those without.   

 
 
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Information Technology  
As a result of intensive studies following the Human Genome Project, much of the human 
genome, transcriptome, and proteome have been mapped, although interpretation remains 
incomplete and continues to evolve. Rapid technological advances have made sequencing 
faster and significantly more affordable, enabling broader clinical and research use. This 
represents the foundational step in applying genomic analysis across technologies, but the 
industry is still progressing from data generation to routine clinical implementation. 
Information technology plays a central role in this transition, supporting three essential 
functions: sharing genomic data to build well-curated variant databases, interpreting gene 
variants to establish clinically relevant guidelines, and disseminating actionable insights to 
clinicians for patient care. The scale of global genomic research continues to expand, with 
large population studies and biobank initiatives generating vast datasets. IT infrastructure 
enables aggregation and analysis of these data, improving understanding of variant-disease 
relationships. Data-sharing has become a cornerstone of the field, with both public and 
private consortia facilitating collaboration, particularly in rare diseases and precision 
oncology. 
As gene targets are validated and incorporated into targeted assays and multiplex panels, the 
challenge has shifted toward interpretation and clinical integration. Laboratories and 
clinicians increasingly require tools that can manage and interpret continuous streams of 
genomic data. In response, IVD and life sciences companies are investing heavily in 
bioinformatics, decision-support tools, and integrated software platforms, often through 
partnerships and acquisitions. These tools are delivered both as standalone solutions and as 
components embedded within diagnostic workflows. 
Companies such as QIAGEN have expanded their offerings to include custom business 
solutions and clinical decision-support platforms that integrate molecular data into laboratory 
and clinical workflows. Technology companies are also playing a growing role. Apple Inc. 
continues to advance health data integration through platforms such as Apple Watch, 
ResearchKit, and HealthKit, supporting large-scale data collection and patient engagement. 
Cloud-based genomics platforms like DNAnexus provide secure environments for storing, 
analyzing, and sharing genomic data at scale, supporting both research and clinical 
applications. Collaborative efforts with organizations such as Intel Corporation have focused 
on improving data-processing efficiency in large-scale sequencing workflows. 

 
 
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Regulatory and collaborative initiatives have also advanced. Platforms such as 
precisionFDA, developed with input from the U.S. Food and Drug Administration, support 
the evaluation and standardization of bioinformatics pipelines for next-generation 
sequencing. Large-scale data initiatives from companies like Google have evolved into 
broader life sciences efforts, such as Verily, that focus on integrating genomic and clinical 
data for research and healthcare applications. 
QIAGEN’s acquisition of N-of-One strengthened its position in clinical interpretation, 
providing oncology-focused decision support that has been incorporated into diagnostic 
workflows globally. These types of platforms highlight the growing importance of combining 
genomic data with expert interpretation to deliver clinically actionable insights. 
Technological and research advances have brought routine genomic medicine closer to 
clinical reality, but widespread adoption depends on effective integration into healthcare 
systems. The next critical step is developing scalable systems that deliver clear, actionable 
genomic information to clinicians and patients, enabling informed decisions in precision 
medicine. 
Next-generation sequencing has made it possible to generate detailed individual genomic 
profiles, but the value of this information depends on interpretation. The complexity and 
volume of genomic data require sophisticated bioinformatics tools and expert analysis to 
translate results into meaningful clinical guidance. IT and diagnostics companies continue to 
respond to this need, driving the convergence of genomics, data science, and clinical 
decision-making 
 
 

 
 
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Table 8-5: Selected IT Innovations in Molecular Diagnostics 
Company 
Location 
Area 
Details 
Advaita Bioinformatics 
U.S. 
multi-omic 
iPathwayGuide, multi-omic data integration and 
analysis  
Advanced Biological Lab 
Luxembourg 
NGS 
with Tute Genomics, OncoChek, NGS data 
analysis platform  
Advanced Biological Lab 
Luxembourg 
HIV 
DeepChek-HIV NGS with Illumina's BaseSpace 
Apps 
Advanced Biological Lab 
Luxembourg 
micro 
IT decision support for viral genome analysis   
Advanced Cell Diagnostics 
U.S. 
CTC 
RNAscope/ISH image analysis software  
 Agilent 
U.S. 
sequencing 
MedGenome's OncoMD Cancer knowledge base 
in Bench Lab NGS 
 Agilent 
U.S. 
sequencing 
CollabRx’s Genetic Variant Annotation in Lab 
Bench NGS 
Ambry Genetics (owned by 
Tempus AI) 
U.S. 
prenate 
Progeny Genetics  Software for prenatal 
analysis, service 
Apple 
U.S. 
app 
ResearchKit, open-source IT to create research 
apps 
Apple 
U.S. 
app 
HealthKit IT to create consumer health apps  
BGI 
China 
sequencing 
QIAGEN's Ingenuity Variant Analysis with BGI's 
sequencing services 
BioView 
Israel 
CTC 
BioView imaging IT for Screen Cell's cyto kit 
Data4Cure 
U.S. 
exome 
IT analyze genomes, exomes and targeted gene 
panels 
Deep Genomics 
Canada 
general 
Splice AI  
Definiens (MedImmune) 
Germany 
histo 
IT for Clarient's Scope IA Platform  
Definiens (MedImmune) 
Germany 
big data 
Tissue Phenomics big data analysis tissue tests 
Definiens (MedImmune) 
Germany 
histo 
Biomarker Datafication Services tissue 
biomarkers, service  
Dell Healthcare 
U.S. 
histo 
link for Chinese labs to Leica's histology, cloud 
network 

 
 
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Company 
Location 
Area 
Details 
Deloitte/ConvergeHEALTH 
U.S. 
cancer 
with Moffitt's M2GEN biomarker data, 
personalized cancer  
DNAnexus 
U.S. 
sequencing 
with Intel, elPrep, IT to prepare genomic data, 
sequence analysis 
DNAnexus 
U.S. 
whole genome 
supports HgV framework, precision medicine 
Fabric Genomics 
U.S. 
cancer 
Phevor (Phenotype Driven Variant Ontological 
Re-ranking tool) 
Genalice 
Netherlands 
big data 
GENALICE MAP, NGS big data 
Genalice 
Netherlands 
sequencing 
with Knome turn-key IT, NGS data interpretation 
Genologics (Illumina) 
U.S. 
LIS 
Clarity LIMS X, LIS Illumina SeqLab 
Genome Diagnostics 
Netherlands 
HLA 
SBTengine is a software package for HLA-typing  
GenomeNext 
U.S. 
general 
cloud, software-as-a-service, hospital genomic 
analysis 
GenomOncology 
U.S. 
sequencing 
GenomAnalytics, NGS gene variants database 
Golden Helix 
U.S. 
CTC 
 VarSeq information platform for CTC 
sequencing 
Google Genomics 
U.S. 
autism 
Autism Speaks MSSNG portal on the Google 
Cloud Platform 
Google Genomics 
U.S. 
big data 
Verily  Baseline Study  
Google Genomics 
U.S. 
cloud 
Cancer Genomics Cloud, cancer genomic 
database  
Illumina 
U.S. 
sequencing 
DRAGEN Bio-IT Processor sequencing analysis IT 
Illumina 
U.S. 
sequencing 
Intel's Xeon processors for NGS data analysis 
Illumina 
U.S. 
general 
GeneInsight-Illumina Network, variant analysis 
IT 
Illumina 
U.S. 
cloud 
BaseSpace OnSite genomic test analysis, cloud 
IntegraGen 
France 
cancer 
data interpretation of next-generation 
sequencing of cancer 
Intel Corporation 
U.S. 
genome 
with DataDirect HPC infrastructure for genomic 
data analysis 

 
 
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Company 
Location 
Area 
Details 
Intel Corporation 
U.S. 
genome 
with DNADirect HPC infrastructure, genomic 
data analysis  
Lab7 Systems 
U.S. 
sequencing 
sample-to-answer data management LIS for NGS 
Labcorp 
U.S. 
genome 
Enlighten Health Genomics genomic test 
interpretation, service 
Labcorp 
U.S. 
genome 
Omicia's Opal Clinical, Software-as-a-Service 
genomic interpretation  
Labcorp 
U.S. 
prenate 
Edico Genome's DRAGEN Bio-IT, genomic 
analysis, service  
Life Technologies/Thermo 
Fisher 
U.S. 
all mol 
Select Dx, database developments in molecular 
diagnostics 
Life Technologies/Thermo 
Fisher 
U.S. 
exome 
Ion Reporter Software for exome CNVs, SNPs, 
and indels  
Life Technologies/Thermo 
Fisher 
U.S. 
micro 
Ridom GmbH, SeqSphere+ whole genome 
bacterial typing, Ion Torrent 
Massive Bio 
U.S. 
cancer 
oncology decision support platforms  
Maverix Biomics 
U.S. 
sequencing 
Analysis Kits variants in whole genome, exome, 
NGS 
Mayo Medical Lab 
U.S. 
general 
Optum Labs with UnitedHealth data-mining 
venture, service  
Mayo Medical Lab 
U.S. 
IT 
Oneome, genomics interpretation prescription 
drugs, service  
NantOmics 
U.S. 
cancer 
IT and database for variation interpretation, 
treatment choice 
Omicia (now Fabric Genomics) 
U.S. 
genome 
Opal Clinical, Software-as-a-Service genomic 
interpretation  
Omixon (now Fabric Genomics) 
Hungary 
HLA 
Global Genomics IT, validate HLA sequencing 
datasets 
PierianDx 
U.S. 
PGx 
Clinical Genomicist Workstation NGS 
management IT  
PierianDx 
U.S. 
PGx 
PDx Score algorithm for PGx therapy report  
QIAGEN 
U.S. 
sequencing 
NGS analysis for CeGaT GmbH (Tubigen, 
Germany) panels 

 
 
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Company 
Location 
Area 
Details 
QIAGEN 
U.S. 
cancer 
CNV interpretation for Affymetrix OncoScan 
assay  
QIAGEN 
U.S. 
cancer 
IT for NeoGenomics solid tumor NGS tests 
QIAGEN 
U.S. 
cancer 
interpretation for BloodCenter of Wisconsin’s 
HemeOnc cancer NGS  
QIAGEN 
U.S. 
cancer 
clinical interpretation for CeGaT’s cancer NGS 
QIAGEN 
U.S. 
cancer 
clinical interpretation for OncoDNA's cancer 
NGS (EU, Asia, Middle East) 
QIAGEN 
U.S. 
app 
Variant Interpreter app on Illumina’s BaseSpace 
Apps 
QIAGEN 
U.S. 
sequencing 
N-of-One’s services from within the Cartagenia 
Bench Lab NGS  
QIAGEN 
Netherlands 
sequencing 
QIAGEN Clinical Insight, DNA variants in NGS 
QIAGEN 
Netherlands 
sequencing 
Ingenuity Pathway Analysis IT with Maverix's 
interpretation RNA-seq data 
QIAGEN 
Netherlands 
genome 
FastQ-to-insight solution, CLC Workbench with 
Ingenuity Variant Analysis 
QIAGEN 
Netherlands 
genome 
numerous ingenuity collaborations 
QIAGEN Bioinformatics 
U.S. 
microbiome 
CLC Microbial Genomics Module, microbiome 
analysis 
QIAGEN/Biobase Wolfenbuttel 
Netherlands 
genome 
annotated gene mutation databases 
Revvity 
U.S. 
multi-omic 
Integromics' OmicsOffice, variant analysis IT 
Seegene 
Korea 
multi-omic 
SySDx big data multi-omic analytics with assays 
Selventa 
U.S. 
multi-omic 
SySDx big data multi-omic analytics 
Sunquest Information 
U.S. 
histo 
with GeneInsight, IT analysis pathology gene 
data  
Thermo Fisher Scientific 
U.S. 
cfDNA 
QuantStudio 3D Rare Mutation Analysis 
Solution, cfDNA 
Thermo Fisher Scientific 
U.S. 
micro 
MicrobeBridge IT, Sanger sequencing on CDC 
MicrobeNet database 

 
 
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Company 
Location 
Area 
Details 
Thermo Fisher Scientific 
U.S. 
general 
Ingenuity iReport with Affymetrix expression 
microarray products 
Thermo Fisher Scientific 
U.S. 
histo 
Biodiscovery's Nexus for OncoScan FFPE 
Software  
Source: Kalorama Information 
Artificial Intelligence (AI) 
Dozens of new AI and machine learning products have been added to the FDA list of 
approved clinical applications. Artificial intelligence has been getting a lot of attention in 
recent years. As technology advances, laboratory scientists are making great strides in AI's 
capabilities and sophistication.  While some people may worry about patient confidentiality 
and other concerns, much of the AI in use today can actually help humanity.  Artificial 
intelligence has been heavily promoted as the next big thing in healthcare for nearly a decade.  
AI was expected to revolutionize how doctors treat patients.  
Some AI-based FDA approvals in 2024-2026 include: 
• NeoBeat, NeoBeat Mini – Laerdal Medical  -cardiovascular 
• eCART v5 Clinical Deterioration Suite – AgileMD – cardiovascular 
• Corvair  and Impala– AliveCor – cardiovascular 
• ASSURE Wearable ECG -Kestra Medical -cardiovascular 
• AUTION EYE AI-4520 Urine Particle Analysis System – Hematology 
• GI Genius  ColonPro – Cosmo AI- GI and urology 
• Galen Second Read – Ibex Medical – Pathology 
• Tempus ECG-Low EF –  Tempus Ai - Cardiovascular 
• HeartFlow Analysis – HeartFlow -  Cardiovascular 
• US2.ca- Us2.ai – Cardiovascular 
• Withings ECG App- Withings - Cardiovascular 
• Volta AF-Xplorer – Volta Medical – Cardiovascular 

 
 
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• X100/X100HT with Full Field Peripheral Blood Smear – Scopio Labs- Hematology 
• TriVerity- Inflammatix – Microbiology 
• MagentiQ-Colo – Magentiq Eye- GI 
• Maestro System – Moon Surgical – GI 
The most notable AI use is currently in radiology; several new applications for clinical use 
are entering the market and are in development.  
Forensic Studies – An Emerging Opportunity 
Every year, investigators collect tens of thousands of biological samples from crime scenes 
that may hold valuable clues to solving criminal cases.  Genetic research since the completion 
of the Human Genome Project in 2003 has uncovered thousands of biomarkers that can be 
applied to DNA-based forensics and human identification testing.  
The U.S. Federal Bureau of Investigation (FBI) updated its current DNA databasing 
standards to include an Addendum to the Quality Assurance Standards (QAS) for DNA 
Databasing Laboratories performing Rapid DNA analysis and Modified Rapid DNA 
Analysis Using a Rapid DNA Instrument 
The revision of the QAS enables the use of rapid DNA analysis in ways that are actionable 
for law enforcement in local communities.  The Addendum describes the requirements that 
accredited laboratories performing Rapid DNA analysis or modified Rapid DNA analysis 
must meet for their results to be considered for inclusion in the Combined DNA Index System 
(CODIS).   
Several IVD companies already had arrangements with law enforcement agencies for the 
genetic analysis of crime scene samples in centralized laboratories.  This created a backlog 
of samples for analysis that was thought to be a barrier to the quick resolution of some crimes.  
Rapid DNA analysis generates DNA profiles in less than two hours for use in local and 
regional law enforcement to potentially fight violent crime with speedy results.  This 
technology may also be used to prevent human trafficking and fraudulent asylum requests.  
Further, the act clears the way for decentralization of DNA technology, enabling state and 
local law enforcement jurisdictions to perform rapid DNA analysis on subjects with tests and 
technologies that meet the new guidelines.  

 
 
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Always in search of new uses for their products, IVD companies have entered the market for 
rapid forensic DNA testing.  The total available market is very large and includes agencies 
at every level of government, from cities to the country.  It is estimated that there are 
approximately 400 accredited forensic crime laboratories analyzing more than four million 
casework and reference samples per year in the U.S. alone.  
The following companies are active in forensic and human identification  DNA testing. Most 
offerings in this segment are delivered as laboratory-based systems or services, although a 
small number of vendors are advancing portable or near-field DNA analysis concepts. For 
example, NEC Corporation has developed a portable rapid DNA analyzer concept intended 
for use outside traditional laboratories, including disaster victim identification and field 
applications, although deployment remains limited and use cases are specialized. 
IntegenX, now part of Thermo Fisher Scientific, is widely regarded as a pioneer in rapid 
human DNA identification. The RapidHIT system family integrates microfluidics, optics, 
and validated biochemistry to deliver sample-to-answer DNA profiling for law enforcement 
and forensic workflows. When used with GlobalFiler Express STR chemistry, RapidHIT 
profiles can be generated in hours and are compatible with upload to the FBI’s CODIS 
system, supporting booking-station and investigative use cases. 
Illumina established an early leadership position in forensic genomics with the MiSeq FGx 
Forensic Genomics System, which enabled next-generation sequencing–based analysis of a 
broader range of forensic markers than capillary electrophoresis-based methods. The system 
combined the MiSeq FGx sequencer with ForenSeq DNA Signature Prep Kits and dedicated 
analysis software. While Illumina has since refocused its strategic priorities, the MiSeq FGx 
platform remains relevant through its installed base and validated forensic workflows, 
particularly in advanced forensic laboratories. 
QIAGEN is a major supplier of forensic reagents through its Investigator STR assay kits, 
which are used for DNA evidence analysis in forensic laboratories worldwide. These kits 
enable simultaneous analysis of multiple STR loci for human identification and include 
quality-assessment tools that help laboratories determine sample suitability early in the 
workflow. The Investigator STR portfolio aligns with current FBI CODIS core locus 
requirements and is also compliant with European and INTERPOL standards, facilitating 
international data exchange. 

 
 
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For more than two decades, Thermo Fisher Scientific, through its Applied Biosystems brand, 
has been a dominant supplier to forensic laboratories. Thermo Fisher offers a fully integrated 
HID testing ecosystem, spanning sample preparation, STR amplification, capillary 
electrophoresis instruments, and data analysis software. Its GlobalFiler and GlobalFiler 
Express chemistries incorporate all CODIS core loci along with additional markers 
commonly used in Europe, reducing the probability of adventitious matches and enabling 
more robust cross-border forensic comparisons. 
Table 8-6: Selected Innovations in Forensic DNA Testing 
Company 
Location 
Details 
Genomica 
Spain 
Forensic medicine DNA analysis 
Illumina 
San Diego, CA 
MiSeq FGx Forensic Genomics System 
IntegenX 
Pleasanton, CA 
RapidHIT 200 Human Identification System 
IntegenX 
Pleasanton, CA 
Life Technologies global filler on RapidHIT, automated DNA 
Labcorp 
Burlington, NC 
Cellmark Forensics and Bode Technology forensic services 
Life Technologies/Thermo Fisher 
Carlsbad, CA 
Applied Biosystems' GlobalFiler Express, DNA  
NEC Corporation 
Japan 
Portable P-DNA Analyzer  
QIAGEN 
Netherlands 
Investigator STR assay kits DNA evidence analysis in U.S. 
Source: Kalorama Information 
PCR opened up many doors in genetic research, including DNA analysis and identification 
of different genes based on their DNA sequences, and sequencing builds on many of the same 
underlying principles. Innovation in these core molecular techniques has largely depended 
on scientists refining and adapting them to make testing faster, more sensitive and specific, 
easier to use, and more cost-effective. Molecular tests generally consist of three key 
components: once genetic material is isolated from a sample such as blood, urine, stool, 
buccal cells, or tissue, probes bind to specific target sequences to provide test specificity; 
amplification processes then increase the amount of target material so it can be measured 
and, in sequencing, so the order of base pairs can be determined, although some newer 
methods can bypass amplification; finally, the nucleic acid, whether amplified or not, is 
labeled with colorimetric, fluorescent, or chemiluminescent markers to generate a 

 
 
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measurable signal, contributing to overall test sensitivity. These elements can be combined 
in many ways across different platforms. PCR, qPCR, and digital PCR rely on thermal 
cycling and require external heating through a thermal cycler to drive amplification, while 
isothermal technologies such as LAMP, TMA, bDNA, and NASBA operate at a constant 
temperature using simpler heating systems, eliminating the need for thermal cycling and 
making them well-suited for point-of-care and decentralized testing environments. 
Test Platforms 
Table 8-7: Key Molecular Technologies and Major Players 
Technology 
Major Players 
bDNA 
Grifols, Siemens Healthineers 
Bead Array 
Luminex, Illumina, BD 
digital PCR 
Standard BioTools, Thermo Fisher Scientific, RainDance Technologies, Bio-Rad 
Laboratories 
Electrochemical Array 
Enzo Biosciences 
HDA (Helicase Dependent 
Amplification) 
New England Biolabs, Meridian Biosciences, Great Basin Scientific (Roche), 
QuidelOrtho 
In-situ Hybridization 
QIAGEN/Digene, Roche/Ventana, Tripath/BD, Abbott/Vysis, Dako/Agilent 
LIPA 
Innogenetics/Fujirebio 
LLA 
Bio-Rad Laboratories 
LAMP 
Eiken and licensees 
Microarray/Biochip 
Affymetrix, Thermo Fisher Scientific 
NASBA 
bioMérieux 
PCR/QPCR 
Roche Diagnostics and licensees  
SDA 
BD Diagnostics 
Sequencing 
Roche Diagnostics, Illumina, Thermo Fisher Scientific, Complete Genomics (BGI) 
and more 
TMA 
Hologic/Gen-Probe 
 Source: Kalorama Information 

 
 
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One aspect of making molecular tests more accessible to healthcare professionals is the 
automation of these tests and the commercialization of new platforms that build on basic 
technologies. Of interest are platforms for sequencing and mass They are slowly transitioning 
to clinical applications used primarily in large medical centers and reference laboratories. 
More importantly, test platforms that use digital formats such as digital PCR, gel drop PCR 
and integrated circuits, eliminate the fluorescent label step.  This, according to the developers, 
allows for more precise quantification of target nucleic acid molecules, enabling accurate 
determination of copy number variation and the detection of rare mutation events, such as 
those seen in certain tumors and mutated pathogens. Applications of these capabilities could 
provide new strategies for diagnosing inherited disorders, cancer, and infectious diseases. 
Devices using flow-through microfluidic cassettes, lateral flow, and biochip arrays set the 
stage for integrating molecular testing into routine practice by simplifying sample-to-result 
testing into a one-step procedure.   
Tabletop systems are considered the prerequisite technological advancement to providing 
molecular testing in small laboratories and resource-limited test sites anywhere in the world. 
The market is moving beyond these systems and the next generation of sample-to-result 
molecular test instruments is focusing on bringing genetic medicine to a much broader 
audience. The commercialization of these platforms and tests is the next major development 
in the future of molecular diagnostics, as they have the potential to improve the quality of 
healthcare by enhancing the affordability and accessibility of advanced diagnostic solutions, 
even in remote areas where challenges of skilled manpower and infrastructure are acute. 
Government investments in academic research and initiatives to support startup companies 
in the field are also driving growth in the molecular diagnostics sector.  
QIAcube workstations of QIAGEN enable automated sample processing, and they are now 
launching the next-generation QIAcube Connect with advanced digital capabilities and full 
connectivity. These solutions assure standardization of sample preparation and save Cepheid 
is a molecular diagnostics company that develops, manufactures, and markets integrated 
systems for testing in the clinical and non-clinical markets. Its systems enable molecular 
testing for organisms and genetically based diseases by automating manual laboratory 
procedures. The company's main platform is the GeneXpert system, a benchtop PCR system 
that integrates sample preparation, DNA amplification, and detection. The Smart Cycler 
system from Cepheid integrates DNA amplification and detection to enable sample analysis. 
Cepheid also offers a wide range of tests that can be run on the Xpert system. 

 
 
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Roche provides the cobas Prime Pre-analytical System to improve efficiency in molecular 
diagnostic laboratories. The system minimizes repetitive manual tasks associated with 
processing the wide variety and high volume of sample tubes, vials and containers seen in 
today’s molecular lab. 
Bruker markets its LiquidArray Gastrointestinal PCR Assay for broad syndromic testing. The 
LiquidArray Gastrointestinal is a syndromic panel that enables simultaneous detection of up 
to 26 pathogens. 
PathogenDx developed its first UTI assay using its D3 Array technology. The D3 Array 
offers multiplexed, targeted sequence detection designed to mimic a three-dimensional 
structure microarray. It can simultaneously provide identification and drug-resistance results 
in a single test and detect a wide variety of bacteria, viruses and fungi. It can detect over 100 
targets in a single reaction.  
The chart below presents a selection of molecular test platforms that are planning to make 
their mark as novel approaches to molecular testing. Some are based on miniaturization and 
biochip technology.  Of interest are platforms for sequencing and mass spectrometry – 
sophisticated technologies traditionally used in research settings.  Since many molecular tests 
are still used in research mode, the mix of new technologies and tests provides some idea of 
the evolution of molecular tests.   
 
 

 
 
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Table 8-8: Selected Molecular Test Platform Innovations 
Company 
Location 
Area 
Details 
Agena Bioscience 
U.S. 
mass spec 
MassARRAY 24-Well System, low volume labs  
Biocartis 
Switzerland 
PCR 
Idylla, PCR from PPFA tissue 
BioFire Diagnostics/ 
bioMérieux 
U.S. 
PCR 
FILMARRAY Torch platform, advanced  
BioFire Diagnostics/ 
bioMérieux 
U.S. 
PCR 
BioFire FILMARRAY 2.0 system 
Bio-Techne 
U.S. 
sequencing 
Protein Simple 
Coyote Bioscience 
China 
PCR 
InstantGene, miniature gene sensor  
DestiNA Genomics 
Scotland 
genetic 
SMART Nucleobase technology: DNA/RNA 
DestiNA Genomics 
Scotland 
genetic 
e-BRID System with STMicroelectronics’ In-Check 
Platform 
Diasorin 
Italy 
PCR 
ELITe InGenius automated sample to answer  
Diasorin 
U.S. 
PCR 
ARIES sample to answer molecular system 
Diasorin 
U.S. 
sequencing 
Aries M1, a low throughout version of Aries 
System 
Direct Genomics 
China 
genetic 
GenoCare, Helicos-based sample to result, clinic 
Douglas Scientific (LGC) 
U.S. 
PCR 
IntelliQube & Array Tape liquid handling, 
detection, IT 
Eiken Chemical Co 
Japan 
LAMP 
automated multi-plex chip, sample to answer 
Enzo Biochem 
U.S. 
PCR 
AmpiProbe -based Real Time Amplification 
Detection platform  
Genomic Vision 
France 
genome 
high-throughput scanner for molecular combing  
Genomic Vision 
France 
genome 
Genomic Morse Code: Molecular Combing System  
Genomica 
Spain 
cancer 
CLART (Clinical Array Technology) platform  
HTG Molecular Diagnostics 
U.S. 
sequencing 
molecular tests on Thermo Fisher's Ion Torrent 
PGM NGS  
HTG Molecular Diagnostics 
U.S. 
cancer 
Edge RNA analysis automation, extraction free  

 
 
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Company 
Location 
Area 
Details 
HTG Molecular Diagnostics  
U.S. 
sequencing 
HTG EdgeSeq on Thermo Fisher Ion Torrent 
Illumina 
U.S. 
sequencing 
desktop MiniSeq system 
Illumina 
U.S. 
sequencing 
Bio-Rad's droplet technology with sequencing  
Illumina 
U.S. 
sequencing 
desktop MiniSeq system, targeted sequencer 
Illumina 
U.S. 
sequencing 
Project Firefly, semiconductor sequencing system  
Illumina 
U.S. 
cell 
Illumina's sequencing with Bio-Rad ddPCR for 
single cells 
Illumina 
U.S. 
sequencing 
MiSeq FGx Forensic Genomics System 
IncellDx 
U.S. 
flow 
InCellCept assay: molecular markers in cells 
Intel Corporation 
U.S. 
chiparray 
silicon microarray chip  
Medical Innovation 
Ventures  
Malaysia 
PCR 
GenoAmp Real-Time RT-PCR  
Oxford Nanopore 
Technologies  
UK 
nanopore 
MinION, PromethION and GridION, single 
molecule  
Pacific Biosciences (PacBio) 
U.S. 
genome 
Sequel, tech & IT for Single Molecule, Real-Time 
sequencing, Revio 
QIAGEN 
Netherlands 
PCR 
QIAsymphony RGQ MDx system for clinical labs 
QIAGEN 
Netherlands 
sequencing 
GeneReader benchtop NGS sequencer 
enhancements 
QIAGEN 
Netherlands 
genetic 
multi-DNA/RNA copy numbers, expression levels, 
mutations  
Savyon Diagnostics 
Israel 
chiparray 
NanoCHIP: automated DNA-to-Result   
Standard BioTools 
U.S. 
mass spec 
Helios, a CyTOF single cell analysis 
Standard BioTools 
U.S. 
cancer 
Precision Cancer Monitoring platform, urine  
Takara Bio 
U.S. 
chiparray 
Multi-Patient Array for Infiniti, chiparray 
instrument  
Takara Bio 
U.S. 
sequencing 
NGS clinical tests on  Seq-Ready SmartChip TE  
Thermo Fisher 
U.S. 
genomic 
Axiom genotyping platform  

 
 
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Company 
Location 
Area 
Details 
Thermo Fisher 
U.S. 
gene/ immuno 
Luminex with ProcartaPlex immunoassays & 
QuantiGene Plex 
Vela Diagnostics 
Singapore 
sequencing 
Sentosa, automated NGS platform  
Zeesan Biotech 
China 
platform 
Sanity 2.0 System fully integrated and automated 
molecular diagnostic platform 
Source: Kalorama Information 

 
 
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Major Players 
Since 2000, sales of all molecular tests have increased almost tenfold, and the number of 
companies and tests has literally exploded.  At least 950 companies are actively involved in 
molecular diagnostics.  This is not surprising, given there are molecular applications in just 
about every segment of the IVD industry.  Company revenues include sales of molecular 
tests in all segments of the IVD market.  It is beyond the scope of this report to segment 
company molecular revenues by test segment with certainty. 
Table 8-9: Molecular Test Revenues of Selected IVD Vendors, 2022, 2023, 2024, and estimated 2025 
($ million) 
Company 
2022 
2023 
2024  
2025 (E) 
Danaher 
4,901 
3,576 
3,393 
4,901 
Exact Sciences 
1,724 
2,179 
2,432 
2,820 
Roche 
3,159 
2,295 
2,604 
2,618 
bioMérieux 
1,609 
1,576 
1,766 
2,503 
Thermo Fisher 
1,448 
1,071 
916 
1,448 
QIAGEN 
1,160 
1,067 
1,021 
1,402 
Hologic 
2,123 
1,256 
1,294 
1,312 
Agilent 
833 
956 
1,013 
1,029 
Myriad Genetics 
678 
746 
838 
838 
Illumina 
674 
700 
672 
665 
Source: Kalorama Information 
It is beyond the scope of this research to tease out these companies’ revenues for genomic 
molecular tests.  These leaders market a wide portfolio of automated infectious disease tests 
and have been launching tests for cancer diagnosis and companion diagnostics for cancer 
therapeutics. 

 
 
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These major companies hold more than 70% of the total world market for molecular tests.  
Their dominance derives from a continuous involvement in the most dynamic molecular test 
segments – infectious diseases, cancer assays and HPV testing. 
Below is a brief overview of selected molecular company participants.  
Cepheid provides the Xpert Xpress CoV-2/Flu/RSVplus, which is a rapid molecular test for 
qualitative detection of the COVID-19 virus. Cepheid markets the  Xpert Xpress CoV-2plus. 
The test is a rapid molecular test for the qualitative detection of COVID-19.  The plus portion 
of the test enables consistent virus detection, incorporating a 3rd conserved genetic target for 
SARS-CoV-2 detection. Cepheid offers its Xpert nPM1 Mutation, a molecular test for 
quantifying mutant nPM1 mRNA transcripts in peripheral blood from patients with AML. 
Roche Diagnostics offers a broad product portfolio, which includes molecular diagnostic 
tests for oncology, virology, microbiology, and blood screening.  The company’s molecular 
test revenues are bolstered by the continued dominance of Ventana Medical’s histology 
business. The company continues to expand geographically with special emphasis on the top 
seven emerging countries: Brazil, Russia, India, China, South Korea, Mexico and Turkey.     
Roche offers its high-throughput monkeypox test. The test, MPXV, is designed to be run on 
the cobas 6800/8800 Systems and is a real-time PCR test for the qualitative detection of DNA 
from MPXV. The test targets two different regions of the MPXV genome.  
Hologic, Inc. is a leading developer, manufacturer and supplier of diagnostic products, 
medical imaging systems and surgical products dedicated to women’s health. Hologic 
provides products for mammography and breast biopsy, radiation treatment for early-stage 
breast cancer, cervical cancer screening, treatment for menorrhagia, permanent 
contraception, osteoporosis assessment, preterm birth risk assessment, mini C-arm for 
extremity imaging, and molecular diagnostic products, including HPV and reagents for a 
variety of DNA and RNA analysis applications. Hologic’s PANTHER Fusion EBV Quant 
Assay and PANTHER Fusion BKV Quant Assay are innovative additions to the market. The 
assays are in vitro NATT tests that are run on the PANTHER Fusion system. PANTHER 
Fusion EBV Quant is used with whole blood and plasma for the management of transplant 
patients, monitoring viral levels. The BKV Quant is used with plasma and urine samples to 
identify important biomarkers when using quantitative NAATs for the diagnosis and 
management of transplant patients.  

 
 
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The company markets its PANTHER Fusion SARS-CoV-2/Flu A/B/RSV assay. The test is 
a molecular test that detects and differentiates four of the most prevalent respiratory viruses 
in a single sample. The new test, called the RespDirect collection kit, runs on the PANTHER 
Fusion system.  
Exact Sciences is a molecular diagnostics company that has mostly focused on colorectal 
cancer. The company has exclusive intellectual property protecting its non-invasive, 
molecular screening technology for the detection of colorectal cancer. Stool-based DNA 
(sDNA) technology is included in the colorectal cancer screening guidelines of the American 
Cancer Society and the U.S. Multi-Society Task Force on Colorectal Cancer.  Exact Sciences 
markets the OncoExTra therapy selection test. The test is an NGS-based comprehensive 
DNA and RNA genomic test for profiling tumors.  
Molecular diagnostics is a growing focus for BD, as evidenced by the rollout of infectious 
disease products, including the BD MAX platform for HAI and syndromic panel testing, and 
BD Viper for sexual and women’s health testing using PCR and SDA protocols. The 
company's molecular diagnostics portfolio includes STD testing systems, RNA probe-based 
tests for vaginitis, and GeneOhm tests for HAIs. The BD MAX competes primarily in the 
molecular HAI and enteric testing markets. BD has developed its own assays for the BD 
MAX platform and also partnered with other companies to strengthen its test menu. Clinical 
assays for the BD MAX include Chlamydia, gonorrhea, and Trichomonas vaginalis C. 
difficile, MRSA, MRSA extended detection, S. aureus/MRSA, carbapenem-resistant 
organisms, an enteric bacterial panel (Salmonella, Campylobacter, Shigella/enteroinvasive 
E. coli, Shiga toxin genes), and an enteric parasite panel (Giardia, Cryptosporidium, and E. 
histolytica).  

 
 
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Market Analysis 
The clinical market for DNA assays includes: 
• Infectious disease (discussed in Chapter 11) 
•  Blood bank screening (discussed in Chapter 12) 
• Thrombophilia SNPs (discussed in Chapter 10) 
• Oncology- CDx,  
•  Genetic/Inherited Diseases  
• Tissue Typing (HLA) 
•  Prenatal test services - NIPT 
Markets in this chapter focus on genomic testing and smaller molecular segments; the 
markets for molecular tests for infectious diseases, blood screening, and thrombophilia SNPs 
are covered in their respective chapters.   
The 2025 market for oncology, transplant, and genetic assays worldwide is estimated at 
$4,417 million. Over the forecast period, the market will grow at roughly 11% annually and 
reach $7,400 million worldwide in 2030. The NIPT market will grow to $1,530 million by 
2030, with a 7% CAGR.  
Table 8-10: Global Genomic, HLA, NIPT, and Oncology Molecular Test Sales, by Type with NIPT, 2025-2030  
($ million) 
Type 
2025 
%Mkt 
2030 
%Mkt 
CAGR 
Oncology Assays (incl. CDx) 
 2,570  
58% 
 4,400  
60% 
11% 
Genetic/Inherited Disease Assays 
 1,010  
23% 
 1,650  
22% 
10% 
Transplant Testing (HLA) 
 837  
19% 
 1,350  
18% 
10% 
Subtotal 
4,417 
100% 
7,400 
100% 
11% 
Prenatal Testing - NIPT 
1,070 
-- 
1,530 
-- 
7% 
Total 
5,487 
-- 
8,980 
-- 
10% 
Source: Kalorama Information 

 
 
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Oncology 
One of the most explored applications of molecular diagnostics is oncology; it is used for 
screening, therapy selection, diagnosis, and relapse monitoring of cancer. Genetic analysis 
of samples using PCR and NGS technologies enables the detection of mutations, gene 
fusions, copy number variations, and epigenetic changes in tumor tissues, helping physicians 
determine the most effective treatment options for individual patients. In recent years, 
molecular testing has expanded beyond diagnosis to include minimal residual disease (MRD) 
detection, in which highly sensitive assays identify trace levels of circulating tumor DNA 
after treatment, enabling earlier detection of recurrence and more informed decisions 
regarding adjuvant therapy. 
Since at least the mid-1900s, testing of formalin-fixed paraffin-embedded (FFPE) tissue 
biopsy material using histological staining, immunohistochemistry (IHC), and in situ 
hybridization (ISH) has been the mainstay of cancer diagnostics. Histopathology remains the 
gold standard for initial diagnosis and tumor classification. However, as targeted therapies 
have become more prevalent, molecular techniques have increasingly complemented 
histology. Methods applied to FFPE-derived material now include PCR, targeted sequencing 
panels, fluorescence in situ hybridization, and broader genomic profiling to identify 
actionable biomarkers. 
Histological staining of tumor tissue remains an important starting point, but the shift toward 
gene-targeted therapies has driven adoption of more advanced molecular tools. These include 
PCR-based assays, microarrays, SNP analysis, comparative genomic hybridization for copy 
number analysis, and sequencing approaches that provide detailed insight into tumor biology. 
At the same time, tumors are increasingly classified based on molecular and genomic profiles 
rather than tissue of origin alone, supporting the continued growth of precision oncology and 
biomarker-driven treatment strategies. 
Cancer testing now extends well beyond diagnosis. Improved treatment outcomes have 
increased survival rates, creating a growing need for ongoing monitoring. Patients are often 
followed at regular intervals after treatment to detect recurrence. In this setting, invasive 
tissue biopsies are increasingly complemented by noninvasive approaches that analyze 
circulating tumor DNA and other biomarkers in blood and body fluids. These liquid biopsy 
techniques are also used to monitor treatment response and identify emerging resistance 
mutations during therapy. 

 
 
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Advances in cancer research continue to drive the development of molecular tumor marker 
testing in blood and urine. Early liquid biopsy approaches focused on DNA methylation 
signals, with Epigenomics playing a pioneering role in demonstrating that tumor-associated 
methylated DNA fragments could be detected in plasma using PCR-based methods. While 
early assays such as mSEPT9-based colorectal cancer testing established proof of concept, 
newer approaches now incorporate multiple molecular signals to improve performance and 
broaden clinical utility. 
The field has evolved significantly with the emergence of multi-cancer early detection 
testing, which analyzes blood samples for molecular signals associated with multiple tumor 
types simultaneously. These assays combine methylation patterns, sequencing data, and other 
genomic features to improve early detection, although clinical adoption remains in the early 
stages and continues to depend on long-term outcome data and reimbursement support. 
The analysis of circulating DNA and RNA fragments enables noninvasive approaches for 
early cancer detection, disease monitoring, and assessment of treatment effectiveness. The 
underlying technology has been validated through earlier applications, such as noninvasive 
prenatal testing, which demonstrated the feasibility of detecting rare DNA fragments in blood 
and helped accelerate the development of liquid biopsy applications in oncology. 
Despite the promise of liquid biopsy and NGS technologies, their integration into routine 
clinical practice remains uneven. While adoption has accelerated in advanced healthcare 
markets, many tests are still offered through centralized laboratories rather than as widely 
distributed standardized kits. Regulatory complexity, reimbursement challenges, and the 
need for extensive clinical validation continue to influence the pace of adoption. 
NGS enables comprehensive characterization of germline and somatic mutations as well as 
tumor RNA expression profiles, providing a depth of information beyond earlier single-
marker assays. However, translation into routine clinical practice takes time, and well-
established biomarkers such as EGFR, KRAS, and BRAF continue to play a central role in 
guiding decisions on targeted therapy. As a result, single-gene and small-panel molecular 
assays, particularly those based on real-time PCR, remain widely used due to their speed, 
cost-effectiveness, and clinical utility. 
The molecular oncology diagnostics market is therefore evolving toward a complementary 
model. Tissue-based histopathology and molecular testing remain foundational, while liquid 
biopsy, MRD testing, and NGS-based profiling are expanding as important adjuncts. 

 
 
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Together, these technologies are gradually reshaping cancer diagnosis and management, with 
their full clinical impact continuing to develop as evidence, standardization, and access 
improve. 
The global market for all molecular tests for cancer diagnostic testing is held almost 
exclusively in North America and Europe (83%). Japan and the rest of the world account for 
the remaining 17% of product sales. 
Table 8-11: Global Molecular Cancer Test Sales Distribution, by Region, 2025 (%) 
 
[Asia Pacific; Europe; North America; Rest of World] 
 Region 
% Mkt 
North America  
54% 
Europe 
29% 
Asia Pacific 
9% 
RoW 
8% 
Total 
100% 
Source: Kalorama Information 
Enthusiasm for biomarkers is increasing, with major initiatives in Europe (European 
Medicines Agency) and the U.S. working to support their validation, and their path into 
routine testing is increasing. Several genetic biomarkers are endorsed for routine PGx testing 
– EGFR and associated gene mutations, HER, ALK, and BCR/ABL.   
One of the developments expected to increase the utility of blood-based oncology tests is the 
detection of circulating nucleic acids.  This differs from CTCs in that the targets for analysis 
are not cell-based but free nucleic acids in plasma.   
Tests for HPV using cervical fluid are covered in Chapter 13.  Commercial tests for cancer 
available - B and T cell gene arrangement studies for lymphoma, Bcr/abl for leukemia, HER2 
for breast cancer, HPV for head and neck and cervical cancer, septin for colon cancer, EGFR 
mutations and FLT3 Mutation Assay.  Most labs run research-use and lab-developed tests 
that they design in-house to meet their physicians' needs.  

 
 
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The market leaders in the molecular cancer assays are Natera, Roche, Illumina, QIAGEN, 
bioMérieux, Myriad Genetics, and Veracyte.  In addition, there are three leaders in the POC 
molecular assay space-Exact Sciences, Guardant and Beckman Coulter.   
Table 8-12: Selected Molecular Tumor Marker Test Innovations 
Company 
Location 
Area 
Details 
Abbott Diagnostics 
U.S. 
FFPE 
FGFR3 gene mutations, urine, FFPE, bladder cancer 
Agendia 
Netherlands 
cancer 
MammaPrint FFPE breast cancer recurrence test  
Biocartis 
Switzerland 
PGx 
Idylla BRAF & KRAS 
BioRad 
U.S. 
dPCR 
glioma-associated mRNA mutations from CSF 
BioRad 
U.S. 
dPCR 
RainDance HemOnc Consortium, hematological 
BioRad 
U.S. 
sequencing 
 Cancer Panels: solid tumor, hematological 
Bio-Techne 
U.S. 
FFPE 
Quantidex DNA Assay, copy number in FFPE  
Bio-Techne 
U.S. 
leukemia 
Quantidex BCR-ABL IS CMR, leukemia  
Biotype Diagnostic 
Germany 
PCR 
Mentype AMLplexQS, multiplex AML  
Bruker 
U.S. 
FFPE 
186-gene signature for liver cancer, miRNA  
Bruker 
U.S. 
platform 
benchtop nCounter SPRINT Profiler, miRNA 
Bruker 
U.S. 
FFPE 
nCounter Dx FLEX & Prosignia Breast Cancer, miRNA  
Bruker 
U.S. 
platform 
nCounter MAX system for clinical labs 
Bruker 
U.S. 
FFPE 
nCounter PanCancer Progression Panel, miRNA 
Bruker 
U.S. 
FFPE 
nCounter RNA:Protein tumor profiling  
CeGaT GmbH 
Germany 
sequencing 
NGS panel to analyze more than 550 cancer-relevant 
genes  
DiamIR 
U.S. 
niRNA 
Universal Screening Test, miRNA  
DxTerity Diagnostics 
U.S. 
PGx 
REDI-Dx radiation PGx multi-test 
EKF Molecular Diagnostics 
UK 
smpl enrich 
PointMan DNA Enrichment  
EKF Molecular Diagnostics 
UK 
PGx 
PointMan cancer companion diagnostics 

 
 
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Company 
Location 
Area 
Details 
Epigenomics 
Germany 
lung 
Epi proLung tissue assay, septin 
Epigenomics 
Germany 
colon 
Epi proColon septin colon cancer screen 
Exact Sciences 
U.S. 
GI 
gastrointestinal cancers with the Mayo Clinic 
Exact Sciences 
U.S. 
lung 
lung cancer with MD Anderson, blood 
Exact Sciences 
U.S. 
colon 
Cologuard  
Exosome Diagnostics 
U.S. 
exoRNA 
prostate cancer predictive score, exoRNA 
Genomic Vision 
France 
breast 
breast ca and Lynch on Genomic Vision's Morse Code 
Genomica 
Spain 
PGx 
CLART CMA KRAS•BRAF•PI3K and NedxA 
Genomica 
Spain 
platform 
CLART (Clinical Array Technology) platform  
HTG Molecular Diagnostics 
U.S. 
miRNA 
HTG EdgeSeq miRNA Whole Transcriptome, multiplex 
HTG Molecular Diagnostics 
U.S. 
RNA 
Edge RNA analysis automation, extraction free  
HTG Molecular Diagnostics 
U.S. 
RNA 
breast cancer panel with Merck 
HTG Molecular Diagnostics 
U.S. 
sequencing 
Illumina's sequencing technology for HTG EdgeSeq 
platform 
Illumina 
U.S. 
FFPE 
MiSeqDx for FFPE samples, NGS 
Mirxes 
Singapore 
Cancer 
GASTROCLEAR 
Myriad Genetics 
U.S. 
cancer 
Tumor BRACAnalysis CDx, breast 
Natera 
U.S. 
Cancer 
Signatera 
Ovagene Oncology 
U.S. 
platform 
oncology tests on HTG Edge Platform, gene expression 
QIAGEN 
Netherlands 
exosomes 
Exosome Diagnostics' biomarkers, lung cancer 
QIAGEN 
Netherlands 
PCR 
therascreen EGFR RGQ Plasma PCR kit, lung 
Quest Diagnostics 
U.S. 
breast 
BRCA 1/2 on Genomic Vision's Morse Code 
Sophia Genetics 
Switzerland 
IT 
Copy Number Variations algorithm in BRCA1/2, breast  
Standard BioTools 
U.S. 
transrenal 
urine-based cell-free BRAF & KRAS, PGx  
Standard BioTools 
U.S. 
transrenal 
Precision Cancer Monitoring platform, urine  

 
 
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Company 
Location 
Area 
Details 
Takara Bio 
U.S. 
sequencing 
BRCA1/2 on  Seq-Ready SmartChip TE, breast 
Thermo Fisher Scientific 
U.S. 
sequencing 
Ion AmpliSeq Cancer Hotspot Panel v2  
Thermo Fisher Scientific 
U.S. 
sequencing 
Oncomine Solid Tumor DNA panel, FFPE, lung, colon 
Thermo Fisher Scientific 
U.S. 
sequencing 
universal next generation for solid tumors on Ion PGM Dx 
Transgenomic 
U.S. 
platform 
Multiplexed ICE COLD-PCR (MX-ICP) for cfDNA 
Ventana Medical/Roche 
U.S. 
PCR 
cobas 4800 BRAF V600 Mutation Test  
Ventana Medical/Roche 
U.S. 
PGx 
Roche’s HER2-targeted Perjeta and Kadcyla  
Ventana Medical/Roche 
U.S. 
PGx 
Translational Genomics prostate cancer  
Ventana Medical/Roche 
U.S. 
PGx 
companion tests with Incyte Corp 
VolitionRx 
Belgium 
nucleosomes 
NuQ Nucleosomics tests, epigenetic cancer screening 
VolitionRx 
Belgium 
nucleosomes 
NuQ test: ovarian cancer 
VolitionRx 
Belgium 
nucleosomes 
NuQ test: prostate cancer 
Source: Kalorama Information 
 Inherited/Genetic Diseases, Thrombophilia SNPs and Other Disorders 
Single nucleotide polymorphism (SNP) analysis of tissue, blood, urine and saliva is the main 
technique used for gene mutations for inherited diseases. SNPs are DNA sequence variations 
that occur when a single nucleotide (A, T, C, or G) in the genome sequence is altered. Many 
SNPs have no effect on cell function, but scientists believe others could predispose people to 
disease or influence their response to a drug.  Although more than 99% of human DNA 
sequences are the same, variations in DNA sequence can have a major impact on how humans 
respond to disease, environmental factors such as bacteria, viruses, toxins, and chemicals, 
and drugs and other therapies. This makes SNPs valuable for biomedical research and for 
developing pharmaceutical products or medical diagnostics. SNPs are also evolutionarily 
stable—not changing much from generation to generation—making them easier to follow in 
population studies. 

 
 
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Given the human genome's approximately 25,000 genes and an estimated diagnostic 
significance of about 5%, the eventual commercialization of 1,500 gene-based tests can be 
expected.  This is a huge market opportunity set to revitalize the market for molecular tests 
for inherited diseases including autoimmune disorders, diabetes, psychiatric conditions, 
neurological diseases and cardiac disease. 
The market for molecular tests for inherited diseases comprises two segments: tests for 
thrombophilia and molecular assays and genetic tests for the diseases shown below.   
Hemex Health offers the Gazelle Hb Variant test, a POC blood test designed to provide rapid 
diagnosis of sickle cell disease and beta-thalassemia. The Gazelle uses disposable cartridges 
to analyze a fingerstick blood sample. The test is available in more than 40 countries across 
Africa, India, the Middle East, and Southeast Asia.  

 
 
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Table 8-13: Most Frequently Requested Genetic Tests 
Tests 
AML 
Apolipoprotein E genotyping 
ASPA—Canavan disease 
CML 
Cystic Fibrosis 
Duchenne muscular dystrophy 
Familial adenomatous polyposis coli (APC) 
Fetal sex 
Fragile X 
Gaucher’s disease 
Hemochromatosis 
Hemophilia A 
Huntington’s disease 
Lymphomas 
Multiple Sclerosis 
Myotonic dystrophy 
Neurofibromatosis (NF-1) 
Prader Willi/Angelman 
Sickle Cell anemia 
Spinal muscular atrophy 
Thalassemia (alpha and beta) 
 Source: Kalorama Information 

 
 
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Research into the cardiac disease continuum has pointed to an increasingly important role of 
genetics in the evolution of hypercoagulopathies.  More and more evidence has been 
collected that illustrates the use of genetic procoagulation and thrombolytic markers in 
assessing risk for CVD.  In addition to the traditional coagulation cascade factors several 
related molecular markers have grown in importance.  These tests include thrombophilia 
molecular assays Factor V Leiden, and Factor II Prothrombin, along with 
pharmacodiagnostic tests for anticoagulant dosing. 
Thrombophilia markers such as Factor V Leiden and prothrombin G20210A mutations do 
have well-established associations with inherited clotting risk and are used in selected clinical 
scenarios, although their routine use varies depending on patient history and guidelines. In 
contrast, the clinical role of MTHFR testing has been significantly scaled back. While 
MTHFR is involved in folate metabolism and can influence homocysteine levels, common 
MTHFR polymorphisms are no longer considered clinically meaningful markers of 
thrombophilia in most settings. Mild to moderate elevations in homocysteine are influenced 
by multiple factors, including diet, renal function, and vitamin status, and the direct link 
between MTHFR variants and increased risk of cardiovascular disease or thrombosis has not 
been consistently supported in more recent evidence. As a result, routine MTHFR genetic 
testing is generally not recommended as part of standard thrombophilia workups. 
Elevated homocysteine has been linked to cardiovascular risk and certain adverse pregnancy 
outcomes, but the relationship is complex and influenced by multiple factors beyond genetics 
alone. While folate and B-vitamin supplementation can lower homocysteine levels, this does 
not consistently translate into reduced cardiovascular risk. Neural tube defects, such as spina 
bifida, are strongly associated with inadequate folate status, which is why folic acid 
supplementation before and during early pregnancy remains the standard preventive 
approach rather than routine genetic screening for common MTHFR variants. 
Factor V is a cofactor in blood coagulation, regulated by the Protein C system.  The Factor 
V Leiden mutation results in hypercoagulability and is the leading genetic cause of venous 
thrombosis.  Factor II Prothrombin is a key protein in the blood coagulation system.  
Mutations in the gene that codes for Factor II are indicative of a significant increase in risk 
for clotting disorders.  These conditions are commonly treated with blood thinners such as 
coumadin (warfarin), which has led to the commercialization of several tests for warfarin 
sensitivity. 

 
 
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These genes have been implicated in diseases that are more common than generally realized. 
One in one thousand individuals develops deep vein thrombosis (DVT) or pulmonary 
embolism (PE) annually.  These conditions are caused by acquired and genetic risk factors, 
including age, hospitalization, cancer, surgery, pregnancy, hormone therapy, and air travel.  
The thrombophilia SNPs namely, Factor V Leiden,  and Factor II Prothrombin, have become 
part of the molecular test establishment.  The market for this group of tests is estimated at 
$218 million in 2025, with 2.2% annual growth, and will likely reach $243 million in 2030.   
Table 8-14: Global Molecular Thrombophilia Assay Sales Distribution, by Region, 2025 (%) 
 
[Asia Pacific; Europe; North America; Rest of World] 
 Region 
% Mkt 
North America  
37% 
Europe 
36% 
Asia Pacific 
14% 
RoW 
13% 
Total 
100% 
Source: Kalorama Information 
Factor II and V assays were development targets for companies offering molecular diagnostic 
platforms for POC and decentralized testing. Historically, genetic testing was used almost 
exclusively in large hospitals and reference laboratories that had the resources to develop 
their own assays. Simplification of molecular tests by companies such as Hologic, Fujirebio, 
Luminex, QIAGEN and others is making these tests available to small and mid-sized labs. 
Further, the multiplexing capability of these newer platforms makes them ideal to detect 
mutation variations in patient populations. Many LDTs are currently available for detecting 
mutations in Factor II and Factor V. Approximately 2.2 million Factor II and Factor V 
genotyping tests are estimated to be performed annually worldwide (excluding Japan). 
Genomic research is opening the possibility of genetic and protein marker tests for number 
of autoimmune diseases not usually diagnosed with PGx tests, including arthritis, disorders 

 
 
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of the gastrointestinal tract, Crohn’s disease and inflammation.  This area of personalized 
medicine is in the early phase of development.   
Kalorama anticipates that the next five to ten years will likely bring moderate but steady 
growth in commercial molecular tests targeting gene-based inherited diseases. Growth will 
be supported by expanding clinical utility data, declining sequencing costs, broader adoption 
of carrier screening, and greater integration of genomics into specialty care. 
However, several structural challenges continue to moderate adoption. One of the most 
significant barriers is aligning key stakeholders such as payers, physicians, researchers, 
health systems, and regulators to bridge the gap between research discovery and routine 
clinical implementation. While research has rapidly identified disease-associated variants, 
translating these findings into reimbursed, guideline-supported clinical tests requires 
extensive validation, health economic evidence, and consensus-building. 
Reimbursement remains a critical constraint, particularly for expanded panels and 
exome/genome sequencing in inherited disorders, where evidence of clinical utility may still 
be evolving. Regulatory clarity around laboratory-developed tests and evolving oversight 
frameworks also influences commercialization timelines. 
Physician education represents another important lever for market expansion. Many 
clinicians, particularly outside genetics and oncology specialties, require additional support 
in interpreting genomic results, understanding variant classification, and integrating findings 
into patient management. Expanded access to genetic counseling, decision-support tools, and 
standardized reporting formats will be essential to accelerate appropriate test utilization. 
Overall, while the scientific foundation for inherited disease molecular testing is strong, 
market growth will depend as much on ecosystem alignment and clinical integration as on 
technological advancement. 
Alzheimer’s Disease and Dementia 
Alzheimer’s disease (AD) is an aging-associated disease that manifests as dementia. The 
progression of the disease is associated with declines in memory and cognition, impaired 
judgment, and deterioration of personality. The disease afflicts over 5 million in the United 
States and is expected to reach 16 million by 2050.  

 
 
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In vitro diagnostic testing for AD is represented by only a few companies. Thermo Fisher’s 
Athena Diagnostics markets a blood-based LDT service, ADmark ApoE Genotype Analysis 
& Interpretation (Symptomatic), that types the ApoE gene for late-onset AD and PSEN1, 
PSEN2, or APP for early-onset AD. The company consolidated its position in the AD 
molecular testing market by collecting exclusive patent rights to the genes from Duke 
University. However, commercialization of its AD test service has not been well accepted in 
clinical care since there are no efficient drugs available for treatment. Without more effective 
therapy or preventive treatments for AD, molecular diagnostics developed in research are 
unlikely to find successful commercialization in routine clinical care.  
Certain alleles of the apolipoprotein E (ApoE) gene are known to be major risk factors for 
the development of AD. The advent of economical whole-genome and exome sequencing in 
research has spurred investigation into weaker or secondary genetic loci for the disease. 
Whole genome sequencing of AD patients has identified several gene markers, including 
CLU, CRI, PICALM, BIN1, and CNTN5.  
Cardiovascular Disease 
Cardiovascular disease, including heart attack and stroke, is the leading cause of death in the 
world and claims more lives than all forms of cancer combined. The number of deaths from 
cardiovascular disease (CVD) worldwide is projected to reach approximately 24 million by 
2030. Approximately 80% of CVD-related deaths are in low- and middle- income countries. 
In developed countries such as the United States, CVD is one of the leading killers. Globally, 
CVD is on the rise as a result of a sedentary lifestyle, changes in diet related to development 
(higher consumption of animal products), and smoking.  
Cardiovascular health and heart disease events, such as heart attacks, are monitored and 
diagnosed primarily with immunoassays and clinical chemistry. Cholesterol panels, cardiac 
markers and other inflammation markers are used in primary care as well as acute care. 
Genetic testing is increasingly used in cardiovascular care to detect potential cardiac 
conditions and implement preventive care. Genomics also plays a significant role in 
therapeutic efficacy, as exemplified by anticoagulants discussed earlier in this chapter.  
Some genes linked to CVD are involved in lipid metabolism, particularly in the removal of 
low-density lipoprotein (LDL) cholesterol from the bloodstream. Certain genotypes can 
result in the accumulation of LDL in arteries and the development of coronary artery disease. 
The ApoE gene is one of several genes found to affect LDL blood levels.  

 
 
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Table 8-15: Selected Genomic Tests for Inherited Diseases 
Company 
Location 
Area 
Details 
Almac Diagnostics 
UK 
Alzheimer's 
Exonhit Aclarus Alzheimer test 
Ambry Genetics 
U.S. 
cardiac 
cardiovascular genetic testing panels  
ArcticDx 
Canada 
mac degen 
Macula-Risk macular degeneration 
ARUP 
U.S. 
cardiac 
whole genome sequencing: pulmonary hypertension 
Athena Diagnostics/Quest 
U.S. 
epilepsy 
Epilepsy Advanced Sequencing Evaluations 
Autogenomics 
U.S. 
fever 
INFINITI FMF Panel, familial Mediterranean Fever 
Avant Diagnostics 
U.S. 
MS 
Diogenix's MSPrecise, NGS relapsing multiple 
sclerosis  
Axial Biotech 
U.S. 
scoliosis 
ScoliScore AIS Prognostic Test 
Blueprint Genetics 
U.S. 
Autism 
Autism Spectrum Disorders Panel 
Canon Biomedical 
U.S. 
platform 
Novallele genotyping assays for inherited diseases 
CapitalBio Corp 
China 
deafness 
deafness gene mutation detection array 
Chronix Biomedical 
U.S. 
neuro 
neurological disease PGx service 
Chronix Biomedical 
U.S. 
rare diseases 
next gen sequencing, orphan diseases 
Circadian Tech 
Australia 
lung 
lymphangioleiomyomatosis, lung disease 
Clinical Data 
U.S. 
cardiac 
FAMILION DCM Test, cardiomyopathy 
CombiMatrix (Invitae) 
U.S. 
autism 
ATScan, pre-disposition screening, autism 
Diagnósticos da América  
Brazil 
wellness 
Pathway Genomics wellness assays 
Emory Genetics Lab 
U.S. 
autism 
Targeted sequencing-based test for autism 
Exagen Diagnostics 
U.S. 
gastro 
eXaUC/CD, ulcerative colitis/Crohn’s disease  
Genetic Analysis 
Norway 
gastro 
Applied BioCode’s Barcoded Magnetic Bead 
Technology 
Genetic Analysis 
Norway 
gastro 
GA-map IBS Dysbiosis, gut microbiota for IBD 
Genoma SA 
Switzerland 
autism 
IntegraGen's autism spectrum disorder genetic risk  
Genomas 
U.S. 
cardiac 
statin drug PGx on WaferGen INFINITI 
Genomas Inc. 
U.S. 
cardiac 
PhyzioType System, statin PGx 
Genomics Ltd. 
UK 
rare diseases 
EchiDNA rare disease gene variant database, IT 

 
 
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Company 
Location 
Area 
Details 
Global Genomics Group 
U.S. 
cardiac 
integrated Omics plus Big Data, cardiac disease, IT  
Google Genomics 
U.S. 
autism 
Autism Speaks MSSNG Google Cloud Platform 
Illumina 
U.S. 
cystic fibrosis 
MiSeqDx cystic fibrosis tests 
Illumina Clinical Lab 
U.S. 
rare diseases 
TruGenome Undiagnosed Disease Test 
Innogenetics (Fujirebio) 
Belgium 
Alzheimer's 
CSF kit for Aβ42, tau  
IntegraGen 
France 
autism 
ARISk Risk Assessment Test 
Interleukin Genetics  
U.S. 
periodontal 
Interleukin Genetics' PST genetic test 
Labcorp 
U.S. 
rare diseases 
ExomeReveal, whole exome pediatric diseases 
Labor Dr. Bayer/synlab  
Germany 
gastro 
Genetic Analysis GA-map IBS Dysbiosis, gut 
microbiota  
Luminex 
U.S. 
cystic fibrosis 
xTAG Cystic Fibrosis 39 Kit v2 
Myriad Genetics 
U.S. 
musc 
dystrophy 
Multi-Analyte Profiling, Spinal Muscular Atrophy  
PGXL Laboratories 
U.S. 
sleep 
Obstructive Sleep Apnea  
Progenika Biopharma 
Spain 
cardiac 
Seqpro Lipo IS, lipid genes 
Progenika Biopharma/ 
Grifols 
Spain 
cardiac 
LipoChip 
Progenika Biopharma/ 
Grifols 
U.S. 
pancreatitis 
LPLchip, LPL gene mutations in blood or saliva 
Prometheus Labs 
U.S. 
gastro 
PROMETHEUS Crohn's Prognostic test 
Quest Diagnostics 
U.S. 
ALS 
Athena ALS 
Quest Diagnostics 
U.S. 
cardiac 
Celera's real-time PCR KIF6 gene 
RainDance Technologies 
(Bio-Rad) 
U.S. 
autism 
Syndromic Autism 62-Gene Panel  
RainDance Technologies 
(Bio-Rad) 
U.S. 
arthritis 
RainDance HLASeq Research Screening Panel 
Randox Laboratories 
Ireland 
cardiac 
Familial Hypercholesterolemia (FH) Arrays  
Randox Laboratories 
Ireland 
cardiac 
Cardiac Risk Prediction Array  
Selventa 
U.S. 
arthritis 
Clarify-RA, TNF responders database  
Selventa 
U.S. 
gastro 
ClarifyIBD, anti TNF responders 

 
 
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Company 
Location 
Area 
Details 
Sophia Genetics 
Switzerland 
cystic fibrosis 
CFTR IVD Solution CF single NGS, IT 
Tepnel Diagnostics 
UK 
cardiac 
Elucigene FH20, familial hypercholesterolemia 
Thermo Fisher 
U.S. 
Intellectual 
disability 
CytoScan Dx Assay detects chromosomal 
aberrations 
Transgenomic 
U.S. 
rare diseases 
Nuclear Mitome Test, mitochondrial disorders 
Transgenomic 
U.S. 
scoliosis 
Axial Biotech’s ScoliScore  
Xceed Molecular  
U.S. 
gastro 
Inflammation Xpress Chip  
Source: Kalorama Information 
Depression and Psychiatric Disorders 
A number of molecular and pharmacogenetic test services have been introduced for 
psychiatric disorders over the past decade, particularly in the area of psychotropic medication 
response. However, broad adoption among psychiatrists remains variable. While 
pharmacogenomics (PGx) has gained some traction—especially for antidepressant and 
antipsychotic prescribing—many clinicians remain cautious due to ongoing debate regarding 
clinical utility, guideline integration, and payer reimbursement. 
Genes commonly included in commercially available psychiatric pharmacogenomic panels 
typically fall into two categories: 
1) Pharmacokinetic genes (drug metabolism and transport): 
• CYP2D6, CYP2C19, CYP1A2, CYP3A4/5 – cytochrome P450 enzymes affecting 
metabolism of antidepressants, antipsychotics, and mood stabilizers 
• UGT1A4 – glucuronidation pathway involved in drug metabolism 
• ABCB1 (P-glycoprotein) – influences drug transport across the blood–brain barrier 
2) Pharmacodynamic / neurotransmitter-related genes (variable evidence strength): 
• SLC6A4 – serotonin transporter 
• HTR2A / HTR2C – serotonin receptors 

 
 
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• DRD2, DRD4 – dopamine receptors 
• SLC6A3 (DAT1) – dopamine transporter 
• COMT – catechol-O-methyltransferase 
• CACNA1C – calcium channel gene associated with mood disorders 
• ANK3 – neuronal membrane protein linked to bipolar disorder risk 
• OPRM1 / OPRK1 – opioid receptors 
• MTHFR – folate metabolism (clinical relevance in psychiatry remains debated) 
• GABA receptor genes – occasionally included in extended panels 
Several companies offer commercially available psychiatric pharmacogenomic testing 
services. Genomind markets the Genecept Assay, a multi-gene panel that evaluates variants 
involved in drug metabolism and selected pharmacodynamic pathways relevant to 
psychiatric medication management. Myriad Genetics offers GeneSight Psychotropic, one of 
the most widely marketed psychiatric PGx panels, which focuses primarily on CYP450 
metabolism genes along with selected receptor markers to help guide antidepressant and 
antipsychotic selection. Castle Biosciences provides IDgenetix, a pharmacogenetic test 
designed to support psychiatric medication management, based largely on polymorphisms in 
metabolic genes. Pathway Genomics previously marketed the Mental Health DNA Insight 
panel, an SNP-based psychiatric pharmacogenetic test, although its current market visibility 
is more limited than in prior years. SureGene’s STA2R panel has also been referred to as a 
medication-response genetic test, though its current commercial status is less clear. In 
addition to these branded panels, numerous clinical laboratories offer standalone testing for 
genes such as MTHFR and various CYP450 enzymes; however, professional guidelines 
increasingly caution against overinterpretation of isolated MTHFR variants in psychiatric 
practice without a broader clinical context. 
Clinical adoption of psychiatric pharmacogenomic testing continues to evolve as evidence 
accumulates and professional guidance becomes more refined. Major pharmacogenomic 
consortia, including the Clinical Pharmacogenetics Implementation Consortium (CPIC), now 
provide dosing guidelines for medications affected by variants in genes such as CYP2D6 and 
CYP2C19, which has supported selective payer coverage in certain clinical scenarios. Even 
so, broader reimbursement depends on continued demonstration of clear clinical utility and 
outcome improvement. Standardized reporting frameworks and expanded clinician education 
are essential to ensure appropriate interpretation and integration into practice. Many 

 
 
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psychiatrists still rely primarily on symptom-based treatment algorithms and clinical 
experience rather than genetic stratification alone. As a result, psychiatric molecular testing 
remains largely a laboratory service–driven market with limited penetration of FDA-cleared 
kit-based IVD products. While pharmacogenetics is expected to continue to grow 
incrementally, expansion into predictive genetic testing for psychiatric disease susceptibility 
remains constrained by evidentiary limitations and ongoing ethical considerations. 
Prenatal and Newborn Testing 
Noninvasive prenatal testing is more accurate than traditional serum biochemical and nuchal 
translucency screening tests for fetal anomalies and, consequently, is less likely to result in 
invasive follow-up tests. But the higher price tag affects decisions about using it upfront. 
This is a fast growing area but mostly driven by LDTs and the revenues will be generated 
largely from the sales of instruments, reagents and consumables for offering LDT services. 
The basis of prenatal screening is an analysis of the 23 pairs of chromosomes that every 
human being has. Using a variety of techniques, a cytogeneticist examines the number, shape 
and staining pattern of these chromosomes to detect extra chromosomes, missing 
chromosomes, or rearranged chromosomes. Most common disorders include Down 
syndrome (chromosome 21 trisomy), Turner’s syndrome, Fragile X syndrome for mental 
retardation, neural tube defects, spina bifida, inherited diseases (cystic fibrosis, Thalassemia, 
Canavan disease, Tay-Sachs, sickle cell disease), chronic myelogenous leukemia (CML), and 
Burkitt’s lymphoma. Prenatal genetic testing is performed while a fetus is still in utero and 
considered to be at risk. It is also used to analyze embryos before implantation in in vitro 
fertilization (IVF) to ensure that disease-free embryos are implanted. Finally, genetic testing 
can be performed on newborns to screen for a wide number of gene-based diseases.  
Kalorama estimates the world market for prenatal test services by cell-free NIPT is $1,070 
million in 2025 and, with 7.4% annual growth, will reach $1,530 million in 2030.  Growth is 
increasingly related to consumers opting for prenatal carrier testing and the use of genomic 
screening of embryos for in vitro fertilization.  The reader is reminded that products in this 
test segment are used by test service providers.  
The U.S. market is fairly mature, and payer groups negotiate lower payments; however, 
demand is increasing.  Europe is also beginning to mature and face the same restraints in 
payment structures. Therefore, future growth is expected to come from the more developed 

 
 
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emerging economies in Asia Pacific, Latin America, and the Middle East, including India, 
China, and Brazil. 
Table 8-16: Global Prenatal Test Sales Distribution, by Region, 2025 (%) 
 
 
[Asia Pacific; Europe; North America; Rest of World] 
 Region 
% Mkt 
North America  
46% 
Europe 
27% 
Asia Pacific 
20% 
RoW 
7% 
Total 
100% 
Source: Kalorama Information 
The most advanced technology in this test segment is non-invasive prenatal testing (NIPT), 
which sequences DNA extracted from fetal cells in the mother’s blood. This test segment has 
become very hot lately, partly because the test technologies are becoming more user-friendly, 
using Illumina’s arrays and sequencing tools primarily. There has also been growing 
consumer demand, which is endorsed by medical guidelines and screening programs 
supported by payer groups.  
The information presented below clearly illustrates the quite amazing market acceptance of 
NIPT and other advanced prenatal screening tests (beyond the major companies).  Labs 
worldwide are beginning to offer these tests, and companies that have commercialized 
market-clearing tests have seen significant success.  Further, the wide availability of NIPT 
democratizes prenatal screening for women everywhere, and especially in countries that 
recognize the CE Mark. 
 Myriad Genetics expanded into the consumer prenatal segment through its acquisition of 
Gateway Genomics, developer of the SneakPeek early gender DNA test, a direct-to-
consumer assay that analyzes fetal cell-free DNA (cfDNA) from maternal blood early in 
pregnancy. In the clinical reproductive market, Natera strengthened its position by acquiring 

 
 
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select reproductive health assets from Invitae, reinforcing its Panorama® non-invasive 
prenatal testing (NIPT) and carrier screening portfolio.  Natera also offers a cfDNA-based 
fetal RhD test that noninvasively determines fetal RhD status and supports more targeted 
administration of Rh immune globulin. Expanding NIPT offerings internationally, Yourgene 
Health offers  IONA Care+ in the UK in  2025, an enhanced version of its IONA test that 
broadens screening beyond common trisomies to include selected sex chromosome 
abnormalities and microdeletion syndromes, reflecting the continued evolution of expanded 
NIPT panels. 
Table 8-17: Selected Prenatal Services Provided 
Company 
NIPT 
Average Pregnancy 
Miscarriage 
Preimplant Testing 
Agilent 
X 
 
 
 
ARUP 
X 
 
 
 
Berry Genomics 
X 
 
 
 
BGI 
X 
 
 
 
Invitae 
X 
 
X 
X 
Illumina 
X 
 
 
X 
Eurofins LifeCodexx 
X 
 
 
 
Myriad Genetics 
X 
X 
 
 
Natera 
X 
X 
 
X 
Igenomix 
X 
 
 
 
Roche Diagnostics  
X 
 
 
 
Quest 
X 
 
 
 
Labcorp 
X 
X 
 
 
Source: Kalorama Information 
 
 

 
 
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Table 8-18: Selected Molecular Tests for Prenatal Analysis 
Company 
Location 
Details 
Agilent 
U.S. 
Clarigo 
Annoroad Genomics  
China 
NIPT with Illumina's HiSeq 2500  
ARUP Labs 
U.S. 
Non-invasive Prenatal Aneuploidy Screen  
BGI 
China 
NIFTY, NIPT 
BGI 
China 
NIFTY platforms BGISEQ-1000, BGISEQ-100 & reagents 
Biominis 
France 
NIPT with Illumina's HiSeq 2500 Ninalia 
Bio-Reference Laboratories 
U.S. 
Natera's Panorama NIPT 
Birmingham Women's NHS  
UK 
NIPT with Illumina's HiSeq 2500  
DiagCor 
Hong Kong 
Natera's Panorama NIPT in Hong Kong 
Diagnomics 
U.S. 
NGS NIPT with Maverix Dx Cloud IT 
Echevarne 
Spain 
Natera's Panorama NIPT in Spain 
Enzo Clinical Lab 
U.S. 
Sequenom's MaterniT21 
Genea Limited 
Australia 
GeneSyte - Prenatal NIPT Screening 
Genoma 
Netherlands 
Tranquility test using Premaitha's technology in Geneva 
Genoma 
Italy 
NIPT with Illumina's HiSeq 2500  
Genomed 
Switzerland 
BGI's NIFTY 
Genomed 
Switzerland 
Aneufast QF-PCR Test  
Igenomix 
Spain 
NACE NIPT 
Illumina 
U.S. 
Illumina’s Verinata Health's Verifi test 
Inex Innov 
Singapore 
amniocentesis, FISH 
Inex Innovations 
Singapore 
iGene whole genome sequencing 
Innovations Exchange 
Singapore 
BGI's GeneScreen 
Innovations Exchange 
Singapore 
FlashFISH prenatal screen amniocentesis 

 
 
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Company 
Location 
Details 
Innovations Exchange 
Singapore 
NIPT microchip and rare cell isolation with A*STAR 
Labcorp 
Japan 
Sequenom's MateriT21 
Labcorp 
U.S. 
EmbryVu, a preimplantation genetic screen 
Labcorp 
U.S. 
informaSeq Prenatal Test 
Laboratoire Cerb 
France 
Sequenom's MateriT21 in the Middle East 
Lifelabs Medical 
Canada 
Natera's Panorama test 
MAP Diagnostics 
UK 
MA-Test urine screen Down Syndrome  
Mayo Medical Lab 
U.S. 
Sequenom's MateriT21 
MedGenome 
India 
Natera's Panorama NIPT, exclusive license for India 
Myriad Genetics 
U.S. 
SneakPeek Early Gender Test  
Myriad Genetics 
U.S. 
self-collection kit under the SneakPeek brand 
Myriad Genetics 
U.S. 
Foresight Carrier Screening, Prequel, SneakPeak 
Natera 
U.S. 
Panorama NIPT 
NewBridge Pharmaceuticals  
UAE 
Verinata verifi prenatal test in the Middle East 
NIPD Genetics 
Cyprus 
methylation enrichment of fetal DNA & PCR 
NIPD Genetics LTD  
Cyprus 
Veracity test 
NX Prenatal  
U.S. 
NeXosome, microvesicles/exosomes spontaneous preterm birth risk 
Prenetics 
Hong Kong 
Prenetics V Test, technology from Stanford University 
Primary Health Screen 
Australia 
INEX's GeneScreen in Australia 
ProPath Pathology 
U.S. 
Natera's Panorama NIPT 
Quest 
U.S. 
Natera's Panorama NIPT 
Quest Diagnostics 
U.S. 
Sequenom's MateriT21 
Quest Diagnostics 
U.S. 
replace Natera with own QNatal Advanced 
Randox Laboratories 
UK 
Pre-Pregnancy Genetic Screen  
Rarecells Diagnostics 
France 
ISET-PND, fetal cells in blood 

 
 
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Company 
Location 
Details 
Recombine (Cooper Genomics) 
U.S. 
FertilityMap, Illumina microarray, infertility markers 
Revvity 
U.S. 
Vanadis, NIPT digital analysis of cfDNA for routine labs 
Sonic Healthcare 
Australia 
Ariosa's Harmony in Australian and UK labs 
St George's University Hospitals  UK 
Premaitha IONA test in house 
Standard BioTools 
Singapore 
Sequenome's VisibiliT in Asia 
Teva Pharmaceuticals 
Israel 
Verinata verifi prenatal test in Israel 
UniLabs 
Switzerland 
Natera's Panorama NIPT in Europe 
Yourgene Health 
UK 
IONA  
Source: Kalorama information 
Transplant Diagnostics 
The proteins encoded by the Human Leukocyte Antigen (HLA) system are located on the 
surface of body cells and are unique to each person.  The immune system uses HLAs to 
distinguish self-cells from non-self-cells.  Any cell displaying that person's HLA type 
belongs to that person and, therefore, is not an invader.  Thus, the HLA system is involved 
in cases of pathogen invasion and the presence of unrecognizable (and therefore foreign) 
tumor cells and autoimmune antigens. 
HLA typing is the process of testing patient or donor blood or other tissue samples for HLA 
antigens.  The results can then be used to determine compatibility between the donor and 
patient (HLA matching).  More precise HLA matching through the application of molecular-
based typing methods has been shown to significantly improve transplant outcomes, 
particularly for bone marrow transplants.  
HLA testing, also referred to as tissue typing, is therefore a key component in determining 
the compatibility between potential donors and recipients prior to transplantation to 
maximize the chances of graft survival and minimize serious immunologic transplant 
complications.  The better the HLA type match, the higher the likelihood of a successful 
transplant. 

 
 
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In addition to transplantation-related applications, knowledge of an individual's HLA type is 
also relevant to infectious disease progression and autoimmune disorders.  HLA assays are 
expected to play a key role in personalized medicine, as evidenced by recent developments 
and research.  Such tests include, among others, the typing of the HLA-B*5701 allele - a test 
to assess the risk of AIDS patients for severe adverse reactions to the widely prescribed HIV 
drug component Abacavir. 
The global market for molecular transplant (HLA) testing is a growing, competitive segment.  
Illumina’s efforts in facilitating and expanding access to NGS testing technologies have 
resulted in a growing market segment.  Longer-term, much of the HLA testing by sequencing 
will be offered as lab-developed tests.   
At this time, the major application of HLA testing is for transplant management. The total 
worldwide market is estimated at 172,400 organ transplants and 8,000 bone marrow 
transplants per year.  More than 46,000 organ transplants were performed in the U.S in 2023 
and a similar number are performed in Western Europe.  Approximately 80% of HLA testing 
is used for whole-organ transplants, and 20% for bone marrow transplants.   
Table 8-19: Global Molecular HLA Testing Sales Distribution, by Region, 2025 (%) 
 
[Asia Pacific; Europe; North America; Rest of World] 
 Region 
% Mkt 
North America  
46% 
Europe 
26% 
Asia Pacific 
23% 
RoW 
5% 
Total 
100% 
Source: Kalorama Information 
Organ transplantation is practiced primarily in developed countries, which are the main 
markets for molecular transplant diagnostics. In 2023, there were more than 103,223 people 
in the US on the national transplant waiting list. Kidney took the lion’s share of 86% of all 
the organs, for which most people are waiting in the US, followed by liver, heart, and lung 

 
 
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at 9.8%, 3.2%, 1% respectively in 2023. Approximately 46,632 organ transplants were 
performed in the US in 2023 as of  March 2024.  
Figure 8-1: Global Transplant Rate, by Region, 2024 
 
Source: Data of the WHO – ONT Global Observatory on Donation and Transplant Patients  
Key drivers of the molecular transplant diagnostic market in the US include an increase in 
public and private funding for the development of HLA typing technologies, a growing 
number of solid organ transplantation procedures, and a continuous reduction in the average 
cost of gene sequencing.  
In Europe, more than 45,000 organ transplantations were reported in 2024. Demand in 
Europe is expected to grow at a 10.1% CAGR, reaching $348 million by 2030. 
Asia is the most populated region in the world, but has one of the lowest rates of organ 
transplantation and the greatest growth rate for the number of people entering chronic and 
end-stage organ failure.  

 
 
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China, by far, has the shortest waiting time for organ transplantation in the world. 
Government statistics suggest that approximately 20,000 organ transplantations take place 
per year in China. However, the volumes could be much higher than the official statistics.  
The transplant diagnostics market in North America is primarily driven by factors such as 
increased public and private funding for HLA typing technology development, a growing 
number of solid organ transplantation procedures, and a continuous reduction in the average 
cost of gene sequencing. However, financial constraints faced by market players are limiting 
the growth of the transplant diagnostics market in this region.  
The Asia Pacific is poised to grow at about equal to North America and Europe, with a CAGR 
during the next five years at 10.2%, owing to factors such as increasing focus of global life 
science companies in emerging markets, growing public and private support to develop novel 
HLA typing technologies, and strengthening healthcare infrastructure across the region.   
HLA typing has traditionally been performed using serological techniques for immunological 
markers. However, this technique does not detect subtle differences between individuals.  An 
HLA test requires that some six genes be screened in parallel, with each displaying about 100 
important (known) local variants.  This requirement lends itself to technologies such as 
microarrays and sequencing, which can screen for multiple targets. 
The molecular transplant diagnostics space is a competitive market with many companies 
offering PCR- and bead-array-based test kits for characterized HLA genes. Until recently, 
PCR and microarray platforms together accounted for the largest market share in the 
segment, with serology and immunoassays sharing the remaining market demand. NGS has 
been growing in the segment.  
 

 
 
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Table 8-20: Selected Innovations of Molecular Transplant Diagnostics 
Company 
Location 
Product Details 
Biofortuna, UK 
UK 
Freeze-Dried SSPGo HLA- typing kit (PCR-based) 
CareDX 
USA 
AlloSeq Tx 17 
Fujirebio  
Belgium 
INNO-LiPA HLA-DQA1(PCR-based) 
GeneDx 
Netherlands 
SBTexcellerator HLA (Sanger Sequencing-based) 
GeneDx 
Netherlands 
NGSgo-AmpX, HLA (NGS-based) 
GMS Biotech 
USA 
High-Throughput HLA-Typing (micro array based) 
Illumina  
USA 
TruSight HLA Sequencing Panel & Conexio Genomics analysis IT  
(NGS-based) 
Immucor  
USA 
MIA FORA NGS FLEX HLA Typing Kit (NGS-based) 
Linkage Biosciences 
USA 
LinkSeq, HLA PCR (PCR-based) 
PharmiGene, Inc. 
Taiwan 
HLA-B*1502 Assessment Test (PCR-based) 
QIAGEN  
Netherlands 
QuantiFERON Monitor (QFM), immune function, organ transplant,  
(PCR-based) 
Roche Diagnostics 
USA 
Cobas CMV viral load on 6800 & 8800, transplant (PCR-based) 
Thermo Fisher 
USA 
LinkSeq, HLA PCR (PCR-based) 
Thermo Fisher  
USA 
SeCore kits (HLA Sequence-Based Typing)  
Source: Kalorama Information 
Women’s Health 
The global market for women’s health test products is estimated to be worth $14.6 billion in 
2024. For a more in-depth report see Kalorama Information’s Women’s Health Diagnostics 
Markets: Global Outlook and Forecast to 2030. 
A notable development in the women’s health market includes Heranova introduction of its 
LDT, HerResolve, for endometriosis detection. The test uses miRNA biomarkers to provide 
an actionable positive or negative result and employs quantitative PCR to measure the levels 

 
 
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of the biomarkers present. AI and ML are used to train a model to interpret the levels. The 
company is seeking FDA clearance for the test once all clinical data is received. 

 
 
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The Commercial Outlook for Molecular Tests 
The development of the molecular diagnostics market has proceeded in tandem with the 
evolution of molecular technologies. It has become an indispensable tool in clinical medicine 
that touches all aspects of healthcare including treatment decisions in terms of identifying 
antimicrobial resistant (AMR) infections at the earliest, companion diagnostics assisting in 
the evaluation of suitability of various cancer treatment options, pharmacokinetics or patient 
metabolism of drugs for HIV, psychiatric conditions or blood thinners; cancer prognosis and 
therapy, organ matching, blood safety, and the diagnosis of latent and neonatal conditions. 
Rather than replacing other major IVD modalities such as immunodiagnostics, the molecular 
diagnostics market has expanded by addressing clinical needs that have not been met or never 
envisioned with other major testing disciplines. As they become more affordable, the 
displacement of other diagnostics, such as immunodiagnostics, has also occurred owing to 
the high sensitivity and unique insights that molecular diagnostic methods offer. Certain IVD 
segments have been, or are in the process of being, remade worldwide through the application 
of molecular methods, including blood screening, POC diagnostics, cytogenetics, and tissue 
typing.  
Since its inception, molecular diagnostics has steadily progressed from research-emergent, 
highly complex tests performed in a few labs to increased adoption of analyzer-integrated 
and automated sample preparation and analysis. In its earliest stages, clinical molecular 
diagnostics consisted of polymerase chain reaction (PCR) amplification of target sequences, 
followed by detection of amplicons through interpretation of bands on gel electrophoresis 
gels or through in situ hybridization of molecular probes to complementary sequences within 
tissue and liquid samples. In-situ hybridization required microscopy for the detection of 
fluorescence, chromogenic change or antibody-antigen complexes (if molecular probes 
present an attached antigen for detection).  
The development of real-time PCR (qPCR) profoundly expanded the role of molecular 
diagnostics in healthcare; the technology registers amplification-generated fluorescence or 
other optically detected changes in real time to determine positive results and the relative 
amount of analyte or target nucleic acid sequence in the sample. Real-time PCR enables 
quantitative molecular results and has been integral to expanding molecular testing 
capabilities beyond high-complexity labs. The technology minimizes “hands-on” time or 
user requirements, improves test sensitivity, and speeds up the time to results while also 
reducing staff burden. In addition to qPCR, molecular diagnostics is performed with 

 
 
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isothermal amplification technologies, endpoint detection using microarrays, and nucleic 
acid sequencing technologies. 
Molecular assays and lab tests in general hold the key to outcomes research for the new 
generation of biotherapeutics. These face the risk of poor market penetration unless they can 
demonstrate to payer groups that they will improve patient outcomes and be cost-efficient 
relative to incumbent techniques. The only way to do this is to first show that a genetic defect 
is present, and then to demonstrate that a drug's effect is best shown by a reduction in the 
physiological element targeted by the drug. Only lab medicine can provide this information. 
This will become more important as DNA-based diagnostic and therapeutic interventions 
evolving from the Human Genome Project come to market. Payers often cover therapeutics 
that prove economically valuable based on rigorous outcomes research. 
The market for SNP detection is limited more by the utility of these tests than by the 
technology required to perform them. Utility and reimbursement go hand in hand. Almost 
daily, medical researchers announce their findings linking genes and gene sets to diseases.  
The application of molecular technologies to clinical analyses has attracted widespread 
attention worldwide. They have already made their mark in diagnostic systems and will 
continue to expand their market share. There are several key issues that impact market 
success, including:  
• Significant changes in healthcare delivery herald a new era in diagnostic testing 
needs. This new era requires, on one hand, very sophisticated, sensitive assays for 
infectious disease management, disease detection, and drug treatment decisions. On 
the other hand, these tests should be user-friendly and very cost-effective. This bodes 
well for fully automated, sample-to-result test platforms.  
• There is a demand for faster test turnaround time from sample collection to results 
availability.   
• There is a demand for a large menu of tests available on a single platform since 
molecular tests must account for variability in test targets. These tests must have high 
sensitivity for analytes in very small concentrations, be quantitative, and use small 
whole blood, urine, saliva, and CSF samples. 
•  There is a demand for test systems that are easy to use by non-laboratory and 
laboratory personnel. This is especially crucial for the growing use of diagnostic 

 
 
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assays in the physicians' office setting, multi-disciplinary medical clinics and small 
to mid-sized hospitals.  
• There is a demand for low-cost molecular systems as the industry is cost-conscious 
in an attempt to do more with less.   
• The ensemble of these elements creates a market for multiplexed, rapid, user-friendly 
test platforms such as microarrays, liquid bead arrays and other user-friendly 
technologies.  
Among the leading technology platforms in the molecular diagnostics market, PCR accounts 
for the largest share of the global market. Though NGS used for true molecular diagnostics 
purposes (as opposed to pharma research and development or biomarker discovery, RUO 
sales) represents less than 20% currently, it is the platform of the future and in this analysis, 
the fastest-growing molecular diagnostics segment sales of systems are indicative of a bright 
future for molecular sales once regulatory approvals are secured and more applications are 
discovered. Liquid biopsies, consumer DTC testing, new competitors, and the reduction in 
the cost of whole-genome sequencing are all drivers of growth. 

 
 
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Chapter 9: Hematology 
Scope 
Hematology is the study of blood and blood-forming tissues, primarily focused on the 
analysis of peripheral blood and bone marrow cells to diagnose a wide range of blood 
disorders, including leukemias, anemias, clotting abnormalities, and autoimmune 
diseases. The cornerstone of hematology testing is the complete blood count (CBC), 
which provides essential information about various blood components, such as 
hemoglobin, hematocrit, red blood cells (RBCs), white blood cells (WBCs), 
reticulocytes, and platelets. This is segmented into laboratory-based and decentralized 
or POC hematology testing. 
 
 

 
 
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Overview of Hematology and Trends  
The routine hematology test menu remains centered on the complete blood count (CBC) with 
differential, along with related parameters such as hematocrit, hemoglobin (automated and 
manual), erythrocyte sedimentation rate, reticulocyte count, total white blood cell (WBC) 
count, platelet count and indices, and red blood cell (RBC) count. Modern analyzers now 
routinely include expanded parameters, such as RBC indices (MCV, MCH, MCHC, RDW), 
platelet indices, and flags for immature granulocytes and nucleated red blood cells, thereby 
reducing the need for manual review. There continues to be discussion about using a 5-part 
versus a 3-part differential, although current practice favors the 5-part differential in most 
hospital and high-volume laboratory settings. White blood cells play a central role in immune 
defense, and differentiating their subtypes supports the diagnosis and monitoring of infection, 
inflammation, and hematologic disorders. A 3-part differential groups leukocytes into 
granulocytes, lymphocytes, and monocytes, and remains sufficient for basic screening in 
smaller or cost-sensitive settings. In contrast, a 5-part differential provides a more detailed 
breakdown into neutrophils, lymphocytes, monocytes, eosinophils, and basophils, offering 
greater clinical insight. Neutrophils are key responders to bacterial infections; lymphocytes 
are central to viral and adaptive immune responses; eosinophils are associated with parasitic 
infections and allergic conditions; monocytes are involved in inflammation and tissue repair; 
and basophils are primarily linked to allergic and inflammatory responses. As a result, most 
medium- to high-volume laboratories rely on 5-part differentials as standard, supported by 
advances in automation, digital morphology, and flagging algorithms, while 3-part systems 
continue to be used and marketed in physician offices and lower-resource environments due 
to their lower cost and operational simplicity. 
. 

 
 
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Table 9-1: Hematology Analyzer Distribution of Sales, by Menu Capability, 2025 estimated (%) 
Analyzer by Menu Capability 
Distribution of Unit Sales 
5-part diff analyzers 
77% 
3-part diff analyzers 
19% 
Other analyzers 
4% 
Total 
100% 
Note: Distribution based on sales of leading analyzer vendors and reported distribution 
Source: Kalorama Information 
Over the past several decades, the CBC has become one of the most widely used and 
clinically important laboratory tests, playing a central role in patient management across both 
inpatient and outpatient settings. It is routinely performed on hospitalized patients and 
commonly included in general health evaluations, providing clinicians with essential 
information for diagnosing and monitoring a wide range of conditions, including infection, 
anemia, inflammation, and hematologic disorders. 
Since the late 1990s, hematology technology has advanced beyond impedance-based cell 
counting, originally established by the Coulter Principle, through the integration of optical 
and fluorescence-based techniques adapted from flow cytometry. These innovations have 
significantly improved cell identification and classification, allowing automated analyzers to 
detect and quantify cell populations that previously required manual microscopy, while 
increasing accuracy and throughput. 
Product differentiation in hematology analyzers focuses on expanding the range of available 
parameters, extending testing beyond whole blood to body fluids such as cerebrospinal and 
serous fluids, and advancing automation. Modern systems routinely provide enhanced 
parameters, including reticulocyte counts, immature granulocytes, and advanced platelet 
metrics. At the same time, laboratories are adopting automation strategies that include 
integration with core lab tracks, automated slide preparation and staining, digital cell 
imaging, and advanced informatics, all of which streamline workflow and improve 
consistency. 

 
 
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High-end hematology analyzers deliver rapid, near real-time results and support on-demand 
testing with minimal manual intervention. Improved flagging algorithms and imaging 
capabilities have significantly reduced the need for manual differential slide review, limiting 
it primarily to abnormal or flagged samples. Major vendors such as Sysmex, Roche, 
Beckman Coulter, Mindray, and Siemens Healthineers compete by enhancing automation, 
expanding clinical parameters, and improving overall laboratory efficiency. 
Table 9-2: Lab-based Hematology Sales, by Analyte Average Annual Distribution, 2025 (%) 
Analyte 
Distribution of Sales 
CBC 
58% 
Hemoglobin 
27% 
Other specialized 
15% 
Total  
100% 
Source: Kalorama Information 
Digital Image Analysis 
Advances in imaging, automation, and connectivity have driven steady adoption of digital 
workflows in hematology, particularly in the review of peripheral blood smears. Laboratories 
are combining automated analyzers with integrated image analysis systems to streamline 
differential white blood cell counts and reduce reliance on manual microscopy. Standardized 
slide preparation, including automated smearing and staining, improves consistency and 
supports reliable image capture and analysis. Once prepared, slides can be digitized and 
reviewed on-screen, allowing for remote consultation, centralized review, and more flexible 
workload distribution across laboratory networks. 
CellaVision remains the leading supplier of digital cell morphology systems for hematology. 
Its platforms use automated microscopy and image analysis to locate, classify, and present 
white blood cells for review, while also supporting assessment of red blood cell morphology 
and platelet estimation. These systems improve efficiency by reducing the time required for 
manual differentials and standardizing the review process, while still allowing technologists 
to verify and adjust classifications. Adoption has been strongest in mid- to high-volume 
laboratories, but smaller, more compact systems have expanded use into lower-volume 

 
 
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settings. Growth continues to be driven by staffing constraints, the need for standardization, 
and increasing acceptance of remote review. 
Digital morphology in hematology is distinct from broader digital pathology, which focuses 
on whole slide imaging of tissue samples. Companies such as Roche, Philips, and Leica 
Biosystems lead in that segment with platforms designed for histopathology. While these 
systems are part of the same overall shift toward digital imaging, hematology applications 
remain more specialized, centered on blood and body fluid analysis, with increasing overlap 
in areas such as image management, software integration, and AI-assisted interpretation. 

 
 
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Table 9-3: Selected Hematology Image Analysis Innovations 
Company 
Location 
Details 
Abbott Diagnostics 
U.S. 
CellaVision's digital microscopy, Europe 
Beckman Coulter 
U.S. 
DxH Slidemaker Stainer II 
CellaVision AB   
Sweden 
CellaVision Image Capture System, hospital networks 
CellaVision AB   
Sweden 
CellaVision Advanced RBC analysis  
CellaVision AB 
Sweden 
DC-1 
MilliporeSigma/Amnis 
U.S. 
Amnis ImageStreamX Mark II   
Equalis   
Sweden 
CellaVision Proficiency Software, hematology quality control 
HORIBA Medical 
Japan 
Medica’s EasyCell cell image system 
HORIBA Medical 
France 
Medica's EasyCell assistant with Horiba analyzers 
Medica Corporation 
U.S. 
EasyCell assistant cell image analyzer, differential  
Morphogo 
China 
Morphogo hematology 
Roche 
U.S. 
Cobas m 511 Bloodhound 
Scopio Labs 
US 
Scopio X100 
Sysmex Corp 
Japan 
MilliporeSigma Amnis imaging cytometry for hematology  
Sysmex America 
U.S. 
Medica's EasyCell assistant with Sysmex analyzers 
Sysmex Corp 
Japan 
Sysmex DI-60 cell image analysis workcell, CellaVision  
West Medica 
Austria 
Vision Hema Capture digital microscopy 
West Medica 
Austria 
Vision Hema hematology analyzer differential automated  
Source: company reports, Kalorama Information 
Digital Evolution 
Hematology laboratories, like their histology counterparts, continue to adopt technologies 
that reduce cost and turnaround time while maintaining or improving quality. Digital imaging 
has become an important tool in this effort, using cameras, optics, and controlled illumination 

 
 
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to convert images of blood cells into digital data that can be analyzed, stored, shared, and 
reviewed beyond the limits of traditional microscopy. This supports standardized workflows, 
remote access, and more efficient use of skilled personnel. CellaVision offers widely used 
systems for digital differential analysis, enabling images from smaller or satellite laboratories 
to be reviewed at centralized sites, thereby extending expertise across networks and 
addressing staffing constraints. Its platforms, including compact systems designed for small- 
to mid-sized laboratories, enable facilities to transition from manual microscopy to digital 
workflows by automating parts of the white blood cell differential and supporting red blood 
cell morphology assessment and platelet estimation. More recent developments include 
expanded software capabilities that improve workflow, case review, and cross-site 
collaboration, as well as the ability to compare current and historical patient results. 
 Digital morphology is also advancing into more specialized applications, such as bone 
marrow analysis, reflecting a broader trend toward standardization in complex hematology 
workflows. At the same time, integration with automated slide preparation, staining systems, 
and hematology analyzers is becoming more seamless, supporting end-to-end automation 
and faster turnaround times. Partnerships and connectivity with major analyzer vendors such 
as Sysmex Corporation are further accelerating adoption, positioning digital hematology as 
an increasingly routine part of modern laboratory operations rather than a niche capability. 
Quality Control Measurement Programs 
A number of companies offer quality control for hematology. A selected list is compiled 
below. 
 
 

 
 
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Table 9-4: Selected Quality Control Hematology FDA Registrations, 2024 
Company 
Product 
Abbott Laboratories 
CELL-DYN Retic Plus Control 
Advanced Instruments, LLC 
GloCyte Automated Cell Counter System; GloCyte Low- and High-Level Controls 
AirScan, Inc. 
HemaTechnologies ESR Control 
Beckman Coulter - Danaher 
4C Plus TRI Pack 
4C-ES Cell Control 
5C Cell Control 
6C Cell Control; 6C Plus Cell Control (PN C07297) 
AcT 5diff Control Plus 
Body Fluid Control 
FLOW-SET 
IMMUNO-TROL LOW CELLS 
IMMUNO-TROL WHOLE BLOOD CONTROL 
LIN-C Linearity Control 
LIN-X Linearity Control 
Retic-C Cell Control; Retic-X Cell Control 
TruColor Giemsa Stain Kit; TruColor May Grunwald Stain Kit; TruColor Wright Buffer 
Kit; TruColor Wright Giemsa Stain; TruColor Wright's Giemsa Buffer Kit; TruColor 
Wright's Giemsa Stain Kit; TruColor Wright's Stain Kit 
BECTON, DICKINSON & CO. 
BD FACSPresto CD4/Hb Cartridge; BD FACSPresto CD4/Hb Cartridge Kit; BD 
FACSPresto System; BD Multi-Check CD4 Low Control; BD Multi-Check Control; 
Eurotrol FACSPresto Hb Controls (Levels 1-3) 
BD Leucocount Combo Control; BD Leucocount PLT Control; BD Leucocount RBC 
Control; BD Retic-Count Control; BD Multi-Check CD4 Low Control; BD Multi-Check 
Control; BD Stem Cell Control 
Bioarray Solutions Ltd 
PreciseType HEA BeadCheck Kit 
Bionostics, Inc. 
RNA Medical QCHGB Control 

 
 
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Company 
Product 
Bio-Rad Laboratories 
Liquichek Hematology Control (X) 
Liquichek Hematology Control (A) 
Liquichek Hematology Control (C) 
Liquichek Hematology Control (S) 
Liquichek Hematology-16T Control 
Liquichek Reticulocyte Control (A) 
Liquichek Reticulocyte Control (A-1) 
Liquichek Reticulocyte Control (C) 
Liquichek Reticulocyte Control (S) 
Liquichek Reticulocyte Control (X) 
Meter Trax Control 
EKF Diagnostics GmbH 
Hemocontrol 
High Technology Inc 
Hemoglobin Control Set 
Horiba/ABX 
ABX DIFFTROL 
ABX ERYTROL 
ABX Minotrol 16 
ABX MINOTROL CRP 
ABX MINOTROL RETIC 
JAS Diagnostics/Drew 
Scientific 
DS360 HbA1c 2-Level Control Kit; DS5 HbA1c 2-Level Control Kit 
EX-Trol Controls (Low, Normal, High) 
EX-Trol Plus Controls (Low, Normal, High) 
MedTest Dx (Horiba) 
Hemoglobin A1c Controls (H7546-CTL); MedTest DX Hemoglobin A1c Controls 
(HBAQ400, HBAQ480) 
Hemoglobin Controls 
Microgenics Corporation 
Thermo Scientific HEMA-TROL¿ Whole Blood HGB 
Mindray DS USA Inc 
BC-3D Control 
B55 Hematology Control 
BC-6D Hematology Control 
BC-RET Hematology Control 
BC-BF Hematology Control 
SC-CAL Plus Hematology Calibrator 
Nova Biomedical 
Corporation 
Nova 16 
Nova Stat Profile Critical Care Xpress 
Nova Stat Profile PHOx 
Nova Stat Profile PHOx Basic 
Nova Stat Profile PHOx Plus C 
Stat Profile PHOx Plus L 
Stat Profile Prime Plus 

 
 
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Company 
Product 
Progenika Biopharma S.A. 
ID CORE CONTROL 
Quantimetrix Corporation 
Spinalscopics Spinal Fluid Cell Count Control 
R&D Systems Inc 
3K Retic Hematology Control 
4K Retic Hematology Control 
BC-5D Hematology Controls 
Body Fluid Control 
Body Fluid-I Control 
CBC-3D; CBC-3D For Mindray 
CBC-3D+CRP Hematology Control 
CBC-3K; CBC-4K; CELL-DYN Drift Control 
CBC-4K Plus Retics 
CBC-5D Hematology Control 
CBC-5D Plus Retics Hematology Control 
CBC-7; CBC-7 For Hemocue; CBC-8; HGB Extended 
CBC-LINE For HemoCue Linearity Kit; CBC-LINE Linearity Kit; CBC-LINE Low Range 
Linearity Kit; CBC-LINE Ultra Low Linearity Kit; CBC-LINE Ultra Low Plus RBC 
Hematology Linearity Kit; PLT-LINE Linearity Kit 
CBC-SYS Hematology Control 
CBC-Tech 
CBC-X 
CBC-XE Hematology Control 
CSF Automated Control 
Diesse ESR Control; SEDRite III; SEDRite Plus 
HC WBC Hematology Control 
HCT Extended Control 
LH-NRBC Hematology Control 
Platelet-Trol II 
QBC Hematology Control 
R&D ADVIA Retic Plus 
R&D Platelet-Trol Extended 
R&D Retic-I Plus 
Retic Hematology Control; Retic-I 
RET-LINE B Linearity Kit; RET-LINE C Linearity Kit; RET-LINE Linearity Kit 
XERet Hematology Control 

 
 
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Company 
Product 
Randox Laboratories Ltd 
RANDOX HEMATOLOGY CONTROL - LEVEL 1 (HAEM CNTL - LEVEL 1); RANDOX 
HEMATOLOGY CONTROL - LEVEL 2 (HAEM CNTL - LEVEL 2); RANDOX HEMATOLOGY 
CONTROL - LEVEL 3 (HAEM CNTL - LEVEL 3) 
Shenzhen Mindray Bio-
Medical Electronics Co., Ltd 
BC-3D CONTROL (Low, Normal and High) 
BC-5D Hematology Control 
Siemens 
ADVIA 120; ADVIA 120/2120; ADVIA 2120 
ADVIA 120; ADVIA 120/2120; ADVIA 2120 
ADVIA Hematology 
Stanbio Laboratory 
Hematology Quality Control 
Streck, Inc 
Alinity H-Series Control 29P 
Beckman Coulter IQ Body Fluids 
Cell-Chex Auto 
CELL-DYN Retic Plus Control; Retic-Chex for CELL-DYN 
CSF Reagent (1 X 8 ML) 
CVA; CVA for CELL-DYN; Sysmex Plt-CHECK; Sysmex RANGE CHECK X II; Sysmex RANGE 
CHECK X III; WRP CHECK; WRP CHECK EX 
EIGHTCHECK-3WP; EIGHTCHECK-3WP X-TRA; Para Check 
Para 4 
Retic-Chex II 
Retic-Chex Linearity For BC 
Sysmex E-CHECK XE 
Sysmex E-CHECK; Sysmex E-CHECK XS 
TESTpoint CSF Controls (2 X 3 ML) 
TESTpoint Retic High Control (4 X 4 ML); TESTpoint Retic Low Control (4 X 4 ML) 
UA-Cellular For IQ 
XN CHECK 
XN CHECK BF 
XN-L CHECK 
XW QC CHECK 
STS Corporation 
STSC, General, Mixture, Hematology Quality Control 
Sysmex America Inc 
Plt-CHECK; WRP CHECK; WRP CHECK EX 
XW QC CHECK 

 
 
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Company 
Product 
Sysmex Corporation 
E-CHECK(XE) 
E-CHECK; E-CHECK(XS) 
EIGHTCHECK-3WP; EIGHTCHECK-3WP IQAS 
Plt-CHECK; WRP CHECK; WRP CHECK EX 
XN CHECK 
XN CHECK BF 
XN-L CHECK 
XW QC CHECK 
Source: FDA database 

 
 
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Laboratory-based Hematology Testing 
Laboratory-based hematology IVD testing is a cornerstone of clinical diagnostics, combining 
automated cell counting with coagulation testing, flow cytometry, and, increasingly, 
molecular and genomics-based methods. The field is more integrated and digitized than in 
the past, with automation, connectivity, and advanced parameters supporting faster decision-
making and more consistent results. Hematology plays a huge role in infection management, 
anemia evaluation, oncology support, and overall patient monitoring, while more specialized 
genomic insights are typically generated on separate molecular platforms and then integrated 
into clinical workflows. 
Sysmex Corporation continues to lead the market with its XN series, including high-
throughput systems such as the XN-9000, which provide advanced parameters such as 
nucleated red blood cells, immature granulocytes, reticulocyte hemoglobin, and immature 
platelet fraction, along with strong automation and connectivity. Beckman Coulter is a major 
competitor with its DxH series and integrated slide maker and stainer systems, supporting 
automated workflows, advanced flagging, and reduced manual intervention. Abbott 
Laboratories offers its Alinity h-series with integrated slide preparation and scalable 
automation, while Siemens Healthineers provides high-volume solutions through the Atellica 
HEMA systems, emphasizing workflow efficiency and system-wide integration. 
Mindray has become an increasingly important competitor, particularly in high-throughput 
and cost-sensitive segments. Its BC-6800 series uses multi-dimensional cell analysis to 
improve detection of abnormal cell populations, while the CAL-8000 system integrates 
analyzers with slide-making and staining into a fully automated workcell capable of 
continuous loading, intelligent sample routing, and minimal manual handling. The company 
has also expanded into compact systems that combine CBC and ESR testing, extending 
advanced hematology capabilities into smaller laboratories and decentralized settings. 
The cobas m 511 is Roche’s offering in the hematology analyzer market, and it’s positioned 
differently from most competitors. It combines a standard CBC with integrated digital 
morphology in a single system, enabling it to perform cell counts and automatically prepare, 
stain, image, and classify blood cells within a single workflow. This is a key differentiator, 
as most other vendors rely on separate systems (like CellaVision) for digital morphology. 
 

 
 
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Horiba continues to compete with its Yumizen and Pentra platforms, offering compact 
systems with 5-part differentials, reticulocyte analysis, and integrated ESR capabilities, 
particularly for mid- and lower-volume laboratories. Across the market, the main areas of 
advancement include tighter integration of analyzers with slide preparation, staining, and 
digital imaging; expanded clinical parameters that support earlier detection of conditions 
such as sepsis and iron-restricted erythropoiesis; and improved middleware and decision-
support tools that standardize workflows. High-end systems now function as part of fully 
automated workcells with bidirectional sample transport, automated rerun and reflex testing, 
and the ability to prioritize urgent samples without interrupting routine operations. At the 
same time, vendors continue to introduce smaller, lower-cost systems with advanced 
capabilities, reinforcing the shift toward fully integrated, automated, and connected 
hematology solutions rather than standalone instruments.  

 
 
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Table 9-5: Selected Hematology Innovations 
Company 
Location 
Details 
Abbott 
U.S. 
Alinity h-series integrated hematology testing system 
Diatron MI Plc 
Hungary 
Abacus 3CP, automated, bench-top hematology analyzer 
HORIBA Medical 
Japan 
Microsemi CRP hematology analyzer, CBC & CRP 
HORIBA ABX 
France 
ABX Micros ES 60, desktop  
HORIBA ABX 
France 
Pentra XLR, fluorescent retics 
HORIBA ABX 
France 
Yumizen H500 hematology systems 
HORIBA ABX 
France 
Yumizen H550 hematology solution 
HORIBA Medical 
Japan 
Pentra DX Nexus analyzer, 8-part diff 
HUMAN Diagnostics 
Germany 
HumaCount 80TS, automated 3-part differential 
Mindray Medical 
China 
Mindray BC-5390 Auto Hematology Analyzer & BC-7500 
Mindray Medical 
China 
BC-5150, 5-part mid-sized volume, BC-700 Series 
Mindray Medical 
China 
BC-30s Auto Hematology Analyzer, compact 3 part  
Mindray Medical 
China 
CAL-8000, BC-6800 analyzer with slide maker/stainer SC-120  
Mindray/MedTest Dx 
China 
Mindray BC-3600 Auto Hematology Analyzer 
Nihon Kohden 
Japan 
MEK-1303 automated hematology analyzer 
Radiometer America 
U.S. 
ABL90 blood gas analyzer 
Roche Diagnostics 
U.S. 
Cobas m511 integrated hematology analyzer 
Shenzhen Dymind  
China 
DH-56 hematology with flow cytometry 
Siemens Healthineers 
Germany 
Atellica HEMA 
Sysmex Corp 
Japan 
XN series of automated hematology analyzers 
Trinity Biotech 
U.S. 
Premier Resolution System 
Source: Kalorama Information, company reports 
 

 
 
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Table 9-6: Global Laboratory-based Hematology Test and Instrument Market, 2025 and 2030 ($ million) 
Market 
2025 
2030 
CAGR 
Lab-based hematology analyzers/reagents 
5,495 
7,455 
6.3% 
Source: Kalorama Information 
Regional Laboratory-based Hematology Test and Instrument Market 
The United States and Canada account for the largest share of sales for hematology in the 
laboratory segment with 44%, followed by Europe with 30%, Asia Pacific with 20% (of 
which Japan accounts for over half of Asia Pacific sales) and ROW with the remaining 6%.   
Table 9-7: Global Laboratory-based Hematology Test and Instrument Market, by Region, 2025 (%) 
 
[Asia Pacific; Europe; North America; Rest of World] 
 Region 
% Mkt 
North America  
44% 
Europe 
30% 
Asia Pacific 
20% 
RoW 
6% 
Total 
100% 
Source: Kalorama Information 

 
 
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Decentralized Hematology Testing 
The complete blood count is one of the most widely used diagnostic tests, and its role has 
expanded beyond the central laboratory into decentralized and near-patient settings. Growth 
in physician offices, outpatient clinics, urgent care centers, and oncology treatment sites is 
driving demand for compact hematology systems that deliver rapid results with minimal 
operator intervention. While centralized laboratories still account for the majority of testing 
volume, decentralized hematology is gaining traction, with an estimated 10%–20% of testing 
performed outside the core lab, depending on region and healthcare structure. This shift is 
supported by the need for faster turnaround times, reduced dependence on highly trained 
staff, and the continued movement of patient care into outpatient settings. 
Technology in this segment focuses on ease of use, a small footprint, and workflow 
simplification. Decentralized systems are typically benchtop analyzers rather than fully 
handheld devices, but they are designed to support both venous and capillary samples, 
including fingerstick collection. Many systems incorporate cartridge-based or closed-tube 
systems to minimize sample handling and reduce contamination risk. At the same time, 
improved connectivity allows these instruments to link with laboratory information systems 
and provide remote oversight, enabling centralized review of results across distributed sites. 
Sysmex Corporation, Beckman Coulter, Abbott Laboratories, Siemens Healthineers, and 
Mindray all offer compact hematology analyzers designed for lower-volume environments, 
extending core lab capabilities into decentralized settings. Other companies, such as PixCell 
Medical, are helping to define the emerging near-patient segment with cartridge-based 
systems like HemoScreen, which provide 5-part differentials using small sample volumes 
and simplified workflows. 
Despite these advances, true point-of-care CBC testing remains an emerging segment, with 
most decentralized testing still performed on small analyzers that operate similarly to 
laboratory instruments. Adoption is expected to grow steadily as technology continues to 
simplify operations, integrate quality control, and expand clinical parameters. Increasing use 
of advanced CBC-derived metrics—such as immature granulocytes, reticulocyte 
hemoglobin, and platelet indices—at the point of care is also enhancing clinical decision-
making without requiring additional tests 

 
 
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Hemoglobin/Hematocrit at the POC 
Dedicated POC devices for hemoglobin/hematocrit have been available for many years.  
Hemoglobin test systems are used by office labs, hospitals, blood banks, dialysis centers, and 
public health agencies.  The pioneer and leader in this field is HemoCue (now part of 
Danaher), whose portable red device is readily recognizable in most hospitals in the U.S. 
Europe and in Asia.  HemoCue’s B-Hemoglobin Photometer was granted CLIA waived 
status in 1993.    
Table 9-8: POC Hematology Distribution, by Specialty, 2025 (%)  
 
[Hematocrit/Hemoglobin vs. Other Routine Hematology (WBC, Erythrocyte, Platelet)] 
Specialty 
Distribution of Revenue (%) 
Hematocrit/Hemoglobin POC 
60% 
Other routine hematology POC (WBC, erythrocyte, platelet, etc.) 
40% 
Total 
100% 
Source: Kalorama Information 
Decentralized hematocrit and hemoglobin testing has expanded as care has shifted to 
physician offices, outpatient clinics, urgent care centers, and blood donation settings. These 
tests are among the most commonly performed near the patient because they are simple, 
rapid, and clinically useful for screening anemia and monitoring chronic disease. The market 
is driven by the need for fast turnaround, minimal sample preparation, and ease of use for 
non-specialized staff, with many systems designed to operate with both capillary and venous 
samples. 
Established providers such as EKF Diagnostics and HemoCue offer widely used devices for 
quantitative measurement of hemoglobin and hematocrit in decentralized settings, 
particularly in clinics and blood banks. Abbott Laboratories and Nova Biomedical provide 
handheld and near-patient systems that include hemoglobin and hematocrit as part of broader 
critical care and blood gas testing menus. In addition, Radiometer, Siemens Healthineers, 
and Werfen play important roles through blood gas and acute care platforms that incorporate 
hemoglobin and hematocrit measurements in hospital and near-patient environments. 

 
 
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Masimo Corporation and OrSense Ltd. have developed noninvasive technologies that allow 
continuous or spot-check hemoglobin monitoring without a blood draw, primarily for 
screening and trending rather than definitive diagnosis. Technology trends in this segment 
emphasize portability, rapid turnaround, often within seconds to a minute, and built-in quality 
control and connectivity. Many systems now include data management features, wireless 
communication, and integration with laboratory or hospital information systems, allowing 
centralized oversight of decentralized testing. Additionally, capillary sampling is becoming 
more common, reducing the need for phlebotomy and improving patient access. While 
noninvasive methods are advancing, blood-based measurement remains the standard for 
diagnostic accuracy. 
Table 9-9: Selected POC Hemoglobin and Hematocrit Systems 
Company 
Chemistry System 
Abbott Diagnostics 
i-STAT (waived) 
ApexBio 
HemoSmart (non-U.S.) 
Boditech 
Hemochroma PLUS (non-U.S.) 
Clarity Diagnostics 
Clarity Hb Check (waived) 
DiaSys 
QDx Hemostat 
Diatron 
Aquila (non-U.S.) 
EKF Diagnostics 
Hemo Control (waived), HemoPoint H2 Hemoglobin 
System (waived), DiaSpect 
Germaine Laboratories 
AimStrip Hgb (waived) 
GlysBy 
Hematocrit Quantitative Rapid Test 
HemoCue (Radiometer) 
Hb 201+, Hb 201 DM, Hb 301 systems (waived); 
Plasma/Low Hb system 
Masimo 
Pronto-7, Rad-67 
Separation Technology (EKF Diagnostics) 
UltraCrit (waived) 
Stanbio Laboratory (EKF Diagnostics) 
STAT-Site M Hgb (waived) 
Source: Kalorama Information 

 
 
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Hematology analyzers for small laboratories and near-patient settings represent one of the 
most competitive segments of the market, with numerous manufacturers and OEM suppliers 
offering compact, lower-cost systems. These instruments are typically semi-automated and 
often provide 3-part differentials, although newer models increasingly include expanded 
parameters and improved automation. While many are described as point-of-care, most 
function as low-volume laboratory analyzers rather than true bedside devices. Companies 
such as Nihon Kohden, Mindray, Boule Diagnostics, Diatron, QBC Diagnostics, and Orphée 
remain active in this segment, particularly in regional and cost-sensitive markets. 
For hemoglobin and hematocrit testing specifically, decentralized solutions are well 
established and widely used. Nova Biomedical offers near-patient systems such as StatStrip 
that provide rapid, direct measurement of hemoglobin and hematocrit from capillary or 
venous samples and are used in blood banks, dialysis centers, and outpatient settings. EKF 
Diagnostics and HemoCue continue to lead in dedicated hemoglobin testing devices for 
screening and monitoring. Abbott Laboratories and Radiometer, along with Siemens 
Healthineers and Werfen, provide hemoglobin and hematocrit measurements through blood 
gas and critical care platforms used in near-patient and hospital environments. 
Additional innovation is occurring in noninvasive and home-based testing. Masimo 
Corporation and OrSense Ltd. offer noninvasive hemoglobin monitoring technologies for 
screening, while Sanguina provides a home-use hemoglobin test for consumer screening. 
Emerging systems, such as those from Ad Astra Diagnostics, are working to bring more 
advanced hematology parameters closer to the point of care, although adoption remains in its 
early stages.  
 

 
 
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Table 9-10: Selected POC Hematology Analyzer Systems 
Company 
System* 
Abbott Diagnostics 
Cell-Dyn Emerald, Cell-Dyn Pearl 
Beckman Coulter 
Ac·T 5diff, Ac·T diff, Ac·T diff2, DxH 50 AL 
Boule Diagnostics 
Medonic M-16/M-20 (various sample configurations), Swelab Alfa, Quintus 
DiaSys 
Innova Star, SensoStar 
Diatron 
Abacus 5, Abacus 380, Abacus 3 CT, Abacus Junior 30, Abacus Junior 30 ND 
HORIBA Medical 
Pentra 60, Pentra 60C+, Pentra ES 60, Micros 60, Micros ES 60, Micros CRP 200, 
Microsemi CRP, Yumizen H500 
Instrumentation Labs 
GEM Premier 4000 
Mindray 
BC-5300, BC-5150, BC-5000, BC-3600, BC-3200, BC-3000Plus, BC-2800, BC-2300 
Nihon Kohden 
Celltac F MEK-8222, Celltac Es MEK-7300, Celltac E MEK-7222, Celltac a MEK-6500, 
Celltac a MEK-6400 
Orphée 
Mythic 18, Mythic 22 AL, Mythic 22 OT, Mythic 22 CT 
PixCell Medical Technologies 
HemoScreen Hematology Analyzer 
QBC Diagnostics 
QBC STAR 
Radiometer 
ABL FLEX90 PLUS 
Siemens Healthineers 
RAPIDPOINT 405 
Sysmex 
pocH-100i, XP-300, KX-21N, XW-100 
Note: *Not all systems available in the United States 
Source: Kalorama Information 
As the industry develops, there is a concerted demand for lab-style and handheld hematology 
test devices for physician offices and clinics, as well as rural centers, worldwide.  The 
handheld-style device is especially in demand in developing countries, where almost no 
diagnostic services are available outside urban centers.  Therefore, Kalorama estimates that 
the world market for decentralized hematology tests and instruments is $951 million in 2025 

 
 
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($723 for lab-style instruments and $228 for handheld devices).  With 5.3% annual growth, 
this market segment will reach $1,230 million by 2030. 
Table 9-11: Decentralized Hematology Test and Instrument Market, by Type, 2025 and 2030 ($ million)  
 
[Instruments, Lab-Style; Handheld Devices] 
 Type 
2025 
2030 
CAGR 
Lab-type instruments 
723 
947 
5.5% 
Handheld devices 
228 
283 
4.4% 
Total POC Hematology 
951 
1,230 
5.3% 
Source: Kalorama Information 

 
 
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Market Analysis: Leading Suppliers 
Growth in the hematology market is being fueled by several key factors, including the 
increasing adoption of automated hematology instruments, expanding market penetration of 
POC hematology testing, and the introduction of technologically advanced analyzers.  
In the United States, sales remain moderate. Growth is supported by an aging population and 
a heightened emphasis on laboratory testing as a critical tool for diagnosis and treatment. 
Nevertheless, the overall market has been tempered by a highly cost-conscious healthcare 
environment. Additionally, replacement demand for hematology analyzers in this mature 
market has been affected by continued laboratory consolidation and the growing influence 
of group purchasing organizations, which have contributed to pricing pressures and slowed 
instrument turnover. 
The indicators mentioned above, in addition to other macro-economic factors provide, 
Kalorama’s estimate indicates that hematology vendors can expect the global market to show 
2% annual growth from $6,446 million in 2025 to $7,175 million in 2030, including lab based 
and POC.  The major players in this discipline are Sysmex, Beckman Coulter/Danaher, 
Roche, Mindray and Siemens Healthineers.  In 2025, the top five companies hold 
approximately $4.6 billion or nearly 71% of the hematology market.   
Table 9-12: Top Hematology Company Revenues (Laboratory and POC), 2025 ($ million) 
Company 
Revenues 
Market Share % 
Sysmex 
$2,019 
31% 
Beckman Coulter/Danaher 
$884 
14% 
Roche 
$630 
10% 
Mindray 
$607 
9% 
Siemens 
$453 
7% 
Others 
$1,853 
29% 
Total 
$6,446 
100% 
Source: Company reports and Kalorama Information 

 
 
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Figure 9-1: Market Share for Top Hematology Companies (Laboratory and POC), 2025 (%) 
 
Source: Kalorama Information 
Sysmex Corporation continues to hold a strong global position, supported by its leadership 
in Asia and ongoing expansion into emerging markets. China remains an important region, 
although growth has moderated compared with earlier periods, particularly in more mature 
segments such as hemostasis instruments. The company maintains a well-balanced 
geographic revenue mix across EMEA, the Americas, Japan, China, and the broader Asia 
Pacific region, reflecting its diversified global footprint. 
Sysmex’s competitive strength is driven by the breadth of its product portfolio and its ability 
to integrate systems into automated core laboratory environments. Its hematology platforms, 
led by the XN series, are widely used and can be connected to track-based automation 
systems for high-throughput laboratories. Sysmex has strengthened its position by expanding 
the range of advanced clinical parameters available on its systems, including immature 
granulocytes, reticulocyte hemoglobin, and immature platelet fraction, which are 
increasingly used for infection detection, anemia management, and clinical decision support. 

 
 
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The company also benefits from a strong installed base supported by recurring reagent and 
service revenue, which reinforces long-term customer retention. Sysmex has expanded its 
reach into mid- and low-volume laboratories with compact analyzers and simplified 
workflows, enabling it to compete more effectively in decentralized and emerging-market 
settings. 
Table 9-13: Global Hematology (Laboratory-based and POC) Sales Distribution, by Region, 2025 (%) 
 
[Asia Pacific; Europe; North America; Rest of World] 
Region 
% Mkt 
North America  
43% 
Europe 
32% 
Asia Pacific 
19% 
RoW 
6% 
Total 
100% 
Source: Kalorama Information 

 
 
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The Commercial Outlook for Hematology Tests 
The hematology market in 2025–2026 continues to evolve, driven by steady clinical demand, 
advances in automation, and ongoing pressure to improve laboratory efficiency. Growth 
remains largely incremental rather than disruptive, with innovation focused on enhancing the 
clinical value of routine testing and improving workflow. The expansion of advanced 
parameters on hematology analyzers and the broader use of body fluid analysis have helped 
sustain interest in the sector, while laboratories continue to upgrade to more automated and 
connected systems. 
In developed markets, growth is modest due to high penetration of automated hematology 
systems, while growth is stronger in emerging regions as access to diagnostics improves. 
Vendors such as Sysmex Corporation, Beckman Colter, and Mindray are driving the adoption 
of fully automated workcells that integrate analyzers with slide preparation, staining, and 
digital imaging. These systems support higher throughput, reduce manual intervention, and 
address ongoing staffing constraints in laboratories. 
A trend is the increasing use of advanced CBC-derived parameters for clinical decision 
support. Measurements such as immature granulocytes, reticulocyte hemoglobin, neutrophil-
to-lymphocyte ratio, and platelet indices are increasingly used to support early detection of 
infection, assess sepsis risk, and guide anemia management without requiring additional 
tests. At the same time, digital morphology solutions, including those from CellaVision, are 
becoming more widely adopted, enabling automated pre-classification of cells, remote 
review, and improved standardization across laboratory networks. 
Decentralized and near-patient hematology testing is also gaining traction, particularly in 
outpatient and lower-volume settings, supported by smaller instruments, simplified 
workflows, and improved connectivity. However, most testing continues to be performed in 
centralized laboratories, with decentralized systems functioning as an extension of the core 
lab.  

 
 
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Chapter 10: Coagulation 
Scope 
The coagulation market consists of all products, technologies and services used to assess 
blood clotting function for diagnosis, monitoring and associated reagents. It is divided 
into laboratory-based systems and decentralized/POC devices and consumables.  
 

 
 
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Overview and Trends of Coagulation and Immunohematology Tests  
Hemostasis is a complex physiological process that maintains blood flow while preventing 
excessive bleeding. It involves a balance among coagulation, platelet function, and 
fibrinolysis, ensuring that clots form when needed and are removed once healing occurs. In 
clinical practice, disruption of this balance can lead to bleeding or thrombotic disorders, 
making hemostasis testing a critical component of patient management. 
Anticoagulant and antithrombotic therapies are widely used to reduce the risk of thrombotic 
events such as stroke, myocardial infarction, deep vein thrombosis, and pulmonary 
embolism. Warfarin remains in use, particularly in patients with mechanical heart valves and 
certain high-risk conditions and requires regular monitoring using prothrombin time 
expressed as the international normalized ratio (PT/INR) to maintain appropriate dosing. 
However, direct oral anticoagulants such as rivaroxaban, apixaban, and dabigatran are now 
widely used and generally do not require routine laboratory monitoring. When testing is 
performed for these agents, it is typically in specific clinical situations such as bleeding, 
urgent surgery, or suspected overdose, and standardized testing approaches are still evolving 
across laboratories. 
Heparin continues to be used primarily in hospital settings, with monitoring performed using 
activated partial thromboplastin time (aPTT) or, increasingly, anti-factor Xa assays, which 
offer improved specificity and are now widely adopted. Heparin-induced thrombocytopenia 
remains a serious immune-mediated complication requiring confirmation through antibody 
and functional testing.  
The routine coagulation test menu includes PT/INR and aPTT for screening, as well as 
fibrinogen, D-dimer, and molecular coagulation testing. More specialized testing includes 
coagulation factor assays for conditions such as hemophilia and von Willebrand disease, as 
well as evaluation for antiphospholipid syndrome using markers such as anticardiolipin and 
anti-beta2 glycoprotein I antibodies. Genetic testing for thrombophilia, including Factor V 
Leiden and Prothrombin G20210A, is used selectively in patients with unexplained or 
recurrent thrombotic events, with more targeted use in current clinical practice and is 
discussed in Chapter 8.  
Advances in automation and integration have expanded the role of coagulation testing within 
the core laboratory. D-dimer and certain chromogenic assays are now commonly performed 
on high-throughput chemistry and immunoassay platforms, improving turnaround time and 

 
 
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workflow efficiency. At the same time, dedicated coagulation analyzers continue to support 
both routine and specialized testing, increasingly integrated into automated laboratory lines 
with middleware and decision-support rules. 
Demand for decentralized coagulation testing is also increasing, particularly in 
anticoagulation clinics and physician offices, where point-of-care PT/INR systems allow 
rapid dose adjustment for warfarin therapy. Growth is driven by the number of patients on 
anticoagulant therapy and the need for timely clinical decisions. Special Topics 
There are several developments that warrant special discussion as they have significant 
impact on the development of coagulation testing. 
COVID-19 
COVID-19 is recognized as a hypercoagulable state, particularly in moderate to severe 
disease. Early in the pandemic, clinicians observed increased rates of venous 
thromboembolism, microvascular thrombosis, and, in critical cases, disseminated 
intravascular coagulation, although the coagulopathy seen with COVID-19 differs from 
classic consumptive DIC and is often characterized by elevated fibrinogen and D-dimer 
rather than severe factor depletion. Coagulation biomarkers, especially D-dimer, were 
strongly associated with disease severity and outcomes, and monitoring of D-dimer, 
prothrombin time, platelet count, and fibrinogen became standard in hospitalized patients to 
support risk assessment and management. 
Management has since evolved. Routine prophylactic anticoagulation remains standard for 
hospitalized patients, but more aggressive anticoagulation strategies are now applied 
selectively based on risk. While thrombotic complications remain a concern, rates have 
declined compared with the early pandemic period due to improved treatment protocols and 
vaccination. 
In post-acute and long-COVID settings, evidence of persistent coagulation abnormalities is 
variable, but there is continued clinical interest in potential endothelial dysfunction and low-
grade hypercoagulability in some patients. This remains an area of ongoing research rather 
than a clearly defined clinical standard. 
 

 
 
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Professional organizations such as the American Society of Hematology, the International 
Society on Thrombosis and Hemostasis, the American College of Cardiology, and the British 
Society for Hematology continue to provide guidance on thrombosis risk assessment and 
anticoagulation management in COVID-19, though current recommendations are more 
refined and less aggressive than those issued early in the pandemic. 
Direct Oral Anticoagulants (DOACs)  
Direct oral anticoagulants (DOACs)—including apixaban, rivaroxaban, edoxaban, and 
dabigatran—remain the standard of care in 2026 for many thromboembolic conditions, 
including nonvalvular atrial fibrillation and venous thromboembolism. No new DOACs have 
been introduced in recent years, and this group continues to dominate due to predictable 
pharmacokinetics, fixed dosing, and the lack of routine monitoring requirements. Clinical 
practice emphasizes targeted laboratory testing only in specific situations such as bleeding, 
urgent procedures, renal impairment, or suspected overdose, rather than routine monitoring. 
The most important area of innovation in this space is the development of next-generation 
anticoagulants targeting Factor XI and Factor XIa in the coagulation cascade. These agents 
are being evaluated as potential successors to current therapies, with the goal of reducing 
thrombotic risk while minimizing bleeding complications, which remains the primary 
limitation of existing anticoagulants. Early clinical data suggest that they may offer 
comparable efficacy with improved safety, particularly regarding bleeding risk. In addition 
to oral agents, some are being developed as long-acting injectable therapies, offering the 
potential for less frequent dosing and greater flexibility in patient management. 
Although monitoring is not required for patients on DOAC therapy, it has been recognized 
that there are exceptions when measurement may be appropriate.  Examples include patients 
who present to the ED with an adverse event, require immediate reversal of anticoagulation, 
experience renal or liver failure, have suspected or known interaction with other drugs, or 
require verification of pre-operative drug clearance. 
It is beyond the scope of this research to quantify the market for DOAC tests with certainty.  
However, coagulation leaders Diagnostica Stago and Werfen remain committed to this genre 
of tests. 

 
 
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D-dimer 
D-dimer testing has been in clinical use since the 1990s and has become a routine tool for 
evaluating suspected thrombotic disease. It measures a fibrin degradation product formed 
when cross-linked fibrin is degraded during fibrinolysis, and its presence indicates recent or 
ongoing clot formation and breakdown. D-dimer testing is widely used to help exclude 
conditions such as deep vein thrombosis and pulmonary embolism in selected patients, and 
it is also used in the evaluation of disseminated intravascular coagulation. Its clinical value 
lies primarily in its high sensitivity and strong negative predictive value rather than 
specificity, and it is now increasingly used within structured diagnostic algorithms, including 
age-adjusted and risk-adapted approaches that improve clinical efficiency and reduce 
unnecessary imaging. 
Testing is performed using both laboratory-based and point-of-care methods. Laboratory 
testing remains dominant and is carried out on automated coagulation analyzers as well as 
on core laboratory chemistry and immunoassay platforms. Over time, D-dimer has become 
one of the most prominent coagulation assays to migrate into the core laboratory 
environment, driven by high-throughput immunoassay methods, continuous availability, and 
faster turnaround times. Point-of-care and near-patient D-dimer testing has expanded in 
emergency and acute care settings, providing rapid triage and clinical decision-making. 
A wide range of manufacturers offer D-dimer assays across different platforms, including 
Roche, Abbott Laboratories, Beckman Coulter, Siemens Healthineers, Sysmex Corporation, 
and Thermo Fisher Scientific, along with coagulation-focused specialists such as Werfen and 
Diagnostica Stago, and specialty reagent providers including Diazyme Laboratories and 
Nordic Biomarker.  
Annually, over 67 million D-dimer tests are performed worldwide.  Considering the test cycle 
and an increase in population growth over the forecast, and an average cost of $18-$19 per 
test (which includes cost of reagents, calibration and devices) the market for D-dimer tests 
performed in laboratories is $1,475 million in 2025.  With 3.0% CAGR the market for D-
dimer tests is likely to reach $1,710 million in 2030.   
European coagulation professionals were the first to recognize the D-dimer test as an 
important tool for evaluating a patient’s risk of a cardiac event related to thrombotic activity.  
In the U.S., this linkage was slower to take effect.  As such the demand for D-dimer tests is 
robust in Europe in terms of volume accounting for about half of all test volume; however, 

 
 
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in the U.S. most tests are performed on special coagulation instrumentation, which, in turn, 
carries a slightly higher unit cost. Together, this places the market value about equal for North 
America and Europe with roughly 37% and 36% respectively. 
Table 10-1: Global D-dimer Sales Distribution, by Region, 2025 (%) 
 
[Asia Pacific; Europe; North America; Rest of World] 
 Region 
% Mkt 
North America 
37% 
Europe 
36% 
Asia Pacific 
14% 
RoW 
13% 
Total 
100% 
Source: Kalorama Information 
Horiba offers D-dimer testing within its Yumizen G hemostasis platform, including systems 
such as the G200, a two-channel analyzer designed for lower-throughput laboratories. These 
systems enable small and mid-size labs to perform routine coagulation screening, clotting 
factor assays, and D-dimer testing as part of an integrated workflow. Horiba has also 
expanded functionality on its hematology platforms, including malaria screening on the ABX 
Pentra XL 80 and Pentra XLR, although this is separate from its coagulation portfolio. 
LumiraDx (Roche) developed a rapid, quantitative D-dimer test capable of delivering results 
from a fingerstick sample within minutes, with a CE-marked exclusion claim for use in ruling 
out venous thromboembolism when combined with clinical probability assessment. The 
system demonstrated very high negative predictive value at standard cutoff levels, supporting 
its use in low-risk patients to avoid unnecessary imaging. 

 
 
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Market Analysis 
The increasing complexity of both routine and specialized coagulation assays has driven the 
use of information technology tools to support clinical decision-making. As test menus 
expand and interpretation becomes more complex, particularly with newer anticoagulants 
and specialized assays, clinicians rely more on digital resources to guide test selection and 
understand results. While early adoption included standalone mobile applications, the trend 
has shifted toward integration of decision support within laboratory information systems, 
middleware, and electronic medical records, allowing more seamless and standardized 
interpretation at the point of care. 
Diagnostica Stago provides educational tools such as the iHemostasis application, which 
offers reference material on the coagulation cascade, fibrinolysis, testing pathways, and 
interpretation guidelines. Although standalone apps remain available, most vendors now 
emphasize integrated digital platforms, automated flagging, and rule-based interpretation 
embedded within laboratory workflows. Other educational tools illustrate the broader 
availability of decision-support resources, though these are generally supplementary rather 
than central to clinical practice. 
Anticoagulants are widely prescribed for conditions such as atrial fibrillation, deep vein 
thrombosis, pulmonary embolism, stroke prevention, and other thrombotic disorders. 
Coagulation testing plays a critical role in assessing patients prior to procedures and in 
monitoring therapies that affect clotting. It has long supported individualized treatment 
decisions, particularly in warfarin management, and continues to contribute to more 
personalized approaches to anticoagulation therapy. 
Technologies used in coagulation testing include clot-based assays, chromogenic assays, and 
immunoassays, with molecular diagnostics applied selectively for thrombophilia evaluation. 
The market is typically segmented into central laboratory testing and decentralized testing. 
Central laboratory testing includes routine screening assays such as PT/INR and aPTT, along 
with D-dimer and specialized coagulation factor assays. Professional point-of-care testing 
includes PT/INR systems, ACT testing for heparin monitoring, and selected near-patient 
coagulation assays used in acute care settings. Patient self-testing is largely limited to PT/INR 
monitoring for individuals on long-term warfarin therapy. 
 

 
 
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Overall product development in coagulation testing has focused on expanding anti-factor Xa 
assays for heparin and selected anticoagulant monitoring, increasing adoption of viscoelastic 
testing systems for real-time clot assessment, and advancing fully automated coagulation 
workcells integrated with core laboratory platforms. Vendors such as Werfen and 
Diagnostica Stago continue to expand automated systems and assay menus, while Sysmex  
and others are extending automation and connectivity across laboratory networks. Compact 
systems such as those from Horiba are bringing coagulation testing, including D-dimer and 
routine assays, to smaller and decentralized laboratories. Digital integration and middleware-
based decision support have become an important part of new product development, helping 
laboratories standardize interpretation and improve workflow efficiency. 
Table 10-2: Global Coagulation Sales, by Segment, 2025-2030 ($ million)  
 
[D-dimer; Molecular; Professional POC; Professional Self; PT/INR Labs] 
Segment 
2025 
% Mkt 
2030 
% Mkt 
CAGR 
PT/INR Labs 
1,576 
38% 
1,855 
39% 
3% 
D-dimer 
1,475 
36% 
1,710 
36% 
3% 
Professional POC 
805 
19% 
892 
18% 
2% 
Molecular 
218 
5% 
243 
5% 
2% 
Professional Self 
90 
2% 
95 
2% 
1% 
Total 
4,164 
100% 
4,795 
100% 
3% 
Source: Kalorama Information 
The 2025 global coagulation tests market (lab-based and all POC) is valued at $4,164 million 
and is expected to see 3.0% annual growth to reach sales of $4,795 million in 2030.  The 
market is fueled by POC tests and steady performance expected for D-dimer performed in 
the laboratory.  D-dimer generates $1,475 million for 2025, is added to the coagulation testing 
market highlighting its growing role in the market.  D-dimer, growing at 3.0% annually, is 
expected to reach $1,710 million by 2030. 
Overall, North America and Europe each account for about 37% of the market, Asia Pacific 
approximately 13%, and ROW 13%.  While more INR/PT and PTT tests are performed in 

 
 
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North America than in Europe, European labs perform more specialized coagulation factor 
tests than labs in North America.  
Table 10-3: Global Coagulation Test and Instrument Market, by Region, 2025 (%) 
 
[Asia Pacific; Europe; North America; Rest of World] 
 Region 
% Mkt 
North America  
37% 
Europe 
37% 
Asia Pacific 
13% 
RoW 
13% 
Total 
100% 
Source: Kalorama Information 

 
 
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Lab-based Testing 
Coagulation testing and instrumentation have advanced from early manual clot detection 
methods, with recent innovation focused on automation, workflow efficiency, and expanded 
test menus rather than entirely new test types. Increasing test volumes and ongoing laboratory 
staffing constraints have driven demand for higher levels of automation, integrated systems, 
and improved throughput in coagulation analyzers. 
The menu of laboratory-based coagulation tests is extensive and includes routine screening 
assays such as prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT), 
along with specialized tests such as D-dimer, fibrinogen, coagulation factor assays (Factors 
II, V, VII, VIII, IX, X, XI, XII, XIII), antithrombin, protein C and protein S, plasminogen, 
and tests for fibrinolysis and platelet function. Molecular assays, including Factor V Leiden 
and prothrombin gene mutation testing, are used selectively for thrombophilia evaluation. 
Some older tests, such as bleeding time, are now largely obsolete in routine practice and have 
been replaced by more standardized platelet function assays. 
The PT/INR test remains one of the most widely used coagulation assays and is commonly 
ordered to evaluate bleeding risk and to monitor warfarin therapy. PT assesses the extrinsic 
and common pathways of the coagulation cascade, while aPTT evaluates the intrinsic and 
common pathways. Together, these tests provide a broad assessment of coagulation function. 
INR standardization allows comparison of PT results across laboratories and is essential for 
consistent warfarin dosing. While test volumes are high globally, growth has stabilized in 
many regions due to increasing use of direct oral anticoagulants, which do not require routine 
monitoring. 
Modern coagulation analyzers are fully automated and perform clot-based, chromogenic, and 
immunologic assays on a single platform. Current systems support high-throughput testing, 
automated sample handling, and integrated quality control. Newer generations of analyzers 
are designed to integrate into automated laboratory tracks, including advanced data 
management and connectivity, and offer expanded assay menus, including D-dimer and anti-
factor Xa testing. Anti-factor Xa assays are now widely used in many laboratories for heparin 
monitoring and, in selected cases, for assessment of direct oral anticoagulants. 
Diagnostica Stago offers its STA R Max and STA Compact Max systems, which are widely 
used for coagulation testing and anticoagulant monitoring. Sysmex Corporation offers the 
CN series, including systems such as the CN-6000, designed for automated, high-throughput 

 
 
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coagulation testing with integrated workflow capabilities. Other major participants in lab-
based coagulation testing include Werfen, with its widely used ACL TOP analyzer family, 
and Siemens Healthineers, which offers the CS and Atellica COAG systems, both of which 
are widely deployed in automated core laboratory environments. Roche offers the cobas t 
511 and cobas t 711 coagulation analyzers for mid- to high-volume laboratories, supporting 
routine and specialized coagulation testing. 
Table 10-4: Selected Lab-based Coagulation Innovations 
Company 
Location 
Area 
Details 
ARUP Laboratories 
U.S. 
PGx 
PGXL's PerMIT/warfarin  
Diagnostica Stago 
France 
DOAC 
DOAC anticoagulant menu expansion 
Diagnostica Stago 
France 
instrument 
STA MAX systems - high and low volume labs 
Diagnostica Stago 
France 
instrument 
STA-ECA II Assay for Dabigatran 
Diagon Ltd 
Hungary 
instrument 
COAG family of hemostasis diagnostics systems  
HUMAN Diagnostics 
Germany 
instrument 
HumaClot Pro, fully automated bench top 
coagulation analyzer 
Instrumentation Laboratory 
(Werfen) 
U.S. 
PT/INR 
ACL TOP 300/500/700 CTS Hemostasis Testing 
Systems 
Mayo Medical Lab 
U.S. 
PGx 
The Tailored Antiplatelet Therapy, personalized 
platelet therapy  
PGXL Laboratories (Prescient 
Medicine) 
U.S. 
PT/INR 
PerMIT/warfarin  
Roche 
E.U. 
instrument 
Cobas t 511/ t 711 
Sekisui Diagnostics 
U.S. 
PT/INR 
CP3000 coagulation  
Sekisui Diagnostics 
U.S. 
PT/INR 
Coapresta 2000 (CP2000) Coagulation System 
Siemens 
U.S. 
factors 
Sysmex CS-2500 
Sysmex 
Japan 
factors 
Revohem FVIII chromogenic assay reagent 
Sysmex 
Japan 
PT/INR 
Revohem PT reagent 
Source: Kalorama Information 

 
 
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Genetic Markers of Hypercoagulopathies 
Coagulation testing has been a component of individualized patient care, particularly in 
anticoagulant selection, dosing, and monitoring. While the broader concept of personalized 
medicine has gained attention in oncology and other fields, coagulation testing has 
historically played a similar role, especially in warfarin management and in assessing 
thrombotic risk. Thrombophilia genetic testing has been part of the clinical toolbox for more 
than two decades, although its use today is more selective than in the past. 
Advances in the understanding of thrombosis and cardiovascular disease have contributed to 
both acquired and genetic risk factors. Molecular testing for inherited thrombophilia most 
commonly includes Factor V Leiden and the prothrombin G20210A mutation, which are 
associated with increased risk of venous thromboembolism. These tests are used in selected 
patients, such as those with unexplained or recurrent thrombosis, thrombosis at a young age, 
or a strong family history, rather than as routine screening tools. Although these markers are 
well established, they are not considered part of standard testing for all patients with 
thrombotic disease and are not typically used to guide routine anticoagulant selection. 
The clinical role of some previously common tests has changed. MTHFR polymorphism 
testing is now widely regarded as having little clinical utility in the evaluation of 
thrombophilia or cardiovascular risk and is generally not recommended in current clinical 
practice. Earlier assumptions linking MTHFR variants and mild hyperhomocysteinemia to 
thrombotic risk have not been consistently supported, and use of this test has declined 
accordingly. 
Pharmacogenetic testing for warfarin sensitivity, involving genes such as CYP2C9 and 
VKORC1, was once expected to play a larger role in guiding therapy. In practice, its use has 
remained limited, partly due to variability in clinical benefit and the increasing use of direct 
oral anticoagulants, which do not require routine monitoring or genetic guidance. 
Venous thromboembolism remains a common condition, with an estimated incidence of 
roughly 1 to 2 cases per 1,000 individuals annually. These events are influenced by a 
combination of genetic and acquired risk factors, including age, immobility, surgery, cancer, 
pregnancy, and hormone therapy. While genetic testing can provide useful information in 
selected cases, most clinical management decisions continue to rely on patient history, 
clinical presentation, and standard laboratory testing. 

 
 
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Molecular thrombophilia testing represents a relatively small and mature segment of 
coagulation diagnostics, with modest growth and stable demand. Utilization has historically 
been strong in Europe and is well established in the United States, although current practice 
emphasizes targeted testing based on clinical need rather than broad population screening. 
Table 10-5: Related CMS Codes for Reimbursement National Limits, Molecular, 2025 
 Code 
Description 
Reimbursement 
National Limit 
81241 
F5 (Coagulation factor V) (e.g., hereditary hypercoagulability) gene analysis, 
20210G>A variant 
$73.37 
81400 
Molecular pathology procedure, Level 1 (e.g., identification of single germline variant 
[e.g., SNP] by techniques such as restriction enzyme digestion or melt curve analysis) 
$63.96 
Source: CMS 
Table 10-6: Global Molecular - Thrombophilia SNP Sales Distribution, by Region, 2025 (%) 
 
[Asia Pacific; Europe; North America; Rest of World] 
 Region 
% Mkt 
North America  
37% 
Europe 
36% 
Asia Pacific 
14% 
RoW 
13% 
Total 
100% 
Source: Kalorama Information 
There is a chance the availability could become more commonplace with the migration of 
these molecular analyzers offered by companies including Cepheid, Roche and Illumina. 
Even with moderate acceptance of these molecular tests, the segment has attracted new 
entrants, partly with test services, targeting cardiac patients and anticoagulant dosing.  Of 
particular interest is Agena Bioscience's test, IMPACT Dx (developed by Sequenom), using 

 
 
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a mass spectroscopy platform.  The table below presents a selection of molecular coagulation 
test innovations. 
Table 10-7: Selected Molecular Coagulation Test Innovations 
Company 
Location 
Details 
Affinity Biologicals 
Canada 
VisuDep-F Frozen Factor VIII/XI Deficient Plasma  
Agena Bioscience  
U.S. 
Sequenom's Impact Dx Factor V Leiden/Factor II  
ARUP Laboratories 
U.S. 
warfarin  
Cepheid 
U.S. 
Xpert FII & FV; genetic risk thrombosis assay 
GenMark Diagnostics 
U.S. 
Thrombophilia Risk Test with eSensor technology 
SeraCare Life Sciences 
U.S. 
ACCURUN 611 coagulation gene markers, quality control  
Source: Kalorama Information 
Additionally, the development of the LDT segment for specialty coagulation testing, such as 
Factor II (prothrombin), and DNA analysis offered by Lab Corp. is also emerging at a faster 
rate. 

 
 
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Leading Suppliers: Laboratory Systems 
The market is highly diversified and, for the most part, a different set of companies is active 
in each subsegment. The table below presents coagulation revenues for the major companies 
involved in the laboratory coagulation test market. 
Table 10-8: Top Coagulation Company Market Share Laboratory-based, 2025 (%) 
 Company 
Market Share % 
Werfen 
21% 
Diagnostica Stago 
21% 
Sysmex 
16% 
Siemens Healthineers 
13% 
Beckman Coulter 
5% 
Others 
24% 
Total 
100% 
Note: Includes some revenues for D-dimer 
Source: Kalorama Information 
This market is highly competitive with no real dominance by any one company.  These five 
companies account for roughly 76% of the global market for laboratory coagulation 
instruments and reagents.  Sysmex and Werfen are the strongest instrument vendors; the 
strongest reagent vendors are Siemens Healthineers, Stago and Beckman Coulter/Danaher.  
Other companies involved in the coagulation reagent business include Grifols, Roche, 
Menarini, and Mindray.  

 
 
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Decentralized Coagulation Testing – Professional Use 
Most decentralized coagulation testing for professional use occurs in hospitals, physician 
office laboratories and specialized anticoagulation clinics. The activated clotting time (ACT) 
test is commonly performed in patients receiving heparin during cardiovascular surgery and 
interventional procedures such as those performed in catheterization laboratories. The 
PT/INR test is used to monitor and adjust warfarin therapy in patients with conditions such 
as atrial fibrillation, mechanical heart valves, and other thrombotic disorders. 
Point-of-care coagulation systems are used in several key clinical settings. One major 
application is in acute cardiovascular care, where coagulation testing complements cardiac 
markers in patient triage and management. A second important use is real-time monitoring 
of heparin therapy during surgical and interventional procedures using ACT testing. A third 
area is professional near-patient monitoring of PT/INR in anticoagulation clinics and 
outpatient settings, although this segment has narrowed with the increasing use of direct oral 
anticoagulants that do not require routine monitoring. 
The primary professional POC coagulation tests include PT/INR and ACT, with more limited 
use of aPTT and D-dimer in decentralized settings. Growth in this segment is driven more 
by procedural testing, critical care needs, and demand for rapid turnaround times, rather than 
by the expansion of warfarin monitoring alone. 
Kalorama estimates that the global market for professional POC coagulation testing is $805 
million in 2025 and, with 2.0% CAGR, will reach $892 million in 2030.  The U.S. accounts 
for approximately 38% of the market, Europe 40%, Japan 7% and the ROW 15%.  Growth 
is partly attributed to a growing base of people on warfarin therapy. 
ACT testing remains stable at $118 million and is an essential segment of decentralized 
coagulation testing, supported by its role in cardiac surgery and interventional cardiology. 
Multiple manufacturers provide ACT systems, including Roche, Werfen, Helena 
Laboratories, and Medtronic. No single company dominates this segment, and demand 
remains steady due to ongoing procedural requirements. 
CLIA-waived PT/INR systems have enabled broader use of coagulation testing outside 
central laboratories. These systems support connectivity, electronic data management, and 
integration with anticoagulation management programs. Examples include systems from 
Roche, such as the CoaguChek platform, and devices from Werfen, including the Hemochron 

 
 
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Signature Elite. Abbott Laboratories also offers PT/INR and ACT testing through its i-STAT 
handheld system as part of a broader critical care testing menu. Siemens Healthineers 
provides the Xprecia Stride analyzer for professional near-patient PT/INR testing, supporting 
decentralized anticoagulation management. 
Recent developments in professional decentralized coagulation testing include emerging 
technologies for rapid assessment of anticoagulant activity in acute care settings. Emerging 
companies such as Perosphere are developing portable whole-blood coagulometers designed 
to assess anticoagulation status, including heparin and direct oral anticoagulants, at the 
bedside. Other companies, such as DOASENSE, are developing rapid detection methods for 
direct oral anticoagulants to support urgent clinical decision-making. Established vendors 
continue to enhance their existing platforms by improving speed, connectivity, and workflow 
integration.  
Decentralized Coagulation Testing – OTC 
Self-monitoring can involve either self-testing, where the user performs the INR test 
themselves and then contacts a health professional for advice on any change to the dosage of 
anticoagulant that may be required, or self-managing, where the user performs the INR test 
themselves and then adjusts the dosage of their anticoagulant medication by following an 
agreed care protocol. 
Proponents of self-testing highlight that greater use of self-monitoring offers clinical and 
patient benefit, and over time is likely to result in reductions in heart attacks and strokes 
caused by blood clots. 
The world market for OTC coagulation testing is estimated to grow at an average annual rate 
of 1.1% by 2030.  Roche Diagnostics has pioneered the coagulation self-test market since the 
mid-1990s.  A significant increase was anticipated in the U.S.; however, only about 5% of 
patients on warfarin perform self-testing, compared with at least 20% in Europe, particularly 
in Germany.  Most patients are elderly and the devices for PT will have to evolve with more 
user-friendly features similar to those developed for glucose self-testing 
New biosensor-based devices have emerged from companies such as Microvisk and T2 
Biosystems.  This advanced technology helps simplify and standardize POC coagulation 
tests.  Also, POC D-Dimer immunoassays are a part of the market. POC D-dimer in 2025 
totaled $81 million.  

 
 
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HemoSonics offers a POC QStat Cartridge assay, which provides hemostasis data during 
trauma and liver transplantation procedures.  The cartridge is designed for use with the 
Quantra Hemostasis System.  
The table below presents a selection of innovations in decentralized coagulation testing.   
Table 10-9: Selected POC Coagulation Test Innovations 
Company 
Location 
Area 
Details 
Akers Biosciences 
U.S. 
prof 
PIFA PLUSS PF4 Rapid Assay, HIT whole blood 
bioMérieux 
France 
prof 
Vidas D-dimer/Vidas D-dimer Exclusion II, immunoassay 
Diagnostica Stago 
France 
app 
iHemOStasis app coagulation cascade information 
Diagon Ltd 
Hungary 
prof 
COAG S handheld point-of-care INR  
Haemonetics 
U.S. 
prof 
TEG 6s system 
Helena 
U.S. 
PT/INR 
Cascade Abrazo 
Microvisk Technologies 
UK 
prof 
CoagMax PT/INR system, strip sensor 
Microvisk Technologies 
UK 
OTC 
CoagLite device, home PT/INR 
Mitsubishi Chemical 
Japan 
Prof, D-dimer 
Pathfast chemiluminescent immunoassay 
Point of Care Decision Support 
U.S. 
IT 
POC software anticoagulant treatment support 
Point of Care Decision Support 
U.S. 
IT 
POC anticoagulation Software update 
Roche Diagnostics 
U.S. 
PT/INR 
CoaguChek XS Plus meter 
Roche Diagnostics 
U.S. 
D-dimer 
Cobas h 232 POC system 
Roche Diagnostics 
U.S. 
PT/INR 
CoaguChek Vantus 
Siemens 
U.S. 
prof 
Xprecia Stride, PT/INR 
Source: Kalorama Information, company reports. 
 

 
 
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Platelet Testing 
Platelet function testing has been studied extensively in relation to antiplatelet therapies such 
as aspirin and clopidogrel (Plavix), which are used to reduce thrombotic risk in 
cardiovascular disease but can increase bleeding risk in certain patients. Variability in patient 
response to these agents has been observed, although the concepts of “aspirin resistance” and 
“clopidogrel resistance” are not consistently defined and remain areas of ongoing 
investigation. 
Aspirin remains widely used for secondary prevention of cardiovascular events, though its 
use in primary prevention is now more selective. Interest in decentralized platelet function 
testing has been driven by the need to assess the effectiveness of antiplatelet therapy, 
particularly in cardiology and perioperative settings. However, adoption has been limited by 
the lack of standardized testing methods and the absence of clear evidence linking test results 
to improved clinical outcomes. As a result, routine platelet function testing is not broadly 
recommended and is generally reserved for selected high-risk or specialized patient 
populations. 
Several systems have been commercialized for near-patient platelet function assessment. 
Werfen markets the VerifyNow system, which is widely used in cardiology settings to assess 
platelet response to antiplatelet agents. Helena Laboratories offers the Plateletworks test, a 
bedside platelet aggregation assay used in specific clinical environments. Other assays, 
including aspirin response tests such as AspirinWorks, have been introduced, but their 
clinical role remains limited and adoption has been uneven. Some earlier or smaller 
developers have had reduced visibility in recent years as the market has consolidated and 
clinical demand has narrowed. 
Hematology analyzer manufacturers have expanded platelet-related parameters in routine 
complete blood count testing, including the immature platelet fraction and other platelet 
indices that provide indirect information about platelet production and activity. Companies 
such as Sysmex Corporation have enhanced these capabilities, although these measurements 
do not replace dedicated platelet function testing. 
More recent developments have focused on laboratory-based automation rather than true 
decentralized expansion. Randox Laboratories has introduced automated platelet function 
assays designed for core laboratory use, reflecting a shift toward centralized testing for more 
complex platelet assessments. At the same time, early-stage innovation is exploring new 

 
 
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point-of-care approaches that more closely replicate physiologic clot formation using whole-
blood and shear-based systems, although these technologies are not yet widely 
commercialized. 
Table 10-10: Selected Platelet Activity Test Innovations 
Company 
Details 
Corgenix (Werfen) 
AspirinWorks Test 
Helena Labs 
Plateworks Bedside Platelet Aggregation test 
Roche 
Multiplate analyzer 
Werfen 
VerifyNow II System, POC, platelet PGx 
Werfen 
VerifyNow P2Y12 Test, anticoagulants added  
Source: Kalorama Information compilation 

 
 
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Leading Suppliers: POC Systems 
The market is highly diversified and, for the most part, a different set of companies is active 
in each subsegment.  
The leader in the POC market is Roche Diagnostics, with estimated 2025 sales of 
approximately $330 million, generated by professional and self-test devices. Next, in order 
of market share, are Radiometer, Werfen, Siemens Healthineers and Abbott.  
For some companies, the growth strategy involves separating from distribution agreements.  
However, for others distribution is the key to success.   
The table below presents Kalorama Information’s estimated coagulation revenues for the top 
companies involved in the POC coagulation test market. 
Table 10-11: Top Coagulation Company Revenues, POC, 2025 ($ million, estimated) 
 Company 
Revenues 
Roche Diagnostics 
330 
Radiometer 
162 
Werfen  
126 
Siemens Healthineers 
81 
Abbott 
29 
Source: Kalorama Information 

 
 
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The Commercial Market for Coagulation Tests 
Several factors contribute to growth in the coagulation testing market, including an aging 
population, rising incidence of cardiovascular disease and thrombotic disorders, and ongoing 
improvements in laboratory and near-patient testing technologies. While earlier research in 
coagulation focused heavily on bleeding disorders such as hemophilia, there has been 
increasing recognition over the past decade that disorders of excessive clotting play a major 
role in conditions such as venous thromboembolism and other cardiovascular diseases. 
Advances in understanding the coagulation cascade and its interactions with inflammation 
and the immune system have led to the development of more specialized assays that provide 
insight into both clot formation and breakdown. This includes tests that assess fibrinolysis, 
coagulation factors, and thrombotic risk markers. Recent trends in coagulation testing include 
increased use of anti-factor Xa assays for heparin monitoring and selected anticoagulant 
assessment, as well as broader adoption of D-dimer testing in emergency and core laboratory 
workflows. 
Specialized coagulation tests, such as D-dimer, selected thrombophilia genetic assays, and 
antibody-based tests, have become well established in developed healthcare markets, where 
they are used in clinical practice. However, their adoption is more limited in lower-resource 
regions, where testing is often focused on routine assays due to cost constraints, limited 
infrastructure, and clinical priorities. At the same time, thrombophilia testing is now applied 
more selectively, reflecting a more targeted approach to genetic risk assessment. 
The introduction and widespread use of direct oral anticoagulants has reshaped the testing 
landscape. These drugs generally do not require routine monitoring, thereby reducing 
demand for some traditional coagulation tests, such as PT/INR. However, they have also 
created a need for targeted laboratory assessment in specific situations such as bleeding, 
urgent procedures, or suspected drug interactions. 
Coagulation testing is increasingly being integrated into fully automated core laboratory 
environments, with track-based systems, middleware, and rule-based workflows improving 
efficiency and turnaround time.  

 
 
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Table 10-12: Major Anticoagulants Uses and Tests 
Drug 
Test Options 
Users 
Uses 
Apixaban 
anti-factor Xa 
oral self-medication 
Prevents stroke and blood clots in people 
with (AFib) not caused by a heart valve 
problem 
Argatroban 
PTT 
intravenously in hospitalized 
patients 
Prevent & treat thrombosis in patients 
with heparin-induced thrombocytopenia 
(HIT) 
Bivalirudin 
ACT 
in hospitalized surgical 
patients 
As an alternative to heparin 
Dabigatran 
Thrombin Time for 
residual anti-factor 
Xa  
oral self-medication 
Prevents stroke and blood clots in people 
with (AFib) not caused by a heart valve 
problem 
Edoxaban 
anti-factor Xa 
oral self-medication 
Treatment of deep vein thrombosis and 
pulmonary embolism. 
Fondaparinux 
anti-factor Xa 
subcutaneous injection by 
patient or in hospital 
Prevention of deep vein thrombosis in 
patients who have had orthopedic 
surgery as well as for the treatment of 
deep vein thrombosis and pulmonary 
embolism. 
Heparin 
PTT, anti-factor Xa 
in hospitalized surgical 
patients 
Prevents the formation of blood clots 
Heparin, LMW 
anti-factor Xa 
in hospitalized surgical 
patients 
Prevents the formation of blood clots 
Lepirudin 
PTT 
intravenously in hospitalized 
patients 
Treatment of heparin-induced 
thrombocytopenia (HIT) 
Rivaroxaban 
anti-factor Xa 
oral self-medication 
Prevent blood clots for people who had 
deep vein thrombosis or pulmonary 
embolism 
Warfarin 
PT/INR 
oral self-medication 
Prevents the formation of blood clots in 
the blood vessels and their migration 
elsewhere in the body 
Source: Kalorama Information, company reports. 
 
 

 
 
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Point-of-care coagulation systems are used in several key clinical areas. One major 
application is in acute and emergency care, where rapid coagulation results may complement 
other tests in patient triage, although cardiac markers remain the primary tools for diagnosing 
a heart attack. A second, more established use is monitoring heparin therapy during 
cardiovascular surgery, catheterization procedures, and other interventions, in which 
activated clotting time testing is routinely used. A third area is near-patient and self-testing 
of PT/INR for patients on warfarin therapy, particularly in anticoagulation clinics and 
selected home settings. However, this segment has become less prominent due to the 
increasing use of direct oral anticoagulants, which do not require routine monitoring. 
Recent developments in point-of-care coagulation testing have focused on technological and 
workflow improvements rather than on the introduction of entirely new test types. Newer 
systems increasingly use microfluidic and electrochemical detection methods to improve 
speed, accuracy, and ease of use. There has also been expanded use of POC coagulation 
testing in emergency, trauma, and critical care settings, where rapid results are essential for 
clinical decision-making. In addition, ongoing product development emphasizes 
miniaturization, connectivity, and integration with laboratory and hospital information 
systems. Early efforts toward multiplex and multi-parameter testing are emerging, although 
these remain in the early stages of adoption. 
 

 
 
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Chapter 11: Microbiology and Virology 
Scope 
For decades, the gold standard in clinical microbiology has been culture-based testing—
growing microorganisms on selective or differential media, followed by organism 
identification and antimicrobial susceptibility testing (AST) using additional reagents, 
media, and antimicrobials. These processes were traditionally manual and labor-
intensive, requiring skilled microbiologists and significant time—often 24 to 72 hours 
or more—to deliver actionable results to clinicians. 
While automation has long transformed other diagnostic disciplines such as clinical 
chemistry and hematology, microbiology remained largely insulated from these 
advances, due in part to the inherent complexity and variability of microbial growth 
and behavior. That resistance to automation is now rapidly eroding. Rising demand for 
microbiology testing, fueled by the global burden of infectious disease, combined with 
critical shortages of trained technologists, has accelerated the adoption of next-
generation microbiology automation platforms. 
Modern microbiology labs are increasingly adopting automated culture systems, digital 
imaging for plate reading, and automated ID/AST platforms, allowing faster, more 
standardized, and scalable workflows. These tools are helping laboratories manage 
higher test volumes while maintaining accuracy and reducing turnaround times.  
 
 

 
 
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The Real Impact of Infections 
Infectious diseases are particularly concerning not only because of their acute effects but also 
because of their long-term consequences that may persist or emerge well after the primary 
infection has been treated. These secondary effects, including cancer, cardiovascular disease, 
and autoimmune conditions, raise the stakes for early and accurate diagnosis and highlight 
the growing importance of comprehensive microbiology testing. 
Traditionally, microbiology has focused on identifying active infections. However, mounting 
evidence shows that certain pathogens may act as triggers or contributors to chronic disease, 
suggesting a broader role for infectious disease diagnostics in risk stratification, preventive 
care, and long-term monitoring. 
Herpes and Alzheimer’s Disease 
Researchers are investigating whether HSV-1 infection and/or reactivation is associated with 
an increased risk of Alzheimer’s disease, with accumulating epidemiologic and mechanistic 
evidence but no definitive proof of causation. Alzheimer’s risk may also be influenced by 
other viral infections. In addition, experimental work suggests VZV-related inflammatory 
events can reactivate latent HSV-1, providing a plausible indirect pathway linking VZV to 
AD-relevant changes. 
 Ebola and Cancer 
EBV infection increases a person’s risk of getting nasopharyngeal cancer and certain types 
of fast-growing lymphomas, such as Burkitt lymphoma. It may also be linked to Hodgkin’s 
lymphoma and some cases of stomach cancer. Many scientists believe that the immune 
system is also important in attacking and destroying newly formed cancer cells. A weak 
immune system might let new cancer cells survive long enough to grow into a serious, life-
threatening tumor. 
HIV and Cancer 
HIV infection has been linked to a higher risk of developing Kaposi sarcoma and cervical 
cancer. It is also associated with several forms of non-Hodgkin lymphoma, particularly 
primary central nervous system lymphoma. Infection with HHV-8 is causally associated with 

 
 
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Kaposi sarcoma and has also been linked to rare lymphoid malignancies such as primary 
effusion lymphoma. 
H pylori and Cancer 
Long-term infection of the stomach with Helicobacter pylori (H. pylori) can cause peptic 
ulcers and chronic inflammation that damages the stomach lining. Over time, these changes 
may increase the risk of gastric cancer, particularly cancers arising in the lower portion of 
the stomach. H. pylori infection is also associated with certain lymphomas of the stomach, 
especially mucosa-associated lymphoid tissue (MALT) lymphoma. 
Bacteria and Parkinson's 
Some researchers have proposed that bacteriophages may contribute to the gut microbiome 
changes observed in Parkinson’s disease. Studies have reported differences in bacteriophage 
abundance between patients with Parkinson’s disease and healthy individuals, suggesting 
that phages may influence bacterial populations associated with neurological pathways. 
Certain gut bacteria, including Streptococcus and Lactobacillus species, can produce 
microbiota-derived neurochemicals such as dopamine-related compounds, which may 
interact with the gut–brain axis and potentially influence Parkinson’s disease pathology. 
However, these relationships remain under active investigation and have not yet been 
established. 
HPV and Cancer 
Human papillomaviruses (HPV) are a group of more than 150 related viruses. A subset of 
high-risk HPV types is the primary cause of cervical cancer and is also associated with 
cancers of the penis, anus, vagina, vulva, and oropharynx (mouth and throat). 

 
 
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Microbial Antibiotic Resistance – The Role of Clinical Tests 
For nearly as long as antibiotics have existed, the medical community has voiced concern 
about antimicrobial resistance (AMR), which is a growing global health threat that 
undermines the effectiveness of life-saving treatments. To combat this, antimicrobial 
stewardship programs (ASPs) have become central to promoting appropriate antibiotic use. 
Professional guidelines consistently encourage clinical microbiology laboratories to 
participate in these programs. However, the recommended stewardship interventions have 
historically involved limited use of laboratory diagnostics—often focusing instead on 
prescribing practices, formulary restrictions, or clinician education. 
That dynamic may be poised to change. With advances in diagnostic technology, especially 
in rapid molecular testing, pathogen identification, and resistance gene detection, laboratories 
are now better equipped to play a more active, frontline role in stewardship efforts. Faster, 
more precise diagnostic tools can support earlier de-escalation or escalation of therapy, guide 
targeted treatment, and reduce unnecessary broad-spectrum antibiotic use—key goals of 
ASPs. 
As these technologies mature and integrate more fully into clinical workflows, microbiology 
laboratories are likely to evolve from passive participants to core drivers of stewardship 
success. 
Fast Identification 
The long-standing goal of the clinical microbiology laboratory is to develop a test that can 
rapidly identify a pathogen and determine antimicrobial susceptibility, guiding treatment 
decisions during the same clinical encounter—ideally within 30 minutes or less. While this 
benchmark has not yet been fully achieved for most organisms, significant advances in rapid 
diagnostics have dramatically shortened the time required to identify pathogens and detect 
resistance. 
Traditional microbiology methods rely on culturing microorganisms, identifying them 
through staining and microscopy, and performing antimicrobial susceptibility testing (AST). 
These conventional workflows often require 48–72 hours or longer to produce definitive 
results. In recent years, however, the introduction of molecular diagnostics, mass 

 
 
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spectrometry, multiplex PCR panels, and rapid phenotypic susceptibility platforms has 
significantly accelerated microbial identification and resistance detection. 
Multiplex molecular diagnostics systems such as the BIOFIRE FILMARRAY and the 
Luminex VERIGENE System enable rapid identification of bacteria, viruses, and 
antimicrobial resistance markers directly from clinical specimens or positive blood cultures 
without requiring traditional culture-based identification steps. These syndromic testing 
platforms have transformed the detection of bloodstream, respiratory, and gastrointestinal 
pathogens. 
At the point of care, rapid diagnostic tests are now widely available for infectious diseases 
such as HIV, malaria, influenza, respiratory syncytial virus, and group A Streptococcus. 
Many of these assays operate on compact molecular platforms designed for decentralized 
testing environments. Examples include the cobas Liat System and the ID NOW, which 
provide results in approximately 5–20 minutes for several respiratory and infectious disease 
targets. Rapid molecular point-of-care assays are also available for sexually transmitted 
infections, including Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas 
vaginalis. 
Rapid phenotypic antimicrobial susceptibility testing remains a critical objective in 
microbiology. One of the most notable commercial systems designed to shorten AST 
turnaround time is the Accelerate Pheno System developed by Accelerate Diagnostics. The 
system’s blood culture test panel can identify a range of bacterial and yeast pathogens directly 
from positive blood cultures and determine antimicrobial susceptibility. The platform uses 
automated fluorescence in situ hybridization (FISH) for organism identification and time-
lapse imaging to measure bacterial growth in the presence of antibiotics, providing a true 
phenotypic measurement of susceptibility. Organism identification can be achieved in 
approximately 90 minutes, with susceptibility results typically available in about 7 hours, 
significantly faster than conventional culture-based AST. 
Another 
approach 
to 
rapid 
microbial 
identification 
is 
matrix-assisted 
laser 
desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry, which is widely used 
for routine organism identification in microbiology laboratories. Systems such as the MALDI 
Biotyper from Bruker Corporation allow laboratories to identify bacteria and fungi within 
minutes once cultures are available. Bruker expanded its capabilities in antimicrobial 
susceptibility testing through the acquisition of MERLIN Diagnostika, whose MICRONAUT 

 
 
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system provides phenotypic susceptibility testing and customizable antibiograms, using 
panels that cover a broad range of antibiotics. 
Other companies have explored alternative rapid AST technologies. Roche previously 
pursued rapid detection approaches by acquiring GeneWEAVE BioSciences, whose 
Smarticles technology used engineered bioparticles to detect viable bacteria and antibiotic 
resistance via luminescent signaling. Although Roche later discontinued the commercial 
development of this platform, the concept illustrated ongoing efforts to achieve rapid 
detection of viable pathogens and antimicrobial resistance directly from clinical samples. 
Overall, advances in molecular syndromic panels, MALDI-TOF identification, rapid 
phenotypic AST systems, and decentralized molecular testing platforms have significantly 
reduced the time required to identify infectious organisms. While the goal of obtaining both 
pathogen identification and full antimicrobial susceptibility information within 30 minutes 
remains largely aspirational, continued innovation in microfluidics, digital imaging, AI-
assisted phenotypic analysis, and direct-from-specimen testing is expected to further shorten 
diagnostic timelines in the coming years. 
bioMérieux markets the VITEK REVEAL AST System, which qualitatively determines 
antimicrobial susceptibility using an array of sensors that detect organic compounds 
produced by growing bacteria.  
These and other companies developing and commercializing faster methods for microbial 
antimicrobial identification and susceptibility/resistance testing are summarized in the 
following table. 
 
 

 
 
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Table 11-1: Selected Companies Developing Faster Identification, Some Also with Antimicrobial 
Susceptibility/Resistance Tests 
Company 
Activities Developing Faster ID/AST or ID/Resistance Tests 
3iDx 
Developing based on BioSpectrix technology; Pathogens are identified using infrared 
molecular profiling technology. 
Abacus Diagnostica Oy 
(Uniogen) 
GenomEra CDx products: 
•MRSA/SA Multi Swab 
•MRSA/SA Nasal Swab 
•MRSA/SA Diagnose 
•MRSA/SA AC (with mecC) 
•MRSA/SA Blood Culture 
AB ANALITICA s.r.l. 
•Reverse line blot tests for genotyping 
Abbott (Acquired Alere) 
Alere I, and Alere i Influenza A & B test, Alere i: Alere i RSV and Alere i Strep A test 
Accelerate Diagnostics 
•Accelerate Pheno system - Uses genotypic technology to identify (ID) pathogens and 
phenotypic technology to conduct antibiotic susceptibility testing (AST).   
•First test: Accelerate Pheno BC Kit, provides identification and antibiotic susceptibility 
test rests for patients with bacteremia or fungemia. 
Akonni Biosystems, Inc. 
TruDiagnosis - Point-of-Care testing platform: TruDx2000 and TruDx3000 (a fully 
integrated system) 
Atlas Genetics Ltd. (now 
Binx Health) 
io platform - includes the io instrument and io cartridge -  
•Sexually transmitted disease cartridges: Chlamydia trachomatis; Dual Chlamydia 
trachomatis & Neisseria gonorrhoeae (CT/NG); Trichomonas vaginalis (TV); Multiplex STI 
(mSTI) - CT, NG, TV and Mycoplasma genitalium (MG) 
Hospital acquired infections (HAIs) cartridges: Methicillin-Resistant Staphylococcus 
aureus (MRSA); Dual MRSA/MSSA (Methicillin-Sensitive Staphylococcus aureus); 
Clostridium difficile; Norovirus 
AutoGenomics, Inc. 
(Diasorin) 
INFINITI System, INFINITI PLUS Analyzer (PLUS), and INFINITI High Throughput System 
(HTS)On the market 
•Infiniti H. pylori 
•Infiniti HPV Genotyping 
•Infiniti HPV-HR QUAD 
•Infiniti RVP Plus 
•Infiniti Flu A-sH1N1 
•Infiniti UroGen QUAD 
•Infiniti Bacterial Vaginosis QUAD 
•Infiniti Candida Vaginitis QUAD 
RUO tests in US for Bacterial Vaginosis QUAD, Bacterial Vaginosis QUAD, CT-NG QUAD, 
Flu A-sH1N1, HPV Genotyping, HPV-HR QUAD, Leuko QUAD (three STDs), MDR-TB, NTM 
Panel, Resolve QUAD, RVP Plus, STD-6, UroGen Plus QUAD, HCV QUAD, H. pylori QUAD, 
GUD QUAD 
RUO infectious disease tests in Europe. 
Becton Dickinson (BD) 
BD Max System:  BD MAX CT/GC/TV 

 
 
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Company 
Activities Developing Faster ID/AST or ID/Resistance Tests 
Bruker 
Advances for the MALDI Biotyper 
Cepheid (A Danaher 
company) 
•Hospital acquired infections: Xpert C. difficile, Xpert C. difficle/Epi, Xpert Carba-R, Xpert 
MRSA NxG, Xpert MRSA/SA BC, Xpert MRSA/SA SSTI, Xpert Norovirus, Xpert SA Nasal 
Complete, Xpert® vanA 
•Critical infectious diseases: Xpert MTB/RIF, Xpert Flu, Xpert Flu/RSV XC, Xpert EV, Xpert 
Xpress Flu, Xpert Xpress Flu/RSV, Xpert Xpress Strep A 
•Sexual Health: Xpert CT/NG, Xpert GBS, Xpert GBS LB, Xpert TV 
Rapid results (30 minutes or less): 
Xpress Flu, Xpert Xpress Flu/RSV, Xpert Xpress Strep A 
Coyote Bioscience Co., 
Ltd. (China) 
Mini8 Plus - Portable qPCR system 
Curetis (OpGen) 
Unyvero System: 
•Unyvero HPN Pneumonia Cartridge  
•Unyvero ITI Cartridge  
•Unyvero BCU Cartridge  
•Unyvero IAI Cartridge  
 
•Unyvero LRT Lower Respiratory Tract Cartridge 
Diasorin S.p.A. 
Simplexa molecular assays for use on the 3M Integrated Cycler 
GenMark Diagnostics 
(Roche) 
ePlex Instrument System panels: 
•ePlex Respiratory Pathogen (RP) Panel  
•ePlex BCID Fungal Pathogen (BCID-FP) Panel 
•ePlex Blood Culture Identification Gram-Positive (BCID-GP) Panel 
•ePlex Blood Culture Identification Gram-Negative (BCID-GN) 
Central Nervous System Panel (CNS) 
Gastrointestinal Pathogen Panel (GI) 
HCV Genotyping Panel (HCVg) 
iCubate, Inc. 
iCubate System (iC-system) - One step multiplex PCR platform 
•iCubate iC-GPC Assay [Gram Positive Cassette (FDA cleared) 
•Gram-Negative Cassette (In regulatory process) 
•Flu Typing; HAI; MYCO; STD products (in pipeline) 
•Respiratory-V; Respiratory-B; Diarrheal products (Research use only 
LeukoDx 
Accellix-HLADR system: Accellix platform and Accellix-HLADR Cartridge 
Mesa Biotech (Thermo 
Fisher( 
Mesa Biotech Dock and Flu A/Flu B Test Cassette 
Micronics Inc. (A Sony 
Group Company) 
PanNAT Molecular Diagnostic System.  Assays in development: 
•Shiga-toxin producing E. coli (STEC) and other enteric pathogens 
•STDs, respiratory pathogens, HAIs 
•Other bacterial & viral pathogens 
MP Biomedicals, LLC 
FASTSURE TB DNA Rapid Test 

 
 
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Company 
Activities Developing Faster ID/AST or ID/Resistance Tests 
OptiGene 
•Genie II and Genie III instruments - isothermal amplification 
•Assays: easyplex C. difficile; easyplex VRE; easyplex CSF easyplex SuperBug CRE; 
easyplex SuperBug complete A; easyplex SuperBug complete B; easyplex MRSA 
Orion Diagnostica 
(Finland) (Aidian) 
Orion GenRead Campylobacter 
Orion GenRead C. difficile 
Q-linea AB (Sweden) 
ASTrID - Automated platform that provides pathogen identification and phenotypic 
antibiotic susceptibility testing, directly from whole blood, delivering ID after four hours 
and AST in an additional six hours. 
QuantuMDx Group 
Q-POC- portable, battery-operated molecular diagnostic device: 
•Tuberculosis - Combined detection of and drug susceptibility determination  
•STI Panel Test  
•Malaria Assay 
•HPV - For diagnosis of high-risk strains 
Roche 
cobas Liat PCR System - Influenza A/B, Influenza A/B & RSV, and Strep A 
Scanogen 
Molecular diagnostic systems based on single molecule biosensors; TB assay 
Stat-Dx (acquired by 
QIAGEN) 
•DiagCORE - Small-footprint, portable system that utilizes disposable cartridges to power 
a broad menu of tests utilizing a variety of specimens and immunoassay or qPCR 
principles. 
•System branded QIAstat-Dx after acquisition by QIAGEN 
T2 Biosystems, Inc. 
•T2 Magnetic Resonance (T2MR) technology 
•T2Sepsis Solution - T2 Biosystems’ products include T2Dx Instrument, T2Candida Panel, 
and T2Bacteria Panel 
Source: Kalorama Information 

 
 
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Traditional Microbiology and Its Limits 
The traditional microbiology market is distinct from other areas of infectious disease 
diagnostics. It is defined by the use of culture to amplify microbial presence, enabling 
downstream testing of isolates rather than direct clinical samples such as blood, urine, or 
stool. This culture-based approach enables phenotypic susceptibility testing, which remains 
essential for guiding effective treatment in an era of rising antimicrobial resistance. 
As automation advances and integrates with digital technologies and molecular methods, 
microbiology is moving toward a new era of efficiency and clinical impact by balancing 
tradition with innovation. 
Following culture of the sample, pathogen identification can be accomplished using 
fluorogenic and chromogenic substrates that react in the presence of a particular genus or 
species in the culture or cultured sample. Positive results are indicated by the fluorescence or 
color change of the substrate. If the results are inconclusive, it may be necessary to identify 
pathogens via microscopy, or to perform further testing using other diagnostic technologies 
such as immunoassay, molecular probes or diagnostic assays, or mass spectrometry.  
Antibiotic susceptibility or resistance of bacteria is typically determined by exposing cultured 
organisms to graduated or variable drug concentrations. Visual examination, optical 
scanning, fluorogenic/chromogenic substrates or other reagents may be used to determine the 
growth or lack of growth of the bacteria exposed to antibiotics in individual wells, plates, or 
plate areas. 
Antibiotic susceptibility testing systems are utilized to determine which antibiotics will be 
most effective in treating an organism. The organism is tested against various concentrations 
of drugs to determine the organism's resistance or susceptibility to the antibiotic. 
Treatment decisions depend on which microbial agent is present.  Also, antimicrobial drug 
resistance is a significant problem, and these decisions can result in patients being given an 
antibiotic that will not be effective for treatment of their infection.  There is a clear need for 
tests that can identify the microorganism infecting the patient, and to determine which 
therapy will be effective in treating that infection. 
Molecular microbiology is another changing segment of the microbiology lab.  Polymerase 
chain reaction (PCR) and other nucleic acid amplification test (NAAT) technologies have 

 
 
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been used in microbiology laboratories since the 1990s, and these assays are now widely 
used for a range of different pathogens.  Some multiplex assays are now available.  A major 
change in the application of polymerase chain reaction in microbiology has been the 
development of syndromic assays – assays that test for a range of pathogens commonly 
associated with a particular syndrome such as a lower respiratory infection, a gastrointestinal 
infection, or another specific infection. 
The development and use of immunoassays remain an important part of microbiology for 
certain pathogens.  In addition, when new tests are needed for emerging pathogens, 
immunoassay technology is sometimes utilized (in addition to PCR or other molecular 
diagnostic technology). 

 
 
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The New Microbiology - Innovations 
Meanwhile, the physician must immediately make a decision regarding which antibiotic to 
use to treat the patient.  As a result, the treatment decision must be made empirically, without 
the results of a definitive diagnostic test.  This can result in treatment with an antibiotic that 
will not work for that patient and microbial infection.  A different antibiotic may be 
prescribed a few days later, but effective treatment has been delayed for that patient.  Many 
patients may then respond to the second antibiotic and recover, suffering only from a delay 
before recovering from the infection.  However, initial treatment with an ineffective 
antibiotic can sometimes result in complications and even death for certain patients. 
Liquid Based Microbiology and Automation Innovations 
Microbial identification and antimicrobial susceptibility testing are the endpoint of the 
majority of work performed in a microbiology lab on a daily basis and is very time 
consuming. Since the mid-1990s, ID/AST vendors have responded to the need for quicker 
test systems for many sample types. These systems can provide a definitive test result in 6 
hours versus 1 to 2 days with non-automated systems.  Other differentiating factors between 
systems are the reagent mix contained in the panels and bioinformatics that provide bacterial 
identification to the genus/species level. 
Automation has greatly improved ID/AST by speeding up the process with more sensitive 
detection methods and hands-off sample or culture preparation. In contrast to core lab 
diagnostics, microbiology stations must handle a variety of samples beyond blood tubes 
including swabs, feces, sputum, pus, body fluid and urine that arrive in different containers 
and differ significantly as sample matrices. Automating ID/AST, particularly at the front end, 
has required unique innovation.  
The leader in ID/AST automation is COPAN Diagnostics, which developed and assembled 
the pieces for Liquid Based Microbiology. Swabs stand apart among microbiology samples 
due to their incompatibility with otherwise liquid-based specimen handling lab infrastructure 
and workflows. Uniform liquid-based protocols in microbiology are more amenable to 
automation and streamlined processing, providing improved workflows and shaving time off 
of testing by removing the need for specimen transfer from swabs to other media. 

 
 
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Liquid-based microbiology systems are increasingly integrated with automated specimen 
processing and laboratory automation platforms to streamline microbiology workflows. One 
of the most widely adopted systems is the COPAN Walk-Away Specimen Processor 
(WASP), which automates specimen handling tasks including decapping, plating, streaking, 
and recapping of culture samples. The WASP functions as an open modular platform 
designed to interface with laboratory information systems (LIS) and major microbiology 
identification and antimicrobial susceptibility testing (ID/AST) systems. These capabilities 
allow microbiology laboratories to standardize specimen processing and reduce manual 
handling while improving reproducibility and turnaround time. 
A central component of the liquid-based microbiology workflow is COPAN’s ESwab 
collection system, which uses a flocked swab placed into a tube containing approximately 1 
mL of liquid Amies transport medium. After collection, microorganisms are eluted into the 
liquid medium, maintaining organism viability for downstream culture or molecular testing. 
The liquid sample can be aliquoted multiple times for repeat or parallel testing, enabling 
compatibility with culture, molecular diagnostics, or other microbiology assays. The ESwab 
system integrates directly with the WASP automation platform, allowing seamless specimen 
processing and improved workflow efficiency in the microbiology laboratory. 
Additional modules have expanded the capabilities of the WASP platform to support broader 
laboratory automation. After specimen processing, plates can be transferred via conveyor to 
the WASPLab automated incubation and digital imaging system. Within WASPLab, plates 
are barcoded, automatically loaded into incubators, and imaged at scheduled intervals to 
allow digital review of culture growth. Plates are automatically inverted during incubation to 
minimize condensation on the lid and prevent droplets from interfering with plated media. 
The system supports remote image review and digital culture interpretation, enabling 
microbiologists to analyze results from any location with secure network access. 
COPAN has also developed specialized modules to automate additional microbiology tasks. 
The Gram SlidePrep module automatically prepares Gram stain slides immediately after 
specimen plating, producing standardized smears with controlled sample volumes and 
printing patient identification directly onto the slide using an integrated inkjet printer. 
Another WASP module enables automated inoculation of enrichment broths, while the ID 
Disc Application module places reagent discs onto culture plates for downstream 
identification workflows. These modules expand the scope of automated microbiology 
processing from specimen receipt through culture workup. 

 
 
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To support downstream microbiology analysis, COPAN also markets Colibrí, an automated 
colony picking and preparation instrument designed to select isolated colonies for MALDI-
TOF identification or antimicrobial susceptibility testing. In conjunction with Colibrí, 
COPAN has introduced PhenoMATRIX software, including colony detection and tagging 
algorithms that assist laboratories in identifying and selecting colonies for workup, 
supporting the broader trend toward AI-assisted microbiology automation. 
Major diagnostic companies have recognized the potential of full microbiology automation 
and liquid-based microbiology workflows. Several companies collaborate with COPAN to 
integrate automated specimen processing with downstream diagnostic systems. COPAN has 
announced partnerships and distribution agreements with major microbiology companies 
including Beckman Coulter (Danaher), bioMérieux, and Thermo Fisher Scientific, enabling 
laboratories to combine automated specimen processing with automated identification and 
susceptibility testing systems. 
Thermo Fisher Scientific provides additional automation solutions for antimicrobial 
susceptibility testing through its Sensititre platform. The Sensititre AIM automates 
inoculation of microtiter plates used for minimum inhibitory concentration susceptibility 
testing and supports both dry and frozen antibiotic panels. The modular benchtop design 
allows the system to be placed in biosafety cabinets or on standard laboratory benches. 
Thermo Fisher also offers automated incubation and reading instruments such as the 
Sensititre Vizion or ARIS platforms, which enable laboratories to perform high-throughput 
ID/AST testing with automated data capture and interpretation. 
Thermo Fisher also developed the VersaTREK automated culture system, designed to 
support blood culture testing, sterile body fluid culture, and mycobacterial detection and 
susceptibility testing on a single platform. VersaTREK systems are available in 
configurations capable of handling up to 240 or 528 culture bottles, with automated 
monitoring of cultures approximately every 24 minutes. The system detects microbial growth 
by measuring changes in gas consumption or production within culture bottles. Integrated 
software supports barcode tracking, automated bottle loading and removal, and workflow 
standardization across specimen types including blood, urine, and body fluids. 
Another major automated blood culture system is the BacT/ALERT VIRTUO system from 
bioMérieux, which supports high-efficiency automated blood culture workflows and 
integrates with laboratory information systems for centralized data management. The system 
incorporates automated bottle handling, continuous incubation monitoring, and advanced 

 
 
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software to streamline laboratory operations. bioMérieux has also received FDA clearance 
for testing leukocyte-reduced apheresis platelets using the BacT/ALERT VIRTUO platform. 
As microbiology laboratories become increasingly automated, middleware and software 
connectivity have become critical components of laboratory workflow integration. Systems 
such as bioMérieux’s MYLA middleware centralize microbiology laboratory management 
by connecting multiple instruments, collecting workflow and performance data, and 
interfacing with LIS systems. These platforms support laboratory quality management, 
antimicrobial resistance monitoring, and infection control reporting. Thermo Fisher’s 
Sensititre SWIN software provides similar integration capabilities by coordinating the 
operation of multiple Sensititre instruments and enabling LIS connectivity, as well as image 
capture and reporting through systems such as Sensititre Vizion. 
Overall, automation platforms such as WASP, WASPLab, and automated AST systems are 
transforming microbiology laboratories by enabling standardized liquid-based specimen 
processing, digital culture imaging, and integrated data management. These technologies are 
supporting faster identification, improved workflow efficiency, and greater consistency in 
microbiology testing, while positioning laboratories for further advances in artificial 
intelligence-assisted interpretation and fully automated microbiology workflows. 
Revvity’s EUROIMMUN offers its UNIQ 160, an automated indirect immunofluorescence 
test (IIFT) system for autoimmune disease diagnostics. The product is available in CE mark 
countries.  And is an all-in-one solution for sample preparation, incubation, washing and 
mounting of slides as well as image acquisition and analysis.  
Personalis offers the NeXT Personal Dx which is a tumor-informed molecular residual 
disease liquid biopsy with ultra-high sensitivity and specificity for breast and lung cancer. 
The test uses whole genome sequencing k, advanced bioinformatics, and personalized 
signatures based on about 1800 variants.  
Post-Blood Culture Microbial ID 
Positive blood cultures have been a target for sensitive and rapid identification testing.  
Recent innovation has resulted in numerous identification assays for use with positive blood 
cultures. Multiple technologies including fluorescent in situ hybridization), multiplexed PCR 
and mass spectrometry are finding use as highly specific and rapid testing options. The 
vibrancy of the blood culture identification test space is a positive indicator for at least the 

 
 
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short-term health of the blood culture market within ID/AST. Alternative rapid tests for 
bloodstream infections directly from whole blood samples are available on the market but 
have yet to appreciably counter the strength of blood culturing in terms of cost (on 
significantly greater scales) and its comparable utility in most healthcare episodes. 
Molecular amplification technologies have become increasingly important for the rapid 
identification of pathogens in positive blood cultures, significantly reducing the time required 
to identify bloodstream infections compared with conventional culture-based identification 
methods. These assays typically use multiplex PCR or other nucleic-acid amplification 
technologies to detect multiple bacterial and fungal targets, along with key antimicrobial 
resistance genes, directly from positive blood culture bottles. 
Several diagnostic companies have developed multiplex molecular panels for rapid 
bloodstream infection identification. One of the most widely used systems is the BIOFIRE 
FILMARRAY Blood Culture Identification Panel, now available in updated formats such as 
BCID2, which detects a broad range of Gram-positive bacteria, Gram-negative bacteria, 
yeasts, and multiple antimicrobial resistance markers. The system performs fully automated 
sample preparation, amplification, detection, and analysis, delivering results in 
approximately one hour. 
Another platform previously used in clinical laboratories was the Nanosphere Verigene 
system, which offered Gram-Positive, Gram-Negative, and Yeast Blood Culture Tests 
capable of detecting pathogens and resistance genes from positive blood cultures. The 
Verigene platform was later acquired by Luminex, and the product line has since been 
discontinued and replaced by newer multiplex molecular systems, including the Luminex 
VERIGENE II and the ePlex blood culture identification panels, which provide expanded 
organism coverage and resistance marker detection. 
Becton Dickinson offers molecular testing for bloodstream infections through its BD MAX 
platform, including assays such as BD MAX StaphSR, designed for the rapid detection of 
Staphylococcus aureus and methicillin-resistant S. aureus. BD also markets the BD MAX 
Blood Culture Identification assays, which enable rapid molecular identification of 
pathogens from positive blood culture samples. 
Additional molecular assays have been developed to identify bloodstream infections directly 
from blood samples without requiring prior culture, although adoption has been more limited 
due to sensitivity and workflow considerations. Examples include the Cepheid Xpert 

 
 
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MRSA/SA BC assay, which detects S. aureus and MRSA directly from positive blood culture 
bottles on the GeneXpert system. Another example was the Roche LightCycler SeptiFast test, 
which used multiplex PCR to detect multiple bloodstream pathogens directly from whole 
blood; however, the SeptiFast assay has since been withdrawn from the market in many 
regions. 
Many of these molecular blood culture identification panels incorporate detection of 
clinically relevant antimicrobial resistance genes, such as mecA/mecC, vanA/vanB, KPC, 
NDM, VIM, IMP, and OXA-48–like carbapenemases. The ability to identify both pathogens 
and resistance markers rapidly allows clinicians to optimize antimicrobial therapy earlier in 
the course of infection, supporting antimicrobial stewardship programs and improving 
management of sepsis and other bloodstream infections. 
Mass spectrometry has emerged as another alternative to blood culture identification. Mass 
spectrometry and activities of Bruker and bioMérieux in this market are discussed separately. 
These and other companies are developing and introducing tests to improve identification 
and antibiotic susceptibility testing of blood culture samples.  While these assays shorten 
turnaround time compared to traditional blood culture techniques, the overall blood culture 
process remains lengthy because a culturing step is still required. 
PCR and Other NAAT-Based Tests for Infectious Diseases 
Polymerase chain reaction and other nucleic acid amplification test (NAAT) technologies 
have been used in microbiology laboratories since the 1990s, and these assays are now widely 
used for a range of different pathogens.   
For many years, polymerase chain reaction assays were limited to the detection of a single 
or a limited number of pathogens.  This would mean that multiple tests might be required to 
identify which pathogen has infected a particular patient.  A major change in the application 
of polymerase chain reaction in microbiology has been the development of syndromic assays. 
These are assays that test for a range of pathogens commonly associated with a particular 
syndrome, such as a lower respiratory infection, a gastrointestinal infection, or another 
specific infection.   
PCR-based panels have been developed to detect pathogens and drug resistance genes from 
potentially long lists of microbes and resistance genes.  These are often syndromic assays.  

 
 
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However, these assays are expensive, and PCR/NAAT-based tests for a single or a limited 
number of microbes are still often used to test low-risk, otherwise healthy patients.  Examples 
include tests for influenza (or influenza and RSV) and also screening tests for chlamydia and 
gonorrhea. 
Microarrays can perform more assays than PCR or other NAATs, but they cannot detect 
unknown microbial species. 
Sequencing-based assays provide the most comprehensive information and can detect novel 
or unexpected microorganisms. Advances in workflow design, automation, and 
bioinformatics have reduced both costs and turnaround times, and sequencing is now 
increasingly used in clinical microbiology for targeted applications such as outbreak 
investigation, resistance profiling, and identification of difficult-to-identify organisms. 
However, compared with routine molecular methods, sequencing still requires more complex 
infrastructure, more data interpretation, and higher overall costs, which can limit its use in 
high-volume or time-sensitive settings. 
MALDI-TOF mass spectrometry is now an established technology in microbiology 
laboratories. Laboratories considering adoption continue to face a significant upfront capital 
investment, but once installed, the cost per test is low, and the turnaround time for organism 
identification is very rapid. The technology performs best with cultured isolates and is less 
sensitive for detecting organisms present at low abundance or directly from primary 
specimens, although workflow improvements have expanded its use in certain direct-from-
sample applications. 
 
 

 
 
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Table 11-2: Selected Nucleic Acid Amplification Test and Other Molecular Companies in Microbiology 
Company 
Technology/Product(s) 
AB ANALITICA s.r.l. 
Real-time PCR tests for CMV, EBV, HSV 1, HSV 2, HSV 6, HSV 7, HSV 8, VZV, Enterovirus, BK 
virus, JC virus, Parvovirus B19, Adenovirus, Mycobacterium tuberculosis complex,  
Abbott 
•Abbott m2000 RealTime System; Range of infectious disease assays available: Abbott 
m2000 RealTime System; Range of infectious disease assays available updated to Alinity m 
System 
• ID NOW 
altona Diagnostics 
•RealStar Zika Virus RT-PCR kit 
•RealStar MERS-CoV RT-PCR Kit US 
•Broad line of real-time PCR tests marketed under the RealStar PCR Kit name.  Includes tests 
for: Human adenovirus, herpes- and polyomaviruses; Respiratory viruses, bacteria and fungi; 
Enteric viruses and bacteria; Blood borne viruses; Tropical and other viruses, bacteria and 
parasites 
Atlas Genetics Ltd. (binx 
health) 
io platform - includes the io instrument and io cartridge -  
•Sexually transmitted disease cartridges: Chlamydia trachomatis; Dual Chlamydia 
trachomatis & Neisseria gonorrhoeae (CT/NG); Trichomonas vaginalis (TV); Multiplex STI 
(mSTI) - CT, NG, TV and Mycoplasma genitalium (MG) 
Hospital acquired infections (HAIs) cartridges: Methicillin-Resistant Staphylococcus aureus 
(MRSA); Dual MRSA/MSSA (Methicillin-Sensitive Staphylococcus aureus); Clostridium 
difficile; Norovirus 
Becton Dickinson (BD) 
•BD Max System: BD MAX C.diff assay; Enteric Bacterial Panel; Enteric Parasite Panel; BD 
MAX GBS assay; BD Max MRSA XT assay; BD MAX Staph SR assay; BD MAX Vaginal Panel; BD 
Max CT/GC/GV, BD MAX SARS-CoV-2, BD MAX MTB, BD MAX Enteric Viral Panel 
•BD Viper LT System and BD Viper with XTR Technology; BD ProbeTec ET System – 
Chlamydia and gonorrhea 

 
 
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Company 
Technology/Product(s) 
BioFire Diagnostics, LLC 
(A bioMérieux 
Company) 
FILMARRAY platforms: FILMARRAY Torch, FILMARRAY 2.0 system, and FILMARRAY EZ 
Configuration 
•FILMARRAY Respiratory Panel (RP) 
•FILMARRAY Meningitis/Encephalitis (ME) Panel  
•FILMARRAY Gastrointestinal (GI) Panel  
•FILMARRAY Blood Culture Identification (BCID) Panel  
•FILMARRAY Respiratory Panel EZ 
Respiratory Panel 2.1 (RP2.1) 
Blood Culture Identification 2 (BCID2) 
Pneumonia Panel 
Pneumonia Panel Plus 
Meningitis/Encephalitis Panel 
GI Panel 
Joint Infection Pane 
Bioneer Corporation 
ExiStation Universal Molecular Diagnostic System with multiple PCR-based infectious disease 
tests, ExiStation 48 
Cepheid, Inc. (A 
Danaher Company) 
• GeneXpert System 
•Hospital acquired infections: Xpert C. difficile, Xpert C. difficile/Epi, Xpert Carba-R, Xpert 
MRSA NxG, Xpert MRSA/SA BC, Xpert MRSA/SA SSTI, Xpert Norovirus, Xpert SA Nasal 
Complete, Xpert vanA 
•Critical infectious diseases: Xpert MTB/RIF, Xpert Flu, Xpert Flu/RSV XC, Xpert EV, Xpert 
Xpress Flu, Xpert Xpress Flu/RSV, Xpert Xpress Strep A 
•Sexual Health: Xpert CT/NG, Xpert GBS, Xpert GBS LB, Xpert TV 
Check-Points B.V. 
•Multiplex real-time PCR assays for screening and confirmation: Check-Direct CPE; Check-
Direct ESBL (in development); Check-Direct CPE for BD MAX; Check-Direct CPE Screen for BD 
MAX; Check-Direct ESBL Screen for BD MAX™; Check-Direct ESBL Screen for BD MAX 
•Microarray assays (include amplification step): Check-MDR CT101 - For epidemiology of 
suspected ESBL- and AmpC-producers with a single test; Check-MDR CT102 - For 
carbapenem-resistant Enterobacteriaceae (CRE); Check-MDR CT103 XL - Comprehensive CE-
IVD assay for molecular beta-lactamase identification 
•Ligation-mediated real-time PCR: Check-MDR Carba; Check-MDR ESBL 
Coyote Bioscience Co., 
Ltd. (China) 
Mini8 Plus - Portable qPCR system 

 
 
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Company 
Technology/Product(s) 
Curetis (OpGen) 
Unyvero System: 
•Unyvero HPN Pneumonia Cartridge  
•Unyvero ITI Cartridge  
•Unyvero BCU Cartridge  
•Unyvero IAI Cartridge  
•Unyvero LRT Lower Respiratory Tract Cartridge 
Diasorin S.p.A. 
Simplexa molecular assays for use on the LIAISON MDX platform 
GenePOC Inc. (Meridian 
Bioscience) 
•GenePOC C.diff 
•GenePOC GBS LB - For Group B Streptococcus from Lim Broth samples 
•GenePOC GBS DS - For direct screening of Group B Streptococcus at intrapartum 
Genetic Signatures 
EasyScreen Gastrointestinal Parasite Detection Kit 
Genmark Diagnostics 
(Roche) 
•XT-8  system panels: Respiratory Viral Panel (RVP); HCVg Direct Test  
•ePlex Instrument System panels: ePlex Respiratory Pathogen (RP) Panel; ePlex BCID Fungal 
Pathogen (BCID-FP) Panel; ePlex Blood Culture Identification Gram-Positive (BCID-GP) Panel; 
ePlex Blood Culture Identification Gram-Negative (BCID-GN) 
•Central Nervous System Panel (CNS) 
•Gastrointestinal Pathogen Panel (GI) 
•HCV Genotyping Panel (HCVg) 
Hologic, Inc. 
•Platforms: PANTHER Fusion system, PANTHER system, Tigris DTS system, DTS system 
•PANTHER Fusion assays on the market: PANTHER Fusion Flu A/B/RSV Assay, PANTHER 
Fusion Paraflu Assay, PANTHER Fusion AdV/hMPV/RV Assay 
•PANTHER Fusion assays in development: MRSA, Clostridium difficile, Group B streptococcus 
(GBS), Infectious Disease, SARS-CoV-2 
•Aptima assays on the market: Aptima Combo 2 Assay for CT/NG, Aptima Chlamydia 
trachomatis Assay, Aptima Neisseria gonorrhoeae Assay, Aptima Trichomonas vaginalis 
Assay, Aptima HPV Assay, Aptima HPV 16 18/45 Genotype Assay, Aptima Mycoplasma 
genitalium Assay, Aptima HIV-1 Quant Dx Assay, Aptima HCV Quant Dx Assay, Aptima HBV 
Quant Assay, Aptima HSV 1 & 2 Assay 
•Aptima assays in development: Bacterial vaginosis and Candida vaginalis, Atima SARS-CoV-2 
•Cervista HPV tests 
•ThinPrep Pap tests (with instrumentation) 
•Prodesse ProGastroSSCS Assay, Prodesse ProFAST+ Assay (for FluA Sub-Typing), Prodesse 
ProFlu+ Assay, Prodesse Adeno+ Assay, Prodesse ProParaflu+ Assay, Prodesse Pro hMPV+ 
Assay, and Prodesse 

 
 
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Company 
Technology/Product(s) 
Luminex Corporation 
(Diasorin) 
•Platforms: ARIES Systems; Verigene System; LUMINEX 100/200; MAGPIX System 
•Respiratory disease 
o Targeted testing: ARIES Flu A/B & RSV Assay, ARIES® Bordetella Assay, ARIES® Group A 
Strep Assay 
o Syndromic testing: NxTAG Respiratory Pathogen Panel 
o Flexible testing: VERIGENE Respiratory Pathogens Flex Test 
•Gastrointestinal disease 
o Targeted testing: ARIES C. difficile Assay and ARIES® Norovirus Assay (CE marked in June 
2017, not FDA cleared) 
o Syndromic testing: VERIGENE Enteric Pathogens Test and xTAG® Gastrointestinal Pathogen 
Panel 
•Bloodstream infection 
o VERIGENE Gram-Positive Blood Culture test 
o VERIGENE Gram-Negative Blood Culture Test 
•Women’s health 
o ARIES GBS Assay 
o ARIES HSV 1&2 Assay 
o MultiCode-RTx HSV 1&2 Kit 
o xMAP MultiFLEX Zika RNA Assay 
Meridian Bioscience, 
Inc. 
illumigene Molecular Diagnostic System with tests for: C. difficile, Group A Streptococcus, 
Group B Streptococcus, HSV 1&2, Mycoplasma, Mycoplasma Direct, Pertussis 
Mesa Biotech (Thermo 
Fisher) 
Mesa Biotech Dock and Flu A/Flu B Test Cassette 
Mobidiag Ltd (Hologic) 
•Amplidiag - Family of diagnostic tests for high-volume screening of gastrointestinal 
pathogens and antibiotic resistances 
•Novodiag - Fully automated molecular testing platform for diagnostics of infectious 
diseases; Cartridges in development for Gastrointestinal infections, Antibiotic resistances, 
Parasites, Meningitis 
Molbio Diagnostics Pvt. 
Ltd. (India) 
Truelab Real Time micro–PCR System - Includes Truelab Uno Real Time Micro PCR Analyzer 
and Truenat Chip Based Real Time micro–PCR Tests. 
•Available tests include: Mycobacterium tuberculosis (MTB), TB resistance, HBV viral load, 
Malaria Pf, Dengue, H1N1, Chikungunya, Salmonella 
•Products in development: Salmonella, HCV viral load, HIV viral load, HPV - Cervical Cancer, 
Chlamydia, Gonorrhea, Trichomonas 

 
 
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Company 
Technology/Product(s) 
OpGen 
(Acquired AdvanDx) 
AdvanDx FISH product line: 
•QuickFISH Products: Staphylococcus QuickFISH; Enterococcus QuickFISH; Gram-Negative 
QuickFISH®; Candida QuickFISH® 
•PNA FISH Products: S. aureus/CNS PNA FISH; E. faecalis/OE PNA FISH; Gram-Negative PNA 
FISH; Candida PNA FISH" 
  
OptiGene 
•Genie II and Genie III instruments - isothermal amplification 
•Assays: easyplex C. difficile; easyplex VRE; easyplex CSF easyplex SuperBug CRE; easyplex 
SuperBug complete A; easyplex SuperBug complete B; easyplex MRSA 
Omega BioTek 
Mag-Bind Blood HIV DNA automated extraction 
PreTect AS 
(Formerly called 
NorChip AS) 
(Wholly owned 
subsidiary of Holta Life 
Sciences AS) 
•PreTect SEE - Qualitative NASBA assay for specific genotyping of E6/E7 mRNA from HPV 16, 
HPV 18 and HPV 45. 
•PreTect HPV-Proofer - Qualitative NASBA assay for specific genotyping of E6/E7 mRNA from 
HPV 16, HPV 18, HPV 31, HPV 33 and HPV 45. 
•PreTect HPV-Proofer HV - Qualitative NASBA assay for specific genotyping of E6/E7 mRNA 
from HPV 16, HPV 18, HPV 31, HPV 33 and HPV 45; 35, 52 or 58 is optional. 
QIAGEN 
•QIAsymphony system; includes Roto-Gene Q (Roto-Gene Q MDx in US) 
•Molecular assays (automated and/or manual) available for BK virus, CT/NG, CMV, EBV, 
HBV, HCV, HIV-1, HSV-1/2, M. tuberculosis, and VZV 
QuanDx Inc. 
• High Risk HPV Genotyping Assay  
• TB Drug-Resistant Mutation Test Kit 
• Q-MRSA Detection Kit 
QuantuMDx Group 
Q-POC - portable, battery-operated molecular diagnostic device: 
•Tuberculosis - Combined detection of and drug susceptibility determination  
•STI Panel Test  
•Malaria Assay 
•HPV - For diagnosis of high-risk strains 

 
 
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Company 
Technology/Product(s) 
QuidelOrtho 
AmpliVue tests  for Bordetella pertussis, C. difficile, Group B Streptococcus (GBS), and HSV 1 
& 2 
•Solana C. difficile Assay 
•Solana GAS Assay 
•Solana GBS Assay 
•Solana HSV 1+2/VZV Assay 
•Solana Influenza A+B Assay 
•Solana Respiratory Viral Panel 
•Solana RSV + hMPV Assay 
•Solana Strep Complete Assay 
•Solana Trichomonas Assay 
•Lyra Adenovirus Assay 
•Lyra Influenza A+B Assay 
•Lyra Parainfluenza Virus Assay 
•Lyra RSV + hMPV Assay 
•Lyra Direct C. Difficile Assay 
•Lyra Direct HSV 1+2/VZV Assay 
•Lyra Direct Strep Assay 
R-Biopharm AG 
RIDA GENE-kits - For detection of gastrointestinal, hospital acquired, and respiratory 
infections 
--Can be performed on common PCR instruments 
Randox Laboratories 
•Respiratory Multiplex Array (detects 22 viral and bacterial pathogens) 
•STI Multiplex Array (detects 10 viral, bacterial and protozoan STIs) 
Roche 
cobas 4800 assays… 
•Healthcare-associated infections – Clostridium difficile testing (cobas C.diff Test) and the 
cobas MRSA/SA Test 
•Sexually transmitted infections – cobas 4800 CT/NG Test and cobas® HPV Test 
•cobas® HSV 1 and 2 Test 
cobas 8800 system and the cobas 6800 system assays: 
•Infectious diseases and viral load include respiratory disease): HIV-1, HBV, HCV, CMV, HIV-
1/2, Qual MTB (in development), MAI (in development), RIF/INH (in development) 
•Sexual health: HPV, CT/NG, TV/MG (in development) 
Roche 
cobas Liat PCR System - Influenza A/B, Influenza A/B & RSV, and Strep A, SARS-C0V-2, MTB-
RIF/INH 

 
 
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Company 
Technology/Product(s) 
Seegene, Inc (Korea) 
•Respiratory pathogen tests/panels: Allplex Respiratory Panel Assays; Allplex Respiratory 
Panel 1; Anyplex II RV16 Detection; Anyplex II RB5 Detection; Anyplex MERS-CoV(upE & 
orf1a) Real-time Detection; Anyplex FluA/B Typing Real-time Detection; Seeplex RV15 ACE 
Detection; Seeplex PneumoBacter ACE Detection; Seeplex RV7 Detection; Seeplex RV15 
OneStep ACE Detection 
•Gastrointestinal pathogen tests/panels: Allplex Gastrointestinal Panel Assays; Seeplex® 
Diarrhea ACE Detection 
•Sexually transmitted infections: Allplex STI/BV Panel Assays; Allplex STI Essential Assay; 
Allplex Genital ulcer Assay; Allplex Candidiasis Assay; Allplex Bacterial Vaginosis Assay; 
Anyplex II STI-7 Detection; Anyplex II STI-5 Detection; Anyplex CT/NG Real-time Detection; 
Seeplex STI Master ACE Detection; Seeplex STD6 ACE Detection; Seeplex HSV2 ACE Detection 
•Human papillomavirus: Anyplex II HPV28 Detection; Anyplex II HPV HR Detection; Seeplex 
HPV4A ACE Detection 
•Tuberculosis: Anyplex II MTB/MDR Detection; Anyplex II MTB/XDR Detection; Anyplex 
MTB/NTM Real-time Detection; Seeplex MTB/NTM ACE Detection; Seeplex MTB Nested ACE 
Detection 
•Sepsis: Magicplex Sepsis Real-time Test  
•Meningitis: Seeplex Meningitis ACE Detection 
•Other: Anyplex VanR Real-time Detection; Seeplex VRE ACE Detection; Seeplex H. pylori-
ClaR ACE Detection 
Vela Diagnostics 
(VelaDx) (Singapore) 
qPCR tests for 
•Human Herpes and Polyomaviruses: BKV Quant, CMV Quant, EBV Quant, HSV-1/2 Quant, 
HSV-1/2 Qual, VZV Quant 
•Respiratory viruses: Influenza A/B & RSV 
•Tropical infections: Zika Virus, Zika Triplex 
Veredus Laboratories 
Pte Ltd (Singapore) 
VereChip - Lab-on-Chip (multiplexed PCR followed by hybridization microarray)" 
•VereFlu: Detects, differentiates and identifies Influenza A: H1, H3, H5, H7, H9 with subtype 
ID’s of H1N1, A/H1N1-2009, H3N2, H5N1 and H9N2 and Influenza B. 
•VereMTB: Detects, differentiate and identify: 10 different mycobacterium strains with 
special emphasis on Mycobacterium tuberculosis Complex (MTBC) and its Resistance to 
Rifampicin and/or Isoniazid from Pulmonary Clinical Specimens or Cultivated Samples (MDR-
TB) 
Source: Kalorama Information 
A more recent development has been the introduction of syndromic tests that can detect and 
differentiate between a much larger number of pathogens associated with a specific disease 
syndrome such as respiratory or gastrointestinal infection.  These syndromic tests can often 
also provide some information about antibiotic resistance genes, although identification of 
unknown pathogens complete information on antibiotic susceptibility are not yet available 

 
 
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from current syndromic tests.  The growing development and use of syndromic tests will 
continue to fuel growth of the molecular microbiology market. 
Microbiome-Related Microbiology Tests 
While study of the microbiome has attracted enthusiastic media attention and venture capital, 
its findings are largely preliminary. However, some IVD companies are already developing 
a greater appreciation for the microbiome’s contributions to human biochemistry and have 
launched tests that measure microbiome changes to monitor disease progression. 
Illumina 
 Illumina launched the iSeq 100 Sequencing System, born out of the Firefly project that the 
firm initially announced in 2016.  The iSeq system uses sequencing-by-synthesis chemistry 
coupled with CMOS detection technology. The iSeq 100 has a "cartridge-based upgrade 
roadmap” and is expected to open up new markets to next-generation sequencing (NGS), 
including monitoring hospital-acquired infections, testing for foodborne pathogens, and rapid 
microbiome sequencing.   
The company has added additional platforms, including NextSeq 1000/NextSeq 2000, 
NovaSeq X/NovaSeq Plus 
Bio-Rad 
Bio-Rad acquired the distribution rights for the CE-marked GA-Map test developed by 
Genetic Analysis. The assay tests the gut microbiota and detects bacterial imbalances to 
diagnose and manage conditions such as inflammatory bowel disease and irritable bowel 
syndrome.  GA-map uses 16S rRNA amplification and several proprietary analytical 
technologies. 
Bio-Rad Laboratories entered into a collaboration with Genetic Analysis AS and Bioaster, a 
French microbiology research institute, to study alterations in the gut microbiome in 
metabolic disorders.  The project will look for microbiota signatures of dysbiosis in metabolic 
disorders like diabetes and obesity in order to pursue diagnostics development.  It will use 
Bioaster's deep and 16S-targeted sequencing technologies and advanced data analysis 
pipelines to highlight new gut microbiome biomarkers, according to a statement. 

 
 
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QIAGEN 
QIAGEN and Biomillenia entered into a collaboration for the use of QIAGEN’s Microbial 
Genomics Pro Suite to generate next-generation sequence data on microbes identified using 
Biomillenia’s proprietary microbiome-on-a-chip technology. Biomillenia’s approach can 
identify unculturable pathogen strains. 
Biomillenia has developed a proprietary droplet-based microfluidics chip platform that 
cultures bacterial species directly from natural samples at the single-cell level.  QIAGEN’s 
bioinformatics platform provides an easy-to-run infrastructure for analyzing microbial 
genomes, from sequence assembly to microbe identification. 
QIAGEN introduced its QIAseq 16S/ITS Panels and UCP Multiplex PCR Kit with a new 
generation of reagents to enable microbial community profiling from complex microbiome 
samples. QIAGEN offers solutions for sequencing through the launch of QIAseq Targeted 
DNA Pro Panels and the QIAseq UPXome RNA Library Kit.      QIAGEN also offers its 
QIAseq Normalizer Kit, which speeds up the equalization of DNA concentrations.                                            
Luminex (Diasorin) 
The GA-map IBS Dysbiosis Test was CE marked and positioned as one of the first diagnostic 
tests for detecting dysbiosis in patients with IBS, and Genetic Analysis entered into an 
agreement with Luminex to develop, market, and sell the test on the Luminex instrument 
platform. This allowed the company to leverage its installed base of instruments while also 
expanding its placement in new laboratories, creating potential commercial synergies in 
gastrointestinal testing. Multiplexing technology remains well-suited for microbiome 
analysis, as it enables simultaneous detection of multiple targets and supports more efficient 
characterization of complex microbial communities, although the direct impact on clinical 
outcomes in IBS continues to be established. Luminex, now part of Diasorin, offers 
gastrointestinal pathogen panels based on xMAP technology, including assays that detect a 
broad range of bacterial, viral, and parasitic targets from stool samples using platforms such 
as MAGPIX, with the portfolio now integrated into DiaSorin’s broader molecular diagnostics 
business. 

 
 
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inBiome BV 
inBiome developed a microbiota-based diagnostic platform aimed at inflammatory bowel 
disease, building on earlier CE-marked components of its microbiome analysis technology 
and molecular tools for bacterial detection. While early positioning suggested it could 
become one of the first PCR-based microbiome diagnostics for IBD, the market has since 
evolved and multiple approaches to microbiome testing are now in development or use. 
Unlike most microbiome analysis methods, which rely on sequencing, inBiome’s approach 
uses PCR to characterize microbial patterns in a sample. The method uses rRNA intergenic 
spacer, enhanced with fluorescent labeling to differentiate microbial groups, allowing 
fragment length and signal detection to estimate composition and relative abundance. This 
approach provides a rapid, culture-free workflow that can be completed in several hours and 
is compatible with standard PCR systems and capillary electrophoresis instruments. While 
effective for profiling microbial communities, the technique is generally better suited for 
pattern recognition than for precise species-level identification. 
DNA Genotek 
DNA Genotek offers the CE-marked OMNIgene•GUT microbiome collection kit, an all-in-
one system that enables individuals to easily self-collect high-quality microbial DNA from 
feces/stool for gut microbiome profiling in clinical laboratory and research settings.  The 
product ensures that the fecal sample is fully stabilized immediately upon collection and 
maintains an accurate and reliable profile for weeks at room temperature.  The product is for 
research use only in the United States. 
Thermo Fisher Scientific 
Thermo Fisher markets the Applied Biosystems Axiom Microbiome Array for simultaneous 
detection of archaea, bacteria, fungi, protozoa and viruses in human and non-human samples. 
Developed in collaboration with the Lawrence Livermore National Laboratory, the array is 
designed to increase the understanding of microorganisms while accelerating the translation 
of these insights into human health and agricultural applications. 

 
 
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Others 
Colorectal cancer remains one of the leading causes of cancer mortality worldwide, and 
interest in microbiome-based diagnostics continues to expand across oncology and other 
disease areas. A number of companies are developing tools that use microbial signatures to 
aid in detection, risk stratification, and disease monitoring, although the field is still emerging 
and not yet widely adopted in routine clinical practice. Efforts are underway to apply 
microbiome analysis to a range of conditions, including gastrointestinal cancers, head and 
neck cancer using saliva-based sampling, and the female reproductive tract microbiome. 
Other groups are exploring microbiome-driven liquid biopsy approaches to detect and 
differentiate cancers, as well as investigating links between the gut microbiome and 
neurological diseases such as Parkinson’s disease. 
At the same time, the broader system supporting microbiome diagnostics has matured. Long-
read sequencing platforms are being used for more detailed characterization of pathogens 
and the microbiome, while plasma microbial cell-free DNA testing has established a role in 
the detection of infectious diseases. Advances in metagenomic analytics, sample preparation 
technologies, and sequencing kits have made microbiome research more accessible and 
scalable. Some companies are focused on microbiome-based diagnostics, while others are 
increasingly integrating these insights into therapeutic development and precision medicine 
strategies. Microbiome-based diagnostics are progressing, but their clinical utility is still 
being defined as evidence continues to build. 
Next-Generation Sequencing-Based Microbiology Approaches 
Nucleic acid sequencing has become an increasingly important tool in clinical microbiology 
as advances in sequencing technology have reduced cost, improved speed, and expanded 
analytical capabilities. While early methods such as Sanger sequencing were used primarily 
for research and had limited applications in infectious diseases, newer platforms now enable 
large-scale analysis of microbial genomes for pathogen identification, outbreak tracking, 
antimicrobial resistance detection, and microbiome characterization. Next-generation 
sequencing technologies enable simultaneous analysis of millions of DNA fragments, 
allowing comprehensive evaluation of both individual pathogens and complex microbial 
communities. These systems deliver far greater throughput and lower cost per base than 

 
 
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earlier approaches and have expanded sequencing use across clinical laboratories, public 
health settings, and infectious disease research. 
Several companies are involved in the development of sequencing platforms widely used in 
microbiology. Illumina offers systems widely adopted in clinical and research environments, 
including MiSeqDx for clinical applications and higher-throughput platforms such as 
NextSeq and NovaSeq. Thermo Fisher Scientific provides Ion Torrent–based systems, such 
as the Ion GeneStudio S5, for targeted sequencing, pathogen identification, and antimicrobial 
resistance studies in clinical and public health laboratories. 
Despite these advances, sequencing in routine microbiology diagnostics is still concentrated 
in reference laboratories, academic centers, and public health institutions. Many applications 
continue to be implemented as laboratory-developed tests, including pathogen identification, 
resistance profiling, viral genotyping, and metagenomic detection from complex samples. 
Whole-genome sequencing of bacterial pathogens is a particularly active area, enabling 
detailed characterization of organisms and improved understanding of resistance 
mechanisms. 
Bioinformatics has become a critical component of sequencing-based diagnostics. 
Companies have developed platforms that link genomic data with curated databases to 
support interpretation and clinical decision-making. Efforts such as those developed by 
OpGen through its ARES Genetics unit combine genome sequencing with resistance 
databases to correlate genetic markers with antimicrobial susceptibility patterns and guide 
more targeted therapy. 
Sequencing is expected to play an increasingly important role in clinical microbiology as 
workflows become more automated and interpretation tools improve. It is increasingly used 
in outbreak investigations, antimicrobial resistance surveillance, and the diagnosis of 
difficult-to-diagnose infections, and it is gradually moving closer to routine clinical use. 
QIAGEN supports sequencing workflows with products such as targeted DNA panels, RNA 
library preparation kits, and normalization tools that help streamline sample preparation and 
improve consistency in sequencing applications. 

 
 
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Table 11-3: Selected Companies Applying DNA/RNA Sequencing to Microbiology 
Company 
Sequencing Activity 
Advanced Biological Labs (ABL Diagnostics) 
NGS DeepCheck HIV genotyping 
Curetis (OpGen) 
Agreement with MGI (a fully owned subsidiary of BGI Group (China) to 
develop targeted next-generation sequencing (NGS) IVD assays for 
microbial infections. 
NGS -based molecular antibiotic susceptibility test 
Pathogenetix 
Developing the RESOLUTION Microbial Genotyping System based on 
Genome Sequence Scanning (GSS) technology. 
Source: Kalorama Information 
Syndromic/Multiplex Testing 
Over the past decade, syndromic molecular testing has significantly advanced diagnostic 
testing for respiratory and other infectious diseases. Syndromic panels are multiplex 
molecular assays designed to simultaneously detect multiple pathogens associated with a 
particular clinical syndrome, such as respiratory infections, gastrointestinal illness, 
meningitis, or sepsis. These panels typically use PCR or other nucleic acid amplification 
technologies to detect a broad range of viral, bacterial, and sometimes fungal pathogens from 
a single patient specimen. 
Traditional diagnostic approaches often relied on ordering tests for individual pathogens 
based on clinical suspicion. These methods included culture, antigen or antibody 
immunoassays, and single-target molecular tests. While culture can ultimately identify the 
causative organism and determine antimicrobial susceptibility when the pathogen is 
bacterial, results may require several days. Earlier molecular tests targeted only one organism 
at a time, so if the causative pathogen was not included in the ordered test, the infection could 
remain undiagnosed. 
Syndromic molecular panels address this limitation by simultaneously testing for many of 
the most common pathogens associated with a particular infection. These assays provide 
faster turnaround times, often delivering results in approximately one hour depending on the 
platform. Many panels also include detection of antimicrobial resistance markers that can 
guide early therapeutic decisions. 

 
 
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Syndromic testing is particularly valuable in hospitalized or critically ill patients, where rapid 
identification of the causative organism can affect treatment decisions and infection control 
measures. In cases such as hospital-acquired pneumonia or severe respiratory infections, 
testing multiple pathogens individually can delay treatment and increase the risk of 
complications. Syndromic testing allows clinicians to quickly identify the responsible 
pathogen and initiate targeted therapy. 
Several diagnostic companies offer syndromic testing platforms. bioMérieux’s BIOFIRE 
system is one of the most widely used platforms and provides pathogen-specific results in 
approximately one hour. The system offers multiple syndromic panels, including the 
BIOFIRE Respiratory Panels,  BCID2 Panel, Gastrointestinal Panel, Meningitis/Encephalitis 
Panel, Pneumonia Panel, and Joint Infection Panel, which simultaneously detect numerous 
pathogens and resistance markers associated with specific infections. 
QIAGEN markets the QIAstat-Dx syndromic testing platform, which includes panels for 
respiratory infections, gastrointestinal pathogens, and meningitis/encephalitis. The QIAstat-
Dx Respiratory Panel can detect more than twenty viral and bacterial respiratory pathogens 
in a single cartridge. QIAGEN is also expanding its syndromic testing portfolio with the 
QIAstat-Dx Rise system, a higher-throughput platform designed to increase laboratory 
testing capacity and automation. 
Hologic’s PANTHER Fusion system offers modular syndromic respiratory testing through a 
menu of assays that can be run individually or combined from a single specimen. The system 
allows laboratories to expand respiratory testing capabilities by adding assays for influenza, 
RSV, adenovirus, parainfluenza viruses, and other respiratory pathogens. 
Becton Dickinson’s BD MAX system provides automated real-time PCR testing and includes 
syndromic assays for healthcare-associated infections, enteric pathogens, and sexually 
transmitted infections. The platform automates nucleic acid extraction, amplification, and 
detection within a single instrument and supports both commercial assays and laboratory-
developed tests. 
Multiplex molecular testing has also expanded significantly since the COVID-19 pandemic. 
Numerous assays now allow simultaneous detection of SARS-CoV-2, influenza A/B, and 
RSV from a single patient sample. These multiplex assays help clinicians differentiate 
respiratory infections with similar symptoms and support appropriate patient management. 

 
 
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Examples of multiplex respiratory assays include Cepheid’s Xpert Xpress CoV-2/Flu/RSV 
test on the GeneXpert system and QIAGEN’s QIAstat-Dx Respiratory Panel Plus. Several 
companies also offer point-of-care molecular or antigen tests capable of detecting multiple 
respiratory viruses simultaneously. 
Point-of-care multiplex molecular systems are also expanding. Visby Medical markets a 
disposable handheld PCR respiratory test capable of detecting SARS-CoV-2 and influenza 
A/B with results available in about 30 minutes. Nuclein’s DASH Rapid PCR system provides 
rapid molecular detection of SARS-CoV-2 and influenza A/B at the point of care with results 
in approximately 15 minutes. Pfizer markets the Lucira by Pfizer COVID-19 & Flu Home 
Test, an over-the-counter molecular test that can detect both SARS-CoV-2 and influenza A/B 
in about 30 minutes. 
A number of antigen-based multiplex tests are also available for home or clinical use. These 
include ACON Laboratories’ Flowflex Plus COVID-19 and Flu A/B Home Test and the 
Healgen Rapid Check COVID-19/Flu A&B Antigen Test, which provide rapid qualitative 
detection of respiratory viruses in approximately 15 minutes. 
Additional advances include the development of PCR-based point-of-care analyzers such as 
Spindiag’s Rhonda system, which uses microfluidic technology to detect respiratory 
pathogens, including influenza, RSV, and SARS-CoV-2. The platform is designed to expand 
to larger multiplex panels capable of detecting numerous pathogens from a single sample. 
Syndromic multiplex testing is a growing component of modern infectious disease 
diagnostics. These tests help laboratories manage increasing testing demand while reducing 
hands-on time and improving diagnostic accuracy. As laboratory staffing shortages and 
workflow pressures continue, multiplex testing platforms that require fewer reagents, less 
manual processing, and faster turnaround times are expected to see continued adoption across 
hospital, reference, and point-of-care settings. 
 

 
 
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High-Consequence Infectious Disease Threats 
The downside of globalism is the spread of unwanted conditions.  There have been many 
examples of previously unknown or rare pathogens that have spread and become major global 
problems.  This can happen rapidly as people travel by air around the world. 
Table 11-4: Selected Companies Marketing Products Addressing High-Consequence Infectious Disease 
Threats 
Company 
Location 
Technology 
Target 
Details 
Abbott Diagnostics 
U.S. 
mol 
TB 
RealTime MTB RIF/INH Resistance, on m2000 
Abbott Diagnostics 
U.S. 
mol 
Zika 
Real Time Zika 
Advanced Biological 
Lab (ABL Diagnostics) 
Luxembourg 
mol 
TB 
TB sequencing with DeepChek software 
Advanced Biological 
Lab 
Luxembourg 
mol 
TB 
TB by NGS 
Altona Diagnostics 
Germany 
mol 
Ebola 
RealStar Ebolavirus RT-PCR  
Altona Diagnostics 
Germany 
mol 
Zika 
RealStar Zika RT-PCR  
Atomo Diagnostics 
Australia 
POC 
malaria 
AtomoRapid Malaria, Pf/PAN  
Atomo Diagnostics 
Australia 
POC 
panel 
AtomoRapid dengue and chikungunya  
Biocartis 
Switzerland 
mol 
Ebola 
Ebola test with Janssen Diagnostics on Idylla 
BioInnovation 
Solutions 
Switzerland 
mol 
Ebola 
filoviruses, such as Ebola and Marburg 
Bioneer Corp 
Korea 
mol 
Ebola 
AccuPower EBOV real-time RT-PCR  
Bioneer Corp 
Korea 
mol 
Zika 
AccuPower ZIKV Multiplex Zika, dengue, CHIKV  
Bioneer Corp. 
Korea 
mol 
Ebola 
AccuPower EBOV real-time RT-PCR 
Cepheid 
U.S. 
mol 
TB 
Xpert MTB/RIF, TB & rifampin-resistance 
Cepheid 
U.S. 
mol 
TB 
Xpert XDR-TB, extensive drug resistance, PCR 
Cepheid 
U.S. 
mol 
Ebola 
Xpert Ebola, PCR 
Chembio Diagnostics 
U.S. 
POC 
malaria 
DPP Malaria 

 
 
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Company 
Location 
Technology 
Target 
Details 
Co-Diagnostics HBDC 
U.S. 
mol 
TB 
LogixSma-RT TB Kit  
Coris BioConcept 
Belgium 
mol 
chagas 
T. cruzi satDNA OligoC-TesT, PCR  
CTK Biotech 
U.S. 
POC 
CHICKV 
OnSite Chikungunya IgM Combo Rapid Test 
Epistem Holdings 
UK 
POC 
TB 
Genedrive TB and resistance 
Fio Corporation 
Canada 
POC 
lassa 
Corgenix ReLASV Lassa virus antigen on Deki 
Reader 
Fio Corporation 
Canada 
POC 
micro 
Deki Reader Malaria & Dengue, LF 
GBDbio 
U.S. 
POC 
TB 
TB REaD POC test, fluorescent beta lactamase 
enzyme  
GenArraytion 
(Nephros) 
U.S. 
mol 
zika 
MultiFlex Mosquito-borne Panel, zika etc. 
Globavir Biosciences 
U.S. 
mol 
dengue 
PanGlob RT-PCR Dengue 
Hain Lifescience 
Germany 
mol 
TB 
GenoType MTBDRsl, colonies & sputum  
Thermo Fisher 
Scientific 
U.S. 
mol 
flu 
CDC's influenza A (H7/N9) virus 
Luminex (Diasorin) 
U.S. 
mol 
panel 
GenArraytion MultiFlex Mosquito-borne Panel- 
Zika, CHICKV, Dengue 
Lumora 
UK 
mol 
malaria 
malaria test, LAMP, with FIND and Eiken 
Medical Innovation 
Ventures  
Malaysia 
POC 
dengue 
ProDetect Dengue tests 
Meridian Biosciences 
U.S. 
mol 
TB 
illumigene Mycoplasma Direct assay, improved 
Meridian Biosciences 
U.S. 
mol 
dengue 
TruQuik 
Meridian Biosciences 
U.S. 
mol 
malaria 
illumigene Malaria 
Qiagen 
Netherlands 
mol 
panel 
Altona Diagnostics' RealStar Filovirus RT-PCR Kit 
Quest Diagnostics 
U.S. 
mol 
Zika 
Focus Diagnostics Zika Virus RNA RT-PCR test  
Rheonix 
U.S. 
POC 
zika 
Zika virus, Rheonix CARD cartridge & Encompass 
Optimum  
Roche Diagnostics 
U.S. 
mol 
Ebola 
TIB Molbio's LightMix Ebola Zaire rRT-PCR Test 

 
 
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Company 
Location 
Technology 
Target 
Details 
Thermo Fisher 
Scientific 
U.S. 
mol 
MERS 
Middle East Respiratory Syndrome Coronavirus 
(MERS-CoV)  
TIB MOLBIOL GmbH    
Germany 
mol 
Ebola 
LightMix Ebola Zaire rRT-PCR Test  
TwistDx 
UK 
POC 
Ebola 
Solar-powered Diagnostics-in-a-Suitcase Ebola 
Assay 
TwistDx 
UK 
POC 
TB 
TwistAMP with colorimetric signal, visual  
Ubiquitome 
New 
Zealand 
POC 
Ebola 
Freedom4, battery operated  
Vela Diagnostics 
Singapore 
mol 
Zika 
Zika in Sentosa Tropical Infections Panel, Dengue, 
CHICKV  
Veredus Laboratories  
Singapore 
POC 
panel 
VereTrop, a test to detect 15 tropical diseases 
Source: Kalorama Information 
Tickborne Diseases (TBDs) 
Ticks carry more than just Lyme. There are 19 bacteria, protozoa, and viruses implicated in 
tick-borne diseases, and as the full range is rarely tested, TBDs are likely quite 
underdiagnosed.  Three million clinical specimens are tested for tick-borne diseases annually, 
with diagnoses primarily made using ELISA, indirect immunofluorescence assays, and 
Western blots. Lyme disease, in particular, is tested by ELISA, then by Western blot. 
However, because ticks can carry multiple pathogens, additional testing will be needed. 
Tick-borne diseases, such as Rocky Mountain spotted fever, anaplasmosis, ehrlichiosis, 
Powassan virus, and babesiosis, are on the rise, and prevention should be on everyone’s mind, 
particularly during the spring, summer, and early fall when ticks are most active. From May 
through July, people will get more tick bites and tick-borne diseases than at any other time 
of year in the United States.  
Southern tick-associated rash illness closely resembles Lyme disease and occurs in 
individuals who have not traveled to Lyme-endemic areas.  The actual cause of this infection 
is unknown at the moment, and the diagnosis is made clinically.  

 
 
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In many cases, a lone star tick infection may cause a somewhat delayed allergic reaction after 
eating red meat, such as beef, pork and even lamb, according to Bassett. The serious and 
potentially life-threatening allergic reaction to red meat is caused when a lone star tick carries 
a substance called alpha-gal and injects it into a person via the bite.  The reaction is often 
accompanied by hives and can occur up to 12 hours after ingestion of red meat. 
ID-FISH Technology offers the iDart Lyme IgG ImmunoBlot Kit, a standalone test for 
detecting IgG antibodies against Borrelia, the bacterium that causes Lyme disease.  
TB and Other Infectious Diseases 
Abbott Diagnostics markets molecular assays for tuberculosis on its m2000 molecular testing 
platform, including the Abbott RealTime MTB and RealTime MTB RIF/INH Resistance 
assays. These nucleic acid amplification tests detect Mycobacterium tuberculosis complex 
DNA and identify mutations associated with resistance to rifampin and isoniazid, helping 
clinicians rapidly identify drug-resistant tuberculosis and guide appropriate treatment 
decisions. 
Advanced Biological Laboratories (ABL Diagnostics), provides next-generation 
sequencing–based workflows for tuberculosis testing. The company’s DeepChek platform, 
combined with BacterioChek-TB analysis software, enables targeted sequencing and 
bioinformatic analysis to identify drug-resistance mutations in Mycobacterium tuberculosis. 
These tools are used in clinical and research laboratories for genomic analysis and 
antimicrobial resistance surveillance. 
Several companies offer molecular assays for emerging viral infections. Altona Diagnostics 
markets its RealStar RT-PCR kits for pathogens such as Ebola virus and Zika virus. These 
assays are commonly used by public health and reference laboratories for molecular detection 
of viral RNA during outbreak investigations and surveillance programs. 
Bioneer Corporation of South Korea provides molecular assays for mosquito-borne and 
emerging infectious diseases through its AccuPower real-time RT-PCR test portfolio. 
Products include assays for Ebola virus as well as multiplex panels capable of detecting Zika 
virus, dengue virus, and chikungunya virus simultaneously. 
Cepheid, a Danaher company, offers rapid molecular testing for tuberculosis and emerging 
infectious diseases on its GeneXpert platform. The Xpert MTB/RIF Ultra assay provides 

 
 
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rapid detection of Mycobacterium tuberculosis complex and rifampin resistance, while the 
Xpert MTB/XDR assay expands resistance detection to include additional mutations 
associated with extensively drug-resistant tuberculosis. Cepheid also developed the Xpert 
Ebola assay for rapid molecular detection of Ebola virus in outbreak response settings. 
Co-Diagnostics develops molecular PCR assays for infectious diseases using its proprietary 
primer design technology. The company markets the Logix Smart MTB assay, a molecular 
test for the detection of Mycobacterium tuberculosis DNA in clinical samples. 
Several companies also develop molecular diagnostics for tropical diseases. Coris 
BioConcept markets the OligoC-TesT Trypanosoma cruzi PCR assay for the detection of T. 
cruzi, the causative agent of Chagas disease. CTK Biotech offers the OnSite Chikungunya 
IgM Combo Rapid Test, a point-of-care immunoassay designed for qualitative detection of 
IgM antibodies against chikungunya virus. 
Hain Lifescience, part of the Bruker group, provides molecular diagnostic assays for 
tuberculosis drug resistance. Its GenoType MTBDRsl line probe assay detects resistance to 
second-line tuberculosis drugs directly from clinical samples or culture isolates, supporting 
management of multidrug-resistant tuberculosis. 
Reference laboratories also perform molecular testing for emerging infectious diseases. For 
example, Labcorp offers RT-PCR testing for viruses such as Zika virus in specialized 
laboratory settings when testing is required for surveillance or clinical diagnosis. 
Multiplex molecular detection technologies are also used for mosquito-borne pathogens. 
Luminex, now part of Diasorin, offers multiplex testing using its xMAP technology platform, 
enabling simultaneous detection of pathogens such as Zika virus, dengue virus, and 
chikungunya virus on systems including the MAGPIX instrument. 
Other molecular technologies continue to be explored for infectious disease detection. 
Lumora has developed LAMP-based molecular assays for malaria, designed to provide rapid 
nucleic acid detection in laboratory and field settings.  
All these molecular diagnostic technologies demonstrate the expanding role of nucleic acid 
testing, multiplex PCR, and sequencing-based methods for the detection of emerging and 
tropical infectious diseases, supporting rapid diagnosis, surveillance, and outbreak response 
worldwide. 

 
 
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Chagas 
Chagas disease is caused by the protozoan parasite Trypanosoma cruzi, which is transmitted 
primarily by triatomine insects (“kissing bugs”) that are found throughout the Americas. The 
disease is also known as American trypanosomiasis. Transmission occurs when infected 
insects deposit parasite-containing feces near the bite site and the parasites enter the body 
through broken skin or mucous membranes. In addition to vector transmission, infection may 
occur through blood transfusion, organ transplantation, congenital transmission from mother 
to child, contaminated food or drink, or laboratory exposure. 
Chagas disease is endemic in Latin America, particularly in rural areas where housing 
conditions favor the triatomine insect vector. The World Health Organization estimates that 
approximately 6–7 million people worldwide are infected, primarily in 21 endemic countries 
in Latin America. Because many infections remain asymptomatic for years, it is estimated 
that a large proportion of cases remain undiagnosed. Chronic infection can lead to severe 
complications, including Chagas cardiomyopathy, digestive tract enlargement (megacolon or 
megaesophagus), and neurological disorders. Approximately 20–30% of infected individuals 
eventually develop serious chronic disease, often decades after the initial infection. 
Although historically associated with Latin America, migration has led to an increasing 
number of cases in non-endemic regions, including the United States, Europe, and parts of 
Asia Pacific. In the United States, the Centers for Disease Control and Prevention (CDC) 
estimates that roughly 300,000 people are living with Chagas disease, most of whom acquired 
the infection in Latin America. Autochthonous (locally acquired) transmission is rare but has 
been documented in the southern United States, where triatomine insects are present. 
Chagas disease is considered one of the neglected tropical diseases (NTDs) due to limited 
awareness, underdiagnosis, and historically limited treatment options. Two antiparasitic 
drugs—benznidazole and nifurtimox—are currently available for treatment. Both drugs have 
been used for decades and are most effective during the acute or early stages of infection. In 
the United States, benznidazole and nifurtimox are now FDA-approved therapies, although 
access and diagnosis remain challenges. 
Diagnosis of Chagas disease typically relies on serologic testing for antibodies to T. cruzi, 
particularly during the chronic stage of infection. Molecular tests such as PCR may also be 
used in acute infections or congenital cases. Several in vitro diagnostic companies provide 
assays for the detection of T. cruzi infection. 

 
 
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A number of IVD vendors offer tests for Chagas disease. Meridian Bioscience has marketed 
rapid diagnostic tests under the TruQuick line, which includes assays targeting infectious 
diseases such as dengue, malaria, and Chagas disease for use in international markets. 
Chembio 
Diagnostics 
developed 
the 
Chagas 
STAT-PAK 
assay, 
a 
rapid 
immunochromatographic test that detects antibodies to T. cruzi, uses a small sample volume, 
and requires minimal laboratory infrastructure. 
Other manufacturers provide laboratory-based immunoassays. Diasorin offers Chagas testing 
on its LIAISON automated immunoassay platform, while Roche Diagnostics markets the 
Elecsys Chagas assay, which uses recombinant antigens to detect antibodies to T. cruzi. 
InBios 
International 
produces 
the 
Chagas 
Detect 
Plus 
Rapid 
Test, 
an 
immunochromatographic strip assay for qualitative detection of IgG antibodies to T. cruzi in 
serum, plasma, or whole blood. 
Additional diagnostic products are available from companies such as Wiener Lab, which 
offers serologic tests for Chagas disease used in Latin America and other endemic regions. 
These tests include ELISA-based assays and other immunodiagnostic formats used in blood 
screening programs and clinical diagnosis. 
Despite the availability of diagnostic tests, Chagas disease remains underdiagnosed in many 
regions. Expanded screening programs improved diagnostic access and increased awareness 
among healthcare providers and are considered important steps toward reducing the burden 
of this neglected parasitic infection. 
Dengue 
Dengue fever has increased significantly in recent years, becoming one of the most rapidly 
expanding mosquito-borne viral diseases worldwide. According to the World Health 
Organization (WHO), global dengue activity has surged due to factors such as climate 
change, urbanization, increased international travel, and expanding mosquito habitats. In 
2024, more than 7.6 million dengue cases were reported globally, surpassing the previous 
record of approximately 4.6 million cases reported in 2023. By mid-2025, more than 3.6 
million cases and roughly 1,900 deaths had already been reported worldwide. Several 
countries in Southeast Asia and Latin America have experienced significant outbreaks; for 
example, the Philippines reported a more than 200% increase in cases compared with the 
same period in 2024. 

 
 
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Laboratory diagnosis of dengue relies on a combination of molecular tests, antigen detection 
assays, and serologic immunoassays, depending on the stage of infection. Serologic tests that 
detect anti-dengue antibodies (IgM and IgG) are widely used, particularly in resource-limited 
settings. However, antibody-based assays may exhibit cross-reactivity with other 
flaviviruses, including yellow fever virus, West Nile virus, Japanese encephalitis virus, and 
St. Louis encephalitis virus, complicating interpretation in regions where multiple 
flaviviruses circulate. 
IgM antibody capture assays, particularly MAC-ELISA (IgM antibody capture enzyme-
linked immunosorbent assay), are among the most commonly used tests for diagnosing 
dengue infection during the acute and early convalescent phases, typically beginning about 
5 days after symptom onset when IgM antibodies become detectable. In later stages of 
infection, IgG immunoassays are frequently used to confirm past exposure or infection. In 
cases of secondary dengue infection, IgG antibodies often rise rapidly and may be detectable 
during the acute phase, making IgG assays useful for identifying repeat infections. 
Another important diagnostic approach involves the detection of the non-structural protein 1 
(NS1) antigen, which can be identified in patient blood samples from the first day of 
symptoms through the early acute phase of the disease. NS1 antigen tests are widely used as 
rapid diagnostic tests and ELISA assays, allowing earlier detection before antibody responses 
develop. 
Molecular diagnostic tests, particularly reverse transcription polymerase chain reaction (RT-
PCR) assays, are also widely used for dengue diagnosis during the early stage of infection 
when viral RNA is present in blood. These nucleic acid amplification tests provide high 
sensitivity and specificity and can identify the specific dengue virus serotype. Commercial 
molecular test kits are available globally, and the CDC dengue RT-PCR diagnostic panel has 
received FDA authorization for use in qualified laboratories. 
Several companies have developed diagnostic tests for dengue infection. For example, Bio-
Rad has marketed dengue diagnostic assays based on technology originally developed by 
Globavir Biosciences, designed to detect all four dengue virus serotypes with improved 
specificity relative to other flaviviruses. These assays have received regulatory approvals in 
various international markets. 
Research continues to explore new approaches to dengue diagnostics and disease severity 
prediction. In 2022, researchers at Stanford Medicine reported identifying an eight-gene 

 
 
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immune expression signature that may help predict which patients are at risk of developing 
severe dengue, potentially enabling earlier clinical intervention and monitoring. 
International public health organizations continue to refine diagnostic recommendations as 
dengue incidence increases. Updated WHO guidance released in 2025 emphasizes the use of 
NAATs and NS1 antigen assays for early detection, followed by IgM ELISA testing during 
later stages of infection. Diagnostic algorithms are also being adapted to reflect regional 
differences in circulating dengue serotypes, co-circulating arboviruses, and local 
epidemiology. 
Ebola 
Ebola virus disease was first identified in 1976, when outbreaks of a severe viral hemorrhagic 
fever occurred in northern Zaire (now the Democratic Republic of the Congo) and Sudan. 
The outbreak in Zaire involved 318 reported cases and 280 deaths, making it one of the 
earliest documented outbreaks of the disease. The illness presented initially with nonspecific 
symptoms such as fever, fatigue, sore throat, and headache, but often progressed to severe 
symptoms including abdominal pain, vomiting, diarrhea, rash, and, in some cases, 
hemorrhage. Laboratory investigations determined that the causative agent was a previously 
unknown virus related to Marburg virus, which had been identified in 1967. The new virus 
was named Ebola virus after the nearby Ebola River. 
Ebola virus belongs to the genus Ebolavirus within the Filoviridae family. Several species of 
the virus are known to cause disease in humans, including Zaire ebolavirus, Sudan 
ebolavirus, Bundibugyo ebolavirus, and Taï Forest ebolavirus, while Reston ebolavirus has 
been shown to infect primates and pigs but does not cause disease in humans. Since their 
discovery, these viruses have been responsible for more than 30 outbreaks, primarily in sub-
Saharan Africa. Case fatality rates vary by virus species and outbreak conditions, ranging 
from approximately 25% to over 80%. 
Until the mid-2010s, Ebola outbreaks were generally limited to relatively small, localized 
events in rural areas of Central and East Africa or laboratory exposures. This changed in 
2014, when the largest Ebola outbreak in history began in Guinea and spread to Sierra Leone 
and Liberia. The outbreak ultimately resulted in more than 28,000 reported cases and over 
11,000 deaths, highlighting the global threat posed by emerging infectious diseases and 
prompting significant international investment in diagnostics, vaccines, and therapeutics. 

 
 
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Ebola virus disease continues to be closely monitored by public health authorities and 
remains an area of active research and diagnostic development. In 2022, an outbreak of Ebola 
virus disease caused by the Zaire strain occurred in the Democratic Republic of the Congo, 
while Uganda experienced an outbreak of Sudan ebolavirus beginning in September 2022, 
which resulted in more than 160 confirmed cases and dozens of deaths before it was declared 
over in early 2023. In the same year, Ghana reported its first outbreak of Marburg virus 
disease, a related filovirus infection that causes a similar hemorrhagic fever. 
More recently, Uganda reported another outbreak of Sudan ebolavirus in early 2025, which 
lasted until April 2025. This outbreak involved 14 confirmed cases and 4 deaths, representing 
a smaller but closely monitored event. The outbreak was successfully contained through rapid 
surveillance, isolation measures, and international collaboration. 
Research institutions and diagnostic companies continue to develop new tools for the 
detection of Ebola virus and related filoviruses. For example, scientists at Washington 
University School of Medicine in St. Louis have explored emerging diagnostic technologies 
such as optical microring resonator biosensors, which may enable rapid detection of viral 
pathogens, including Ebola. These technologies are part of broader efforts to improve rapid 
molecular diagnostics, point-of-care testing, and outbreak surveillance systems for highly 
pathogenic viruses. 
Advances in vaccines and therapeutics have also improved outbreak response. Vaccines such 
as rVSV-ZEBOV (Ervebo) are now used in outbreak settings to protect against Zaire 
ebolavirus, and several monoclonal antibody treatments have been developed for infected 
patients. Despite these advances, Ebola virus disease remains a serious public health threat, 
particularly in regions with limited healthcare infrastructure and ongoing zoonotic exposure 
to wildlife reservoirs. 
Chikungunya 
Chikungunya virus infection is characterized by acute fever, rash, and particularly severe 
joint pain. While the disease is rarely fatal, the joint pain can be debilitating and may persist 
for months or even years in some patients, resulting in chronic arthritis-like symptoms and 
long-term disability. Treatment is generally supportive and focuses on relieving symptoms 
through rest, hydration, and pain management. Historically, there was no vaccine available 
for chikungunya prevention; however, recent developments have changed the prevention 

 
 
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landscape. The first chikungunya vaccines were approved in the mid-2020s, providing new 
options for individuals at risk, particularly travelers and populations in endemic regions. 
Public health agencies continue to monitor chikungunya activity through global surveillance 
networks. Organizations such as the CDC’s Global Disease Detection Operations Center and 
regional partners, including the Pan American Health Organization, track outbreaks and 
coordinate response efforts. Surveillance is important because chikungunya is transmitted by 
Aedes mosquitoes, the same vectors responsible for dengue and Zika virus transmission, 
allowing the virus to spread rapidly in tropical and subtropical regions where these 
mosquitoes are present. 
Diagnostic testing for chikungunya includes molecular assays in the early stage of infection 
and serologic tests that detect IgM and IgG antibodies in the later stages. Several companies 
provide immunoassay-based tests for chikungunya infection. For example, bioMérieux 
markets VIDAS Anti-Chikungunya IgM and IgG assays, which are automated 
immunoassays used in clinical laboratories for the detection of antibodies against the virus. 
Rapid diagnostic tests are also available for point-of-care use. Chembio Diagnostics 
developed the DPP Zika/Dengue/Chikungunya multiplex rapid test system, which uses a 
small fingerstick blood sample and can provide results within approximately 15 minutes 
when used with the company’s portable reader. 
Chikungunya activity has increased in several regions in recent years. In 2025, outbreaks 
were reported in parts of Asia and Latin America. China reported a surge of cases in certain 
provinces, while Brazil continued to report the largest number of cases globally, with more 
than 140,000 reported infections during the year. These outbreaks highlight the ongoing risk 
of chikungunya transmission in areas where Aedes mosquito populations are established. 
In response to growing demand for diagnostic tools during outbreaks, manufacturers have 
expanded the availability of rapid tests. For example, Beijing Hotgen Biotech developed a 
Chikungunya IgG/IgM Rapid Test that detects antibodies in approximately 15 minutes. Such 
rapid tests are particularly useful in outbreak settings and in regions with limited laboratory 
infrastructure, where timely diagnosis is critical for surveillance and patient management. 
Overall, chikungunya remains an important emerging infectious disease due to the expanding 
geographic distribution of its mosquito vectors and the potential for explosive outbreaks in 
previously unaffected populations. Continued improvements in surveillance, diagnostic 

 
 
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testing, and vaccination strategies are expected to play a key role in controlling the impact of 
this virus in the coming years. 
Middle East Respiratory Syndrome-Coronavirus (MERS-CoV) 
Middle East Respiratory Syndrome (MERS) is a viral respiratory illness caused by the 
Middle East respiratory syndrome coronavirus (MERS-CoV). The disease was first identified 
in Saudi Arabia in 2012 and is primarily associated with exposure to infected dromedary 
camels or with transmission in healthcare settings. Symptoms can range from mild 
respiratory illness to severe pneumonia and respiratory failure, typically presenting with 
fever, cough, and shortness of breath. Individuals with underlying health conditions are at 
higher risk of severe disease. In the United States, the public health risk remains very low. 
Only two imported cases have ever been confirmed, both identified in May 2014 in healthcare 
workers who had traveled from Saudi Arabia. 
Globally, MERS continues to occur sporadically, particularly in the Middle East. Since its 
discovery, more than 2,600 laboratory-confirmed cases and nearly 1,000 deaths have been 
reported worldwide. Most infections have been reported from countries in the Middle East 
and North Africa, particularly Saudi Arabia, though travel-associated cases have occasionally 
been detected in Europe and Asia. Small clusters continue to occur, often linked to healthcare 
exposure or contact with infected camels. For example, Saudi Arabia reported a small number 
of additional cases during 2025, including infections associated with hospital exposure and 
camel contact. 
Laboratory diagnosis of MERS is primarily based on nucleic acid amplification testing, 
especially real-time reverse transcription polymerase chain reaction. In the United States, 
most state public health laboratories can test for MERS-CoV using a molecular assay 
developed by the Centers for Disease Control and Prevention. This assay has been authorized 
for use under emergency regulatory provisions because there are no widely marketed FDA-
cleared commercial diagnostic tests specifically for MERS-CoV. Syndromic respiratory 
diagnostic panels used in many laboratories may also include targets for MERS-CoV 
detection. 

 
 
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Marburg 
Marburg virus disease is another highly pathogenic viral hemorrhagic fever caused by 
Marburg virus, a member of the filovirus family closely related to Ebola viruses. The disease 
was first recognized in 1967 when laboratory workers in Germany and Yugoslavia developed 
severe hemorrhagic fever after exposure to tissues from infected African green monkeys 
imported for research. The natural reservoir of the virus is now known to be the Egyptian 
fruit bat, which can transmit the virus to humans directly or indirectly. 
Diagnosis of Marburg virus disease relies on several laboratory methods. Molecular 
techniques such as PCR are the primary diagnostic tools during the acute stage of infection. 
Antigen detection tests and IgM antibody capture assays can also help confirm infection 
shortly after symptom onset. Later in the course of the disease or after recovery, IgG antibody 
tests can be used to identify prior infection. Because of the high risk associated with handling 
the virus, laboratory testing must be conducted in specialized high-containment facilities 
using strict biosafety procedures. 
Recent years have seen several Marburg virus outbreaks in Africa. Ghana reported its first 
outbreak in 2022. Additional outbreaks have occurred in multiple countries since then, 
highlighting the continued emergence of filovirus diseases. Rwanda reported its first 
outbreak in 2024, involving dozens of confirmed cases and multiple deaths. In early 2025, 
Tanzania declared a Marburg virus outbreak that resulted in several confirmed and probable 
cases before containment measures were implemented. These outbreaks have underscored 
the importance of rapid diagnostic testing, surveillance, and international cooperation in 
responding to highly pathogenic viral diseases. 
SARS-CoV-2 (COVID-19) 
Diagnosis of viral infections generally relies on two primary methodologies: molecular 
nucleic acid amplification testing, such as real-time reverse transcription PCR and serologic 
immunoassays that detect virus-specific antibodies (IgM and IgG) or viral antigens. 
Molecular testing directly detects viral RNA and remains the most sensitive approach for 
detecting active infection, particularly during the early stages of disease, when viral 
replication is highest. During the COVID-19 pandemic, RT-qPCR became the reference 
method for detecting SARS-CoV-2 because of its high analytical sensitivity and specificity. 

 
 
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However, molecular detection can be affected by several factors, including specimen type, 
the timing of collection relative to symptom onset, and the patient's viral load. If viral RNA 
levels in the specimen are low, such as very early or late in infection or due to inadequate 
sample collection, molecular tests may yield false-negative results. For this reason, specimen 
quality, proper handling, and testing during the appropriate clinical window remain critical 
for accurate RT-qPCR results. 
Serological testing provides another diagnostic approach by detecting the host's immune 
response to infection rather than the virus itself. Immunoassays that detect IgM and IgG 
antibodies can identify individuals who have mounted an immune response following viral 
exposure. Antibodies tend to be more stable than viral RNA and can often be detected even 
after the acute infection has resolved. Serology is therefore useful for identifying prior 
infection, supporting epidemiologic surveillance, and evaluating immune response in 
vaccinated or previously infected individuals. 
Combining molecular and serologic testing can improve overall diagnostic insight, 
particularly when the timing of infection is uncertain. RT-qPCR or other NAAT methods are 
most useful during the acute phase of infection, when viral RNA is present in respiratory 
specimens. Serologic assays become more informative during the later or convalescent 
phase, when antibody production has developed. For diseases such as COVID-19 and other 
viral infections, the complementary use of molecular detection and antibody testing can help 
clinicians better determine infection status, disease stage, and past exposure. 
Monkeypox 
Mpox (formerly commonly called monkeypox) is a viral disease caused by the monkeypox 
virus, an orthopoxvirus in the same family as smallpox. Clinical illness may include fever, 
swollen lymph nodes, fatigue, and a characteristic rash that progresses to vesicles and 
pustules. Although often self-limited, severity varies by viral clade, patient age, immune 
status, and access to care. Transmission occurs through close contact with an infectious rash 
or body fluids, prolonged face-to-face exposure involving respiratory secretions, and contact 
with contaminated materials. Sexual contact has been an important transmission route in 
many outbreaks, but mpox is not limited to sexual transmission. 
From 2024 through 2026, mpox epidemiology has been defined by two parallel realities: 
continued low-level clade II circulation in multiple regions and more concerning clade I 
activity in parts of Africa, including outbreaks driven by clade I sublineages that spread into 

 
 
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areas with limited prior exposure. WHO declared a Public Health Emergency of International 
Concern in August 2024 in response to the upsurge in Africa and cross-border spread; by 
September 2025, WHO determined the emergency designation could be lifted because of 
sustained declines in key hotspots, while emphasizing that mpox remained a public health 
concern requiring ongoing surveillance, testing access, and preparedness. 
Diagnostic capacity has expanded rapidly and is centered on PCR-based detection of MPXV 
DNA from lesion swabs, the preferred clinical specimen type for confirmation. During the 
2022 outbreak response, the CDC’s Laboratory Response Network scaled testing using a 
CDC-developed orthopoxvirus PCR approach, and U.S. health authorities began shipping 
CDC orthopoxvirus testing materials to major commercial laboratories, including Aegis 
Sciences, Labcorp, Mayo Clinic Laboratories, Quest Diagnostics, and Sonic Healthcare, to 
increase national testing capacity and improve access. 
IVD manufacturers also moved quickly to support decentralized and higher-throughput mpox 
testing. BD collaborated with CerTest Biotec to validate the VIASURE Monkeypox assay 
on the BD MAX platform using the system’s open reagents, enabling automated sample-to-
result PCR workflows on an installed base already used for other infectious disease assays. 
Roche offers a high-throughput cobas MPXV real-time PCR assay for the cobas 6800/8800 
systems, using a dual-target design suitable for large clinical laboratories processing many 
specimens. Abbott markets the Alinity m MPXV assay for automated real-time PCR testing 
on Alinity m platforms. Cepheid offers the Xpert Mpox on GeneXpert systems, supporting 
near-patient or rapid-turnaround testing models with on-demand operation in many settings. 
Thermo Fisher Scientific developed multiple PCR tools to support mpox testing workflows, 
including the Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA Kit, which is 
designed to detect MPXV and screen for non-variola orthopoxviruses using common real-
time PCR laboratory infrastructure. Thermo Fisher also supports mpox detection through 
targeted microbe-detection assay options that laboratories can incorporate into validated 
workflows. 
A number of organizations pursued smaller-footprint or point-of-care nucleic acid 
approaches as well. Ustar Biotechnology advanced its EasyNAT Monkeypox Virus Assay, a 
cartridge-based NAAT approach intended for more decentralized testing models, and the 
assay has been evaluated for emergency procurement pathways in global health settings. 
Applied DNA Clinical Labs developed laboratory-developed testing services for mpox and 
subsequently expanded capability to address both clade I and clade II, reflecting the changing 

 
 
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epidemiology and the need for clade-aware confirmation in some contexts. T2 Biosystems 
publicly explored the development of a rapid molecular mpox test during the early outbreak 
period; however, this was communicated as development intent rather than a widely deployed 
commercial assay. 

 
 
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Market Analysis 
Traditional microbiology, molecular microbiology, and mass spectrometry tests are 
commonly performed in microbiology laboratories.  Infectious disease immunoassays are 
frequently performed in the core laboratory on fully automated analyzers that often perform 
both chemistry and immunochemistry tests.  These core laboratory platforms and tests are 
not a significant focus of this chapter.  However, infectious disease immunoassays represent 
a significant segment of the overall microbiology market, and they are competitive methods 
for identifying certain pathogens.  All four major segments (traditional microbiology, 
immunoassays, molecular microbiology, and mass spectrometry applications in 
microbiology) are included in the microbiology market analysis discussed in this chapter.   
Traditional culture-based microbiology methods have been used for many years in 
microbiology laboratories.   
Microbial identification and ID/AST by traditional culture-based methods require a long time 
to complete, and physicians need answers quickly to use the information when making 
treatment decisions.  As a result, culture-based testing faces considerable competition from 
other, faster methods to identify which microbial pathogen is present.  However, culture-
based traditional microbiology will remain an important segment of the overall microbiology 
market. 
Infectious disease immunoassays represent the largest segment of the microbiology market. 
As previously mentioned, many infectious disease immunoassays are now performed on 
large, automated immunochemistry analyzers in the core laboratory, rather than in 
microbiology laboratories. 
Molecular microbiology is also a well-established market, with $6.9 billion in revenues in 
2025 (excluding the $1.8 billion COVID-19 market).   However, technological advances are 
making this market more rapidly growing and dynamic.  Examples of advances that have 
already reached the market include syndromic testing and rapid molecular assays for 
detecting specific pathogens.    
The global microbiology market can also be segmented by geographical regions.  The bulk 
of the market is in developed regions, with North America accounting for 44% and Europe 
accounting for 35%.  Asia Pacific represents about 13% of the market, with the remaining 
8% generated in RoW. 

 
 
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Table 11-5: Global Microbiology Sales Distribution, by Region, 2025 (%)  
 
[Asia Pacific; Europe; North America; Rest of World] 
 Region 
% Mkt 
North America  
44% 
Europe 
35% 
Asia Pacific 
13% 
RoW 
8% 
Total 
100% 
Source: Kalorama Information 
The market analysis in the chapter looks more in depth at the microbiology market segments 
(traditional microbiology, immunoassays, molecular microbiology, and mass spectrometry).  
In the tables that focus on these segments, it can be seen that testing for pathogens such as 
HIV, hepatitis viruses, and respiratory pathogens (both bacterial and viral pathogens) are 
significant parts of multiple segments of the microbiology market.  

 
 
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Market Analysis - Traditional Microbiology ID/AST 
The traditional microbiology market focuses on microbial identification followed by 
antibiotic susceptibility testing (ID/AST).  This traditional area of microbiology remains a 
gold standard for infectious disease confirmatory testing and its growth will persist with 
ID/AST’s advantages in terms of accommodation of high testing volumes and relatively low 
testing costs. 
Companies reported mixed performance for ID/AST technologies. For instance, Becton 
Dickinson reported slower growth in its product lines due to supply disruptions and slow 
returns to "prior levels." While not all news and performance were negative, bioMérieux 
received FDA 510(k) Clearance for its VITEK COMPACT PRO test during the first half of 
2025, which is positioned to drive new growth in the segment; while Abbott Laboratories 
continued to perform well in the segment with mid-single digit growth. 
Table 11-6: Global Microbiology ID/AST Market, by Segment, 2025-2030 ($ million)  
 
[Blood Culture; Chromogenic Media; ID/AST Auto; ID/AST Panels; Rapid Microbiology] 
Segment 
2025 
% Mkt 
2030 
% Mkt 
CAGR 
ID/AST Auto 
1,790 
32% 
2,170 
34% 
4% 
Chromogenic Media 
1,315 
24% 
1,380 
22% 
1% 
Blood Culture 
1,167 
21% 
1,340 
21% 
3% 
Rapid Microbiology 
876 
16% 
943 
15% 
2% 
ID/AST Panels 
438 
8% 
481 
8% 
2% 
Total 
5,586 
100% 
6,314 
100% 
3% 
Supplies 
1,994 
-- 
2,154 
-- 
2% 
Note: Percentages rounded 
Source: Kalorama Information 
The global market for microbiology ID/AST is estimated at $5,586 million in 2025.  With 
2.5% revenue growth, it will reach $6,314 million in 2030. Traditional microbiology includes 
culturing clinical specimens and also testing the resulting culture samples.  Following culture 

 
 
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of the sample, pathogen identification can be accomplished using fluorogenic and 
chromogenic substrates that react in the presence of a particular genus or species in the 
culture or cultured sample.   
Antibiotic susceptibility or resistance of bacteria is typically determined by exposing cultured 
organisms to graduated or variable drug concentrations. Visual examination, optical 
scanning, fluorogenic/chromogenic substrates or other reagents may be used to determine the 
growth or lack of growth of the bacteria exposed to antibiotics in individual wells, plates, or 
plate areas. 
Kalorama Information organizes the microbiology ID/AST market into the following product 
categories:  
• Microbial ID/AST Systems, and Panels and reagents for ID/AST systems 
• Chromogenic media 
• Rapid tests done on colonies selected from culture media 
• Blood culture bottles and systems 
While the markets for each of these product categories continue to grow, they are mature 
markets that, despite innovation, record sales growth a bit slower than the molecular 
microbiology or mass spectrometry markets, which are discussed below. 
The overall market leader for ID/AST systems and reagents is bioMérieux, but competitors 
abound where stable revenue growth is seen.  bioMérieux is estimated to compete for the 
leading position with Abbott Diagnostics and Becton Dickinson. 
 The rise of molecular microbiology, alongside the dominant immunoassay segment, was 
initially expected to drive the gradual replacement of traditional methods for identification 
and antimicrobial susceptibility testing in infectious disease diagnostics. However, this 
transition has progressed more slowly than anticipated, and ID/AST is expected to remain a 
stable and essential part of the market through 2030. While culture-based methods have long 
turnaround times, ranging from a day to several weeks, and require significant laboratory 
labor, they continue to play a critical role in clinical decision-making. Molecular assays offer 
advantages in speed and accuracy, but they are generally more expensive both in terms of 
reagents and overall testing costs compared to high-throughput, automated ID/AST systems, 

 
 
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which continue to provide cost-effective and scalable solutions for routine microbiology 
testing. 
Culture-based traditional microbiology will remain an important segment of the overall 
microbiology market, expected to increase at 2.5% CAGR by 2030.  Immunoassays and 
molecular assays can determine whether a known pathogen is present.  However, a negative 
result only means that the specific microbial pathogens being tested are not present, and it is 
possible that the patient is infected by a different microorganism. Molecular assays also rely 
on probes and primers that remain vulnerable to changing microbial genetics. Traditional 
susceptibility testing may more conclusively demonstrate a pathogen's resistance and 
vulnerability than detecting one or two specific gene markers. However, in particularly 
critical or time-sensitive microbiology workups, such as inpatient infections, ID/AST has lost 
volume to molecular and other rapid alternative systems that enable clinicians to quickly 
initiate informed treatment. 
North America is the largest region for ID/AST testing worldwide (34%), particularly for 
automated systems.  Asia Pacific held steady at 29% in 2025, while the European market 
remained at 27% market share. 
Antimicrobial resistance and nosocomial infections represent leading infectious disease 
threats for the developed world and will be addressed in significant part by ID/AST testing, 
particularly in the treatment of outpatient infections. Remaining growth will be found in 
relatively undeveloped markets where ID/AST capacities have yet to be built out among 
clinical laboratories. 
Table 11-7: Global ID/AST Testing Sales Distribution, by Region, 2025 (%) 
 
[Asia Pacific; Europe; North America; Rest of World] 
 Region 
% Mkt 
North America  
34% 
Asia Pacific 
29% 
Europe 
27% 
RoW 
10% 
Total 
100% 
Source: Kalorama Information 

 
 
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Traditional ID/AST 
The global market for microbial identification and antimicrobial susceptibility systems is 
valued at $3.4 billion in 2025 and is projected to reach $4.0 billion in 2030. ID/AST systems 
can be divided into panels and reagents performed by manual, semi-automated, or automated 
systems.  Panels account for about 20% of the market, while automated systems account for 
the larger share of sales, at 80%. 
Table 11-8: Global ID/AST Testing, Distribution by Systems, (%)  
 
[Auto, Panel] 
 System 
% Mkt 
Auto 
80% 
Panels 
20% 
Total 
100% 
Source: Kalorama Information 
Specific Technologies offers the Reveal Rapid Susceptibility Testing System. The system 
provides quantitative determination of antibiotic efficacy within hours of positive blood 
culture. The Reveal antibiotic susceptibility testing (AST) system offers phenotypic MIC 
matching CLSI gold standard results within an average of 5 hours from positive blood 
sample, while greatly simplifying workflow, at a cost low enough to prompt widespread 
adoption.   
Blood Culture 
Blood culture testing continues to evolve as microbiology laboratories adopt faster diagnostic 
workflows designed to improve the detection and management of bloodstream infections. 
Blood culture bottles and automated incubation systems are used to detect bacteremia (the 
presence of bacteria in the bloodstream) and fungemia (bloodstream infections caused by 
yeasts or other fungi). Physicians typically order blood cultures when patients present with 
symptoms suggestive of sepsis, including persistent fever, chills, hypotension, or other signs 
of systemic infection. Once a blood culture becomes positive, laboratories often employ rapid 

 
 
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identification and resistance testing to accelerate clinical decision-making and guide targeted 
antimicrobial therapy. 
Blood cultures are most commonly performed in hospitalized patients with persistent fever 
of unknown origin or suspected sepsis. Although blood culture systems may also be used in 
specialized circumstances to support testing for disseminated mycobacterial infections such 
as tuberculosis, dedicated mycobacterial culture systems are generally used for routine TB 
diagnostics. The ongoing burden of sepsis worldwide continues to drive demand for blood 
culture systems and associated consumables, as rapid identification of bloodstream infections 
remains critical for reducing morbidity and mortality in hospitalized patients. 
The blood culture instrumentation and consumables market continues to grow steadily as 
hospitals invest in automated microbiology workflows and rapid diagnostic technologies. 
The market is largely dominated by two major suppliers—Becton Dickinson (BD) and 
bioMérieux—whose systems are widely installed in hospital microbiology laboratories 
worldwide. BD markets its BACTEC family of blood culture instruments, while bioMérieux 
offers the BacT/ALERT line of systems. Together, these platforms represent the majority of 
installed blood culture instrumentation globally. 
bioMérieux’s BacT/ALERT VIRTUO is a fully automated, continuously monitoring blood 
culture system designed to streamline workflow in laboratories of varying sizes. The system 
allows laboratory staff to load blood culture bottles at any time, reducing manual handling 
and improving efficiency. Automated unloading, visual alerts, and integration with 
laboratory information systems through middleware solutions support faster reporting and 
improved laboratory productivity. 
BD complements its BACTEC blood culture platforms with laboratory informatics tools, 
such as the BD Synapsys solution, which integrates microbiology workflow data and 
provides laboratories with operational insights to improve turnaround time and performance. 
BD also provides specialized culture media used for platelet quality control testing, enabling 
laboratories and blood banks to detect bacterial contamination in platelet units before 
transfusion, thereby helping reduce the risk of transfusion-associated sepsis. 
In addition to traditional blood culture incubation systems, molecular diagnostic companies 
are introducing rapid, multiplex assays that identify pathogens directly from positive blood 
cultures. DiaSorin, for example, markets multiplex assays on its LIAISON PLEX platform. 
The LIAISON PLEX Blood Culture Yeast Assay detects a panel of fungal pathogens 

 
 
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commonly associated with bloodstream infections, while the LIAISON PLEX Gram-
Negative Blood Culture Assay identifies multiple gram-negative bacteria along with 
important antimicrobial resistance markers. These assays are designed to accelerate pathogen 
identification following positive blood cultures, enabling clinicians to initiate appropriate 
therapy earlier and improve patient outcomes. 
 
 
 
 
 

 
 
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Table 11-9: Selected Advanced Techniques in Positive Blood Culture 
Company 
Location 
Technology 
Details 
Accelerate Diagnostics 
U.S. 
Rapid ID + 
phenotypic AST 
Accelerate Pheno system with Accelerate PhenoTest™ BC 
Kit for organism ID plus rapid phenotypic AST directly from 
positive blood cultures (menu dependent on Gram stain 
workflow) 
Abbott 
U.S. 
Protein/immuno 
(culture isolate) 
BinaxNOW™ PBP2a (for MRSA marker detection from 
cultured isolates; not a direct-from-blood-culture multiplex 
panel) 
Becton Dickinson 
U.S. 
Mycobacterial 
liquid culture 
BACTEC™ MGIT™ systems for mycobacterial culture 
BioFire Diagnostics 
U.S. 
MSLDI-TOF 
 BIOFIRE® Blood Culture Identification 2 (BCID2) Panel: 
broad target menu (bacteria + yeasts + key resistance 
genes) run from positive blood culture bottles 
bioMérieux 
France 
mass spec 
assays for Knome sequencing platform 
bioMérieux 
France 
mass spec 
VITEK MS, ID/AST on Shimadzu mass spec 
bioMérieux 
France 
ID/AST 
BacT/ALERT VIRTUO, 15 min result  
Bruker Biosciences 
U.S. 
mass spec 
MALDI Sepsityper Solution, positive blood culture  
Bruker Biosciences 
U.S. 
mass spec 
integrate MALDI Biotyper with BD Phoenix 
Bruker Biosciences 
U.S. 
mass spec 
MALDI Biotyper  
Bruker Biosciences 
U.S. 
mass spec 
MALDI Biotyper CA System, gram neg  
Cepheid 
U.S. 
PCR 
Xpert MRSA/SA Blood Culture (BC)  
Miacom Diagnostics 
Germany 
FISH 
hemoFISH, blood culture ID, 15 minutes 
Specific Technologies 
U.S. 
PCR 
SpecID, metabolomic fingerprint, bacterial ID during growth  
Source: Kalorama Information 
Chromogenic Media 
Once a sample arrives in the microbiology laboratory, use of organism-specific culture media 
can reduce the time for sample work-up by encouraging the growth of specific organisms 
and also coloring them with stains that they absorb as they grow. This makes the organisms 
visible on the culture plate. 

 
 
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Culture media are available in two major categories. General-purpose products such as blood 
agar and broths are used as the first step in culturing bacteria from specimens such as swabs, 
sputum, and urine. Selective or organism-specific chromogenic (coloring) media for 
organisms such as enterics, Salmonella, Shigella, E. coli, strep B, Staphylococci, Candida, 
hospital-acquired infections, and urinary tract infections – can also be used on selected 
specimens. 
Chromogenic media supplement traditional ID/AST in a manner analogous to lateral flow 
tests, compared with laboratory immunoassays.  In 2025, chromogenic media was worth 
approximately $1,315 million, increasing by 1.0% to $1,380 by 2030. Identification results 
are more easily obtained and interpreted through media color change, but at the expense of 
optimal accuracy and plate-test specificity (negative results can rule out a critical pathogen, 
but do not identify the infectious organism).  
Rapid Tests Performed on Colonies from Culture Media 
In the microbiology segment, rapid tests refer to manual tests performed on colonies picked 
from growth media or swabbed plates.  This differs from the rapid point-of-care or near-
patient tests used directly on patient samples to detect specific pathogens. In 2025, rapid 
microbiology is estimated to be valued at $876 million and will grow at a 1.5% CAGR to 
$943 million in 2030. 
Many traditional microbiology rapid tests (performed following culture) have been replaced 
by analyzer-based immunoassays in developed countries but are still important tools for 
small labs and in developing regions.  
Supplies 
The segment is made up of microbiology supplies such as transport and prepared media, 
sample collection devices and stains 
These are high-margin, low-service products sold primarily by catalog and direct marketing.   
Transport and culture are an important first step in the imperative for faster test turnaround 
times and especially for the new generation of molecular assays.  The role of these collection 
and transport products is to ensure that sufficient numbers of live microorganisms survive to 
provide a true assessment of their presence in the patient.  Thus, the role of these supplies 

 
 
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will always be integral to microbiology, supporting both routine and advanced methods.  A 
sample carrying a pathogen has to reach a lab somehow. 
COPAN Diagnostics, Inc.  is a leading supplier of and innovator in collection and transport 
systems.  COPAN has been supplying bacteriology swabs, viral transport media and 
molecular systems since 1994.   
Organism-specific transport media help maintain the viability of the targeted organism in a 
medium or on a swab.  The media also limit the growth of other flora that could crowd out 
the targeted organism.    

 
 
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Market Analysis - Microbiology Immunoassays 
Infectious disease immunoassays are frequently performed in the core laboratory on fully 
automated analyzers that often perform both chemistry and immunochemistry tests.  These 
core laboratory platforms and tests are not a significant focus of this chapter.  However, 
infectious disease immunoassays represent a significant segment of the overall microbiology 
market, and they are competitive methods for identifying certain pathogens.    
Immunoassays are an important segment of diagnostic testing in which antibodies react with 
a target analyte found in biological fluids such as blood, urine, or saliva.  The analyte is often 
a protein but can be a small molecule such as a drug or toxin.  In some immunoassays, a 
purified antigen may be used to detect an antibody analyte.  There are many different 
immunoassay formats that cannot all be reviewed in detail within the scope of this chapter.  
The major types of immunoassays discussed here are traditional rapid assays and enzyme 
immunoassays. 
It has often been speculated that molecular tests would replace infectious disease 
immunoassays.  This has not proven to be the case; a number of molecular tests have become 
very popular, but immunoassays are less expensive, more automatable, and readily available 
to labs of any size.  Historically, the evolution of molecular tests slowed growth in the 
immunoassay sector.  However, the rapid adoption of COVID-19 antigen and serology-based 
tests has shifted some of the market growth back to the immunoassay segment.      
The combination of Abbott Diagnostics with Alere has created a powerhouse in 
immunoassays for infectious diseases.  The world market for infectious disease 
immunoassays has been dominated by Abbott Diagnostics since the 1980s.  The company's 
strength lies in a broad menu of tests and assay systems. Abbott further consolidated its 
position with the release of a number of FDA-cleared assays. 
Abbott has built a strong immunoassay portfolio.  The company provides a variety of 
instrumentation to meet all levels of ELISA testing, from complete walk-away automation to 
microplate readers and washers.  Abbott also provides immunofluorescence assays, with a 
menu of IFA and DFA tests that includes kits for autoimmune diseases, infectious diseases 
and sexually transmitted diseases.  Abbott’s strength, however, was as the leader of rapid 
immunoassays (discussed below). 

 
 
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Improvements in Microbiology Immunoassays 
Recent improvements in microbiology immunoassays reflect significant advances in speed, 
sensitivity, automation and multiplexing. Many clinical laboratories perform a very large 
number of immunoassays every day, and test automation has been essential.  Historically, a 
common approach with immunoassays was to use a 96-well microtiter plate.  Diagnostic 
companies worked to gradually automate these assays, using automated pipetting devices, 
microtiter plate washers, and microtiter plate readers, eventually developing automated 
analyzers based on microtiter plate technology.   
Single-target and multi-target panels are found in both respiratory and non-respiratory 
segments of the immunoassay market. The immunoassay respiratory market for targeted 
testing is focused on single-target testing, but the multi-target testing is growing.  
Immunoassay multi-target panels are increasingly used because they offer several advantages 
over traditional single-target tests. The primary advantage of immunoassay multiplex panels 
is their ability to reduce time to diagnosis compared with traditional methods such as culture 
or sequential testing. Immunoassay multi-target panel testing consolidates multiple single 
tests into one high-confidence assay, enabling faster and more accurate clinical 
decision-making.  

 
 
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Figure 11-1: Immunoassay Respiratory Testing, by Target Pathogens, 2025 (%) 
 
[Multi-Target, Single-Target] 
 
Source: Kalorama Information 
 
 
 
 

 
 
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Table 11-10: Selected Infectious Disease Immunoassay Innovations 
Company 
Location 
Target 
Details 
Abbott Diagnostics 
U.S. 
HIV 
ARCHITECT HIV Ag/Ab Combo assay 
Ceres Nanosciences 
U.S. 
lyme 
Nanotrap Lyme Antigen (LA) Test  
Curetis/Ares Genetics 
Germany 
Sepsis/AMR 
response 
Acumen's AcuSept panel, sepsis immune response  
Diasorin 
Italy 
campy 
LIAISON Campylobacter stool test 
Diasorin 
Italy 
GI 
Liaison bacterial stool-testing panel  
Diaxonhit 
France 
inf 
avidity portfolio active vs older infections 
Diaxonhit 
France 
sepsis 
BJI InoPlex test staph antibodies in blood 
Dynamiker Biotechnology  
China 
fungi 
ELISA invasive fungal disease  
EKF Diagnostics 
UK 
sepsis 
Stanbio LiquiColor Procalcitonin, automated analyzers  
Genalyte Inc. 
U.S. 
Ebola 
Ebola antigens and IgM/IgG antibodies 
Global BioDiagnostics 
UK 
TB 
TB, Reporter Enzyme Fluorescence  
Gold Standard Diagnostics 
U.S. 
syphilis 
AIX1000 Rapid Plasma Reagin (RPR) Automated 
MBio Diagnostics  
(Light Deck Diagnostics) 
U.S. 
malaria 
LightDeck Malaria cartridge 
MBio Diagnostics 
U.S. 
instr 
LightDeck, multiplexed immunoassay platform, 
cartridge  
MeMed Diagnostics 
Israel 
response 
ImmunoXpert pathogen immune response proteins 
Nanologix 
U.S. 
instr 
Nanologix N-Assay, ELISA 
Pearl Diagnostics 
U.S. 
Resp 
MycoMEIA Aspergillus  Immunoassay 
Quansys Biosciences  
U.S. 
resp 
14‐plex Pneumococcal Array  
Quidel 
U.S. 
resp 
Sofia RSV Fluorescent Immunoassay 
Quidel 
U.S. 
resp 
Sofia Strep A+ Fluorescent Immunoassay  
Response Biomedical 
Canada 
sepsis 
RAMP Procalcitonin  
Singulex 
U.S. 
pathogens 
single molecule counting technology 

 
 
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Company 
Location 
Target 
Details 
Transasia Bio-Medicals  
India 
STD 
ErbaLisa Syphilis 
U. of California, Irvine 
U.S. 
HCV 
HCV-AGS EIA acute HCV in urine 
ViroCyt 
U.S. 
sample 
ViroTag & Virus Counter 3100  
Source: Kalorama Information 
Most immunoassays performed in large, centralized laboratories today are done on fully 
automated, random-access analyzers that are not based on 96-well microtiter plates.  
Diagnostic companies that offer fully automated, random-access analyzers include Abbott, 
Beckman Coulter, Bio-Rad Laboratories, bioMérieux, Grifols, Eiken Chemical, 
QuidelOrtho, Roche, Siemens Healthineers, Tosoh Bioscience, and many others.  
The major categories of strength for immunoassay testing are hepatitis, HIV, sexually 
transmitted disease, infectious diseases and respiratory diseases.   
 
 
 
 

 
 
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Table 11-11: Global Clinical Laboratory-Based Microbiology/Infectious Disease Immunoassay Market,  
by Pathogen, 2025($ million) 
 
 
[HAIs/Sepsis; Hepatitis; HIV; Lyme Disease; Mycology; Parasitology; Respiratory; STDs; ToRCH; Other] 
Pathogen/Disease Indication 
2025 Sales 
% Mkt 
Respiratory 
2,991 
23% 
Hepatitis 
2,100 
16% 
HAIs/Sepsis 
1,755 
13% 
HIV 
1,685 
13% 
STDs 
1,350 
10% 
ToRCH 
1,335 
10% 
Parasitology 
224 
2% 
Lyme Disease 
172 
1% 
Mycology 
73 
<1% 
Other* 
1,480 
11% 
Total 
13,165 
100% 
Note: *includes immunoassays for EBV, Chagas, Dengue, Malaria, etc. 
Note: Percentages rounded 
Source: Kalorama Information 
 
 

 
 
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North America is the largest geographical segment of the microbiology/immunoassay 
market, followed by Europe.   
Table 11-12: Global Laboratory-Based Microbiology/Infectious Disease Immunoassay Market Distribution, 
by Region, 2025 (%)  
 
[Asia Pacific; Europe; North America; Rest of World] 
 Region 
% Mkt 
North America  
52% 
Europe 
30% 
Asia Pacific 
11% 
RoW 
7% 
Total 
100% 
Source: Kalorama Information 
Hepatitis Testing 
The term “hepatitis” means inflammation of the liver.  Many things can cause the liver to 
become inflamed including drugs, toxins, excessive alcohol, and infections by certain 
bacteria and viruses.  Several viruses can cause hepatitis including hepatitis A virus (HAV), 
hepatitis B virus (HBV), hepatitis C virus (HCV), Hepatitis D virus (HDV), hepatitis E virus 
(HEV), and hepatitis G virus (HGV). The most common types in the United States, and the 
focus of much of the hepatitis immunoassay testing, are HAV, HBV, and HCV.   
Hepatitis has been increasingly important due to new guidelines suggesting testing for all 
Baby Boomer-aged results.   
The first immunoassays for hepatitis B virus became available in the 1970s.  Enzyme 
immunoassays are now available for several HBV markers including:  
• HBsAg – Hepatitis B surface antigen  
• Anti-HBs – Antibody to hepatitis B surface antigen  
• HBcAb or Anti-HBc – Hepatitis B core antibody  

 
 
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• HBeAg – Hepatitis B e antigen  
• HBeAb or Anti-HBe – Antibody to hepatitis e antigen  
Hepatitis C remains a significant challenge for the medical community. According to the 
CDC, around 3.9 million people in the United States have a chronic HCV infection or nearly 
1% of the population. An estimated 2 million people in the United States have a chronic HBV 
infection. Worldwide an estimated 58 million people have chronic hepatitis C with about 1.5 
million new infections every year.  
Both qualitative and quantitative tests are available for HBsAg, as well as HBsAg 
confirmatory tests.   Together, results from these assays can be used to differentiate between 
acute or chronic hepatitis B infection and whether a person has been infected with HBV in 
the past. 
Immunoassays HBV markers for anti-HAV IgG, anti-HAV IgM, and anti-HCV are also 
available from many companies, including on the major immunoassay analyzers and 
integrated systems of the major diagnostic companies.  In addition, many companies that 
market lateral flow tests, especially companies who market their products in countries such 
as China and India, market assays for HBV and HCV.  This reflects the importance of 
hepatitis B diagnostic tests in these markets.  
Abbott received CE Mark for the Determine HbsAg 2 test for use with serum, plasma, or 
whole blood. The test is a rapid lateral flow test that enables the identification of those with 
hepatitis virus infection and facilitates linkage to care. It is now commercially available in 
Europe, Africa, Asia Pacific and Latin America. It has received CE Mark, and data have been 
submitted for WHO prequalification.  
The guidelines have fueled a surge in hepatitis testing, and this is a large market as a result.   
Selected commercially available immunoassay and molecular IVD tests for hepatitis include:  
• Abbott RealTime HCV Genotyping II molecular assay (Abbott) 
•  ADVIA Centaur HBsAgII Assay (Siemens) 
•  ADVIA Centaur HCV Assay (Siemens) 
•  Aptima HBV Quant Assay (Hologic) 
•  Aptima HCV Quant Assay (Hologic) 

 
 
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•  COBAS AmpliPrep/COBAS TaqMan HBV Test (Roche) 
•  COBAS AmpliPrep/COBAS TaqMan HCV Test (Roche) 
•  cobas DPX Test (Roche) 
•  cobas MPX Test (Roche) 
•  cobas TaqScreen DPX Test (Roche) 
•  cobas HBV Test (Roche)  
•  DeepChek HBV RT real time PCR genotyping and DR assay (Advanced Biological 
laboratories) 
• DeepChek HBV Core/PreCore Assay based on real-time PCR (Advanced Biological 
Laboratories) 
• Dual Probe HCV (Roche) 
•  Elecsys HBsAg II Assay (Roche) 
•  Elecsys HBsAg II assay (Roche) 
•  Elecsys Anti-HCV II Assay (Roche) 
•  GS HBsAg EIA (Bio-Rad) 
•  HBV Sequencing Assay (Abbott) 
•  INNO-LiPA HBV Genotyping assay (Fujirebio Diagnostics) 
•  INNO-LiPA HBV Multi-DR reverse hybridization line probe assay (Fujirebio 
Diagnostics) 
•  INNO-LiPA HBV PreCore reverse hybridization line probe assay (Fujirebio 
Diagnostics) 
•  LIAISON Anti-HAV chemiluminescence immunoassay (Diasorin) 
•  LIAISON HBsAg chemiluminescent immunoassay (Diasorin) 
•  LIAISON HCV Ab chemiluminescence immunoassay (Diasorin) 
•  MONOLISA Anti-HAV EIA (Bio-Rad) 
•  MONOLISA Anti-HBc EIA (Bio-Rad) 
•  MONOLISA Anti-HBs EIA (Bio-Rad) 

 
 
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•  MUREX HBs Ag ELISA test (Diasorin) 
•  MUREX anti-HBc ELISA test (Diasorin) 
•  MUREX anti-HCV ELISA test (Diasorin) 
•  MUREX HCV Ag/Ab ELISA test (Diasorin) 
•  ORTHO HCV Version 3.0 ELISA Test System (Ortho-Clinical Diagnostics) 
•  TruQuick HBsAg/HCV Combo Test 
•  TruQuick HEV IgG/IgM Test (Meridian Bioscience) 
•  UltraGene HBV Assay based on real-time PCR (Advanced Biological Laboratories) 
•  VITROS Anti-HAV Assay (QuidelOrtho) 
•  VITROS Anti-HBe Assay (QuidelOrtho) 
•  VITROS Anti-HBs Assay (QuidelOrtho) 
•  VITROS Anti-HCV Assay QuidelOrtho) 
Roche markets the Elecsys HCV Duo immunoassay test. The assay is the first available 
immunoassay to simultaneously determine hepatitis C virus antigen and antibody status from 
a single sample. This  test enables earlier diagnosis of active hepatitis C virus infection, which 
can lead to earlier intervention for patients. 
Fujirebio offers the INNO-LiPA HCV 2.0 genotyping assay is a line probe assay designed 
for the qualitative detection and identification of Hepatitis C genotypes 1 to 6 and subtypes 
a and b of genotype 1.  
Sepsis 
Sepsis syndrome is the 11th-highest cause of death in the United States, and its incidence has 
increased consistently over the past 20 years.  Worldwide, sepsis is responsible for over 4.5 
million deaths, making sepsis one of the world’s fastest-growing healthcare problems.  
The IVD industry can rightly take some credit for the current focus on sepsis.  It is not a 
disease that is obvious from symptoms alone, and many hospital deaths previously written 
off have been attended to because of better testing protocols and technology.  This is one of 
the reasons the disease is called “the invisible killer.”  The main test for sepsis has been blood 

 
 
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culture, which does not provide a definitive answer for at least 24 hours and requires a 
significant concentration of bacteria in the blood to yield a quick, definitive result.  The hunt, 
therefore, was on for earlier, more efficient markers of sepsis.   
The diagnosis of sepsis has been greatly improved by biomarker discovery.  Procalcitonin 
(PCT) was identified as a sensitive biomarker for systemic bacterial infections about 15 years 
ago. It is a peptide precursor of the hormone calcitonin, which is involved in calcium 
homeostasis. Procalcitonin may sometimes be ordered, along with other tests such as a C-
reactive protein, blood culture, and complete blood count to help detect or rule out sepsis or 
detect/rule out bacterial pneumonia in those who are seriously ill and in children with a fever 
of unknown origin. 
In response to bacterial infections, nearly all tissues in the body release PCT, especially the 
lungs.  In normal metabolism, procalcitonin is produced in the thyroid gland and helps 
regulate the calcium and phosphate balance in the body. In Europe, PCT is commonly used 
to determine a bacterial-infection immune response from viral infections or an inflammatory 
response not linked to a pathogen. 
Procalcitonin testing is commonly used in hospitals to help assess patients admitted with 
suspected significant bacterial infection, particularly in suspected sepsis and lower 
respiratory tract infections, and to support antibiotic stewardship decisions. PCT can rise 
within roughly 6–12 hours after a systemic bacterial inflammatory response begins, and serial 
measurements are often used to track response to therapy. Many hospital pathways obtain an 
initial PCT on admission and repeat testing every 24–48 hours to evaluate trends, with 
decreasing values supporting clinical improvement and, in appropriate cases, earlier 
antibiotic de-escalation or discontinuation. 
Thermo Fisher Scientific’s 2009 acquisition of B.R.A.H.M.S established a leading position 
in sepsis-related biomarker testing. B.R.A.H.M.S-branded PCT assays are among the most 
widely used and clinically validated PCT methods in Europe and are also available in the 
U.S. on selected platforms. Through partnerships and assay implementations, PCT testing 
aligned with B.R.A.H.M.S methods has been available on major immunoassay systems, 
including bioMérieux VIDAS, Roche cobas e/Elecsys, and, depending on country-specific 
registrations, selected Siemens and Abbott immunoassay platforms. Fujirebio also offers a 
procalcitonin assay on its LUMIPULSE immunoassay platform, providing another 
automated option for measuring this bacterial-infection–associated biomarker in clinical 
laboratories.  

 
 
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Through agreements with third-party immunoassay companies, the B.R.A.H.M.S/Thermo 
Fisher assay or assay technology is available on the following platforms: 
• bioMérieux VIDAS immunoanalyzers 
• Siemens Healthineers’ ADVIA Centaur CP immunoanalyzers (outside of the United 
States) 
• Abbott Diagnostics ARCHITECT i and ci integrated chemistry and immunoanalyzers 
(outside of the United States) 
• Roche Diagnostics cobas e and Elecsys instruments 
• Diasorin LIAISON instruments 
Fujirebio Diagnostics is also in the game, offering the procalcitonin assay for testing on its 
LUMIPULSE platform. Procalcitonin is an interesting biomarker specific to bacterial 
infections, and its levels are proportional to the patient’s risk of developing sepsis.  
In the U.S., vendors of the procalcitonin test received FDA clearance to market the test for 
expanded use that follows the protocol used in Europe.  Based on a recent study, monitoring 
PCT levels over 4 days can help doctors determine which septic patients are at the greatest 
risk of death, enabling them to adjust or intensify the medical care for those patients. 
One traditional and commonly used clinical biomarker for sepsis is blood lactate. Elevated 
levels of lactate, fever and elevated white blood cell counts can serve as early inclusion 
criteria for sepsis. Elevated lactate is associated with increased morbidity and mortality in 
sepsis, but only when using a high cut-off value that excludes patients with developing sepsis 
or those still in need of intervention. Lactate levels can also produce false positives, as 
elevated results can also be observed in patients without sepsis. As a fast yet imperfect 
screening biomarker for sepsis, lactate is bound to be supplemented by other biomarkers to 
improve the accuracy and sensitivity of sepsis screening. Kalorama information does not 
include lactate as a sepsis biomarker within the scope of this report; lactate assays are most 
often performed on blood gas analyzers, which are included under the non-infectious critical 
care POC IVD segment. 
The global lab-based microbiology immunoassay sepsis market is estimated at $1,566 
million in 2025.  Innovation in PCT methods has fueled growth in recent years, generating a 
market worth about $478 million in 2025 and, with a 3% growth rate, reaching $548 million 
by 2030. 

 
 
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The global lab-based microbiology immunoassay sepsis market is divided into two areas: 
• Traditional testing 
• Procalcitonin marker testing 
The traditional testing for sepsis totaled 54% of the market and the newer PCT marker testing 
totaled 46% of the sepsis market. The PCT marker testing will likely continue to make 
inroads.  
Figure 11-2: Global Lab-based Microbiology Immunoassay Sepsis Market Distribution, by Type, 2025 (%) 
 
[PCT, Traditional] 
 
Source: Kalorama Information 
HIV Immunoassay Testing 
HIV testing has been available since the mid-1980s and remains a cornerstone for screening 
blood and blood products as well as diagnosing infection. HIV exists as two main types, HIV-
1 and HIV-2, with multiple subtypes of HIV-1 identified. Over time, blood tests have evolved 

 
 
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to detect antibodies to both HIV-1 and HIV-2, along with a broad range of subtypes. 
Continuous improvements in assay sensitivity have shortened the time from infection to 
detection. Current fourth-generation immunoassays combine detection of HIV-1 p24 antigen 
with antibodies to HIV-1 and HIV-2, enabling earlier identification of infection than 
antibody-only tests. 
Globally, approximately 40 million people are living with HIV, and annual deaths remain in 
the hundreds of thousands, although both incidence and mortality have declined over time 
due to improved access to testing and treatment. HIV/AIDS continues to represent a major 
healthcare challenge, particularly in sub-Saharan Africa, where the burden of disease remains 
highest and access to diagnostics and treatment can be limited in some regions. Expanding 
access to testing, early diagnosis, and treatment remains critical to reducing transmission and 
improving outcomes. 
Modern laboratory testing is characterized by high-throughput immunoassay platforms such 
as the Elecsys HIV combi PT from Roche, a widely used fourth-generation assay that detects 
both HIV-1 p24 antigen and HIV-1/2 antibodies in a single test. This dual-detection approach 
shortens the diagnostic window and improves the identification of early infection. These 
assays are routinely incorporated into laboratory testing algorithms and are commonly run 
alongside other infectious disease screens on automated analyzer systems to support efficient, 
high-volume workflows. 
As HIV diagnostics have become faster and more standardized, many health systems have 
adopted routine “opt-out” screening, in which HIV testing is offered as a standard part of 
care rather than limited to high-risk populations. This approach has helped normalize testing, 
reduce stigma, and increase early detection, supporting earlier treatment initiation and 
lowering transmission rates. The continued expansion of routine screening programs and the 
streamlining of laboratory workflows remain key drivers of HIV testing volume worldwide. 
Commercially available IVD tests for AIDS/HIV include: 
• ADVIA Centaur CHIV Assay (Siemens) 
• Aptima HIV-1 Quant Assay (Hologic) 
• COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (Roche) 
• Determine HIV-1/2 Ag/Ab Combo Test (Abbott) 
• Elecsys HIV combi PT assay - 4th generation (Roche) 

 
 
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• Geenius HIV 1/2 Supplemental Assay (Bio-Rad)  
• GS HIV Combo Ag/Ab EIA (Bio-Rad) 
• GS HIV-1 Western Blot (Bio-Rad) 
• INNO-LIA HIV I/II Score line immunoassay - Fujirebio Diagnostics 
• UltraGene HIV real-time PCR Assay (Advanced Biological Laboratories) 
• Uni-Gold Recombigen HIV-1/2 (Trinity Biotech)  
• ViroSeq HIV-1 Genotyping System (Abbott) 
• VITROS HIV Combo Test (QuidelOrtho)   
Hologic received CE marking for its Aptima HIV-1 Quant Dx assay, a nucleic acid 
amplification test performed on the fully automated PANTHER system for the detection and 
quantitation of HIV-1 RNA. The assay is widely used for viral load monitoring and plays an 
important role in the clinical management of patients infected with HIV-1, helping guide 
treatment decisions and assess response to therapy. While earlier positioning suggested 
broader applications, viral load assays are not typically used as primary diagnostic or 
confirmatory tests for HIV infection; instead, diagnosis relies on antigen- and antibody-based 
testing algorithms. The Aptima HIV-1 Quant Dx assay may be used alongside clinical 
presentation and other laboratory markers to support disease monitoring and prognosis but 
claims regarding use for early infant diagnosis or as a dual-purpose diagnostic are not broadly 
supported in current clinical practice. 
OraSure offers its OraQuick HIV Self-Test for HIV-1 and HIV-2 in Europe. The test is 
available in six European countries, including the United Kingdom, Germany, France, Italy, 
Spain, and Portugal. The company also offers the OraQuick Advance HIV 1-2 Rapid 
Antibody Test and the OraQuick In-Home HIV Test. 
Chembio offers several HIV tests, including its DPP HIV-Syphilis assay, which is a multiplex 
single-use test. Chembio also offers the HIV1/2 STAT-PAK assay, THE Sure Check HIV 
1/2 Assay, Sure Check  HIV Self-Test and the STAT VIEW  HIV 1/2. 
Bio-Rad offers a line of next-generation HIV multiplex flow immunoassays. Products 
include the BioPlex 2200 HIV Ag-Ab multiplex immunoassay, and the GS HIV Combo 
Ag/Ab EIA kit paired with the EVOLIS system. It also offers the Geenius HIV 1/2 

 
 
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Supplemental Assay. The Geenius HIV 1/2 Supplemental Assay is the only FDA-approved 
test for the confirmation and differentiation of antibodies to HIV-1 and HIV-2.  
Cepheid markets its X-pert HIV-1 Viral Load XC and Xpert HIV-1 Qual XC. Both tests are 
next-generation, extended coverage tests for HIV testing. Xpert HIV-1 Viral Load XC adds 
a second target for HIV-1 detection that provides extended strain coverage to improve 
performance and address the risk of false negative results due to gene mutations or deletions. 
Xpert HIV-1 Viral Load XC is intended to assess viral load levels, which are used to monitor 
the effectiveness of antiretroviral treatment. 
Xpert HIV-1 Qual XC also adds a second target for early identification of HIV-1 infections 
up to 7-10 days before seroconversion. The test has been cleared for use with infants, 
adolescents, and adults in both laboratory and near-patient testing environments. With all 
reagents on board in one fully integrated cartridge, Xpert HIV-1 Qual XC facilitates dried 
blood spot (DBS) sample processing and a simplified workflow. Finally, Xpert HIV-1 Qual 
XC does not contain guanidinium thiocyanate (GTC), making cartridge disposal simpler and 
more environmentally friendly. 
 

 
 
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Table 11-13: Selected HIV Assays 
Vendor 
Product 
Format 
Abbott 
ARCHITECT HIV Ag/Ab Combo 
CMIA 
Abbott 
PRISM HIV Ag/Ab Combo 
ChLIA 
Abbott 
Alinity HIV -1/2 Ag/Ab Combo 
Immunoassay 
bioMérieux 
VIDAS HIV DUO Ultra 
N/A 
Bio-Rad 
Genetic Systems 
ELISA 
Bio-Rad  
Genetic Systems HIV-1/HIV2 Peptide  
ELISA 
Bio-Rad 
Genetic Systems HIV-1/HIV-2 Plus O  
ELISA 
Bio-Rad 
GS HIV-1 Western blot 
Western blot 
Bio-Rad 
BioPLex 2200 HIV Ag-Ab 
Multiplex flow 
Bio-Rad 
GS HIV Ag/Ab Combo EIA 
EIA 
Diasorin/Murex Diagnostics 
Murex SUDS hIV-1 
Rapid ELISA 
Roche 
Elecsys HIV combi PT 
Immunoassay 
Siemens Healthineers 
ADVIA Centaur HIV Ag/Ab Combo 
Microparticle 
chemiluminometric 
immunoassay 
Source: Kalorama Information 
Sexually Transmitted Diseases (STDs) 
Sexually transmitted diseases (STDs) include hepatitis B, hepatitis C, and HIV, which have 
already been discussed.  Two additional STDs that are important for immunoassay testing 
worldwide are syphilis and chlamydia. Immunoassay testing revenues for the remaining STD 
segments are estimated at $1.4 billion for 2025.  
Syphilis is a significant global public health concern.  Management of symptomatic cases of 
syphilis is not sufficient.  The World Health Organization estimated there were over 8 million 
new cases of syphilis worldwide.  This is important because syphilis infection during 
pregnancy results in 70,000 fetal and neonatal deaths, 115,000 cases of infant congenital 

 
 
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disease, and 55,000 cases of premature birth/low birth weight each year, according to the 
WHO.   
Most cases of syphilis worldwide are outside of the United States.  In 2022, the CDC reported 
that 207,000 people in the United States contracted syphilis.  In addition, the U.S. Preventive 
Services Task Force recommends that all pregnant women be screened for syphilis infection. 
In 2022, there were 3,755 babies born with syphilis in the U.S., which reflects a 937% 
increase in the past decade. However, syphilis is also an important problem in developing 
countries.  
Sexually transmitted diseases are passed from one person to another through intimate 
physical contact,  such as heavy petting,  and from sexual activity, including vaginal, oral, 
and anal sex. STDs are very common. In fact, the CDC estimates 20 million new infections 
occur every year in the United States.  
The traditional algorithm for serological syphilis testing starts with a non-treponemal assay, 
such as the VDRL (Venereal Disease Research Laboratory) or RPR (Rapid Plasma Reagin) 
tests, to screen patients, with reactive samples followed by a Treponema-specific method. 
Immunoassays have been developed and are now available on many automated analyzers.  In 
developing countries, rapid tests for syphilis are often used. 
Chlamydia and gonorrhea were two of the first infectious disease targets for commercialized 
clinical molecular tests and have since been joined by a suite of other molecular sexually 
transmitted disease assays. Chlamydia is a common target for rapid STD screening and is 
often now multiplexed with gonorrhea in molecular assays for improved screening coverage 
from a single test, due to the lack of other rapid screening methods available for gonorrhea. 
Chlamydia and gonorrhea are also commonly screened due to a lack of early symptoms and 
a related high number of unknown cases. 
In the United States, STDs have been problematic from a public health standpoint, and 
sustained screening has been necessary for the elimination of certain diseases or to otherwise 
reverse growing incidences. 
With consistent national reporting, it has become apparent that STDs have rebounded from 
reported historical lows and have been resilient to eradication goals. 
Commercially available  selected IVD tests for syphilis include: 

 
 
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• Alere Determine Syphilis TP immunoassay (Abbott) 
• Captia Syphilis IgG EIA (Trinity Biotech)  
• Elecsys Syphilis Assay (Roche) 
• INNO-LIA Syphilis Score line immunoassay (Fujirebio Diagnostics) 
• LIAISON Treponema Screen chemiluminescence immunoassay (Diasorin) 
• RPR Quicktest (EKF Diagnostics)  
• SERODIA TP•PA agglutination test for Treponema pallidum (Fujirebio Diagnostics) 
• Trep-Sure Syphilis Total Antibody EIA (Trinity Biotech)  
• TruQuick Syphilis Test (Meridian Bioscience) 
Roche markets the Treponema pallidum assay, a fully automated assay for the detection of 
antibodies to Treponema pallidum for use on all Roche immunoassay systems for low-, mid-
, and high-volume testing environments, including the cobas e 411, cobas e 601, cobas e 602, 
and MODULAR ANALYTICS E170 analyzers.  The Treponema pallidum assay is intended 
as an aid in the diagnosis of syphilis infection on an automated analyzer. 
Siemens Healthineers offers an FDA-cleared menu of Atellica infectious disease 
immunoassays, including: HIV Ag/Ab Combo (CHIV), HBsAg II, HCV, and Syphilis.  The 
HBsAg II SMART algorithm and the hot zone help reduce repeat testing and decrease 
turnaround time. 
Bio-Rad offers its BioPlex 2200 Syphilis Total & RPR assay, a novel one-step universal 
testing method to aid in the diagnosis of syphilis infection.  The BioPlex 2200 Syphilis Total 
& RPR (rapid plasma reagin) assay offers laboratories the first fully automated 
Treponemal/non-Treponemal dual assay, which simultaneously detects antibodies to T. 
pallidum and reagin antibodies as well as RPR titer (the level of antibody) determination for 
effective treatment monitoring.  
Chembio offers several HIV tests, including its DPP HIV-Syphilis assay, which is a multiplex 
single-use test.  

 
 
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ToRCH  
ToRCH is an acronym for a group of infectious diseases that can cause illness in pregnant 
women and may cause birth defects in their newborns. The test is generally part of the 
traditional screen for pregnant women in developed countries.  It is a common test area, and 
many companies compete in a market valued at about $1.3 billion in 2025.  Roche, Diasorin, 
Siemens Healthineers, and Zeus Scientific (Sebia) are among many ToRCH panels available.   
Toxoplasma gondii is the most commonly used part of the ToRCH panel.  It is a ubiquitous 
intracellular parasite that can affect virtually all warm-blooded vertebrates. Infections usually 
lead to lifelong persistence of the protozoan in muscle and nerve tissues. According to rough 
estimates 25% – 50% of the global human population carry the parasite, with pronounced 
geographical and regional differences. Typical sources of infection are the consumption of 
raw or undercooked meat and the uptake of free spores released by cats into the environment. 
The TORCH panel includes tests for antibody levels to cytomegalovirus (CMV), herpes 
simplex virus type 1 (HSV-1), herpes simplex type 2 (HSV-2), and rubella.  Differentiation 
between IgG and IgM is important to distinguish between maternal antibodies and IgM 
antibodies being produced by the newborn because of infection.  
Bio-Rad markets its BioPlex 2200 ToRC IgM Assay.  The automated and multiplexed panel, 
which complements the company's BioPlex 2200 ToRC IgG Assay, is designed to detect 
IgM-class antibodies to congenital disease-associated pathogens, including Toxoplasma 
gondii, rubella, and cytomegalovirus. 
Randox provides its serology ToRCH controls for newborn infectious disease testing. The 
controls for ToRCH, a blood test screening for infectious diseases including toxoplasmosis, 
rubella, cytomegalovirus, and herpes simplex, are available from Randox Laboratories and 
are used to ensure accurate ToRCH test results and system performance. 
Lyme Disease 
In light of the increasing importance of this disease, this year’s edition expands segment 
reporting to include Lyme Disease.  Ticks (Ixodes scapularis and I. pacificus) transmit 
Borrelia burgdorferi, the most common cause of Lyme disease.  Since the late 1990s, the 
number of reported cases of Lyme disease in the United States has tripled and the number of 
counties in the northeastern and upper Midwestern United States that are considered high-
risk for Lyme disease has increased by more than 300%. One explanation for this trend is 

 
 
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that the ticks that can transmit Lyme disease have expanded their geographic range and are 
now being found in places they weren’t seen 20 years ago.  
Lyme disease is spread by four species of bacteria and accounts for an estimated 1.2 million 
new cases per year, occurring mostly in the temperate climates of the Northern Hemisphere. 
Borrelia burgdorferi and Borrelia mayonii are the main causes of the infection in the United 
States, while Borrelia afzelii and Borrelia garinii account for most afflictions in Europe and 
Asia. Lyme disease is transmitted to humans via the bite of infected blacklegged ticks. Its 
common symptoms include fever, fatigue, headache, and a skin rash known as erythema 
migrans. Although not usually life-threatening, Lyme disease is curable with antibiotics and 
preventable with a commercially available vaccine. However, if untreated, the infection can 
lead to a number of debilitating complications, including Bell’s palsy, chronic joint 
inflammation, heart arrhythmias, memory disorders, meningitis, and neuropathy. 
Lyme testing represents an area where IVD has contributed.  Patients who previously thought 
they suffered from another disease have been properly identified with the aid of immunoassay 
testing. 
The Centers for Disease Control and Prevention recommends a two-step process when testing 
blood for evidence of antibodies to the bacteria that cause Lyme disease, and both steps can 
be performed using the same blood sample. The first step uses an enzyme immunoassay 
(EIA) or immunofluorescence assay. If the initial result is negative, no further testing is 
recommended. If the result is positive or indeterminate, a second test is performed. 
Traditionally, this second step has been an immunoblot (Western blot) test, and the result is 
considered positive only when both steps are positive. More recently, an alternative approach 
using two sequential EIAs has also been adopted in many laboratories, eliminating the need 
for a Western blot while maintaining comparable or improved performance. 
Lyme disease can be challenging to diagnose, particularly in the early stages of infection 
when antibody responses may not yet be detectable. As a result, test sensitivity is lower early 
in the disease and improves as the infection progresses. IgM-based immunoblot results are 
more prone to false positives, especially when used outside the appropriate clinical context, 
leading to more careful interpretation and increased use of newer testing algorithms. 
Commercially available  selected IVD tests for Lyme disease include: 
• Captia B. burgdorferi IgG/IgM EIA (Trinity Biotech) 

 
 
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• LIAISON Borrelia IgG chemiluminescent immunoassay (Diasorin) 
• LIAISON Borrelia IgM Quant chemiluminescent immunoassay (Diasorin) 
• LIAISON Borrelia IgM II chemiluminescent immunoassay (Diasorin) 
• MarDx B. burgdorferi IgG Marblot Western Blot (Trinity Biotech)  
• MarDx B. burgdorferi IgM Marblot Western Blot (Trinity Biotech)  
• Sofia Lyme FIA (QuidelOrtho) 
• Sofia 2 Lyme FIA (QuidelOrtho)    
The Bio-Rad Anti Borrelia (Lyme) EIA is used for the qualitative and/or semi-quantitative 
detection of IgG, IgM, and IgA antibodies to Borrelia burgdoferi in human serum. This assay 
is highly sensitive and specific for Lyme borreliosis and is used as an aid in diagnosing Lyme 
disease. Its improved sensitivity combines purified Bb lysate and recombinant p39 proteins 
as antigens. For higher specificity, serum is absorbed in a blocking solution containing E. 
coli proteins. 
QuidelOrtho's 
Sofia 
Lyme 
Fluorescent 
Immunoassay 
(FIA) 
uses 
advanced 
immunofluorescence-based lateral-flow technology to provide rapid differential detection of 
human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens 
from patients suspected of B. burgdorferi infection. Sofia Lyme FIA, with the Sofia 2 or 
Sofia analyzer, provides automated, objective results in 10 minutes, enabling Lyme testing 
in near-patient settings. 
Bio-Rad markets its BioPlex 2200 Lyme Total Assay, a multiplex test method to aid in the 
diagnosis of Lyme disease.  The Assay can simultaneously detect multiple targets.  The 
release of the BioPlex 2200 Lyme Total assay is the latest offering in Bio-Rad's infectious 
disease menu for the BioPlex 2200 System, an automated multiplex technology platform.  
Researchers from multiple institutions—including the Center for Infection and Immunity at 
Columbia University, the U.S. Centers for Disease Control and Prevention (CDC), the 
National Institute of Allergy and Infectious Diseases (NIAID), Roche Sequencing Solutions, 
Farmingdale State College, and Stony Brook University—collaborated to develop a 
multiplex serologic assay known as the TBD-Serochip. The development of this technology 
reflects ongoing challenges in diagnosing tick-borne diseases (TBDs), including variable 
performance of existing tests, inter-laboratory differences in results for pathogens such as 
Anaplasma, Babesia, Ehrlichia, and Rickettsia, and the absence of widely available 

 
 
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diagnostics for several emerging tick-borne pathogens. These limitations have become more 
significant as the number and geographic spread of tick-borne infections in the United States 
continues to increase. 
The TBD-Serochip is a high-density peptide microarray designed to detect antibodies to a 
wide range of tick-borne pathogens using a single patient sample. The platform screens 
immune responses against more than 170,000 peptide fragments derived from tick-borne 
pathogens, enabling simultaneous detection of antibodies associated with infections such as 
Anaplasma phagocytophilum, Babesia microti, Borrelia burgdorferi, Borrelia miyamotoi, 
Ehrlichia chaffeensis, and Rickettsia rickettsii, as well as viral agents including Powassan 
virus and Heartland virus. Because the platform is built on a flexible peptide array design, 
new pathogen targets can potentially be incorporated relatively quickly as additional tick-
borne pathogens are discovered or characterized. 
The TBD-Serochip remains primarily a research or advanced development tool rather than a 
routinely deployed clinical diagnostic assay. Additional clinical validation, regulatory 
review, and workflow optimization are still required before it can be implemented widely in 
clinical laboratories. Another limitation of serologic approaches such as this is that antibody 
detection may reflect previous exposure rather than active infection, which means the assay 
would likely need to be interpreted alongside established diagnostic algorithms—such as the 
two-tiered Lyme disease testing strategy or pathogen-specific molecular testing—to help 
distinguish current infections from past exposures. 
Despite these limitations, multiplex serologic technologies such as TBD-Serochip 
demonstrate the potential for broad-spectrum surveillance and improved differential 
diagnosis of tick-borne diseases, particularly in patients with complex or atypical 
presentations where multiple pathogens may be possible. Further development of these 
platforms may eventually support more comprehensive testing strategies as the landscape of 
tick-borne infections evolves. 

 
 
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Market Analysis - Molecular Microbiology  
Over the past 25 years, PCR-based infectious disease testing has exploded into a highly 
competitive market. There are three companies, Cepheid, Roche, and bioMérieux, that 
provide a significant share of molecular microbiology test sales. A diverse set of other major 
players compete in the field, each with its own niche in instrumentation, assays, or integrated 
workflows. Other major companies in the molecular microbiology market include  Hologic, 
Beckman Colter, Thermo Fisher, QIAGEN, BD, Abbott, Diasorin, and Siemens 
Healthineers. 
The molecular microbiology market has grown rapidly over the past decade, reaching $6.9 
billion in 2025 (excluding specific COVID-19 testing, which is valued at $1.8 billion for the 
year.  The market is expected to grow to $10.6 billion by 2030, demonstrating a CAGR of 
4.2% over the forecast period. 
Molecular microbiology tests are expensive compared to traditional microbiology or 
immunology, and the largest geographical markets for molecular microbiology tests are 
currently in developed regions such as North America (44%) and Europe (35%), Asia Pacific 
(13%).  Indeed, use of molecular technology continues to be a function of a developed world 
but is only 8% of the molecular microbiology testing market.  
Table 11-14: Global Molecular Microbiology Sales Distribution by Region, 2025 (%)  
 
[Asia Pacific, Europe, North America, RoW] 
 Region 
% Mkt 
North America  
44% 
Europe 
35% 
Asia Pacific 
13% 
RoW 
8% 
Total 
100% 
Source: Kalorama Information 

 
 
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Cost is an important issue in all clinical laboratories.  Microbiology has been undergoing 
significant changes for many years now.  It is certainly not surprising that technologies with 
advantages in speed and quality of results are also more expensive than traditional 
microbiology. 
Traditional microbiology remains viable, and its reagents are inexpensive compared to many 
other technologies now used in the microbiology laboratory.  However, traditional 
microbiology is very labor-intensive and can take days to generate results.  Many laboratories 
have invested in equipment to automate some or all of the traditional microbiology methods. 
Immunoassays are relatively inexpensive and can be performed on automated analyzers. 
They can also generate results relatively quickly.  However, immunoassays that detect 
organisms or their antigens are typically less sensitive than molecular methods. 
The major pathogens/disease indications targeted by companies in this market are hepatitis, 
HIV, healthcare-acquired infections and sepsis, respiratory pathogens, and sexually 
transmitted diseases/women’s health.   
 
 

 
 
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Table 11-15: Global Molecular Microbiology Market, by Pathogen/Disease Indication, 2025-2030 
($ million)  
 
[Blood Bank Screening; GC/Chlamydia; HAI; Hepatitis; HIV; Mycobacteria/TB; Organism ID; Respiratory; 
Others] 
Pathogen 
2025 
% Mkt 
2030 
% Mkt 
CAGR 
Respiratory (including COVID) 
3,408 
39.3% 
4,103 
38.6% 
4% 
HAI 
1,772 
20.4% 
2,090 
19.7% 
3% 
Hepatitis 
1,419 
16.4% 
1,932 
18.2% 
6% 
HIV 
946 
10.9% 
1,060 
10.0% 
2% 
GC/Chlamydia 
465 
5.4% 
544 
5.1% 
3% 
Mycobacteria/TB 
270 
3.1% 
410 
3.9% 
9% 
Organism ID 
200 
2.3% 
225 
2.1% 
2% 
Others 
192 
2.2% 
267 
2.5% 
7% 
Total 
8,672 
100% 
10,631 
100% 
4% 
Blood Bank Screening 
1,330 
-- 
1,790 
-- 
6% 
Note: Percentages rounded 
Source: Kalorama Information 
The table above represents the market for molecular microbiology tests.  The market is 
estimated at $8,672 million, with an additional $1,330 million representing blood bank 
screening.  With 4% growth, the segment is expected to reach $10,631 million in 2030. 
Molecular blood bank screening will likely make moderate gains, reaching $1,790 in 2030.    
Molecular diagnostics demonstrated their value during the COVID-19 pandemic, 
accelerating adoption across microbiology laboratories and reinforcing the role of nucleic 
acid amplification technologies in infectious disease testing. The widespread deployment of 
molecular testing during the pandemic highlighted its ability to deliver high sensitivity, rapid 
turnaround times, and scalable testing capacity. As a result, molecular methods have become 
increasingly integrated into routine microbiology workflows and continue to influence the 
direction of the diagnostic market. Recent advances in molecular microbiology, including 

 
 
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multiplex PCR panels, syndromic testing, and decentralized testing platforms, have the 
potential to further transform how infectious diseases are diagnosed and managed. 
These advances are particularly relevant in areas such as community-acquired pneumonia, 
where traditional diagnostic approaches often have limited sensitivity and may take days to 
produce actionable results. Studies examining diagnostic challenges in pediatric conditions 
have emphasized the limitations of conventional microbiological methods and the growing 
importance of rapid molecular testing. Rapid detection of the specific pathogen responsible 
for pneumonia, whether bacterial, viral, or mixed infection, can significantly improve clinical 
decision-making, allowing clinicians to target therapy more effectively and reduce 
unnecessary antibiotic use. 
One of the most important developments in recent years has been the emergence of true rapid 
molecular tests designed for near-patient or point-of-care use. These systems combine 
simplified sample preparation, automated nucleic acid amplification, and rapid detection in 
compact platforms suitable for decentralized healthcare settings. Several diagnostic 
companies have commercialized molecular platforms that deliver results in under an hour 
and have achieved CLIA-waived status for selected assays, enabling their use in physician 
offices, urgent care clinics, pharmacies, and other point-of-care environments. 
Companies such as Roche, Cepheid (Danaher), Abbott, Sekisui Diagnostics, and 
QuidelOrtho have introduced rapid molecular diagnostic systems targeting respiratory 
infections and other infectious diseases. These platforms support point-of-care detection of 
pathogens such as SARS-CoV-2, influenza, RSV, and Group A Streptococcus. The 
continued development of rapid molecular diagnostics, combined with the increasing 
availability of CLIA-waived assays, is expected to expand access to accurate testing at the 
point of care and further reshape the clinical microbiology testing landscape. 
Lab Automation and Molecular Diagnostics 
The foundations of clinical molecular diagnostics began to take shape in the 1960s with early 
work in nucleic acid analysis and molecular biology. The modern era of molecular testing, 
however, began with the invention of the polymerase chain reaction by Dr. Kary B. Mullis 
in the 1980s while working at Cetus Corporation in Emeryville, California. PCR provided a 
method for amplifying extremely small amounts of DNA, enabling the rapid and highly 
sensitive detection of genetic material. In 1991, Cetus sold the PCR intellectual property 
rights to F. Hoffmann-La Roche Ltd. for approximately $300 million. At the time, the price 

 
 
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was widely viewed as excessive, but PCR ultimately became the core technology underlying 
modern molecular diagnostics, proving to be one of the most influential innovations in 
clinical laboratory medicine. 
During the early expansion of molecular diagnostics, Roche introduced PCR-based platforms 
such as the Amplicor and LightCycler systems, which became widely adopted in molecular 
laboratories. These instruments helped establish PCR as a routine diagnostic tool for 
detecting infectious diseases, genetic mutations, and other molecular targets. Over time, 
molecular testing evolved toward greater automation, higher throughput, and integrated 
workflows. 
 Roche is one of the leading suppliers of molecular diagnostic systems through its cobas 
portfolio of fully automated PCR platforms. Systems such as the cobas 5800, cobas 6800, 
and cobas 8800 support high-throughput molecular testing and are widely used in clinical 
laboratories for infectious disease diagnostics, viral load monitoring, blood donor screening, 
and other nucleic acid–based assays. These automated platforms integrate sample 
preparation, amplification, and detection in a single workflow, reflecting the continued 
evolution of PCR from a research technique into a cornerstone of modern clinical diagnostics. 
 
 

 
 
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Table 11-16: Selected Automated Molecular Test Instrument Platforms 
Company 
Location 
Technology 
Details 
Abbott Diagnostics 
U.S. 
PCR 
Alinity m molecular 
Abbott Diagnostics 
U.S. 
PCR 
Plex-ID platform 
Abbott Diagnostics 
U.S. 
PCR 
Abbott m2000 RealTime System 
Becton Dickinson 
U.S. 
SDA 
BD ProbeTec ET System and Viper 
Biocartis 
Switzerland 
PCR 
Fast-Track oncology assays on Idylla 
bioMérieux/BioFire  
U.S. 
PCR 
FILMARRAY Torch platform, random access multiplex 
PCR 
Cepheid 
U.S. 
PCR 
SmartCycler and GeneXpert 
Diasorin 
Italy 
PCR 
LIAISON MDX disc platform 
GeneSTAT Molecular Diagnostics 
U.S. 
PCR 
RT-PCR GeneSTAT platform, RNA, DNA 
GenMark Diagnostics (Roche) 
U.S. 
PCR 
ePlex sample-to-answer system, PCR 
Genomica 
Spain 
platform 
CLART (Clinical Array Technology) platform 
Hologic 
U.S. 
TMA 
Aptima reagents on Tigris and PANTHER instruments 
Luminex (Diasorin) 
U.S. 
PCR 
Verigene SP System, automated inf dis testing 
Meridian Bioscience 
U.S. 
PCR 
Revogene infectious diseases 
Meridian Bioscience 
U.S. 
LAMP 
Alethia (illumigene) 
Qiagen 
Netherlands 
PCR 
QIAsymphony RGQ MDx system for clinical labs 
QuidelOrtho 
U.S. 
HDA 
Solana molecular system 
Revvity 
U.S. 
platform 
Applied Biocode 96 well 
Roche Diagnostics 
U.S. 
PCR 
cobas 6800 system 
Roche Diagnostics 
U.S. 
PCR 
cobas Liat PCR system, CLIA waived 
Siemens Healthineers 
U.S. 
PCR 
VERSANT kPCR Molecular System 
Thermo Fisher Scientific 
U.S. 
PCR 
Ion Torrent line 
Source: Kalorama Information 

 
 
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Molecular technology is making a valuable contribution to clinical diagnostics on many 
fronts. Commercially available kits are used for a variety of conditions, including infectious 
diseases, primarily hospital-acquired infections, tuberculosis, hepatitis, gonorrhea, HIV, and 
chlamydia; coagulation gene mutations; HLA tissue typing; hereditary and chronic diseases; 
and a slew of cancers. In most cases, the information provided by these tests will affect the 
choice of therapy and the aggressiveness of the therapeutic strategy to be taken. 
In light of the extraordinary times we are living through as a result of the COVID-19 
pandemic and other infectious disease epidemics, the remainder of this section will focus on 
molecular testing in microbiology and virology. Molecular diagnostic tests directly target 
infectious agents, such as bacteria and viruses, by using DNA and RNA probes that recognize 
their genetic signatures.  
The menu of molecular diagnostics has expanded since the 1990's introduction of PCR tests 
for tuberculosis, HIV and Chlamydia Trachomatis/Neisseria Gonorrhoeae by Roche 
Diagnostics, Gen-Probe (now part of Hologic) and Becton Dickinson.  
The first PCR-based instruments performed tests as unique entities. Now molecular platforms 
from companies such as Abbott Diagnostics, Luminex (Diasorin), bioMérieux’s BIOFIRE's 
Film Array, Roche Diagnostics and others can run panels of up to 30 targets, and in less than 
1 hour in some cases. They are also leading the way to random access rather than batch 
testing, which, while commonplace with immunoassays, has been slower coming to 
microbiology. This is because traditional microbiology has a history of treating each sample 
in a unique process. 
The anticipated demand for molecular infectious disease tests has encouraged the 
commercialization of molecular instrumentation for microbiology and virology testing. Thus, 
microbiology companies continue to expand their product portfolios and upgrade their 
systems, primarily by automating microbiology test procedures across all areas of the test 
segment. The result is the development of a variety of new platforms that bypass the 
traditional ID/AST first step by enabling direct testing of blood, urine, nasal swabs, sputum, 
etc. Note that mass spectrometry analysis is performed on a bacterial culture colony.  
In an era of rapid automated test results, microbiology still has a lot to do. The imperative for 
the 21st century is to determine as quickly as possible if a person has an infection, decide 
whether to treat or not to treat and then select a method of treatment. All too often, patients 
have been given antibiotics when not required. This has contributed to the current problem 

 
 
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of antibiotic resistance in bacteria. It can be argued that efficient rapid tests in hospitals, 
clinics, physician offices and other care sites would have solved many issues related to 
infectious disease diagnostics. 
Yet challenges remain in seeing the new methods developed completely, past regulatory 
hurdles, and integrated successfully in clinical practice. Further, the main advantages culture 
has over newer methods are its comparatively low cost and proven antimicrobial 
susceptibility testing. 
Several trends are evident as the field of molecular infectious diseases evolves: 
• integrated sample to answer test systems respond to the need for easy-to-use 
molecular tests for all sizes of labs 
• random access sample processing on instrumentation 
• direct tests from the sample without time-consuming sample pretreatment for DNA 
extraction 
• tests for high-demand pathogens are coming to market including: C. difficile, TB, 
respiratory infections, and STDs 
• companies are beginning to develop sequencing systems for a wide variety of targets 
• CLIA moderate molecular test instruments provide smaller labs the opportunity to 
run molecular tests in-lab without having to send them out  
Molecular Respiratory Infection Testing 
Respiratory infections are a major public health problem.  Patients who present with these 
infections may have similar symptoms, but it is important to identify the causative virus to 
select appropriate therapy.  Here, molecular is an advantage.  The importance of screening 
for many respiratory diseases as a panel is evident by the number of molecular respiratory 
pathogen panels that have been introduced in recent years. 
Respiratory tract infections were responsible for tremendous morbidity and disease burden.  
Recent flu seasons have taken a toll in the United States, justifying the use of advanced 
systems for detection 

 
 
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• 2025: Between October 1, 2025 and April 11,2026, there have been 31-54 million 
cases of flu  with between 23,000 and 78,000 deaths (preliminary) 
• 2024: Between October 1, 2024 and June 15, 2025, there have been 20-35 million 
cases of flu with 13,000 deaths 
• 2023: Between October 1, 2023 and June 15, 2024, there have been 35-65 million 
cases of flu with 21,000 deaths 
• 2022: Between October 1, 2022 to April 30, 2023, there have been 27-54 million 
cases of the flu and 19,000 -58,000 deaths from the flu. 
• 2021: Approximately 8 million to 13 million people were sickened with the flu 
between October 1, 2021 and June 11, 2022 for this flu season. 
• 2020: Approximately 39 million to 56 million people were sickened with the flu 
between Oct. 1, 2019, and April 4, 2020, according to CDC's last in-season influenza 
burden estimate for this flu season. 
• 2019: CDC estimates that the burden of illness during the 2018–2019 season included 
an estimated 35.5 million people getting sick with influenza, and 34,200 deaths from 
influenza.   
• 2018: one of the more severe flu seasons.   The overall burden of influenza for the 
2017-2018 season was an estimated 45 million influenza illnesses  and 61,000 
influenza-associated deaths  
Respiratory illness leads to mortality in vulnerable populations such as children, the elderly, 
and immunocompromised individuals. The WHO has indicated that respiratory tract 
infections are among the top four causes of morbidity and mortality worldwide. 
Molecular tests were not historically common in flu testing, but due to their sensitivity and 
advances in technology, there has been an uptake.  Kalorama has estimated the market for 
molecular respiratory infections at $1,645 million in 2025 and, with 7.2% growth, will reach 
$2,325 million in 2030.   For the 2024-2025 season, COVID-19 infections led to increased 
testing for other respiratory diseases to confirm or rule out COVID-19.  Major vendors 
reported that the segment delivered above-average revenue growth in flu testing.  Over the 
past couple of years, major vendors have noted an increase in system installations during 
severe influenza seasons or in response to testing demands from the previous year. The rapid 
identification of respiratory pathogens is particularly important for vulnerable populations 
such as hospitalized patients, the elderly, and individuals with compromised immune 

 
 
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systems. Early detection of the causative organism and any associated antimicrobial 
resistance markers helps guide appropriate treatment decisions and supports antimicrobial 
stewardship efforts. Multiplex molecular panels that can simultaneously detect multiple viral 
and bacterial pathogens have therefore become an important component of modern 
respiratory diagnostics. 
One of the most widely used systems is the BIOFIRE FILMARRAY Respiratory Panel, 
marketed by bioMérieux. The current Respiratory Panel 2.1 (RP2.1) detects multiple viral 
and bacterial pathogens in a single test, including influenza viruses, respiratory syncytial 
virus, SARS-CoV-2, adenovirus, parainfluenza viruses, human metapneumovirus, 
rhinovirus/enterovirus, and several bacterial targets such as Mycoplasma pneumoniae, 
Chlamydia pneumoniae, and Bordetella pertussis. The system provides results in 
approximately one hour and is widely used in hospital laboratories and near-patient testing 
environments. 
Multiplex molecular testing for respiratory infections has also been pursued by other 
companies. The Unyvero platform, originally developed by Curetis, included lower 
respiratory tract and pneumonia panels that could detect numerous pathogens and antibiotic 
resistance markers directly from clinical specimens. The technology is now associated with 
OpGen, and while development and regulatory activities have continued in some markets, 
adoption has been more limited than that of leading syndromic PCR systems. 
Several additional manufacturers now offer multiplex respiratory diagnostic panels, 
including Cepheid, Roche, QIAGEN, Seegene, Luminex/Diasorin, and others. These 
platforms provide rapid, sample-to-answer molecular testing that can identify a broad range 
of respiratory pathogens and, in some cases, key antimicrobial resistance markers. The 
continued expansion of multiplex respiratory testing reflects the growing need for rapid 
pathogen identification, improved patient management, and more targeted antibiotic use in 
respiratory infections.is still a flurry of multi-pathogen tests hitting the market.  
Diasorin markets its LIAISON PLEX system, including its first panel of tests, the LIAISON 
PLEX Respiratory Flex Assay. The LIAISON PLEX is a new multiplexing platform that 
enables test customization, providing flexibility for infectious disease syndromic diagnostics. 
The LIAISON PLEX Respiratory Flex Assay tests for 19 pathogens, including 14 viral and 
5 bacterial targets.  

 
 
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Roche offers its breakthrough TAGS technology. Roche markets the cobas Respiratory flex 
test, with TAGS (temperature-activated generation of signal) technology. The technology 
uses multiplex PCR testing combined with color, temperature, and data processing to identify 
15 pathogens in a single PCR test. The cobas Respiratory flex test can detect up to 12 
common respiratory viruses, including influenza A, B, RSV, and SARS-CoV-2, in a single 
sample. The cobas Respiratory flex test runs on the cobas 5800,6800, and 8800 systems.  
The Respiratory Trio – Flu, Strep, RSV 
The success of molecular systems opens opportunities for distinguishing a possible influenza 
result from other diseases.  Other than flu, the most promising respiratory conditions treated 
are RSV and Strep A. RSV is a very common cause of respiratory tract infection, especially 
in young children. RSV is a member of the Paramyxoviridae family of viruses. There are two 
types of RSV, A and B, and many strains. RSV has an RNA genome that encodes 10 viral 
proteins. The virus has a lipid envelope containing viral glycoproteins involved in viral entry 
into cells and fusion of the viral envelope with cell membranes. Much of the pathology 
caused by RSV is related to damage to the lining of the small airways of the respiratory tract. 
Group A Streptococci (GAS) are responsible for most cases of streptococcal pharyngitis, 
although other groups, such as C and G, may also cause disease. Strep throat affects all age 
groups but is most common in children between the ages of 5 and 15 years. Strep throat has 
an incubation period of 2-4 days. Classic symptoms include the abrupt onset of sore throat 
accompanied by fever, malaise and headache. 
QIAGEN markets its QIAstat-Dx syndromic testing system and respiratory assay panel for 
the detection of multiple respiratory viral and bacterial pathogens.  The panel provides 
simultaneous testing for more than 20 pathogens.  Syndromic testing using molecular 
diagnostics can identify illnesses that present with a set of symptoms of uncertain cause, such 
as influenza or pneumonia.  QIAGEN said it expects to release numerous diagnostics for 
infectious diseases, oncology, and other areas. Additional respiratory pathogens targeted in 
molecular POC assay development include Bordetella pertussis, S. pneumoniae, viruses such 
as adenovirus, rhinovirus, human metapneumovirus (hMPV), parvovirus, and parainfluenza. 
A new emerging opportunity in molecular microbiology is DNA and RNA sequencing.  The 
first sequencing-based microbiology test, Abbott’s ViroSeq HIV-1 Genotyping System 
(which is based on Sanger sequencing technology), has been on the market for several years.  
Abbott currently markets two infectious disease assays based on Sanger sequencing.  The 

 
 
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ViroSeq HIV-1 Genotyping System is intended for use in detecting HIV genomic mutations 
that confer resistance to specific types of antiretroviral drugs, as an aid in monitoring and 
treating HIV infection.  It is available in the United States and internationally.  In addition, 
the HBV Sequencing Assay is available outside the U.S. 
Sanger sequencing is both slow and expensive, and this technology has not gained 
widespread use in clinical microbiology.  Next-generation sequencing builds upon the basic 
strategy of Sanger sequencing.   Some companies currently offer laboratory-developed next-
generation sequencing-based tests and sequencing-based IVD tests.  
The sequencing-based microbiology tests and development activities discussed here are 
likely to be just the start of a new era in molecular microbiology testing. 
Figure 11-3: Molecular Respiratory Testing, by Target Pathogens, 2025 (%)  
 
[Multi-Target, Single-Target] 
 
Source: Kalorama Information 

 
 
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Molecular Testing for Sexually Transmitted Diseases 
Sexually transmitted diseases are a foundational area of sales for the molecular testing market 
for GC and Chlamydia, and Kalorama estimates the market at $465 million in 2025 and 
growing to $540 million in 2030 at a CAGR 3% per year.  The first FDA-cleared PCR-based 
test was developed by Roche for the detection of Chlamydia trachomatis, and the sexually 
transmitted disease market remains a major segment of the infectious disease molecular 
diagnostic market.  Many of the chlamydia tests available today are combination tests that 
detect both Chlamydia trachomatis and Neisseria gonorrhea. 
The first clinical test for human papillomavirus (HPV) was developed by Digene, which was 
later acquired by QIAGEN.  Initially, HPV testing was limited to abnormal Pap smear 
samples.  Use of HPV tests as part of cervical cancer screening has expanded, and HPV tests 
are now used together with Pap smears as women are screened.  The market for HPV testing 
expanded but then faced pressure as guidelines changed, recommending Pap smear and HPV 
testing every 3 years.  Four years ago, the FDA approved the use of the cobas HPV test for 
first-line primary screening for cervical cancer and high-risk HPV infection with or without 
a Pap smear.  In 2018, that was expanded for women under 25 as well.  Roche’s HPV test 
remains the only FDA-cleared test for primary screening for cervical cancer.  Other 
companies, including Hologic, also offer HPV tests now.  (HPV revenues are covered in 
Chapter 13). 
The Hologic PANTHER system remains widely used for high-throughput molecular testing, 
particularly for sexually transmitted infection diagnostics, including Chlamydia trachomatis 
and Neisseria gonorrhoeae. The platform supports primary tube sampling and continuous 
random-access loading, allowing laboratories to add samples, reagents, and consumables 
without interrupting workflow. Multiple assays can be performed from a single specimen, 
enabling efficient multiplex testing and high productivity in centralized laboratories. The 
PANTHER system is designed with a relatively compact footprint and automated workflow, 
making it suitable for high-volume clinical laboratories. 
Hologic expanded the PANTHER platform with the PANTHER Fusion module, which adds 
real-time PCR capability to complement the company’s Aptima transcription-mediated 
amplification assays. The Fusion module enables modular syndromic testing, particularly for 
respiratory infections, allowing laboratories to run individual or multiple respiratory assays 
from a single patient sample. The PANTHER component is optimized for high-volume 
liquid-reagent assays, while the Fusion module supports cartridge-based PCR testing suited 

 
 
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to lower-volume or specialized assays. PANTHER Fusion respiratory assays include tests for 
influenza A/B, RSV, parainfluenza viruses, adenovirus, rhinovirus, and human 
metapneumovirus, with additional menu expansion over time. 
Seegene offers the Allplex STI Essential Assay, a multiplex real-time PCR test that 
simultaneously detects multiple sexually transmitted pathogens in a single reaction. The 
assay targets organisms including Chlamydia trachomatis, Neisseria gonorrhoeae, 
Trichomonas vaginalis, Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma 
urealyticum, and Ureaplasma parvum. The test uses Seegene’s proprietary DPO (Dual 
Priming Oligonucleotide) and MuDT (Multiple Detection Temperature) technologies, which 
enable the simultaneous detection and quantification of several targets while reporting 
individual Ct values for each organism. 
Roche Diagnostics offers molecular assays for sexually transmitted infections on its cobas 
6800 and cobas 8800 systems, including the cobas TV/MG assay, which detects Trichomonas 
vaginalis and Mycoplasma genitalium DNA in symptomatic and asymptomatic individuals. 
These high-throughput systems are widely used in large laboratories for infectious disease 
testing, including blood-borne viruses and women’s health applications. 
QIAGEN has also expanded its automated molecular testing portfolio through the NeuMoDx 
96 and NeuMoDx 288 systems, which support random-access PCR testing. These platforms 
provide automated sample preparation, amplification, and detection, allowing laboratories to 
run multiple assays simultaneously. The test menu includes assays for sexually transmitted 
infections, hepatitis viruses, HIV, respiratory pathogens, and transplantation-related 
monitoring, as well as the ability to run laboratory-developed tests. 
Hologic has further broadened its women’s health testing portfolio with assays such as 
Aptima BV and Aptima CV/TV, which detect pathogens associated with bacterial vaginosis, 
Candida infections, and trichomoniasis. The Aptima Multitest Swab Specimen Collection 
Kit allows clinicians to collect a single specimen for testing multiple infections, including 
bacterial vaginosis, Candida species (including Candida glabrata), trichomoniasis, 
chlamydia, gonorrhea, and Mycoplasma genitalium. These assays are performed on the 
PANTHER system using Hologic’s Aptima sample transport tubes. 
Another approach to multiplex STI testing is offered by Randox, whose Sexually Transmitted 
Infection Multiplex Array uses a combination of multiplex PCR and biochip array 
hybridization to detect multiple bacterial, viral, and protozoan pathogens simultaneously. 

 
 
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This system can identify primary infections as well as co-infections, providing a broader 
diagnostic profile for sexually transmitted disease testing. 
BD  markets its Onclarity HPV assay for self-collection. The new approval of self-collected 
samples will provide more individuals with access to cervical cancer screening.  
Molecular Hepatitis Testing 
The two most significant molecular hepatitis tests by revenue are for hepatitis B virus (HBV) 
and hepatitis C virus (HCV), which together account for the majority of the molecular 
hepatitis diagnostics market. In 2025, the global molecular hepatitis testing market is 
estimated at approximately $1.4 billion, driven primarily by viral load monitoring and 
ongoing disease management rather than initial diagnosis alone. Historically, key intellectual 
property for molecular hepatitis diagnostics originated with the Novartis Diagnostics 
business, which Grifols acquired in 2013. This acquisition helped shape the competitive 
landscape, and today the market is dominated by major core laboratory suppliers, including 
Abbott, Roche Diagnostics, Siemens Healthineers, and Hologic, all of which offer integrated 
molecular platforms for high-throughput viral testing. 
Molecular testing plays an important role in the diagnosis and clinical management of HBV 
and HCV infections. Nucleic acid amplification tests are used to confirm infection and, more 
importantly, to quantify viral load, which is essential for monitoring treatment response and 
guiding therapy decisions. Quantitative viral load assays remain the backbone of hepatitis 
management in clinical laboratories. Increasingly, reflex testing algorithms are being 
implemented, in which a positive antibody screen is automatically followed by molecular 
viral load testing, improving diagnostic rates and streamlining workflows. While genotyping 
was historically important, particularly for HCV, its role has declined with the widespread 
adoption of pan-genotypic antiviral therapies. For example, Siemens Healthineers’ 
VERSANT HCV Genotype 2.0 assay (LiPA) was once widely used for genotype 
determination, but demand has decreased as treatment approaches have evolved. 
High-throughput molecular platforms continue to dominate centralized testing. Hologic 
offers HBV and HCV viral load assays on its PANTHER system, enabling parallel testing of 
multiple infectious diseases, including HIV, HBV, and HCV, on a single automated platform. 
Abbott and Roche Diagnostics similarly provide comprehensive viral load menus integrated 
into their core laboratory molecular systems. Sequencing-based assays, once used for 

 
 
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genotyping and resistance detection, have become less common in routine practice, although 
they may still be used in specialized settings. 
Point-of-care and near-patient molecular testing has emerged as a complementary segment, 
particularly for expanding access in decentralized and resource-limited environments. 
Cepheid offers HCV and HBV molecular assays on its GeneXpert platform, providing 
relatively rapid results and enabling testing closer to the patient. In emerging markets, 
companies such as Molbio Diagnostics have developed portable molecular systems, such as 
the Truenat platform for HBV testing, to support broader screening and monitoring 
initiatives. Regional manufacturers, including Shanghai Kehua Bio-Engineering, continue to 
supply PCR-based hepatitis assays tailored to local markets. In addition, alternative sample-
collection approaches, such as dried blood spots and plasma separation cards, are being used 
to simplify logistics and expand access in remote settings. 
The molecular hepatitis testing market is mature and increasingly shaped by global screening 
and elimination efforts, particularly for HCV. Growth is being driven by expanded testing 
programs, improved access to care, and integration with other infectious disease workflows, 
especially HIV, where multi-disease testing platforms improve efficiency and utilization. The 
trend is toward broader access, decentralized testing, and streamlined clinical pathways rather 
than the introduction of entirely new standalone assays. 
Molecular HIV Testing 
The market includes molecular testing such as genotyping, quantitative and qualitative for 
HIV.  A sizable market can be expected based on HIV-positive patient populations in the 
United States and major international markets for HIV care in Latin America, Africa, and 
Asia. Available parameters for HIV patient populations were used to estimate viral load (VL) 
test volume. Available indicators were used to adjust HIV VL to actual market demand (i.e., 
how much demand is instead met by CD4 or p24 antigen testing options for patients on 
antiretroviral therapy. 
Molecular HIV testing is fairly mature, generating $946 million in 2025, with most 
innovation and growth relating to antiviral therapy, including testing for viral load, viral 
tropism, and drug resistance.  Clinical approaches to HIV in the United States, Europe and 
other developed countries emphasize molecular testing as a tool for the management of 
chronic infection and achieving viral suppression. The focus of innovation among molecular 

 
 
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HIV test vendors is to improve their relevance to antiretroviral therapy and to tap 
opportunities in the developing world with simple, affordable tests.  
Rapid HIV screening tests and other advanced diagnostic lab tests are already widely 
available in many developing countries at concessional or discounted prices through 
centralized procurement programs. Molecular HIV diagnostics for viral load testing will 
require similar concessional pricing in order to implement antiretroviral treatment (ART) 
worldwide. Ruggedness, simple operation (integrated test performance), and low-cost 
reagents will be critical features of any molecular HIV diagnostic product intended for 
widespread deployment in the developing world. Currently, molecular tests are very rarely 
used for HIV screening outside of at-risk infants. Detection of HIV DNA is used for early 
infant detection as it bypasses false positives from maternal anti-HIV antibodies. The long-
term development of the molecular HIV test market will depend on improved availability of 
antiretroviral therapy. 
The widespread availability of rapid and laboratory-based immunoassays, which are 
significantly less expensive than molecular methods, continues to limit the growth of 
qualitative molecular HIV testing. In contrast, market growth in HIV diagnostics is largely 
driven by quantitative assays for viral load monitoring and genotyping tests that guide 
antiretroviral therapy (ART) decisions. Advances in antiretroviral drugs have set new 
standards for treatment effectiveness, allowing for near-complete suppression of viral 
replication in many patients. Effective management of HIV requires a combination of testing 
approaches: genotypic assays identify mutations associated with drug resistance, while 
phenotypic assays assess how well the virus replicates at specific drug concentrations. 
The majority of the molecular POC HIV test market would be for quantitative or VL assays 
performed at points of care. Global HIV programs are expected to influence progress from 
earlier campaigns for HIV screening to treatment coverage and viral suppression. As a result, 
the global number of patients on ART is expected to grow significantly, driving demand for 
viral load tests. Without access to testing facilities, many ART patients in low-resource areas 
will rely on rugged, rapid molecular systems used in near-patient settings. Linking ART 
patients to routine VL testing is expected to be one of the primary challenges in the HIV 
testing market.  
In terms of new test launches, several qualitative home-based HIV self-tests have been 
commercialized and continue to generate increasing demand, particularly as public health 
programs expand access to decentralized screening and self-management. Most currently 

 
 
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marketed home HIV self-tests remain non-molecular lateral flow immunoassays, since these 
offer simplicity, affordability, rapid turnaround, and no instrumentation requirements. 
Examples include Atomo HIV Self-Test developed by Atomo Diagnostics and OraQuick In-
Home HIV Test from OraSure Technologies. Atomo’s device has expanded through 
international public health procurement channels, while OraQuick remains one of the most 
established over-the-counter HIV self-tests globally. 
Molecular HIV testing still does not offer the same level of convenience and consumer 
simplicity as lateral flow self-tests, although point-of-care molecular HIV testing remains a 
strategic priority for several molecular diagnostics companies because of its superior 
analytical sensitivity and ability to support viral load monitoring. Cepheid continues to offer 
qualitative HIV detection and viral load assays on the GeneXpert System platform, including 
Xpert HIV-1 Qual and Xpert HIV-1 Viral Load assays, delivering results in approximately 
90 minutes with minimal hands-on time. The self-contained cartridge design reduces the risk 
of contamination and eliminates liquid waste handling, making the system suitable for 
decentralized laboratories and near-patient settings. 
Several other companies have also expanded near-patient molecular HIV testing. Molbio 
Diagnostics continues to market Truenat HIV-1, a chip-based real-time PCR assay run on the 
portable Truenat platform. The system is designed for decentralized, resource-limited 
settings and has gained traction for combining portability, battery operation, and rapid 
nucleic acid amplification in a compact format. Molbio has also broadened its Truenat menu 
across tuberculosis, hepatitis, respiratory infections, and other infectious diseases, 
strengthening its role in near-patient molecular diagnostics. 
The HIV testing market continues to show a dual-track trend: rapid growth in self-testing 
immunoassays for screening and sustained expansion of portable molecular platforms for 
confirmatory diagnosis, early infant diagnosis, and viral load monitoring, particularly in low-
resource and high-burden regions 
Abbott’s ViroSeq HIV-1 Genotyping System is intended for use in detecting HIV genomic 
mutations that confer resistance to specific types of antiretroviral drugs, as an aid in 
monitoring and treating HIV infection.  It is available in the United States and internationally.  
This assay is based on Sanger sequencing.  Next-generation sequencing could make 
sequencers viable clinical platforms for HIV genotyping.  An example of a currently 
available HIV clinical testing service based on next-generation sequencing is ARUP 
Laboratories’ DEEPGEN test for HIV-1 genotyping and tropism. 

 
 
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Outside developed countries, rapid HIV screening tests and other advanced diagnostic lab 
tests are already widely distributed at concessional or discounted prices through centralized 
procurement programs. Molecular HIV diagnostics for viral load testing require similar 
concessional pricing for use with antiretroviral treatment worldwide. Ruggedness, simple 
operation and low-cost reagents will be critical features for any molecular HIV analyzer 
hoping to be widely deployed in the developing world. 
Qualitative molecular HIV tests share the market for HIV detection and diagnosis with rapid 
and lab-based immunoassays. The tests can be used to detect early infections, including those 
in infants born to HIV-positive mothers. Growth in the HIV market is largely driven by 
quantitative tests for viral load monitoring and genotyping tests to assess antiretroviral 
therapy options. Antiretroviral drugs are setting new standards in effectiveness with therapy 
able to completely suppress viral replication. With over 28 individual drugs from six different 
classes approved for the treatment of HIV-1 infections, a combination of different phenotypic 
and genotypic tests is necessary to monitor HIV-infected patients. Genotypic tests identify 
particular mutations associated with resistance and phenotypic tests measure the ability of a 
viral infection to grow in the presence of known drug concentrations.   

 
 
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Table 11-17: Innovations in Molecular POC Diagnostics for HIV 
Company 
Remarks 
Abbott 
Determine for HIV Early Detect 
 RealTime HIV-1 
Atomo Diagnostics 
Atomo HIV Self Test 
Cepheid, USA (Now a part 
of Danaher Company) 
Xpert HIV-1 Viral load: quantitative molecular test; 
RNA extraction, purification, reverse transcription and cDNA real time quantitation -
integrated 
Hologic 
Aptima HIV-1 Quant Dx 
InSilixa, USA 
HIV diagnostic and drug resistance genotyping assays (In development); CMOS 
biochips technology; aiming at 1-hour sample to answer solutions 
Molbio Diagnostics 
Truenat HIV-1 
QuantuMDx Group Ltd., UK 
Q-POC™ device, a portable molecular diagnostic device; provide results in less than 
30 minutes 
Rheonix, USA 
Developed molecular testing solution (microfluidic system and assay); simultaneously 
detect host anti-HIV antibodies and viral RNA in a single specimen of saliva or blood 
Roche 
Cobas HIV-1 
Source: Kalorama Information 
Molecular Tests for Hospital-Acquired Infections (HAIs) 
Hospital-acquired infections (HAIs) are infections acquired by patients during hospital 
treatment.  The broader term healthcare-associated infections refer to infections that patients 
get while being treated at any healthcare facility.  HAIs are a major and often preventable 
problem.   
The table below notes the most common general nosocomial infection types. 

 
 
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Table 11-18: Frequency of the Most Common Nosocomial Infections 
Infection Site  
Incidence: Developed Regions 
Incidence: Developing Regions  
Urinary Tract Infection 
3%-5% of all admissions 
25%-30% of all admissions 
(80% due to device (catheter) use) 
Pneumonia  
1%-2% of ventilated patients/admissions 
10%-15% of ventilated patients 
Surgical Site Infection 
5%-10% of discharges 
15%-20% of wounds  
Central Vascular Line 
5%-15% of central vascular access patients 
15%+ of all patients 
Source: Kalorama Information 
Assessing the Problem: Nosocomial Infection Statistics 
The rise of an aging population presents a major challenge for modern healthcare, particularly 
due to the growing number of immunocompromised patients who are increasingly vulnerable 
to healthcare-associated infections. A critical concern is that many HAIs are caused by 
antibiotic-resistant microorganisms, making them more difficult and costly to treat. 
Antimicrobial resistance is a growing global threat, affecting not only developing countries 
but also advanced healthcare systems in regions like the EU and the United States. 
In the U.S., HAIs are estimated to cause 100,000 deaths annually, with a nosocomial infection 
rate of 5% to 10% among hospital admissions. Similarly, the EU reports over 2 million new 
HAI cases each year, of which more than 400,000 are linked to AMR pathogens, resulting in 
approximately 30,000 deaths annually. These infections significantly increase healthcare 
costs, prolong hospital stays, and strain already limited inpatient resources—posing an urgent 
need for improved infection prevention, rapid diagnostics, and effective antimicrobial 
management. 
Bloodstream infections are considered the most expensive inpatient condition in hospitals, 
costing more than $20 billion in the U.S. healthcare system and more than £2.8 billion in the 
United Kingdom. Hospitals have invested heavily in HAI surveillance, control and clinical 
testing solutions over the past five years in an effort to contain costs. The molecular 
AMR/HAI testing market is concentrated in the developed world, with the United States and 
Europe together representing 80% of the market; less- developed healthcare systems continue 
to rely predominantly on blood cultures and immunoassays for AMR/HAI testing.  

 
 
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Advancements in molecular testing have profoundly changed the landscape of HAI testing. 
Traditionally, blood cultures have been used to detect inpatient infections and sepsis, but 
their effectiveness is limited by long turnaround times and the non-specificity of initial 
results. Molecular diagnostics were first applied to identify pathogens in positive blood 
cultures through qualitative FISH assays. Without target nucleic acid amplification, FISH 
assays rely upon the blood culturing step to improve test sensitivity.  
At present, molecular testing for HAIs and pathogen AMR is primarily performed using PCR 
and other molecular assays that amplify target nucleic acids directly from blood, wound sites, 
respiratory samples, or blood cultures. Nucleic acid amplification tests performed on 
integrated systems provide rapid and reliable multiplex results even outside of traditional 
molecular labs. Rapid testing is the primary growth area in the molecular AMR/HAI market, 
as hospitals seek to implement appropriate care as quickly as possible to save patient lives 
and reduce antimicrobial misuse.  
Patients most at risk from antibiotic-resistant "superbugs" are often those who are already 
weakened by severe viral lung infections such as influenza, SARS, and COVID-19. These 
viral infections can compromise the immune system and damage respiratory tissues, creating 
a vulnerable environment for secondary bacterial infections, including those caused by 
multidrug-resistant organisms. 
In particular, COVID-19 patients frequently experience severe lung inflammation, requiring 
high levels of oxygen and mechanical ventilation. While life-saving, ventilator use 
significantly increases the risk of ventilator-associated pneumonia (VAP). In addition to lung 
damage, patients on ventilators face a heightened risk of long-term cognitive impairment, 
physical debility, and complications related to sedation and prolonged immobility. 
Unlike community-acquired pneumonia, which is more common and generally easier to treat, 
VAP is often caused by highly resistant bacteria, such as Pseudomonas aeruginosa, 
Acinetobacter baumannii, or Klebsiella pneumoniae, making it more difficult to manage and 
often resulting in more severe outcomes. It is estimated that up to 15% of ICU patients who 
require mechanical ventilation develop VAP. Contamination of the ventilator tubing or 
improper airway management can allow bacteria or secretions to bypass the body's defenses 
and colonize the lower respiratory tract. 
Preventing VAP requires meticulous care by ICU staff, including strict adherence to infection 
control protocols, regular oral hygiene, proper maintenance of ventilator circuits, and 

 
 
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minimizing sedation to allow earlier weaning from the ventilator when possible. As 
antimicrobial resistance continues to rise, especially in intensive care settings, the importance 
of infection prevention, rapid diagnostics, and antimicrobial management cannot be 
overstated. 
There are certain limitations to estimating the frequency and incidence of nosocomial 
infections.  Kalorama Information has attempted to gather data from multiple sources and 
provide an estimate based on reported data 
HAIs of common concern include infections by methicillin-resistant Staphylococcus aureus 
(MRSA), multidrug-resistant Escherichia coli, carbapenem-resistant Enterobacteriaceae 
(CRE), vancomycin-resistant Enterococci (VRE), Clostridium difficile (C-diff), and 
noroviruses. MRSA testing is included in all molecular HAI tests. A multiplex molecular 
assay is used to identify Staphylococcus aureus and detect its resistance gene. The U.S. CDC 
estimates that MRSA accounts for about 10% of all HAIs. European countries widely 
implemented MRSA screening for arriving patients to curb infection rates in the late 1990s.  
Clostridium Difficile 
Clostridium difficile (CDF/cdf', or 'C. diff') is a species of bacteria of the genus Clostridium, 
which are Gram-positive bacilli, anaerobic, spore-forming rods (bacilli). C. difficile is the 
most significant cause of pseudomembranous colitis. Clostridium difficile infection (CDI) 
can range in severity from asymptomatic to severe and life-threatening and many deaths have 
been reported, especially among the aged.  
C. difficile is a bacterium living in harmony with other bacteria, not in a parasitic relationship, 
but deriving benefits from one another in the human intestine in a minority of the population.  
In small numbers, it does not result in any significant disease. Antibiotics, especially those 
with a broad spectrum of activity, disrupt the normal intestinal flora, leading to overgrowth 
of C. difficile, which flourishes under these conditions. This leads to pseudomembranous 
colitis.  
Patients who have been staying long-term in a hospital or nursing home are more likely to be 
colonized by this bacterium. Clostridium difficile acquisition is estimated to be 13% in 
patients with hospital stays of up to two weeks and 50% in those with hospital stays longer 
than four weeks.  

 
 
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C. difficile is transmitted from person to person by the fecal-oral route. Because the organism 
forms heat-resistant spores, it can remain in hospital or nursing home environments for 
extended periods. It can be cultured from almost any surface in the hospital. Once ingested, 
spores pass through the stomach unscathed due to their acid resistance. They change to their 
active form in the colon and multiply.  
Toxigenic culture, in which organisms are grown on selective media and then tested for toxin 
production, remains a highly sensitive and specific method, but it is slow and labor-intensive 
and is no longer routinely used for frontline diagnosis. Most laboratories now rely on faster 
molecular assays or multistep testing algorithms to support timely clinical decisions. Current 
practice generally recommends testing a single appropriate specimen rather than multiple 
samples, unless there is a strong clinical reason to repeat testing. Modern assays are designed 
to detect both toxin A and toxin B, or the genes that encode them, reflecting the recognized 
importance of toxin B in disease. Delays in diagnosis can still occur, but these are more often 
related to test selection and workflow rather than limitations in detecting specific toxins, and 
timely, accurate testing remains critical to improving patient outcomes. 
Cepheid remains one of the leading companies in the HAI and AMR molecular diagnostics 
segment. Its Xpert MRSA NxG assay is an important rapid molecular test MRSA 
surveillance, providing accurate results in approximately one hour. Cepheid also 
strengthened its AMR menu through expanded FDA-cleared claims for Xpert Carba-R, a 
rapid molecular assay designed to detect carbapenemase-producing Gram-negative bacteria. 
The expanded claims include testing of perirectal swab specimens and the use of pure 
bacterial colonies, allowing laboratories to support both infection-prevention strategies and 
therapeutic decision-making. Cepheid’s cartridge-based, near-patient molecular format 
continues to make it one of the strongest decentralized AMR platforms globally. 
Becton Dickinson continues to hold a strong position in the U.S. HAI and antimicrobial 
resistance testing market through its combined molecular and microbiology portfolio. The 
BD MAX system supports assays for MRSA, Staphylococcus aureus, vancomycin-resistant 
enterococci, and Clostridioides difficile, while the company’s broad footprint in hospital 
laboratories helps support infection control, surveillance, and antimicrobial stewardship 
efforts. In multiplex molecular screening, bioMérieux remains a key player with its BIOFIRE 
FilmArray panels, including gastrointestinal and blood culture identification tests. These 
syndromic panels detect a wide range of pathogens, along with important resistance markers 
such as mecA/C, vanA/B, and carbapenemase genes, enabling rapid identification of 
infectious organisms and resistance profiles directly from clinical samples. 

 
 
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Roche Diagnostics continues to offer molecular HAI assays on its laboratory analyzers, 
including the Cobas MRSA/SA Test for MRSA differentiation and the Cobas Cdiff Test for 
detection of toxigenic C. difficile. Roche also expanded near-patient HAI testing in Europe 
through its Cobas Liat System, with CE-marked assays that offer rapid molecular detection 
of MRSA and C. difficile in patient care settings. Although Roche remains stronger in 
centralized molecular testing than in decentralized HAI screening, its installed molecular 
base continues to support hospital microbiology workflows. 
Other molecular HAI and sepsis products remain relevant across specialized segments. 
QIAGEN markets molecular assays for C. difficile, MRSA, and VRE on Rotor-Gene 
platforms. T2 Biosystems remains important in bloodstream infection testing with the 
T2Candida Panel and T2Bacteria Panel, which support rapid sepsis diagnosis directly from 
whole blood. Former products, such as the Verigene blood culture tests originally developed 
by Luminex Corporation, now part of DiaSorin, still retain some clinical relevance for rapid 
blood culture organism identification and resistance marker detection.  
 MRSA 
The competitive landscape for healthcare infection testing is fragmented with numerous 
players.  The use of tests makes it difficult to determine market leadership and share, due to 
their use for non-serious infection testing.  
The area of Staphylococcus aureus infection testing, particularly for methicillin-resistant 
Staphylococcus aureus (MRSA), has expanded significantly over the past decade as hospitals 
increasingly adopted rapid molecular screening to support infection control and antimicrobial 
stewardship. Early molecular growth began with platforms introduced by Becton Dickinson 
and Cepheid, and the market later broadened as additional suppliers introduced assays for 
rapid MRSA detection, strain differentiation, and resistance marker identification. Although 
earlier participants such as Luminex Corporation and AdvanDx contributed specialized 
products, the strongest current commercial positions are concentrated among larger 
integrated molecular diagnostics companies. 
Cepheid remains one of the dominant players in this segment through its Xpert MRSA and 
next-generation Xpert MRSA NxG assays, both run on the GeneXpert System. These 
cartridge-based molecular assays provide rapid MRSA detection directly from nasal swabs, 
with results available in approximately one hour, allowing hospitals to identify carriers 
quickly and implement isolation protocols sooner. Cepheid’s MRSA menu has remained a 

 
 
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cornerstone of hospital infection prevention programs because of its decentralized workflow, 
rapid turnaround time, and strong installed base worldwide. 
Randox Laboratories has expanded rapid molecular MRSA testing through the Vivalytic 
MRSA/SA assay on the Vivalytic Analyzer platform. This system differentiates MRSA from 
methicillin-sensitive Staphylococcus aureus in approximately 50–60 minutes and is 
positioned for near-patient and urgent-care use, helping clinicians accelerate patient isolation 
and treatment decisions. Roche Diagnostics also remains active with the Cobas MRSA/SA 
Test, while bioMérieux supports MRSA detection through syndromic molecular and 
microbiology systems. Becton Dickinson continues to market MRSA assays on the BD MAX 
System. By 2026, the leading companies in molecular MRSA testing are Cepheid, BD, 
Roche, bioMérieux, and increasingly Randox, while Abbott has a more limited direct role in 
dedicated MRSA molecular testing compared with these core competitors. 
Molecular TB Testing 
Tuberculosis (TB) remains one of the leading causes of death worldwide. According to the 
World Health Organization, approximately 10.6 million people developed TB in 2023 and 
about 1.6 million died from the disease. TB is closely linked with HIV infection, as 
immunocompromised individuals are significantly more susceptible; TB continues to be a 
leading cause of death among people living with HIV. Drug-resistant TB remains a major 
global health challenge, with hundreds of thousands of new cases showing resistance to 
rifampicin, the most effective first-line drug, and the majority of these cases classified as 
multidrug-resistant TB (MDR-TB). While countries such as China have made progress in 
reducing TB incidence and mortality, many regions remain off track to meet global 
elimination targets. 
Definitive diagnosis of TB relies on identification of Mycobacterium tuberculosis in clinical 
specimens such as sputum, typically through microbiological culture or molecular detection. 
In practice, a combination of diagnostic approaches is often used. Traditional methods 
include smear microscopy and culture, while imaging techniques such as chest X-ray support 
clinical assessment but lack specificity. The tuberculin skin test (Mantoux test) has 
historically been used to detect latent TB infection, but its interpretation is complicated by 
prior BCG vaccination and cross-reactivity, as well as reduced sensitivity in 
immunocompromised individuals. As a result, its role has been supplemented in many 

 
 
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settings by interferon-gamma release assays (IGRAs), which provide improved specificity 
for latent TB infection and are not affected by prior vaccination. 
Molecular diagnostics are an important technology for TB detection and management. PCR-
based assays enable rapid detection of M. tuberculosis DNA and can simultaneously detect 
key drug-resistance markers, particularly rifampicin resistance. Cepheid has expanded its TB 
menu with assays such as Xpert MTB/RIF Ultra, which improves sensitivity over earlier 
versions, and Xpert MTB/XDR, which extends detection to additional resistance markers. 
These cartridge-based systems provide results within a few hours and are widely used in both 
centralized and decentralized settings. Portable molecular platforms such as those from 
Molbio Diagnostics offer Truenat MTB and MTB-RIF assays designed for near-patient use, 
particularly in resource-limited environments. High-throughput molecular systems from 
companies such as Roche Diagnostics support centralized testing in laboratories with 
available infrastructure. 
There is also growing interest in alternative sample types and biomarker-based approaches, 
including urine-based assays, particularly for patients who are unable to produce sputum, 
such as children and individuals with advanced HIV infection. Despite these advances, no 
single test fully addresses all diagnostic needs, and combinations of molecular, immunologic, 
and microbiological methods are often required. 
The intersection of TB and HIV continues to be a critical public health concern. HIV 
infection significantly increases the risk of progression from latent to active TB, and TB 
remains the leading cause of death among HIV-positive individuals. As a result, integrated 
testing and treatment strategies for TB and HIV are a major focus of global health programs. 
TB diagnostics are evolving toward faster, more sensitive, and more accessible molecular 
approaches, with increasing emphasis on early detection, identification of drug resistance, 
decentralized testing, and integration into broader infectious disease control programs. 
The TB diagnostics market is heavily concentrated in high-burden regions, particularly Asia 
and Africa, where national screening programs drive testing volume. Cepheid continues to 
dominate global molecular TB testing, while companies such as Molbio Diagnostics have 
expanded access through portable, decentralized PCR platforms. Recent product 
development has focused on expanded drug resistance detection and increased use of near-
patient systems, rather than the introduction of entirely new diagnostic platforms. 
 

 
 
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Limitations of Molecular Microbiology Testing 
Molecular microbiology has made it possible to detect microorganisms much faster than 
culturing them.  However, there are limitations.  If monoplex tests are performed, multiple 
tests may be required to determine which microorganism is present.  Multiplex tests and 
syndromic test panels reduce the need for multiple tests, but they are more expensive.  
Negative testNex results do not rule out the presence of a microorganism.  Negative results 
only indicate that, if a microorganism is present, it is not one of the pathogens tested. 
Another limitation is that molecular microbiology tests can detect the presence of an 
antibiotic resistance gene, but these tests do not provide phenotypic information, such as 
whether the gene is active and whether the bacteria are actually resistant to the antibiotic.  
How will the bacteria actually react to the presence of that antibiotic? 
Also, most molecular microbiology tests available today are not fast enough for point-of-care 
testing while the patient is still in the physician’s office or clinic.  Molecular microbiology 
tests that require only a few hours to perform represent a significant improvement over 
traditional microbiology in hospitals, where the results can then be used to inform treatment 
decisions for inpatients.   
Some laboratories and diagnostic companies have increasingly incorporated next-generation 
sequencing into the microbiology laboratory. Sequencing enables the analysis of a large 
number of genes in a single test and can identify both known and previously unrecognized 
microorganisms. Its use has expanded in areas such as outbreak investigation, antimicrobial 
resistance detection, and characterization of complex infections. While sequencing has the 
potential to further advance microbial identification and resistance profiling, its routine use 
is still limited by cost, data interpretation requirements, and the need for specialized 
infrastructure. Turnaround times have improved, but in many settings, they are still longer 
than the times required for immediate clinical decision-making in physician offices and 
smaller laboratories. As a result, sequencing is best described as advancing toward broader 
clinical adoption rather than remaining in an early stage. Researchers and diagnostic 
companies have made significant progress in bringing new technologies into the 
microbiology laboratory, but continued innovation is needed to further improve speed, 
accessibility, and clinical integration. 

 
 
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Rapid Microbiology Tests 
Rapid microbiology tests are molecular and immunoassay tests.  
Historically, rapid immunoassays have commonly come in two configurations. One 
configuration is a flow-through assay, which requires several steps, including placing the 
sample on the device, washing, and adding detection molecules that make the test result 
visible to the eye.   In flow-through tests, the biological fluid passes through a porous material 
or membrane into an absorbent.  With this type of immunoassay, the analyte is captured on 
the membrane by the capture molecules.  This is washed with buffer, and then detection 
molecules are added to produce a detectable signal on the porous material. These devices are 
typically encased in a plastic housing, and one sample is tested per cassette. 
A second configuration is the lateral flow test, also called an immunochromatographic test.  
These may be strip tests or housed in cassettes.  With lateral flow tests, the biological sample 
is added to a sample pad located at one end of the strip.  The sample flows along the 
membrane to the conjugate pad, which contains detection molecules consisting of antibodies 
or antigens that are specific to the analyte.  With a dry, unused strip, these detection molecules 
are immobilized on the conjugate pad.  The fluid in the sample solubilizes the detector 
molecules, which then bind to the analyte if it is present.  This analyte/detector mix flows 
further along the strip to the location of an analyte-capture molecule.  If the analyte is present, 
the analyte/detector combination is captured and can be visualized.  This is often a line on 
the strip, but it can be another shape, such as a “+” or other symbol.  A control is also 
included, and the control line should always be visible upon assay completion.  The second 
line is visible if the analyte is present. 
Lab-based immunoassays do not meet the pressing needs for mass screening and diagnostic 
programs required by public health professionals and clinicians in the developing and 
developed world.  Therefore, there is an increasing demand for reliable, rapid tests for 
infectious diseases.  This enables earlier patient diagnosis and treatment, and saves patients 
and healthcare plans money, while avoiding costly delays and unnecessary quarantines.  
Further studies have shown that the majority of individuals seen in clinics do not return to 
receive their lab test results and therefore remain untreated if positive.   
The majority of diagnostic tests currently used for these purposes are rapid immunoassays, 
chosen for their low cost and convenience. However, one of the key downsides of these rapid 

 
 
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tests is their poor sensitivity. Negative samples are typically re-tested in a central lab with a 
more sensitive molecular test, delaying time-to-result by many hours.   
Table 11-19: Global Rapid Microbiology Testing Market, Sales Distribution, by Pathogen, 2025 (%)  
 
[C. Difficile; COVID-19; E. coli; H. pylori; Hepatitis; HIV; Influenza; Malaria; Other respiratory; STD; Other] 
Pathogen 
% Mkt 
Respiratory 
60.8% 
STD 
6.6% 
Hepatitis 
5.2% 
HIV 
5.2% 
C. difficile 
3.7% 
Malaria 
3.6% 
E. Coli 
1.9% 
H. pylori 
1.7% 
Other 
11.3% 
Total 
100% 
Source: Kalorama Information 
POC multi-target panels are increasingly used because they offer several advantages over 
traditional single-target tests. A key advantage of molecular multi-target panels is their ability 
to reduce time to diagnosis compared with conventional methods such as culture or sequential 
testing. By consolidating multiple single assays into a single, high-confidence test, molecular 
multiplex panel testing enables faster and more accurate clinical decision-making, 
particularly in high-acuity cases involving sepsis and central nervous system (CNS) 
infections. 
 

 
 
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Figure 11-4: Rapid Infectious Disease Test Sales, by Respiratory/Non-respiratory Segments, 2025 (%) 
 
Source: Kalorama Information 
Rapid respiratory tests accounted for the largest percentage of cases by pathogen in 2025. 
Rapid Respiratory tests are further divided into testing for single-target and multi-target from 
a single specimen. POC IVD respiratory molecular panels generally use PCR or isothermal 
amplification (NAAT) technologies and are deployed in compact, cartridge-based systems. 
These systems offer laboratory-level sensitivity while providing rapid turnaround times for 
results. 
 

 
 
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Figure 11-5: Rapid Respiratory Testing, by Target Pathogens, 2025 (%)  
 
[Multi-Target, Single-Test] 
 
Source: Kalorama Information 
For some diseases, such as COVID-19 and influenza, physicians cannot wait long to start 
antiviral therapy because available treatments must be initiated within a short window after 
infection. An example of influenza treatment is Flumadine (rimantadine), which must be 
administered within 48 hours of the onset of flu symptoms.  This has fueled the market for 
rapid influenza tests.  
QuidelOrtho offers the Sofia Influenza A+B Fluorescent Immunoassay (FIA) on its Sofia 2 
system.  The test uses advanced immunofluorescence-based lateral-flow technology to detect 
influenza A and influenza B viral nucleoprotein antigens.  Positive results can be obtained in 
as few as 3 minutes, negative results in 15 minutes. 
Selected rapid tests for HIV include: 
• Abbott Alere Determine HIV-1/2 Combo, mPIMA HIV 1/2 VL 

 
 
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• Standard Diagnostics BIOLINE HIV Ag/Ab Combo. 
• Chembio  HIV1/2 STAT-PAK Rapid IgG Antibody Lateral-flow, DPP HIV-Syphilis 
System  
• OraSure OraQuick ADVANCE Rapid HIV 1/2 Assay 
• Trinity Biotech Uni-Gold Recombigen 
• MedMira Reveal Rapid HIV-1  
In the United States, HIV testing has evolved beyond earlier mail-in collection systems to 
include true at-home tests, where individuals can collect a sample, perform the test, and read 
the results themselves. These self-contained tests have made HIV screening more accessible 
and convenient, supporting earlier detection and reducing barriers to testing. At the same 
time, many companies continue to market rapid HIV tests outside of the United States, 
particularly for use in clinical and community-based settings. 
In emerging markets, point-of-care diagnostic tests for diseases such as malaria, HIV, and 
syphilis play a critical role in improving access to care, especially in areas with limited 
laboratory infrastructure. These tests enable faster diagnosis and treatment decisions, helping 
to improve clinical outcomes and support large-scale screening and public health programs. 
Diagnostics are not prioritized in global health, as funding has largely focused on developing 
and delivering therapeutic interventions and vaccines.  The lack of quality standards in the 
evaluation and regulation of diagnostics has also led to the proliferation of low-quality 
diagnostic tests being sold and used without evidence of effectiveness, discouraging 
companies with high-quality tests from competing in the same market.  
Rapid tests are available for: HIV, gonorrhea, syphilis, chlamydia, herpes, hepatitis, strep A, 
strep B, tuberculosis, RSV, influenza, legionella, mononucleosis, mycoplasma pneumonia, 
E. coli, H. pylori, cryptosporidium, giardia, C. difficile, rotavirus, fungal disease, and 
bacterial meningitis. 
NOWDiagnostics received FDA de Novo authorization for OTC and POC diagnostic testing. 
The First To Know Syphilis Test is the first and only rapid syphilis test in the U.S that 
provides an in-home result in 15 minutes.  
 

 
 
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Mass Spectrometry 
One of these innovations, increasingly finding a home in microbiology, is mass spectrometry.  
Mass spectrometry has been used in clinical laboratories for other indications for several 
years.  However, mass spectrometry platforms have become transformative technologies in 
microbiological applications.  Mass spectrometry has quickly emerged as a significant 
advancement for the rapid detection and characterization of bacterial pathogens following 
culture.  Mass spectrometry can identify the microbial pathogen in minutes, compared to the 
hours required for traditional ID/AST. 
Mass spectrometry instrument systems are expensive, and these platforms are primarily used 
in developed countries.  Once a laboratory has acquired a mass spectrometry system, testing 
individual samples is relatively inexpensive. 
 
 

 
 
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Table 11-20: Selected Companies Marketing Mass Spectrometers and/or Assays for the Clinical Laboratory  
 
[CE-Marked and/or 510(k) cleared] 
Company 
Technology/Product 
Agena Bioscience, Inc.  
MassARRAY System Diagnostic panels: 
•MassARRAY Dx Lung Panel 
• MassARRAY Dx Colon Panel 
ALIFAX S.r.l. 
Clinical chemistry kits for LC/MS tests for 
•Endocrinology (hormones)  
•Homocysteine 
•Vitamins 
 
Clinical pharmacology kits for LC/MS therapeutic drug monitoring of 
•Antiepileptics 
•Antiarrhythmics 
•Immunosuppressants 
•Antibiotics 
Andromas SAS 
LT2-Andromas MALDI-TOF mass spectrometer 
Beckman Coulter, Inc.   
(Subsidiary of Danaher 
Corporation) 
MALDI Biotyper 
(Beckman Coulter distributes the MALDI Biotyper in the U.S.) 
bioMérieux SA 
VITEK MS 
Bruker Corporation 
MALDI Biotyper and MALDI CA Biotyper – MALDI-TOF mass spectrometer for 
microbial identification;  
Revvity 
NeoBase 2 MS 
SCIEX  
(SCIEX - A Danaher Company) 
Clinical mass spectrometers offered by SCIEX include: 
• 3200MD Mass Spectrometer 
• 4500MD Mass Spectrometer  
 
Clinical assays available from SCIEX include: 
• Amino Acids and Acylcarnitines in Dried Blood Spots IVD Assay Kit 
• Immunosuppressants IVD Assay Kit 
• 25-OH-Vitamin D3/D2 in Serum/Plasma IVD Assay Kit 
Thermo Fisher Scientific 
Prelude MD HPLC, Endura MD Mass Spectrometer, and ClinQuan MD Software 
Extent System 
Source: Kalorama Information 

 
 
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The Future Outlook for Microbiology 
The future of microbiology diagnostics is strongly tied to growth, driven by both 
technological advancements and the persistent emergence of new infectious diseases. 
Innovations in microbiology testing, especially in molecular diagnostics, have led to 
significant expansion, particularly in infectious disease detection. These modern methods 
offer higher sensitivity and specificity, addressing many previously unmet clinical needs and 
reshaping the clinical diagnostics landscape. 
Molecular techniques have not only transformed traditional microbiology but have also 
enhanced other IVD segments, including immunodiagnostics, by delivering more accurate 
and actionable insights. Application areas such as blood screening, POC diagnostics, 
cytogenetics, and tissue typing have been notably redefined by integrating advanced 
molecular tools. 
Given the ongoing and unpredictable threat of infectious diseases, demand for microbiology 
testing remains strong and is projected to outpace the broader IVD market in revenue growth. 
However, despite the clinical necessity, microbiology diagnostics are not immune to 
economic pressures 
Current technologies cannot meet all the needs of the microbiology lab for identification and 
antibiotic susceptibility testing (ID/AST).  The traditional microbiology market will continue 
to grow, but at a slower pace than certain other segments. 
The expanding capabilities and numbers of molecular diagnostic and mass spectrometry-
based tests, combined with the need for tests that can deliver faster results than traditional 
microbiology, will drive growth in these segments.  Continued advances in technology will 
continue to fuel growth in the microbiology market.   
The ultimate goal in the microbiology market is rapid tests, less than 30 minutes, for 
microbial identification and antibiotic susceptibility testing ID/AST.  These tests can identify 
which microbial pathogen is present, either using a panel of major pathogens associated with 
the syndromic symptoms or a test that can identify unknown pathogens.  In addition, these 
rapid tests would provide antibiotic susceptibility information, informing the physician 
which antibiotics will be effective in treating the infection. 

 
 
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One company, Specific Diagnostics (part of bioMérieux), offers the SPECIFIC REVEAL 
Rapid AST System.  Molecular-based syndromic tests are available to identify microbial 
pathogens (including viral and bacterial) if the pathogen is among the microbes included in 
the panel.  In addition, the first truly rapid (less than 20-minute) molecular tests for influenza, 
RSV, and strep A are on the market and can be used at the POC.  
Microbiology labs are improving all the time. The potential has grown in many areas to make 
faster treatment for certain infections. Please see the following examples: 
• Rapid antigen and PCR tests are now available for the laboratory diagnosis of sore 
throat, with a turnaround time of minutes to a few hours. 
• Bacteriology automation, such as Kiestra TLA, can reduce turnaround times for urine 
cultures to less than a day, and a day and a half for wound swabs.  
• Rapid PCR tests for atypical respiratory pathogens (Legionella spp., Mycoplasma 
pneumoniae, Chlamydia pneumoniae) can mean that macrolide coverage for 
community acquired pneumonia can be stopped early, or not even started. 
• Ultra-fast PCR tests for influenza can prevent any antibiotics being prescribed in 
patients who present with Upper Respiratory Tract Infection (URTI). 
• PCR tests with genotypic antimicrobial susceptibility information can avoid the use 
of indiscriminate antibiotics and selection pressure for antibiotic resistance. 
The molecular market expanded quickly in response to the COVID-19 pandemic, developing 
tests, reducing result turnaround times, and increasing specificity over a short period. The 
demand for molecular technology increased during this period. The installation base of 
molecular analyzers, expanding techniques, and test menus in labs worldwide, grew to meet 
the demand.  Due to this increased demand, more laboratories are now equipped to run 
molecular testing as part of their routine diagnostic test offerings.  
Mass spectrometry in microbiology is promising driven by technological advancements, 
integration with computation AI tools and increasing demand for rapid, accurate microbial 
diagnostics.   
 

 
 
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Chapter 12: Blood Banking Services 
Scope 
This chapter examines the marketplace for in vitro diagnostic products specifically 
related to blood banking.  Among these are:  
• Blood Grouping and Typing Products 
• Immunoassays for Pathogen Detection 
• Molecular Assays for Pathogen Screening  
• NAT Blood Screening Systems 
The market is mature but there are innovations, particularly in molecular testing and 
in information technology systems associated with blood banking products.   
 
 

 
 
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Overview  
Whole blood transfusions are increasingly replaced by blood component therapy, so there is 
a strong demand for platelets that are used for trauma patients, burn victims, and cancer 
patients.  Other changes have also influenced the market, including: 
• new technologies that limit surgical bleeding;  
• improved blood management programs at hospitals; 
• fewer elective surgeries; 
• more sophisticated blood management programs at hospitals. These programs include 
collecting blood lost during surgery and returning it to the patient, maximizing 
hemoglobin levels to prevent anemia, and using medications to reduce intraoperative 
bleeding. 
The Current Status of Global Blood Collection 
The following statistics regarding blood collection are notable: 
• Volunteer Donors Worldwide: According to WHO statistics, 79 countries collect over 
90% of their blood supply from voluntary, unpaid blood donors, and 56 of those 
countries do so for all of their blood supply; however, 54 countries collect more than 
50% of their blood supply from family/replacement or paid donors. 
• Blood Collected: Around 118.5 million units of donated blood are collected each year 
globally, with 42% of the blood collected going to middle- and low-income countries, 
home of 80% of the world’s population. About 13,300 blood centers in 169 countries 
report collecting a total of 106 million donations; the median number of annual 
donations per center is 25,700 in high-income countries, compared with 4,400 in 
middle- and low-income countries. This rate boils down to 31.5 donations per 1,000 
people in high-income countries, compared to 16.4 per mil in middle-income 
countries, and 5 in low-income countries. 
• Practice Changes in Transfusions: Whole blood transfusions are increasingly being 
replaced by blood component therapy; there is strong demand for platelets and Type 
AB plasma. These blood products are used for trauma patients, burn victims, and 

 
 
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cancer patients. Red blood cells are needed for accident and gunshot victims, as well 
as in elective surgeries.  
• United States: According to AABB (formerly American Association of Blood 
Banks), community-based independent blood centers supply about 60% of the U.S. 
blood supply, while the American Red Cross supplies about 40%. The number of 
blood units collected in the United States was  11.6 million in 2023 
• Asia Boosts Blood Collection: The WHO Southeast Asia Region estimates 15.9 
million units are collected in contingent nations per year, a great improvement over 
the 9.4 million units collected, as detailed in this report’s previous edition. However, 
with a requirement of 18 million units, they are still short. 
• India Improves but Needs More: India, with its huge population of over 1.3 billion, 
has 2,903 blood banks, of which 1,043 are public and 1,860 are private, including 
those run by charitable trusts. Together, they collected 14.6 million  
• China Update: China’s blood supply is collected primarily from voluntary, unpaid 
blood donors, following reforms that largely eliminated family/replacement donation 
practices. All donated blood is screened for transfusion-transmissible infections 
(TTIs), including HIV, hepatitis B, hepatitis C, and syphilis. Although blood donation 
rates have increased significantly since implementation of the Blood Donation Law, 
donation levels remain below the 1–3% population donation rate often considered 
necessary for stable supply. The COVID-19 pandemic negatively affected blood 
collection activities, and while donation levels rebounded afterward, China continues 
to face periodic regional and seasonal blood shortages. In 2023, the country recorded 
approximately 17 million voluntary blood donations. 
• Africa - Safety: The WHO believes that the safety of the blood supply is a priority for 
all countries and a particular challenge in sub-Saharan Africa. In addition to well-
known transfusion-transmitted pathogens such as HIV, HBV, HCV, and bacteria, the 
risk remains high due to pathogens endemic to African countries, such as 
chikungunya, dengue, malaria, and Leishmania, for which screening assays may not 
be readily available.  
• Africa - Transfusions: While patients in developed countries receive platelet, plasma, 
or red cell transfusions, in many African countries, whole blood transfusions remain 
common. Obstetric hemorrhage, sickle cell disease, and childhood anemia are among 
the many conditions in Africa requiring transfusion as a critical life-saving 

 
 
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intervention. The African blood supply is also challenged by transfusion-transmitted 
diseases endemic to the region, including malaria, dengue, chikungunya, and yellow 
fever. At the same time, local blood donors have significant rates of well-known 
infectious agents such as HIV, HTLV, and hepatitis, all of which can also be 
transmitted via transfusion. 
• Saudi Arabia: Saudi Arabia has an estimated population of 33.3 million; 10.1 million 
of which are registered foreign expatriates, and an estimated 5 million illegal 
immigrants. There are 185 blood banks run by the Ministry of Health, with 
approximately 800,00 donors in 2024.  All blood units are tested for: HIV 1/2, 
HBsAg, anti HBc, anti HBs, anti HCV, HTLV I/II, syphilis, and malaria. All done by 
ELISA except syphilis, which is done by Rapid Plasma Reagin (RPR). The Ministry 
of Health started using nucleic acid testing (NAT) in 2010 with tests supplied by 
Roche Diagnostics. 
• Latin America: The blood collection environment in Latin America and the Caribbean 
has shown measurable progress in recent years. Total blood donations across the 
region rose by 15.5% from 2020 to 2023, reflecting a stronger donor recruitment and 
improved collection systems. In 2023, the voluntary, unpaid donors accounted for 
56.8% of all blood collected. Screening performance has also strengthened, with 
approximately 90% of collected blood processed into components rather than whole 
blood.  

 
 
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Global Blood Safety 
Of the 171 responding countries, 113 (66%) reported having specific legislation covering 
blood transfusion safety and quality, including 79% of high-income countries, 63% of 
middle-income countries, and 39% of low-income countries. The WHO recommends that all 
donations be screened for transfusion-transmitted infections—HIV, hepatitis B and C 
viruses, and syphilis. Of the 165 nations that have responded, 10 are unable to screen all 
donated blood for one or more of these pathogens, and 4 are unable to screen any donated 
blood for any of them.  
Additionally, some countries report that they screen for Chagas’ disease, malaria, and/or 
human T-lymphotropic virus (HTLV), which can cause adult T-cell leukemia/lymphoma. 
Blood collection facilities in the United States test 100% of donations for the four pathogens 
recommended by WHO and for HTLV, and a portion of donations are tested for Chagas’ 
disease. 
Table 12-1: Laboratory Screening of Blood Donations for Transfusion-Transmissible Infections, Number of 
Countries 
 
[Chagas; HBV; HCV; HIV; HTLV I/II1; Malaria; Syphilis] 
Disease 
Mandatory Screening Policy 
Selective Testing Policy 
Unanswered 
Syphilis 
165 
3 
3 
HCV 
164 
0 
7 
HBV 
156 
0 
5 
HIV 
166 
0 
5 
Chagas¹ 
20 
12 
NA 
Malaria¹ 
20 
31 
NA 
HTLV I/II1 
35 
15 
NA 
Note: The data collection form used for the collection of the 2018 data for the African Region did not include this information. 
Information collected in earlier years (2015 or 2014) was used for the analysis. 
Note: ¹Reporting on Chagas, malaria, and HTLV is limited. This is the most updated information available at this time 
Source: WHO; 2021 Global Status Report on Blood Safety and Availability 

 
 
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The table below illustrates the prevalence of TTIs in blood donations, by countries’ 
socioeconomic statuses. 
Table 12-2: Prevalence of TTIs in Blood Donations [Median (Interquartile range)], by Income Group 
Income group 
HIV 
HBV 
HCV 
Syphilis 
High-income countries 
0.002% (0-0.01) 
0.02% (0.003-0.13) 
0.07% (0.002-0.05) 
0.02% (0.02-0.11) 
Upper middle-income 
countries 
0.10% (0.03-0.23) 
0.29% (0.15-0.62) 
0.19% (0.06-0.35) 
0.35% (0.11-1.08) 
Lower middle-income 
countries 
0.19% (0.03-0.77) 
1.70% (0.76-5.54) 
0.38% (0.03-0.08) 
0.69% (0.16-1.25) 
Low-income countries 
0.70% (0.33-1.66) 
2.81% (2.0-4.50) 
1.00% (0.50-2.23) 
0.90% (0.60-1.81) 
Source: World Health Organization; Blood safety and availability fact sheet 
Zika Virus 
Zika virus is transmitted primarily by the Aedes mosquito. Zika virus can also be spread by 
sexual contact. Although 4 out of 5 people infected with Zika virus never develop symptoms, 
when symptoms do occur, they may include fever, arthralgia (joint pain), maculopapular rash 
(red area with small bumps), and conjunctivitis (red, irritated eyes). In addition, Zika virus 
infection during pregnancy can cause serious birth defects. 
Market growth from these added NAT screens for Zika and other infectious disease threats 
may ultimately prove marginal in the U.S. market. Major health systems and blood banks 
often secure contracts at discounted per-test costs offered by IVD companies looking to win 
accounts in a very tight market. In other words, adding a NAT assay for Zika may add little 
or no value to the largest and most competitive contracts. 
Selected IVD tests on the market in 2025 include 
• Roche cobas Zika test 
• Vela Diagnostics Sentose ZIKV PCR test 
• ARUP Zika RT-PCR test and the Zika IgM MAC-ELISA 

 
 
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Diasorin offers the LIAISON XL Zika Capture IgM II, a fully automated serology assay for 
Zika virus detection.  
Chembio markets its DPP Zika/Dengue/Chikungunya System by ANVISA, Brazil’s health 
regulatory agency. The test is performed using a small drop of fingertip blood and provides 
quantitative results in approximately 15 minutes when used with the company’s handheld 
DPP Micro Reader.  
Blood and Component Collection 
The blood collected is processed into three major components: red cells, platelets, and 
plasma. These blood components are transfused to patients or used to make drugs and 
diagnostic reagents. Of the blood components, red cells are the most frequently transfused, 
accounting for 40 million units annually. An estimated 10 million platelet units are transfused 
each year into patients in North America, Europe and Asia. 
The table below presents how blood components are used in the treatment of various 
conditions. 

 
 
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Table 12-3: Blood Component Usage for Selected Conditions 
Condition 
Blood Components 
Liver Transplant 
6-10 units of red blood cell 
20 units of plasma 
10 units of platelets 
Adult Open-Heart Surgery 
2-6 units of red blood cells 
2-4 units of plasma 
1-10 units of platelets 
Automobile Accident 
4-40 units of red blood cells 
Leukemia 
2-6 units of red blood cells 
6-8 units of platelets daily for 2-4 weeks 
Sickle Cell Disease 
10-15 units of red blood cells for severe cases 
Cancer Chemotherapy 
1-10 units of HLA-matched platelets 
1-3 units of CMV negative red blood cells 
Source: 2000 Nationwide Blood Collection and Utilization Survey conducted by the National Blood Data Resource Center 
Reevaluating Blood Transfusions 
Blood transfusions have become so commonplace that it is easy to forget that blood is an 
organ, and the transfusion is akin to an organ transplant and should be performed only when 
absolutely necessary. This concept has led some hospitals to reevaluate their blood use. They 
found that some 30%-50% percent of blood transfusions were medically non-beneficial and 
may even have contributed to clinical complications such as sepsis and myocardial injury. 
On the other hand, the need to ensure a safe transfusion service has increased the cost to 
produce a transfusion-ready unit of blood and other blood products. Therefore, hospitals are 
encouraged to find a more effective way to manage their blood usage. 

 
 
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Nevertheless, the U.S. is the largest user of blood transfusions: approximately 5 million 
people in the United States receive blood and blood components through 10.9 million 
transfusions per year, which is 44% higher than in Canada and 15% higher than in Europe, 
per capita. 
A blood transfusion introduces a multitude of foreign antigens and living cells into the 
recipient. The result after multiple transfusions, as in the case of some cancer patients, 
patients with sickle cell anemia, and other conditions, may be alloimmunization, an immune 
response generated in response to exposure to these foreign elements in subsequent 
transfusions, resulting in various clinical consequences, including high fever and transfusion-
related acute lung injury. 
AABB has studied the effects of blood transfusions on patient outcomes and has been 
promoting more rational blood utilization. Some of the information collected shows the 
impact of alloimmunization, reinforcing the need to limit the number of transfusions patients 
receive. 
Table 12-4: Impact of Alloimmunization (% of Patients Screening Positive for One or More Antibodies) 
Transfusion History 
Percent 
Never been transfused 
<1% 
Previously transfused 
3%-8% 
Multiple transfusions 
20%-30% 
Source: AABB 
A partial solution for the alloimmunization problem is the development of molecular red 
blood cell genotyping techniques that allow for a more precise and personalized strategy for 
matching donors and the recipients of multiple blood transfusions, such as cancer patients, 
severe anemia, and sickle cell disease. 
A proposed alternative to blood transfusions, or at least a means to rely on fewer of them, is 
the concept of patient blood management, which centers on practicing preventative measures 
to reduce the patient’s potential need for a transfusion. Physicians may treat their patients for 

 
 
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anemia in the weeks before surgery and optimize red cell mass, or they may use medications 
and techniques that minimize blood loss during the operation. 
One such technique, acute normovolemic hemodilution (ANH), involves removing one to 
three units of blood shortly after anesthesia is induced, then maintaining volume with a 
crystalloid or colloid replacement; this technique reduces the amount of hemoglobin lost 
during the operation, and the blood previously withdrawn would be infused back into the 
patient at the procedure’s end.  
ANH can be practiced as a sole blood conservation method or in tandem with preoperative 
autologous donation, blood salvage, or both. Other techniques recommended by AABB 
include intraoperative blood recovery and reinfusion, apheresis, point-of-care testing, 
deliberate hypotension, appropriate positioning, maintenance of normothermia, topical 
hemostatics, fibrin sealants, and perhaps most important of all, an overall improvement in 
surgical technique. 
This evidence-based medical research and guidelines issued by country agencies and other 
programs are beginning to decrease the number of blood transfusions. But this trend may not 
affect the number of units screened for pathogens because even blood units that are destined 
to be processed into platelets, coagulation factors, and plasma have to be screened for the 
presence of infection. 

 
 
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Blood Typing and Grouping Market 
The two major components of the blood banking diagnostics market are blood typing and 
blood testing and screening for pathogen threats.  A variety of different methods are currently 
used to determine blood type. These may be either manual or automated, as discussed below. 
Manual Blood Typing Methods 
Manual blood typing methods include slide/tile testing, tube testing, and microplate testing, 
which differ mainly in terms of the surface on which the blood is tested. For each test, blood 
type is determined by testing for the presence or absence of Rh factor and blood group 
antigens A and B on the surface of red blood cells. This is accomplished with the addition of 
anti-A, anti-B and anti-Rh antibodies. The interaction of antibodies with an antigen produces 
aggregates that result in agglutination and indicate the presence of that antigen in the blood.  
Automated Blood Typing and Screening Methods 
Automated blood typing systems use well-established immunohematology principles to 
classify blood groups while replacing manual interpretation and handling steps with 
instrument-driven processes. These systems typically use microplate or gel card 
methodologies to determine ABO and Rh types, along with solid-phase red cell adherence 
assays or column agglutination techniques for antibody screening and IgG crossmatching. 
Reaction grading and result interpretation are performed using advanced software that 
applies image analysis and rule-based algorithms, rather than true artificial intelligence, in 
most routine systems, although newer platforms are beginning to incorporate machine 
learning to enhance pattern recognition and quality control. 
Automation offers clear advantages over manual blood typing in terms of workflow 
efficiency, standardization, and error reduction. In environments facing ongoing staffing 
shortages, automated platforms help laboratories maintain throughput with fewer highly 
specialized technologists, while still requiring trained oversight for exception handling and 
result validation. Because reactions are interpreted digitally rather than visually by individual 
technologists, variability and subjectivity are reduced, improving consistency and 
traceability. In addition, automation supports improved documentation, integration with 
laboratory information systems, and enhanced quality assurance, all of which contribute to 
safer transfusion practices and more efficient blood bank operations. 

 
 
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Molecular Methods 
Unusual ABO typing results are a frequent challenge in routine blood grouping. Variants in 
the ABO gene can lead to weak or inconsistent antigen expression, making results difficult 
to interpret with standard serologic methods. In addition, clinical factors such as transfusion 
history, malignancy, or transplantation can further complicate testing. To resolve these 
discrepancies, blood banks increasingly rely on molecular techniques, which provide clearer 
characterization of underlying genetic variants. These cases are being encountered more 
often in practice, largely due to more complex patient populations and improved detection 
methods rather than an actual increase in rare alleles. 
PCR-based ABO genotyping is also used in forensic settings to help determine blood group 
from tissue samples. Broader genotyping platforms that assess single-nucleotide 
polymorphisms allow faster and more accurate identification of rare donor types across 
multiple blood group systems. Red blood cells carry a wide range of antigens beyond ABO, 
and antigen combinations vary significantly among individuals, even within the same 
primary blood group. This variability, combined with the presence of specific antibodies in 
recipients and differences in antigen frequency across donor populations, makes locating 
compatible blood units increasingly complex and reinforces the value of molecular typing in 
transfusion support. 
 

 
 
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Table 12-5: Selected Blood Typing and Grouping Innovations 
Company 
Location 
Area 
Technology 
Details 
Agena Bioscience 
U.S. 
ABO 
mass spec 
MassArray for blood group genotyping 
Axo Science 
France 
ABO 
molecular 
HIFI Blood 96 
Etab Sang Pyrénées 
Méditerranée 
France 
ABO 
DNA array 
DNA microarray blood group typing 
Grifols International 
Spain 
ABO 
gel 
DG Gel Cards for blood typing 
Grifols International 
Spain 
ABO 
instr 
Eflexis and Erytra, blood bank instruments 
Grifols International 
Spain 
RBC 
typing 
array 
ID CORE XT, Luminex xMAP 
Grifols International 
Spain 
ABO 
reagents 
Monoclonal Antisere reagents 
Haemokinesis Pty 
Australia 
ABO 
agglutination 
STATUS, automated STAT 1 minute 
Haemokinesis Pty 
Aust. 
ABO 
agglutination 
STARGEL 10-minute Antibody Screening 
Haemokinesis Pty 
Australia 
POC 
ABO 
Group Legible Immunohematology Format, 
paper 
Immucor 
U.S. 
RBC 
typing 
mol 
PreciseType HEA 
Micro Typing Concepts 
(MTC) 
Germany 
ABO 
agglutination 
INVITROGEL TEST-SYSTEM 
Micro Typing Concepts 
(MTC) 
Germany 
POC 
ABO 
INVITROFLOW RAPID TEST, lateral flow paper 
Grifols/Progenika 
Spain 
ABO 
Luminex xMAP 
BLOODchip 
Grifols/Progenika 
Spain 
IT 
Luminex xMAP 
BLOODchip ID Data Analysis 
Grifols/Progenika 
Spain 
platelet 
typing 
Luminex xMAP 
ID HPA XT 
Grifols/Progenika 
Spain 
RBC 
typing 
Luminex xMAP 
IDLine 
Quotient Limited 
(AliveDx) 
U.S. 
ABO 
instr 
MosaiQ, an automated, multiplexed ABO 
microarray 
Quotient Limited 
U.S. 
ABO 
 
ALBAcyte Reagent Red Blood Cell products 
 Source: Kalorama Information 

 
 
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Quotient developed its immunohematology microarray technology for use on the MosaiQ 
platform, a multiplex transfusion diagnostics system designed to integrate blood grouping, 
antibody screening, and infectious disease testing within a single automated workflow. While 
the concept generated significant interest, commercialization of MosaiQ progressed more 
slowly than expected, and the system did not achieve broad routine adoption. Following 
financial challenges and restructuring, key assets were acquired by AliveDx, which has since 
shifted its focus toward selected transfusion diagnostics and specialty assay portfolios rather 
than large-scale rollout of the MosaiQ platform. As a result, MosaiQ remains more notable 
as a technically innovative approach to multiplex transfusion testing than as a widely 
deployed blood bank system. 
Haemokinesis offers rapid emergency blood grouping as a key niche within transfusion 
diagnostics. Its STATUS platform is designed for urgent ABO grouping and limited Rh 
phenotyping in trauma and emergency settings, delivering results in approximately one to 
two minutes using whole blood samples. The system is based on rapid serologic agglutination 
principles rather than traditional column agglutination and is intended to support immediate 
transfusion decisions at or near the point of care. While it can process multiple samples 
sequentially, its primary value lies in speed and ease of use in critical situations rather than 
in high-throughput batch testing. The company has continued to develop additional 
transfusion-related products, focusing on rapid-response applications, including expanded 
typing capabilities and decentralized testing support. 
Grifols is a leading global supplier of automated immunohematology systems. Its Erytra 
family utilizes DG Gel card technology with full automation to perform ABO/Rh typing, 
antibody screening, crossmatching, and investigation of atypical antibodies with minimal 
hands-on time. The WADiana Compact continues to serve smaller laboratories, while newer 
platforms such as Erytra Eflexis offer higher throughput and more flexible workflow 
configurations suited to mid- and high-volume blood banks. Grifols has continued to expand 
its automation footprint, including the broader rollout of Erytra Eflexis in Asia, where 
laboratory modernization and increasing transfusion demand are supporting adoption. 
Growth in automated blood bank systems remains strongest in regions transitioning from 
manual or semi-automated gel workflows to fully integrated platforms. 
The PreciseType platform enables simultaneous identification of dozens of red blood cell 
antigens, allowing blood centers and transfusion laboratories to improve donor-recipient 
matching, identify rare antigen combinations, and preserve scarce donor units for highly 
sensitized patients. Molecular blood typing continues to gain strategic importance as 

 
 
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transfusion medicine increasingly moves toward precision compatibility, especially for 
chronically transfused populations. 
Grifols has also continued strengthening its position in blood bank innovation through growth 
in automated typing systems and molecular typing support. The launch of Erytra Eflexis in 
major international markets reflects continued demand for faster, more flexible blood bank 
automation capable of handling increasingly complex transfusion testing workloads. 
Molecular blood group testing has become an important complement to traditional serologic 
methods in transfusion medicine, particularly as laboratories encounter more complex patient 
populations. Unusual ABO typing results and weak or variant antigen expression can create 
challenges for conventional serology, especially in patients who have been recently 
transfused, those with hematologic malignancies, or individuals with underlying red cell 
disorders. In these settings, molecular testing is used to resolve discrepancies and provide a 
clearer understanding of the patient’s true antigen profile. The growing use of chronic 
transfusion therapy and the rising incidence of alloimmunization have further increased 
reliance on genotyping to support accurate and consistent blood group determination. 
PCR-based blood group genotyping and SNP-based platforms play a central role in extended 
antigen typing, rare donor identification, and selected forensic applications. Because red 
blood cells express a wide range of clinically significant antigens beyond ABO and Rh, 
molecular methods allow laboratories to determine extended antigen profiles with greater 
precision, particularly when serologic testing is limited by reagent availability or interference 
from circulating antibodies. This capability is especially valuable when patients develop 
multiple alien bodies or when compatible donor units are difficult to locate due to uncommon 
antigen combinations within the donor pool. 
Genotyping has proven particularly useful in patients with conditions such as sickle cell 
disease, thalassemia, autoimmune hemolytic anemia, and hematologic malignancies, where 
repeated transfusions or positive direct antiglobulin tests can interfere with serologic typing. 
In these cases, molecular characterization of antigen variants enables more accurate donor 
matching, helping reduce the risk of alloimmunization and improve long-term transfusion 
outcomes. 
Thermo Fisher Scientific has strengthened its position in molecular blood group testing 
through its transfusion diagnostics portfolio, particularly following the integration of the 
Immucor molecular business. The company offers PCR-based and array-based genotyping 

 
 
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solutions designed for extended red blood cell antigen typing, rare donor identification, and 
resolution of serologic discrepancies. Its platforms support detection of clinically significant 
antigens across multiple blood group systems, enabling laboratories to perform high-
throughput genotyping and improve donor–recipient matching in complex transfusion cases. 
Thermo Fisher’s systems are widely used in reference laboratories, blood centers, and 
specialized hospital settings, where molecular typing is increasingly incorporated into routine 
workflows for patients with chronic transfusion requirements, multiple alloantibodies, or 
inconclusive serologic results. 
Size and Growth of Typing Markets 
This market is mature.  The market for blood typing is $1,030 million in 2025. Recovery has 
stabilized with 1.8% CAGR, it will grow to $1,125 million. Aging of the population, 
emerging markets, and new typing systems, including molecular, will drive what growth 
exists in this market.   
Table 12-6: Global Blood Typing Market, 2025-2030 ($ million) 
Market 
IVD Sales 2025 
IVD Sales 2030 
CAGR 
ABO Typing 
1,030 
1,125 
1.8% 
Source: Kalorama Information 
Blood Typing Market by Geography 
The global market for blood typing is driven by sales in North America and Europe, 
accounting for about 90%.  These markets are well established and are common practice in 
these regions.  In developing nations, blood typing is underutilized but also faces barriers to 
growth, including education, limited procedures and pricing. 

 
 
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Table 12-7: Global Blood Typing Sales Distribution, by Region, 2025 (%)  
 
[Asia Pacific; Europe; North America; Rest of World] 
 Region 
% Mkt 
North America  
59% 
Europe 
30% 
Asia Pacific 
7% 
RoW 
4% 
Total 
100% 
Source: Kalorama Information 

 
 
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Blood Testing Market 
In developed nations, donated blood is screened for various pathogens.  It is a mature market, 
but growth comes from new technologies, increased volume and increased testing in 
developing nations.  
In the blood bank and plasmapheresis testing markets, dollar volume closely parallels sample 
volume.  Moreover, with the introduction of molecular diagnostics, a significant increase in 
cost per test is expected with each new method.  Part of this cost increase will be due to 
inflationary effects, but most of it will result from three market conditions for blood 
bank/plasmapheresis center testing products.  The following table represents recent 
innovations in blood testing. 
Table 12-8: Selected Blood Testing Innovations 
Company 
Location 
Details 
Grifols International 
Spain 
Ultrio Elite 4-in-1 assay 
Grifols International 
Spain 
Procleix PANTHER and Ultrio Elite Assay, HIV1/2, HCV, HBV 
Grifols International 
Spain 
Procleix HEV 
Grifols International 
Spain 
Procleix WNV. West Nile 
Grifols International 
Spain 
Procleix Zika Virus Assay 
MP Biomedicals LLC 
U.S. 
HTLV Blot 2.4, Western blot, testing and viral typing 
Roche Diagnostics 
U.S. 
cobas 6800 and 8800 Systems 
Roche Diagnostics 
U.S. 
cobas TaqScreen DPX infectious diseases, cobas s 201 system 
Roche Diagnostics 
U.S. 
cobas TaqScreen DPX, parvo/HAV 
Roche Diagnostics 
U.S. 
cobas TaqScreen MPX Test v2.0, HIV, HBC, and HCV 
Roche Diagnostics 
U.S. 
MPX, HBV, CMV, West Nile on cobas 6800 & 8800 
Roche Diagnostics 
U.S. 
cobas TaqScreen West Nile Virus Test 
Roche Diagnostics 
U.S. 
4-in1 MPX-E assay 
Source: Kalorama Information 

 
 
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Preventing Bacterial Infections 
Bacterial contamination is one of the most important infectious hazards in transfusion 
medicine, particularly for platelet components, which must be stored at room temperature 
and therefore are more susceptible to bacterial growth than other blood products. Although 
blood centers and transfusion services have made major progress in viral screening, bacterial 
risk control for platelets continues to require ongoing attention through improved collection 
procedures, diversion of the initial blood volume, bacterial detection methods, and pathogen 
reduction technologies. Current blood safety practice does not eliminate the need for donor 
screening and infectious disease testing, but increasingly relies on layered strategies to reduce 
transfusion risk. 
Platelets are especially vulnerable to contamination because they are stored under conditions 
that could possibly lead to bacterial proliferation. This is a major concern for patients 
receiving intensive transfusion support, including those with cancer, leukemia, and other 
serious hematologic disorders. To reduce risk, blood centers use measures such as improved 
skin disinfection, diversion pouches that capture the first portion of donated blood, bacterial 
testing protocols, and pathogen reduction approaches. Regulatory and professional standards 
continue to require active bacterial risk control for platelet components rather than reliance 
on any single safeguard. 
Pathogen reduction has become one of the most important proactive safety measures in 
platelet and plasma transfusion. Cerus’s INTERCEPT Blood System remains the leading 
commercial platform in this area, using amotosalen and UVA light to inactivate a broad range 
of pathogens and donor leukocytes in platelet and plasma components. The system is well 
established in the United States and many international markets and has supported a broader 
move away from relying solely on agent-specific testing. Terumo Blood and Cell 
Technologies continues to market the Mirasol pathogen reduction system outside the United 
States, using riboflavin and ultraviolet light to reduce the risk of infection in platelets and 
plasma, with broader international use in select regions. 
Immunoassays 
Immunoassays for HIV, hepatitis B, hepatitis C, and syphilis have been the routine approach 
to testing blood units for blood-borne infectious agents.  All blood banks in Latin America 

 
 
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and some in the U.S. also screen donated units for Chagas disease.  Blood banks in some 
developing countries also screen for Lyme, Dengue fever and malaria.  
The 2025 market for blood screening immunoassays performed by blood transfusion 
services—public, private and hospital-based has been evaluated at $834 million. The market 
is fairly mature, expansion is achieved through the introduction of assays to screen for 
emerging pathogens such as malaria, Dengue, West Nile virus and Chagas disease testing in 
developed countries.  Also, there is a concerted effort in emerging countries to ensure the 
safety of the blood supply.   
Company penetration in this market is designated by geography.  Outside Asia, the blood 
screening market includes Abbott Laboratories and QuidelOrtho.  
In Asia, primarily Japan, Thailand, Korea and Taiwan, the majority of blood banks use 
Fujirebio's RPHA tests. 
Abbott Diagnostics, the leader in immunoassay tests, has made a concerted effort to expand 
its offerings.  Abbott has a long history in blood screening.  The hallmark of Abbott’s blood 
screening products is the PRISM System.  It consolidates testing into a single system, 
automating many of the manual testing procedures and steps currently used to screen blood 
for pathogens.  The system tracks and monitors each sample throughout the testing process, 
providing documentation and quality control for testing facilities.   
QuidelOrtho offers the Avioq HTLV-I/II Microelisa System assay, a new test developed in 
partnership with Avioq, Inc. to screen blood and organ donations for antibodies to human T-
lymphotropic virus (HTLV) type I and II.  The AVIOQ HTLV-I/II Microelisa System assay 
is fully compatible with the ORTHO Summit System platform 
Whole blood donations are screened for a number of different pathogenic agents including 
HIV, hepatitis B and hepatitis C.  Blood banks in some developing countries also test for 
pathogens associated with Chagas disease, Lyme disease, Dengue fever and malaria.  
Additionally, in the US, the FDA’s Center for Biologics Evaluation and Research has sought 
to enhance the safety and effectiveness of blood transfusions by imposing limits on the level 
of leukocytes allowed in cellular components.  The reduction or elimination of leukocytes 
lessens the risk of adverse transfusion reactions, such as the transmission of intracellular 
viruses. 

 
 
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Nucleic Acid Testing (NAT) 
Nucleic acid testing is an important component of blood screening and is widely used to 
detect infectious agents in donated blood. By directly identifying viral genetic material, it 
shortens the window period compared to traditional serologic testing and improves overall 
blood safety. It is routinely used in the United States, Canada, Europe, Japan, Australia, and 
many other regions. Standard NAT screening panels typically include HIV-1 RNA, hepatitis 
C virus RNA, hepatitis B virus DNA, and West Nile virus RNA, with additional targets added 
in some countries based on regional disease patterns. In practice, NAT works alongside 
immunoassay testing as part of a layered approach rather than replacing it. 
Grifols is one of the major global suppliers of NAT-based blood screening systems and 
continues to support screening programs across Europe, Asia Pacific, and other international 
markets. Adoption is already well established in developed regions, while ongoing expansion 
is driven by regulatory requirements, continued focus on blood safety, and the need to address 
emerging infectious risks. 
Size and Growth of the Market 
Manufacturers introduce new assay methods in stages, bringing initial versions to market that 
meet immediate clinical and regulatory needs while leaving room for improvement in 
automation, throughput, and workflow integration. Earlier versions may rely on semi-
automated processes, while more advanced generations offer higher levels of automation, 
improved sensitivity, and better connectivity with laboratory systems. Blood banks continue 
to favor increased automation because it improves standardization, reduces manual handling, 
and lowers the risk of human error. 
Competition in blood and plasma testing remains concentrated among a relatively small 
number of global suppliers, particularly in high-throughput screening and molecular 
diagnostics. However, the market is not without pricing pressure. While the complexity of 
instrumentation and regulatory requirements creates high barriers to entry, large blood 
centers and national screening programs often negotiate long-term contracts that include 
volume-based pricing, bundled reagent agreements, and service commitments. As a result, 
pricing is influenced not only by technological advancement but also by purchasing scale and 
competitive positioning among leading vendors. 
 

 
 
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There has been a clear shift toward molecular testing as part of routine blood screening, with 
nucleic acid testing now well established alongside immunoassays. Growth in molecular 
testing has been driven by its ability to detect infections earlier, while immunoassays 
continue to play a critical role in broad screening due to their efficiency and cost-
effectiveness. Rather than replacing older technologies entirely, laboratories typically use 
both approaches in combination, and upgrades tend to occur gradually as systems are 
replaced or expanded. 
At the same time, expanding global travel and the spread of vector-borne diseases have 
increased awareness of emerging infectious risks in the blood supply. This has led to greater 
interest in proactive safety strategies, such as pathogen-reduction technologies, that can 
address a wide range of known and unknown agents. However, these approaches are not 
universally adopted due to cost considerations and operational factors.  
The following chart details the blood testing market in 2025 and its projections through 2030.  
NAT screens are the largest market segment, primarily due to cost per test.  An increase in 
blood testing in the developing world market will likely drive sales in the immunoassay 
screen segment; while NAT screens will be suppressed due to higher costs in developing 
countries, it will be partially offset by increased use in developed markets. 
Table 12-9: Global Blood Banking Diagnostics Market, 2025-2030 ($ million) 
 
[Immunoassay Screen; NAT Screens] 
Market 
IVD Sales 2025 
% Mkt 
IVD Sales 2030 
% Mkt 
CAGR 
ABO Grouping 
1,045 
33% 
1,150 
30% 
2% 
NAT Screens 
1,330 
41% 
1,790 
47% 
6% 
Immunoassay Screen 
834 
26% 
885 
23% 
1% 
Total 
3,209 
100% 
3,825 
100% 
4% 
Source: Kalorama Information 
Lastly, the market for blood banking and plasmapheresis testing reagents is inelastic.  Blood 
banks must use the latest technology and reagents. For example, blood collection centers 
often utilize equipment that is being studied under an Investigational New Drug (IND) 

 
 
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application pending approval of a Biologics License Application (BLA). Therefore, with 
limited competition, companies have considerable pricing discretion and can maintain 
market share once blood banks and plasmapheresis centers have adopted the assays and 
purchased the necessary instrumentation.  Blood banks and plasmapheresis centers also 
cannot effectively “cherry-pick” their reagents from various molecular diagnostics suppliers, 
even as new competition appears. Pricing and discounting for reagents and supplies are 
generally based on total volume; attempts to spread the business around could actually leave 
the blood bank or plasmapheresis center with less-than-optimal pricing overall.  
The market for blood screening immunoassays is estimated at $834 million in 2025, and with 
1% growth driven primarily by emerging markets where the technology is still used, the 
market will be in $885 million by 2030.  Due to their lower cost, immunoassays are more 
frequently used in developing nations, whereas nucleic acid testing is predominantly used in 
developed countries, although this is changing. The U.S. was the single largest region for 
immunoassay testing revenue, due mainly to its prominent position in the blood industry, 
although U.S. nucleic acid revenue is much higher.  
Kalorama estimates the market for NAT blood screening at $1,330 million, growing at 6% 
due to increasing conversions and the strength of the emerging market NAT conversion.  
Blood Testing Market by Geography 
The following figure demonstrates the market for all blood testing by geography.  The United 
States, Japan, and Germany lead the world market.  China and Latin America are significant 
markets for both immunoassays and nucleic acid test systems. 

 
 
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Table 12-10: Global Blood Testing Market, by Geography, 2025 (%)  
 
[Asia Pacific; Europe; North America; Rest of World] 
 Region 
% Mkt 
North America  
30% 
Asia Pacific 
29% 
Europe 
26% 
RoW 
15% 
Total 
100% 
Source: Kalorama Information 

 
 
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The Commercial Outlook for Blood Banking Testing 
Blood collection declined during the COVID-19 pandemic as lockdowns and reduced 
mobility disrupted donor access, but volumes have largely recovered as healthcare systems 
resumed normal operations. Blood bank testing remains a critical function, focused on 
maintaining a safe and adequate blood supply through infectious disease screening, 
investigation of transfusion reactions, ongoing evaluation of donor screening practices, and 
continuous improvement in collection and testing protocols. 
The global blood banking diagnostics market is shaped by a combination of demographic 
and structural factors. Aging populations in developed regions are increasing demand for 
transfusions, while emerging markets are expanding healthcare infrastructure and access to 
diagnostic services. At the same time, the introduction of new testing technologies and 
workflow automation is showing incremental growth in what remains a relatively mature 
market segment. 
Emerging and re-emerging infectious diseases continue to present ongoing challenges for 
blood safety. While the urgency surrounding certain outbreaks has declined, the experience 
with agents such as Zika demonstrated how quickly new threats can affect blood collection 
and screening practices. Established concerns such as hepatitis B and C, HIV, and West Nile 
virus remain part of routine screening programs, while additional pathogens, including 
dengue, chikungunya, malaria, and other vector-borne diseases, continue to require 
monitoring depending on regional risk. Increasing global travel and climate-related shifts in 
disease patterns are contributing to broader geographic exposure, reinforcing the need for 
adaptable screening strategies. 
Blood systems are increasingly relying on layered safety approaches that combine donor 
screening, immunoassay testing, molecular testing, and targeted risk-reduction measures. 
Pathogen reduction technologies are gaining attention as a proactive strategy to reduce 
infectious risk across a wide range of known and emerging agents, although adoption varies 
due to cost and operational considerations. These technologies are expected to play a growing 
role alongside conventional testing rather than replacing it entirely. 
Advances in blood typing are also affecting the market, particularly in molecular and 
extended antigen profiling. These technologies are becoming more important as transfusion 
practices evolve to support patients with chronic conditions and repeated transfusion needs, 
where precise matching can reduce complications such as alloimmunization. As a result, 

 
 
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laboratories are gradually incorporating more advanced typing methods into routine 
workflows. 
Efforts to improve the donor experience are also emerging as part of broader strategies to 
stabilize and grow the donor base. New digital and engagement tools are being introduced to 
make the donation process more accessible and appealing, particularly to younger donors, 
although these innovations remain supplementary to the core clinical and operational aspects 
of blood collection. 

 
 
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Chapter 13: Histology and Cytology 
Scope 
This chapter concentrates on IVD histology and cytology products, technologies and 
services used to stain, analyze and diagnose diseases based on the microscopic 
examination of tissues and cells. This market includes pathology labs, cancer 
diagnostics and various disease screenings.  
 
 

 
 
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Overview  
Histology and cytology remain the foundation of tissue- and cell-based diagnostics. 
Histology focuses on tissue architecture, while cytology examines individual or small 
clusters of cells. The workflow still centers on preanalytical processing, fixation, embedding, 
sectioning, and slide preparation, followed by staining and interpretation. Common 
specimens include biopsied or surgically excised tissue, as well as fluids such as sputum, 
cervical samples, and synovial fluid. Slides are typically reviewed first by trained 
technologists, with pathologists making the final diagnosis, especially in cases showing 
abnormal or suspicious morphology. Essentially all surgically removed tissue undergoes 
routine histopathologic evaluation. 
Cancer diagnosis continues to rely heavily on determining the tissue of origin, although some 
cases present as cancers of unknown origin. In these situations, pathologists use a broader 
toolkit that includes immunohistochemistry (IHC), in situ hybridization (ISH), fluorescence 
in situ hybridization (FISH), and molecular profiling to define classification. IHC, which uses 
labeled antibodies to detect specific proteins, is most commonly used, while FISH and related 
methods identify genetic alterations within cells. These approaches are complemented by 
next-generation sequencing and other molecular techniques that help define tumor subtype, 
prognosis, and potential treatment pathways. 
The role of biomarkers has expanded significantly. Rather than being limited to structural 
analysis, histology now integrates protein expression, gene alterations, and signaling 
pathways to guide therapy selection. Companion diagnostics for targeted therapies are 
routinely performed on formalin-fixed tissue, and multiplex staining techniques enable 
multiple markers to be evaluated on a single slide. Analysis of circulating tumor cells and 
cell-free DNA in blood and other body fluids is advancing, although these approaches are 
still used selectively and continue to evolve. 
Automation and digital pathology are reshaping laboratory workflows. High-throughput slide 
processors, automated stainers, and whole-slide imaging systems are now common in larger 
laboratories. Digital pathology enables remote review, image sharing, and the application of 
image analysis algorithms, including artificial intelligence tools that assist with screening, 
quantification, and pattern recognition. These systems are helping labs manage rising 
volumes and workforce shortages while improving consistency and turnaround times. 

 
 
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Cytology has also evolved, particularly in cervical cancer screening, where liquid-based 
cytology and HPV testing have improved detection and workflow efficiency. In addition to 
oncology, cytology and histology techniques are used in infectious disease detection, 
chromosome analysis, and evaluation of inflammatory and degenerative conditions. Flow 
cytometry is used for hematologic malignancies, while mass spectrometry and sequencing 
are used in complex or ambiguous cases. 
While many advanced technologies, such as spatial biology, multiplex imaging, and 
integrated genomic-proteomic profiling, are gaining traction, their routine clinical use is still 
expanding. Adoption depends on validation, cost, reimbursement, and demonstrated clinical 
utility. Laboratory-developed tests offered through specialized reference labs continue to 
play a major role in bringing new assays to market, particularly in oncology and rare disease 
diagnostics, where expertise and test complexity limit widespread in-house adoption. 
Our 19th edition of The Worldwide Market for In Vitro Diagnostic (IVD) Tests consolidates 
all aspects of histology testing into a single chapter and includes a Special Topics section that 
addresses histology hot spots. The chapter covers: 
• Histology/Cytology 
• Digital Imaging 
• Tissue Microarrays 
• Pharmacodiagnostic Histology 
• Circulating Tumor Cells 
• Flow Cytometry 

 
 
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Special Topics 
Histology Automation 
Histology slide analysis is highly labor-intensive and subjective. At least this was the 
scenario for this market segment until the commercialization of automation and digital image 
analysis. Now histology is following the trend already in action in other test segments and is 
investing in end-to-end automation of the entire tissue process. From slide preparation 
through analysis to result reporting, combined solutions enable faster turnaround times while 
providing standardized results. 
The growing number of cancer patients is a major factor, but several technological 
advancements also contribute to this growth. Sample preparation for histology has always 
been fairly automated, but companies have invested in improving it with new, faster tissue 
fixatives and systems that enhance nucleic acid extraction from tissue samples. Of note is 
new instrumentation to automate RNA detection in fixed tissues. This is important for 
advanced companion tests. 
Automation of histology has become fairly routine in the developed world and will gradually 
spread to the larger urban centers in developing countries. Automated sample processing and 
slide stainers have been available for some 10 to 15 years; however, end-to-end automation, 
digital optics, and the artificial intelligence algorithms and high-capacity computer power 
necessary to really make these systems work efficiently have only recently become available. 
Innovation in immunohistochemistry (IHC) staining has evolved significantly over the last 
two decades. The process of staining has shifted from labor-intensive, manual techniques to 
semi-automated instruments with off-line processes such as deparaffinization and antigen 
retrieval, and now to a new generation of automated, baking-through-staining 
instrumentation systems that enable standardization, improved staining consistency, and 
expedited turnaround times. 
Agilent Technologies continues to position the Dako Omnis as a high-throughput integrated 
automation platform for advanced pathology laboratories, large hospital systems, academic 
medical centers, and reference laboratories. Dako Omnis combines hardware, workflow 
software, and assay reagents into a fully automated system supporting both IHC and in situ 
hybridization (ISH) on a single platform. The system enables continuous slide loading, batch 

 
 
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processing, and overnight operation, allowing full patient cases to be processed with strong 
workflow consistency and traceability. Operator-level documentation of slide handling, 
reagent use, and maintenance supports quality assurance and regulatory compliance. 
Developed with engineering support from Tecan Group, the platform remains a core 
component of Agilent’s digital pathology and companion diagnostics strategy. Agilent also 
continues to support laboratory workflow connectivity through Dako Link for legacy staining 
systems, although the current emphasis is increasingly on the integrated Omnis workflow 
architecture and digital pathology interoperability. 
Sakura Finetek remains a major leader in pre-analytical tissue processing and histology 
automation. The Tissue-Tek AutoTEC a120 continues to serve laboratories requiring 
automated embedding with barcode-based specimen traceability and connectivity to 
laboratory information systems. The platform processes up to 120 cassettes per hour and uses 
automated specimen orientation technology to improve block consistency, reduce variability 
in tissue handling, and enhance patient safety by minimizing orientation errors and specimen 
loss. Sakura’s integrated pre-analytical workflow remains a major differentiator, particularly 
when combined with its cassette systems, sectioning solutions, and tissue processors. 
Sakura also continues to expand its staining menu on the Tissue-Tek Genie Advanced 
Staining System, with ready-to-use antibody additions that support oncology, 
hematopathology, and precision medicine marker panels. Current menu development 
increasingly emphasizes biomarkers linked to targeted therapy selection, multiplex workflow 
efficiency, and standardized staining performance across decentralized pathology networks. 
BioGenex continues to offer automated sample-preparation and staining workflow solutions 
for formalin-fixed, paraffin-embedded tissue. Its EZ-AR2 Elegance was developed to 
streamline deparaffinization, hydration, and antigen retrieval into a single-step preparation 
process for high-throughput IHC laboratories. The system processes approximately 100 
slides in about 30 minutes and is designed for integration with BioGenex retrieval and 
staining platforms, including microwave-assisted and automated systems. BioGenex 
maintains an extensive antibody portfolio of over 400 markers, supporting broad pathology 
panel development across oncology, infectious diseases, and research applications. 
In March 2025, BioGenex announced a new approach for the retrieval of antigens from FFPE 
tissues and their subsequent staining by IHC. 

 
 
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The introduction of information technology and smart phone applications has come to 
histology. Market leader Roche Diagnostics further solidified its position with the 
introduction of workflow tools that allow pathologists and lab managers to track the progress 
of a slide from preparation to digitization along with other critical slide information. This 
facilitates the exchange of information between pathologists and lab managers, resulting in 
a more streamlined workflow. The table below presents a selection of histology lab 
automation products. 
 
 
 

 
 
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Table 13-1: Selected Histology Lab Automation 
Company 
Location 
Area 
Details 
Applied Spectral Imaging 
U.S. 
full 
Automated imaging analysis 
Biocare Medical 
U.S. 
stain 
ONCORE Automated Slide Staining, IHC, FISH, ONCORE ProX 
BioGenex 
U.S. 
stain 
eFISHiency System, automated histology 
BioGenex 
U.S. 
stain 
EZ-AR2 Elegance; one-step FFPE prep 
BioView, Ltd. 
Israel 
analysis 
Duet-3 automated imaging; detection, classification, 
analysis, counting 
Cerner Corp. (Oracle 
Health) 
U.S. 
full 
Oracle Health Copath anatomic pathology system with 
Labotix lab automation 
Dako/Agilent 
Denmark 
smpl prep 
Dako Omnis automation ISH & IHC tissue processing 
Diagnostic Biosystems 
U.S. 
stain 
Mosaic 360 System, an automated IHC instrument & kits, 
multicolor 
Leica Biosystems 
Germany 
analysis 
Aperio RNA ISH Algorithm for use with Advanced Cell 
Diagnostics’ RNAscope 
Sakura Finetek Europe 
Netherlands 
smpl prep 
Tissue-Tek AutoTEC a120 Automated Embedder 
Sakura Finetek Europe 
Netherlands 
smpl prep 
Paraform Sectionable Cassette System 
Serosep Limited 
Ireland 
smpl prep 
HistoPot mini, formalin specimen container fine needle 
biopsies 
Ventana Medical/Roche 
Diagnostics 
U.S. 
stain 
Roche Digital Pathology Dx with Ventana DP 600n slide 
scanner 
Ventana Medical/Roche 
Diagnostics 
U.S. 
stain 
HE 600 system, a fully automated H&E staining 
Ventana Medical/Roche 
Diagnostics 
U.S. 
stain 
BenchMark Special Stains platform 
Ventana Medical/Roche 
Diagnostics 
U.S. 
stain 
Ventana Gram Stain BenchMark Special Stains instrument 
Visiopharm 
Denmark 
analysis 
Biotopix and Oncotopix software modules for digital 
pathology automation 
Source: Kalorama Information, company reports 

 
 
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A major component of histology automation is information technology tools that facilitate 
sample tracking and also the ability to extract clinically actionable knowledge, thereby 
yielding more precise diagnoses, disease stratification, and selection of patient-specific 
treatments. The table below presents a selection of announced information technology tools. 
Table 13-2: Histology Information Technology Tools 
Company 
Location 
Details 
Barco 
Belgium 
Barco's slide review display systems 
Dako/Agilent 
Denmark 
DakoLink IT connect Dako's Autostainer and Artisan 
Leica Biosystems/Aperio 
U.S. 
Aperio ePathology NETWORK connectivity solution 
Roche Tissue Diagnostics 
U.S. 
Navify Pathology Lab Advantage  
Source: Kalorama Information, company reports 
Advanced Analysis Solutions 
Technologies such as immunohistochemistry and FISH allow visualization of specific 
proteins and genetic alterations in fixed tissue, cells, and selected body fluids. These methods 
are now routinely used in conjunction with molecular techniques, in which targeted cells or 
regions of interest can be further analyzed by PCR, sequencing, and, in specialized settings, 
mass spectrometry. 
Tumor heterogeneity, both cellular and molecular, is a challenge in oncology and has driven 
the adoption of broader profiling approaches. Mass spectrometry imaging, including 
MALDI-based techniques, is gaining traction for mapping molecular distributions within 
tissue sections and has demonstrated value in tumor classification and biomarker research. 
While initially limited to fresh or frozen tissue, improvements now support analysis of FFPE 
samples, although routine clinical use remains limited. 
Next-generation sequencing has become an important tool in tumor profiling, providing more 
comprehensive genomic insight than single-gene methods such as FISH. These approaches 
improve the detection of actionable mutations and expand access to targeted therapies. 

 
 
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FFPE tissue is the standard in pathology, but formalin fixation introduces cross-linking and 
fragmentation that can affect nucleic acid quality. Advances in extraction chemistry, library 
preparation, and assay design have significantly improved the ability to recover usable DNA 
and RNA from archival tissue, enabling reliable downstream molecular testing. 
FFPE-focused workflows emphasize improved nucleic acid recovery, artifact reduction, 
automation, and compatibility with multiplex genomic testing, reflecting the growing 
integration of histology with molecular diagnostics. 
Liquid biopsy offers a less invasive option for genomic analysis of tumors compared to 
traditional tissue biopsy. Tumor-derived DNA circulating in the plasma of cancer patients 
can be analyzed to detect clinically relevant mutations. Because this approach does not 
require an invasive procedure, it is particularly useful when tissue biopsy is not feasible or 
when repeated sampling is needed to monitor disease progression or treatment response. 
Liquid biopsy is used in clinical practice for selected applications, especially in oncology, 
where it provides mutation detection and therapy selection. However, it does not replace 
tissue biopsy, which remains essential for initial diagnosis, tumor classification, and many 
pathology-based assessments. Instead, liquid biopsy is used alongside tissue analysis as part 
of a more comprehensive approach to cancer management.  
While genetic and expression assays provide important insight into cancer, they do not fully 
capture the spatial and cellular complexity of the tumor microenvironment. Tumors develop 
within a dynamic network of epithelial and stromal cells, vascular and lymphatic structures, 
cytokines, and infiltrating immune cells. The type, distribution, and activity of these immune 
cells vary by tumor type and play a significant role in disease progression, prognosis, and 
response to therapy. 
Assessment of the immune environment is an important component of cancer diagnostics, 
particularly 
in 
immuno-oncology. 
Protein- 
and 
gene-based 
assays, 
including 
immunohistochemistry and gene expression profiling, are used to assess immune activity and 
inform treatment decisions, although their predictive value varies by tumor type and clinical 
context. 
Tumor tissue staining continues to provide critical information on tissue design, spatial 
relationships, and tumor heterogeneity. These insights allow pathologists to identify and 
isolate regions of interest within a sample, improving the accuracy of downstream molecular 

 
 
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testing. Higher tumor purity enhances sequencing sensitivity and supports more reliable data 
interpretation. 
Microdissection techniques enable the selection of specific cell populations for molecular 
and sequencing analysis and are used in both research and selected clinical applications 
where precise tumor enrichment is required. As molecular diagnostics and histology become 
more integrated, there is increasing emphasis on linking anatomical pathology with genomic 
analysis through improved sample preparation and workflow coordination. 
Advanced techniques, including multiplex spatial analysis and high-parameter tissue 
profiling, continue to expand and are gradually moving from research into clinical practice, 
particularly in specialized centers. At the same time, molecular diagnostics companies are 
entering the histology space, combining genomic expertise with tissue-based analysis to 
support more comprehensive cancer characterization and treatment planning. 
 
 

 
 
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Table 13-3: Selected Advanced Histology Techniques 
Company 
Location 
Area 
Details 
Abbott Diagnostics 
U.S. 
PCR 
FGFR3 gene mutations, urine, FFPE, bladder cancer; 
exclusive license for use of biomarkers granted by 
Institut Curie 
Agena Bioscience 
U.S. 
mass spec 
MassARRAY Dx PLUS assays gene-specific mutations, PGx 
Agendia 
Netherlands 
DNA 
MammaPrint FFPE breast cancer recurrence test 
Amoy Diagnostics 
China 
DNA 
AmoyDx FFPE DNA/RNA, spin column process 
Amoy Diagnostics 
China 
PCR 
AmoyDx ROS1 Kit 
Amoy Diagnostics 
China 
PCR 
EML4-ALK, PIK3CA, ERCC1 G, BRAF V600 mutations kit 
ArcherDx 
U.S. 
sequencing 
Anchored Multiplexed PCR sequencing libraries 
Asuragen 
U.S. 
DNA 
QuantideX DNA Assay, copy number in FFPE 
Asuragen 
U.S. 
smpl 
integrity 
SuraSeq DNA Quantitative Functional Index, DNA QC 
BioMark Diagnostics 
Canada 
mRNA 
Spermine/Spermidine N-Acetyl Transferase, mRNA 
BioNTech Diagnostics 
Germany 
PCR 
MammaTyper, stratify breast cancer, molecular 
subtyping 
Bruker Biosciences 
U.S. 
mass spec 
rapifleX MALDI-TOF/TOF mass spectrometer 
Bruker BioSciences 
U.S. 
mass spec 
ImageID MALDI TOF/TOF system 
Circulomics 
U.S. 
smpl prep 
Nanobind DNA & RNA extraction from FFPE 
Covaris 
U.S. 
smpl prep 
truXTRAC FFPE RNA extraction kit 
DxTerity Diagnostics 
U.S. 
RNA 
DxDirect, RNA in FFPE 
DxTerity Diagnostics 
U.S. 
RNA 
DxDirect RUO, RNA in FFPE, multiplexed 
Epigenomics 
Germany 
immuno 
Epi proLung tissue assay, Septin 
HalioDx 
France 
immuno 
Immunoscore Colon, CD3/CD8 T cells 
HalioDx (Veracyte) 
France 
immuno 
Immunoscore CR, CD3/CD8 T cells 
HTG Molecular 
Diagnostics 
U.S. 
qNPA 
HTG melanoma signature assays 

 
 
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Company 
Location 
Area 
Details 
HTG Molecular 
Diagnostics 
U.S. 
RNA 
Edge RNA analysis automation, extraction free 
Illumina 
U.S. 
sequencing 
TruSeq Amplicon - Cancer Panel, MiSeq 
Illumina 
U.S. 
sequencing 
MiSeqDx for FFPE samples, NGS 
IncellDx 
U.S. 
smpl prep 
IncellPrep Liquid Biopsy cell suspension: FFPE 
IncellDx, Inc. 
U.S. 
flow 
OncoBreast 3Dx, mRNA, DNA cell ploidy, biopsy 
IncellDx, Inc. 
U.S. 
flow 
Quantitative Single Cell PD-L1 OncoTect iO Assay 
LGC Genomics 
Germany 
smpl prep 
high volume DNA from FFPE 
MO BIO Laboratories 
U.S. 
smpl enrich 
BiOstic FFPE Tissue RNA Isolation, PCR & NGS 
Mo Bio Labs 
U.S. 
smpl enrich 
BiOstic FFPE Tissue DNA/RNA Isolation Kit 
MolecularMD 
Corporation 
U.S. 
DNA 
PTEN gene, tumor growth 
NanoString 
Technologies 
U.S. 
platform 
nCounter MAX system for clinical labs 
Revvity 
U.S. 
immuno 
Mantra Quantitative Pathology Workstation, immune 
cells 
Silicon Biosystems 
Italy 
smpl enrich 
DEPArray tumor cell extraction from FFPE for NGS 
Thermo Fisher 
U.S. 
array 
OncoScan CNV Assay 
Thermo Fisher Scientific 
U.S. 
sequencing 
Oncomine Solid Tumor DNA panel, FFPE, lung, colon 
Transgenomic 
U.S. 
QC 
Horizon's QC products FFPE & genomic DNA 
 Source: Kalorama Information, company reports 
HPV IVD Testing Becomes Main Stream 
HPV refers to a group of more than 200 related human papillomaviruses, many of which 
cause asymptomatic infections. More than 40 types are transmitted through sexual contact 
and infect the genital tract of both men and women, while other types cause non-genital warts. 

 
 
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Although most HPV infections are resolved spontaneously, persistent infection with high-
risk types can lead to cervical, anal, penile, vaginal, and head and neck cancers. HPV types 
16 and 18 account for the majority of HPV-related cancers, while types 6 and 11 are 
responsible for most genital warts. 
HPV is the most common sexually transmitted infection worldwide, with millions of 
individuals currently infected in the United States and millions of new infections occurring 
each year. The role of HPV in oropharyngeal cancers has grown significantly, particularly in 
developed countries, further expanding the clinical importance of HPV testing. 
Cervical cancer screening relies on both cytology and molecular testing. The Pap test detects 
cellular abnormalities associated with HPV infection, while HPV testing identifies the 
presence of high-risk viral nucleic acids. Persistent infection with high-risk HPV is 
recognized as the central cause of cervical cancer. 
QIAGEN, through its acquisition of Digene, played a key role in establishing the link 
between HPV and cervical cancer and commercialized early HPV testing using hybrid 
capture technology. Over time, HPV testing evolved from an adjunct to cytology into a 
primary screening method. Current screening guidelines increasingly support HPV-first 
strategies due to higher sensitivity for detecting precancerous lesions, with cytology used for 
triage. 
 
Liquid-based cytology systems such as Hologic’s ThinPrep and  BD’s SurePath enabled the 
use of a single cervical sample for both cytology and molecular testing, supporting large-
scale screening and automation. These systems are used in laboratory workflows and allow 
seamless integration with molecular platforms for HPV and other sexually transmitted 
infections. 
The HPV testing market now includes a broad range of assays from major diagnostics 
companies, including Abbott, Becton Dickinson, Cepheid, Hologic, Roche, and QIAGEN. 
Modern assays incorporate partial genotyping and risk stratification, particularly for HPV 
types 16, 18, and in some cases 45, enabling more direct clinical decision-making. 
Self-collected sampling has emerged as an important advancement, with PCR-based assays 
demonstrating comparable performance to clinician-collected samples when validated 
methods are used. This approach is expanding access to screening in underserved populations 

 
 
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and is being incorporated into national screening programs. Self-collection manufacturers 
include Roche’s cobas HPV test, BD’s Onclarity HPV assay, Abbott’s simpli-COLLECT 
HPV kit, and QIAGEN. 
Globally, HPV-based screening is expanding, endorsed by public health initiatives and the 
WHO strategy aimed at cervical cancer elimination. Many countries are transitioning from 
cytology-based programs to HPV-first screening models. 
HPV vaccination is now a major factor shaping the future of screening, reducing the 
prevalence of high-risk HPV types in vaccinated populations and gradually altering screening 
strategies and disease incidence patterns. 
The market in Europe is estimated at 32% or $409 million for 2025, and the market in North 
America represents 35%, equal to $448 million.  
Table 13-4: Global HPV Test Sales Distribution, by Region, 2025 (%)  
 
[Asia Pacific; Europe; North America; Rest of World] 
 Region 
% Mkt 
North America  
35% 
Europe 
32% 
Asia Pacific 
22% 
RoW 
11% 
Total 
100% 
Source: Kalorama Information 
Growth in HPV screening has significantly reshaped both the technologies used and the 
competitive landscape for HPV diagnostics. Earlier signal amplification methods, such as 
hybrid capture and other low-throughput approaches, have largely been replaced by high-
throughput automated molecular platforms that provide greater sensitivity, genotype 
information, and scalability for population-based screening. Most clinical HPV testing is 
performed using PCR- or transcription-mediated amplification-based systems running on 
core molecular analyzers rather than slide-based or tissue-oriented methods. 

 
 
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Roche Diagnostics is one of the strongest global suppliers of HPV screening through its cobas 
HPV test and high-throughput cobas platforms, which detect high-risk HPV with partial 
genotyping for types 16 and 18. The company has gained a significant share in organized 
screening programs. 
Hologic and QIAGEN remain major participants, particularly through Aptima HPV mRNA 
testing and QIAGEN’s long-established HPV DNA testing portfolio in international markets. 
Additional suppliers include Abbott Laboratories, Becton Dickinson, Cepheid, Fujirebio, and 
Seegene, as well as several regional multiplex PCR providers. 
Kalorama presents a conservative market estimate that sets HPV testing at $1,270 million in 
2025, and with 11.1% CAGR, will reach $2,145 million in 2030. Roughly 67% of the market 
is held in North America and Europe.  It is estimated that in the U.S. 60% of Pap tests are 
also accompanied by an HPV test. This acceptance level indicates that physicians are 
increasingly following evidence-based guidelines that support HPV plus Pap testing for 
women over age 30. However,  cost is still a barrier to the implementation and widespread 
adoption of combination utilization.  
There are a number of cervical cancer screening programs in operation worldwide. Japan, 
Australia, Singapore, Hong Kong, Taiwan, and Korea have national screening programs. In 
South Korea, the national screening program has about 60% coverage and is showing slow 
but steady increases in screening rates. 
QIAGEN has been promoting HPV testing in low-resource countries and was awarded the 
CE mark for its careHPV Test to bring HPV testing to public health programs in low-
resource, developing countries. In Thailand, Indonesia, Philippines, Vietnam, and Malaysia 
local non-government organizations and healthcare groups run screening programs, but there 
is no national screening policy. 
In Africa, India, Bangladesh, and China, where a vast number of women live, there are no 
official screening programs. However, government and non-government organizations have 
collaborated to provide real data about the prevalence of cervical cancer in these countries. 
Further, QIAGEN was awarded the CE mark for its careHPV Test, bringing human HPV 
testing to public health programs in low-resource, developing countries. 
The table below presents a selection of HPV tests that use a cervical fluid sample but are not 
performed as part of the Pap test. A number of companies still use in situ hybridization; other 
companies, including Enzo Clinical Labs, perform HPV by flow cytometry. 

 
 
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Table 13-5: Selected HPV Test Innovations 
Company 
Location 
Area 
Details 
Becton Dickinson 
U.S. 
PCR 
Onclarity HPV on BD Viper LT System 
Bio-Reference Lab 
U.S. 
PCR 
GenCerv HPV E6/E7 oncogene 
Bio-Reference Lab 
U.S. 
mRNA 
InCellDx GenCerv, HPV mRNA quantification 
Cepheid 
U.S. 
PCR 
Xpert HPV on GeneXpert System 
DiaCarta 
U.S. 
bDNA 
QuantiVirus HPV E6/E7 bDNA test 
Diagcor Bioscience 
Hong Kong 
PCR 
GenoFlow HPV Array, PCR Flow-through 
Enzo Biochem 
U.S. 
flow 
FlowScript HPV E6/E7 assay 
Enzo Biochem 
U.S. 
flow 
IncellDx's HPV OncoTect 
Fujirebio Europe 
Belgium 
array 
INNO-LiPA HPV Genotyping Extra II assay 
Fujirebio/Autogenomics 
Japan 
array 
INFINITI HPV, HPV Genotyping BioFilmChip Microarray 
Hologic 
U.S. 
mol 
TIGRIS DTS System for Aptima HPV & trichomonas 
Hologic 
U.S. 
TMA 
Aptima HPV 16 18/45 genotype on PANTHER & Tigris 
GeneCell Diagnostics 
India 
flow 
InCellDx's HPV test in India 
Genomed 
Switzerland 
PCR 
F-HPV typing 
Genomic Vision 
France 
PCR 
HPV cell integration in cervical fluid smears 
Genomica 
Spain 
array 
CLART HPV 
Greiner Bio-One 
Austria 
chip 
PapilloCheck HPV genotyping 
IncellDx 
U.S. 
flow 
OncoTect 3Dx, cervical fluid 
Kindstar Global 
China 
flow 
InCellDx's HPV test in China 
Luminex 
U.S. 
PCR array 
Luminex HPV 
Milford Medical Lab 
U.S. 
NGS 
HPV genotyping 
PreTect AS 
Norway 
NASBA 
PreTect SEE, mRNA 
PreTect AS 
Norway 
NASBA 
PreTect HPV-Proofer, mRNA 

 
 
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Company 
Location 
Area 
Details 
QIAGEN 
Netherlands 
PCR 
digene HPV Genotyping PS Test 
QIAGEN 
Netherlands 
Signal Amp 
careHPV Test for developing countries 
QIAGEN 
Netherlands 
PCR 
QIAsymphonySP for liquid cytology 
Quest Diagnostics 
U.S. 
RNA 
HPV, E6/E7 messenger RNA 
Roche Diagnostics 
U.S. 
PCR 
cobas HPV using samples collected in SurePath fluid 
Roche Diagnostics 
U.S. 
PCR 
cobas HPV on cobas 4800 System 
Roche Diagnostics 
U.S. 
array 
LINEAR ARRAY HPV Genotyping Test 
Roche Diagnostics 
U.S. 
PCR 
cobas HPV direct from cytology vial 
Roche Diagnostics 
U.S. 
PCR 
cobas HPV Test screen without Pap first 
SeraCare Life Sciences 
U.S. 
QC 
ACCURUN HPV mRNA positive 
Shanghai Fosun Long 
March 
China 
HPV 
Multiplex Probe Amplification, HPV closed tube 
TrovaGene 
U.S. 
tr-DNA 
urine-based HPV-HR, high risk 
Waters 
U.S. 
Self 
Collection 
Onclarity HPV Self-Collection Kit 
Zeesan Biotech 
China 
HPV 
MeltPro High Risk HPV Genotyping Assay 
Source: Kalorama Information, company reports 

 
 
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Market Analysis 
Total Market 
The histology test segment is one of the more consistent sectors in the IVD industry. Though 
innovation in histology testing appears to focus on cancer, researchers are investigating 
cellular processes in diabetes, autoimmune diseases, and neurodegenerative conditions, 
among others. In the next 5-10 years, some of these new assays will come to market. 
Histology, cytology and flow cytometry reagents and instruments can be segmented into the 
main categories shown below. Also included in this market assessment is testing for 
circulating tumor cells. All of these techniques involve analyzing cells from either surgical 
or biopsy tissue or body fluids. 
• histology/cytology 
• traditional tissue stains 
• Pap test 
• immunohistochemical stains 
• in situ hybridization staining 
Table 13-6: Global Histology/Cytology Sales, by Type, 2025-2030 ($ million)  
 
[HPV; Immunohistochemistry; in situ hybridization; Pap Tests; traditional non-Pap stains] 
Type 
IVD Sales 2025 
% Mkt 
IVD Sales 2030 
% Mkt 
CAGR % 
Immunohistochemistry 
2,364 
37% 
3,180 
36% 
6.1% 
HPV 
1,270 
20% 
2,145 
25% 
11.1% 
Pap Tests 
1,110 
18% 
1,320 
15% 
3.5% 
in situ Hybridization 
1,045 
17% 
1,515 
17% 
7.7% 
Traditional non-Pap Stains 
498 
8% 
582 
7% 
3.2% 
 Total 
6,287 
100% 
8,742 
100% 
6.8% 
Source: Kalorama Information 

 
 
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Regional Market Analysis 
Histology and cytology testing have always been phenomenon of the developed world. At 
least 80% of the world market for histology/cytology products is held by North America, 
Japan, Western Europe, and Latin America. 
Table 13-7: Global Histology/Cytology Sales Distribution, by Region, 2025 (%)  
 
[Asia Pacific; Europe; North America; Rest of World] 
Region 
% Mkt 
North America 
39% 
Europe 
34% 
Asia Pacific 
22% 
RoW 
5% 
Total 
100% 
Source: Kalorama Information 
The global market for diagnostic reagents, stains, and instruments used in histology and 
cytology is estimated at $6,287 million in 2025. With increasing demand for cancer 
diagnostics and pharmacogenomics, the market will grow at nearly 6.8% annually, reaching 
$8,742 million in 2030.   
An additional $3,192 million in sales is generated by digital imaging, CTCs, and flow 
cytometry, which, with conservative annual growth of 7.0%, will reach $4,480 million by 
2030. 
 Recent product development in digital pathology has shifted toward fully integrated, high-
throughput systems that combine slide scanning, image management, and artificial 
intelligence–based analysis within a single workflow. New platforms such as the VENTANA 
DP series from Roche Diagnostics and expanded Aperio digital pathology solutions from 
Leica Biosystems reflect a move toward scalable enterprise systems designed for large 
laboratory networks. These platforms integrate barcode-driven case assembly, laboratory 
information systems, and secure remote access, allowing pathologists to review slides 

 
 
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alongside case data across locations and devices. At the same time, software providers are 
introducing clinically validated AI tools for tumor detection, biomarker quantification, and 
workflow prioritization, with some platforms offering marketplace-style access to multiple 
algorithms. These developments are accelerating the transition from traditional microscopy 
to fully digital, data-driven pathology workflows that improve efficiency, standardization, 
and diagnostic consistency. 
The table below presents the revenue history of the major histology companies in traditional 
histology markets. Note that these revenues represent a wide variety of histology assay 
technologies, including stains, Pap testing, IHC, and ISH. These companies occupy 
approximately 60% of the market for histology tests and systems. Numerous other companies 
market a host of new and improved histology stains. A selection of these is presented in the 
appropriate subsection below. 
Table 13-8: Revenues of the Major Histology Companies, 2018-2025 ($ million, estimated) 
Company 
2018 
2019 
2020 
2021 
2022 
2023 
2024 
2025 
YOY  
'24-'25 
Roche 
1,147 
1,161 
1,099 
1,347 
1,398 
1,589 
1,833 
1,885 
2.8% 
Agilent 
595 
635 
472 
805 
833 
839 
956 
1,063 
11.2% 
Illumina 
472 
518 
454 
674 
674 
730 
700 
681 
-2.7% 
Danaher  
(Leica Biosystems) 
650 
659 
471 
477 
507 
557 
570 
583 
2.3% 
Hologic 
480 
472 
411 
480 
471 
509 
485 
490 
1.0% 
Abbott Diagnostics 
241 
251 
227 
276 
263 
277 
282 
289 
2.5% 
Becton Dickinson 
180 
180 
112 
121 
164 
130 
138 
120 
-13.0% 
Total 
3,765 
3,876 
3,246 
4,180 
4,310 
4,631 
4,964 
5,111 
3.0% 
   Source: Kalorama Information, company reports 
Roche Diagnostics Tissue Diagnostics remains one of the leading global suppliers of 
automated immunohistochemistry  and in situ hybridization systems. Over the past two 
decades, Roche has built a dominant position through development of automated staining 

 
 
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platforms, a broad menu of diagnostic assays, and integration of workflow and digital 
pathology tools. 
Roche markets instruments and reagents that automate and standardize tissue preparation and 
staining. Core platforms include the BenchMark ULTRA system, a widely adopted random-
access IHC/ISH stainer that supports continuous loading and flexible workflows without 
strict batch processing. Earlier systems, such as BenchMark XT and LT, remain in the 
installed base but are being phased out in favor of newer platforms. Research-focused 
systems such as Discovery XT continue to support translational and life science applications, 
while older platforms such as NexES are largely legacy systems. 
Roche also offers automation for special stains, built around its VENTANA workflow, with 
features including walk-away operation, integrated deparaffinization, and connectivity to 
laboratory workflow solutions. Software integration, remote support, and traceability tools 
are now standard across Roche’s staining platforms, supporting quality control and 
regulatory compliance. 
A major area of expansion for Roche has been digital pathology. The company has introduced 
high-throughput slide scanners, including the VENTANA DP 200 and DP 600 systems, 
designed for large-scale laboratory digitization and integration with image management and 
analysis software. These platforms are increasingly paired with AI-based image analysis 
tools and enterprise workflow systems, reflecting the broader shift toward fully digital 
pathology environments. 
Roche’s strategic focus has also shifted toward companion diagnostics and precision 
medicine. The company offers extensive collaborations with pharmaceutical partners to 
develop tissue-based assays that guide targeted therapies, particularly in oncology. These 
efforts include both IHC-based protein markers and molecular assays linked to specific drug 
therapies. 
Agilent Technologies remains a major competitor in tissue diagnostics through its Dako 
portfolio, offering automated staining systems and a broad menu of antibodies and 
companion diagnostic assays. The company expanded its partnerships with pharmaceutical 
firms to support the development of biomarker-driven therapies. 
Abbott Laboratories participates in tissue-based diagnostics primarily through its molecular 
and cytogenetics portfolio. The Vysis product line includes widely used fluorescence in situ 
hybridization (FISH) assays such as PathVysion HER2 and UroVysion for bladder cancer 

 
 
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detection and monitoring. Abbott continues to invest in molecular oncology and companion 
diagnostics, although it is not a major provider of automated histology instrumentation. 
Becton Dickinson entered the cytology and adjacent histology workflow segment through its 
acquisition of TriPath Imaging. BD’s portfolio includes liquid-based cytology systems such 
as SurePath and automation platforms like the BD Totalys system, which integrates cytology 
sample preparation with molecular testing workflows. The BD Onclarity HPV assay, run on 
BD molecular platforms, supports high-risk HPV detection and genotyping and is integrated 
into cervical cancer screening workflows. BD’s 2025 performance decline was driven 
primarily by reduced research funding affecting its biosciences segment, post-pandemic 
normalization of diagnostics demand, pricing pressure in China, and margin compression, 
with additional impact from the strategic restructuring of its diagnostics and life sciences 
businesses heading into 2026. 
Histology and cytology have historically been labor-intensive and manual, but this has 
changed significantly. Increasing test complexity, higher volumes, and demand for 
standardized results have driven widespread adoption of automation and digital pathology. 
Automated staining, slide preparation, and image analysis systems now support faster 
turnaround times and improved consistency. While most histology testing remains 
centralized in hospitals and reference laboratories, some workflow elements have expanded 
into larger physician practices and integrated health systems, particularly where digital 
pathology enables remote review and collaboration. 
Traditional Stains 
Traditional stains used on all types of formalin-fixed, paraffin-embedded tissues and fluids 
constitute the most mature segment of this market. The most widely used stain is hematoxylin 
& eosin (H&E), which provides a general overview of tissue structures and cells. 
Hematoxylin, a basic dye, stains nuclei blue due to an affinity to nucleic acids in the cell 
nucleus; eosin, an acidic dye, stains the cytoplasm pink. There are hundreds of various other 
techniques that have been used to selectively stain cells and cellular components. The most 
widely used special stains include: Congo red, elastin, Feulgen, giemsa, Gomori, iron, 
Masson, PAS (periodic acid schiff) and reticulin.  
This segment of histology is estimated at $498 million in 2025 and is growing at 3.2% 
annually, reaching $582 million in 2030. Since all tissue sections are stained with one or 

 
 
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more of these stains, growth derives from increased cancer tumor samples. The major players 
are listed below.  
Table 13-9: Selected Vendors of Traditional Histology Stains 
Vendor 
Agilent 
 BioMeda 
Biosource 
Immunon 
QuidelOrtho  
Roche Tissue Diagnostics 
Siemens Healthcare 
Spectrum 
 Source: Kalorama Information 
Pap Testing 
Cervical cancer screening has traditionally relied on the Papanicolaou (Pap) test, which 
remains an important component of cytology laboratories alongside routine staining 
techniques used for a wide range of tissue and cell samples. However, screening strategies 
have evolved, and high-risk HPV molecular testing is increasingly used either alongside 
cytology or as a primary screening method. Cervical cancer remains a major global health 
issue, with approximately 660,000 new cases and 350,000 deaths each year. While it is no 
longer among the most common cancers globally, it continues to be a leading cause of cancer-
related death in women, particularly in low- and middle-income countries, where about 80% 
of cases and deaths occur. 
Screening programs have significantly reduced cervical cancer incidence and mortality in 
developed countries. In the United States, screening rates are below national targets, 
reflecting ongoing gaps in access and follow-up care. Although mortality has declined over 

 
 
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time, the rate of improvement has slowed in recent years. Globally, access to screening 
remains uneven. In many developing regions, barriers such as cost, limited infrastructure, 
shortages of trained personnel, and lack of awareness continue to restrict participation. 
Cultural factors and reluctance to undergo pelvic examinations also play a role, leaving large 
portions of the at-risk population under-screened. 
Advances are reshaping screening practices. Primary HPV testing is now widely adopted for 
women over 30, with cytology used more often for triage. Self-collected HPV sampling has 
emerged as an important development, showing comparable performance to clinician-
collected samples when validated methods are used, and improving access for underserved 
populations. In addition, the introduction of at-home HPV testing options is expanding 
participation among individuals who might otherwise remain unscreened. These 
developments, along with global public health initiatives aimed at increasing screening 
coverage, are expected to further reduce the burden of cervical cancer by improving early 
detection and access to care. 
 
 

 
 
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Table 13-10: Primary and Secondary Prevention of Cervical Cancer, Screening Responses, by Country, 2021 
 Country 
Existence of 
national screening 
program for 
cervical cancer 
Type of national 
cervical cancer 
screening program 
Most widely used 
screening method in 
national cervical cancer 
screening program 
Coverage of national 
cervical cancer 
screening program 
(%) 
Afghanistan 
No 
Not applicable 
Not applicable 
Not applicable 
Argentina 
Yes 
Organized population-
based screening 
HPV test 
Don't know 
Australia 
Yes 
Organized population-
based screening 
PAP smear 
more than 50 but 
less than 70 
Bangladesh 
Yes 
Opportunistic screening 
Visual inspection 
Don't know 
Belgium 
Yes 
Organized population-
based screening 
PAP smear 
more than 50 but 
less than 70 
Brazil 
Yes 
Opportunistic screening 
PAP smear 
70 or more 
Canada 
Yes 
Opportunistic screening 
PAP smear 
70 or more 
Chile 
Yes 
Organized population-
based screening 
PAP smear 
Don’t know 
China 
Yes 
Organized population-
based screening 
PAP smear 
10-50 
Colombia 
Yes 
Organized population-
based screening 
PAP smear 
More than 50 less 
than 70 
Denmark 
Yes 
Organized population-
based screening 
HPV test 
more than 50 but 
less than 70 
Dominican 
Republic 
Yes 
Organized population-
based screening 
PAP smear 
70 or more 
Ecuador 
Yes 
Organized population-
based screening 
PAP smear 
Less than 10 
Egypt 
No 
Not applicable 
Not applicable 
Not applicable 
El Salvador 
Yes 
Organized population-
based screening 
PAP smear 
10 to 50 
France 
Yes 
Organized population-
based screening 
PAP smear 
More than 50 but 
less than 70 
Germany 
Yes 
Opportunistic screening 
HPV test 
70 or more 
Hungary 
Yes 
Organized population-
based screening 
HPV test 
10 to 50 

 
 
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 Country 
Existence of 
national screening 
program for 
cervical cancer 
Type of national 
cervical cancer 
screening program 
Most widely used 
screening method in 
national cervical cancer 
screening program 
Coverage of national 
cervical cancer 
screening program 
(%) 
India 
Yes 
Organized population-
based screening 
Visual inspection 
70 or more 
Indonesia 
Yes 
Organized population-
based screening 
Visual inspection 
10 to 50 
Iran (Islamic 
Republic of) 
Yes 
Organized population-
based screening 
HPV test 
Less than 10 
Iraq 
Yes 
Opportunistic screening 
Visual inspection 
N/A 
Ireland 
Yes 
Organized population-
based screening 
PAP smear 
70 or more 
Israel 
Yes 
Opportunistic screening 
PAP smear 
10 to 50 
Italy 
Yes 
Organized population-
based screening 
PAP smear 
70 or more 
Japan 
Yes 
Organized population-
based screening 
PAP smear 
10 to 50 
Malaysia 
Yes 
Opportunistic screening 
PAP smear 
10 to 50 
Mexico 
Yes 
Opportunistic screening 
PAP smear 
Don't know 
Netherlands 
Yes 
Organized population-
based screening 
HPV test 
more than 50 but 
less than 70 
New Zealand 
Yes 
Organized population-
based screening 
PAP smear 
70 or more 
Peru 
Yes 
Organized population-
based screening 
Visual inspection 
10 to 50 
Philippines 
Yes 
Opportunistic screening 
Visual inspection 
Don’t know 
Poland 
Yes 
Opportunistic screening 
PAP smear 
10 to 50 
Republic of 
Korea 
Yes 
Organized population-
based screening 
PAP smear 
more than 50 but 
less than 70 
Romania 
Yes 
Organized population-
based screening 
PAP smear 
10 to 50 
Russian 
Federation 
Yes 
Organized population-
based screening 
PAP smear 
more than 50 but 
less than 70 
Saudi Arabia 
No 
Not applicable 
Not applicable 
Not applicable 

 
 
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 Country 
Existence of 
national screening 
program for 
cervical cancer 
Type of national 
cervical cancer 
screening program 
Most widely used 
screening method in 
national cervical cancer 
screening program 
Coverage of national 
cervical cancer 
screening program 
(%) 
Singapore 
Yes 
Organized population-
based screening 
PAP smear 
more than 50 but 
less than 70 
Slovakia 
Yes 
Opportunistic screening 
PAP smear 
10 to 50 
Slovenia 
Yes 
Organized population-
based screening 
PAP smear 
10 to 50 
South Africa 
Yes 
Opportunistic screening 
PAP smear 
more than 50 but 
less than 70 
Spain 
Yes 
Opportunistic screening 
PAP smear 
more than 50 but 
less than 70 
Sweden 
Yes 
Organized population-
based screening 
PAP smear 
70 or more 
Switzerland 
Yes 
Opportunistic screening 
PAP smear 
70 or more 
Thailand 
Yes 
Organized population-
based screening 
PAP smear 
more than 50 but 
less than 70 
Turkey 
Yes 
Organized population-
based screening 
HPV test 
70 or more 
Ukraine 
Yes 
Organized population-
based screening 
PAP smear 
Less than 10 
United Arab 
Emirates 
Yes 
Organized population-
based screening 
PAP smear 
Less than 10 
United 
Kingdom of 
Great Britain 
and Northern 
Ireland 
Yes 
Organized population-
based screening 
Pap smear 
70 or more 
United States 
of America 
Yes 
Opportunistic screening 
PAP smear 
Less than 10 
Venezuela 
(Bolivarian 
Republic of) 
Yes 
No data received 
PAP smear 
10 to 50 
Viet Nam 
Yes 
Organized population-
based screening 
PAP smear 
10 to 50 
Note: Most recent data available 
Source: WHO, Global Health Observatory data repository 

 
 
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Table 13-11: Three approaches to cervical cancer screening and future tests 
 
Note: a Current tests; b Tests under evaluation 
Source: WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention, second edition. 
Geneva: World Health Organization; 2021. License: CC BY-NC-SA 3.0 IGO 
The market for Pap testing accounts for $1,110 million in 2025 and with 3.5% annual growth 
will reach $1,320 million in 2030. The market for Pap tests is primarily North America and 
Europe with at least 70% of the market. 
U.S. guidelines align on making primary high-risk HPV testing every 5 years the preferred 
strategy for women aged 30 to 65, with self-collected HPV samples accepted under clinical 
supervision. Younger individuals (21–29) continue with Pap testing every 3 years, while 
options like co-testing (HPV + Pap) every 5 years or Pap alone remain acceptable if HPV 
testing isn't available. Screening is no longer recommended for individuals over age 65 with 
a history of adequate prior testing, or those who’ve had a hysterectomy with no prior high-
grade lesions. 
In 2025, new European guidelines establish primary HPV testing every 5 years (ages 30–64) 
as the preferred cervical cancer screening strategy, replacing cytology or co-testing. 
Organized screening programs should avoid initiating screening before age 25 or beyond age 
64 unless prior adequate screening is absent. Self-sampling and quality assurance 

 
 
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frameworks are key to improving access and effectiveness, with policy goals aiming to have 
at least 70% screening coverage by 2025 and 90% of eligible individuals are offered 
screening. 
Japan, Australia, Singapore, Hong Kong, Taiwan and Korea have national screening 
programs. In Korea, the national screening program has coverage of about 55%, and so the 
country still has a high cervical cancer rate. 
In Thailand, Indonesia, Philippines, Vietnam, and Malaysia local non-government 
organizations and healthcare groups run screening programs, but there is no national 
screening policy. 
There are no official screening programs in Africa and Bangladesh. However, government 
and non-government organizations have collaborated to establish demonstration centers that 
are expected to provide real data about the prevalence of cervical cancer in these countries. 
The heart of cervical cancer control is regular Pap testing as performed in developed 
countries. In developing countries, the test is available to women who can afford it in urban 
areas but is largely unavailable to those living in the rural areas of even higher income 
developing countries. There is a huge need for company-supported initiatives in this area. 
India has more  incidence of cervical cancer cases than any other country in the world, 
followed by China. The World Health Organization (WHO) estimated in 2021, the incidence 
of cervical cancer was 18.7 per 100,000 women. China has an estimated incidence of cervical 
cancer of 15.6 per 100,00 women.  The WHO estimates that only about 5% of women in the 
developing world have been screened for cervical disease in the previous five years, 
compared to 40%-50% in the developed world. 
In China, more than 12 million Pap tests are performed every year, mostly through private 
labs. The available Pap test market comprises 300 million women aged 30 to 50 who have at 
least basic health coverage under government insurance programs. Recent screening rates 
were boosted by the central government-led free screening program for 10 million rural 
Chinese women as part of healthcare reform.  
Continuous improvements have perfected the test in the past 10 years or so. Monolayer 
preparation has become an important development in cytology sample preparation. It is an 
important element in the automated reading of cytological samples such as Pap smear, urine 
cytology, bone marrow, cerebral, and spinal fluid. Hologic’s ThinPrep is the major product 
in this area. Automated Pap smear systems are available from Hologic/Cytyc, BD/Tripath, 

 
 
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Roche/Ventana, Molecular Diagnostics, AccuMed International and Neuromedical Systems. 
Liquid-based Pap tests using liquid transport media such as ThinPrep currently account for 
approximately 75% of the Pap tests performed in the U.S., Europe and Japan. 
The most successful liquid and automated Pap smear analysis systems are available from 
Hologic/Cytyc, Roche Tissue Diagnostics and BD/Tripath. These companies claim that their 
products are used in approximately 90% of the 65 million Pap tests performed in the U.S. 
After almost 20 years on the market, Hologic’s ThinPrep system has become the state-of-
the-art in cervical cell preparation for Pap and other cytology tests. 
Hologic offers the CE marked  ThinPrep Genesis Processor, an automated cytology slide and 
molecular sample system. The ThinPrep Genesis processor provides the same trusted 
reliability as the ThinPrep 2000 system for cytology slide processing, with added features 
such as automated division of the sample into smaller volumes for molecular testing. The 
processor also provides automated barcoding of samples, ensuring accurate sample tracking 
as well as reducing manual steps.  
Widely available in developed countries, the Pap test has led to at least a 50% decrease in 
cervical cancer rates in the last 30 years. However, only 20 million Pap tests are performed 
each year in all of the developing countries. This means that only 1.2% of the at-risk 
population of 1.7 billion women receive a Pap test. So, the right technology at the right price 
can really make a significant difference in the developing nations. 
Immunohistochemistry and In Situ Hybridization 
Despite growing interest in downstream molecular analysis, traditional IHC and ISH 
performed on FFPE tissue sections are used in cancer diagnostics. Histologic evaluation still 
begins with routine morphology, followed by IHC and, when appropriate, ISH-based 
methods to further characterize tumor type, origin, and biomarker status. Advances in 
multiplex IHC and continued expansion of antibody panels have strengthened the role of 
these techniques in both diagnosis and treatment selection. 
Traditional staining methods offers a range of targeted techniques, including IHC, ISH, 
chromogenic ISH (CISH), and fluorescence in situ hybridization (FISH). These methods 
enable the detection of protein expression and genetic alterations directly within tissue 
structure. FISH is an important tool for identifying chromosomal abnormalities and gene 

 
 
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amplifications and is widely used in both hematologic malignancies and solid tumors, 
including breast and lung cancer. 
The markets for IHC and ISH continue to grow, driven by increasing demand for biomarker 
testing, companion diagnostics, and more precise tumor classification. IHC represents the 
larger, higher-volume segment, whereas ISH procedures typically demand higher test costs 
and are used for more targeted applications. Growth in both segments is realized by the 
expanding number of clinically relevant biomarkers and the integration of tissue-based 
testing with molecular diagnostics. 
Interesting developments are expanding the capabilities of these technologies. RNA-based in 
situ hybridization is increasingly being integrated into automated staining platforms, 
allowing faster detection of gene expression while preserving tissue morphology. Platforms 
such as RNAscope from Bio-Techne enable sensitive detection of RNA transcripts, including 
viral markers like high-risk HPV, in head and neck cancers. These methods are moving 
beyond research use and into clinical and translational workflows. At the same time, spatial 
biology approaches are emerging that combine RNA and protein detection within the same 
tissue section, providing more detailed insight into tumor biology and the surrounding 
microenvironment. 
While laboratory-developed tests remain important, particularly in specialized settings, there 
has been a shift toward standardized, automated platforms and validated assays, including 
companion diagnostics linked to targeted therapies. Multiplex staining and high-parameter 
analysis are becoming more common, especially in oncology, where multiple biomarkers are 
assessed on a single slide. In some applications, advanced RNA-based ISH methods are 
beginning to complement or replace traditional FISH approaches. 
 
 

 
 
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Table 13-12: Selected In Situ Hybridization-based Tests 
Company 
Location 
Details 
Abbott Diagnostics 
U.S. 
nonaggressive prostate cancer gene panel 
Abbott Diagnostics 
U.S. 
Vysis ALK Break Apart FISH as companion test 
Abbott Diagnostics 
U.S. 
Vysis ALK Break Apart FISH Probes 
Advanced Cell Diagnostics 
U.S. 
BaseScope single-molecule detection RNA ISH 
Advanced Cell Diagnostics 
U.S. 
multiplexed fluorescence RNA biomarkers in situ 
Advanced Cell Diagnostics 
U.S. 
RNAscope 2.5 RNA biomarkers 
Advanced Cell Diagnostics 
U.S. 
with Leica Biosystems, FISH tests 
Agilent Technologies 
U.S. 
Applied Spectral's GenASIs & Dako Omnis, automated FISH 
Applied Spectral Imaging 
U.S. 
GenASIs ALK gene analysis 
Applied Spectral Imaging 
U.S. 
GenASIs imaging platform, ISH 
BioGenex Laboratories 
U.S. 
Xmatrx Mini system, ISH, isPCR 
BioGenex Laboratories 
U.S. 
eFISHiency system, ISH probes 
Biocare (formerly Cymogen Dx) 
U.S. 
Next-Gen FISH probes enhanced imaging 
Biocare (formerly Cymogen Dx) 
U.S. 
Deletion Detection Probe sets, next-gen multicolor FISH 
BioView Ltd 
Israel 
lung cancer from sputum 
BioView Ltd 
Israel 
DUET Automated FISH Scanning and Analysis systems 
BioView Ltd 
Israel 
QSD certificate from the Taiwanese FDA 
BioView Ltd. 
Israel 
Abbott Vysis ALK Break Apart FISH on DUET 
BioView Ltd. 
Israel 
Lung cancer FISH, early lung cancer, sputum 
Dako/Agilent 
Denmark 
automated HER2 IQFISH pharmDx 
Dako/Agilent 
Denmark 
IQISH technology results in 3.5 hours 
Dako/Agilent 
Denmark 
Ono Pharma PD-L1 companion test 
Dako/Agilent 
Denmark 
HER2 IQFISH pharmDx automated on Dako Omnis 

 
 
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Company 
Location 
Details 
Dako/Agilent 
Denmark 
collaborations with top pharma companies 
Dako/Agilent 
U.S. 
Dako HER assays companion to Roche/Genentech's Kadcyla 
DiaCarta Inc. 
U.S. 
QClamp KRAS, NRAS, EGFR, BRAF, PIK3CA 
Empire Diagnostics 
U.S. 
fluorescent in situ hybridization probes 
Flagship Biosciences 
U.S. 
ACD's RNAScope for B-cell non-Hodgkin lymphomas 
GeneCentric Diagnostics 
U.S. 
Lung Subtype Platform, tumor genome 
Labcorp 
U.S. 
Dako’s PD-L1 IHC 22C3 pharmDx assay 
Leica Biosystems 
Germany 
BMS automated companion Dx on BOND system 
Leica Biosystems 
Germany 
Synthon Biopharmaceuticals companion Dx 
Oxford Gene Technologies 
UK 
Cytocell Aquarius bladder cancer FISH probe kit 
Oxford Gene Technologies 
UK 
Cytocell FISH probes 
Quest Diagnostics 
U.S. 
Dako PD-L1 IHC 28-8 pharmDx, lung cancer/melanoma 
Reveal Biosciences 
U.S. 
Reveal ImageDx IT with Affymetrix ViewRNA ISH 
Skyline Urology 
U.S. 
bladder cancer in urine 
Thermo Fisher (formerly 
Affymetrix) 
U.S. 
ViewRNA ISH portfolio 
Thermo Fisher (formerly 
Affymetrix) 
U.S. 
Quantigene DNA/RNA in tissue 
Thermo Fisher (formerly 
Affymetrix) 
U.S. 
Siemens’ bDNA technology, multiplex CISH and FISH 
Ventana Medical/Roche 
U.S. 
INFORM HER2 Dual ISH DNA Probe cocktail 
Ventana Medical/Roche 
U.S. 
Ventana ALK (D5F3) CDx Assay, lung cancer 
Ventana Medical/Roche 
U.S. 
numerous companion test deals 
Source: Kalorama Information, company reports 

 
 
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Immunohistochemical stains refer to the process of detecting proteins in cells of a tissue 
section by using the principle of antibody/antigen binding specifically to antigens in 
biological tissues. The table below presents a selection of IHC tests. 
Table 13-13: Selected IHC Test Innovations 
Company 
Location 
Details 
20/20 GeneSystems 
U.S. 
PD-L1 companion tests various lung cancer drugs 
Applied Spectral Imaging 
U.S. 
PathFusion, a digital tissue-matching workflow solution 
Becton Dickinson 
U.S. 
BD ProEx C reagent, IHC 
Biocare Medical 
U.S. 
p63 protein in prostate, breast, bladder, and lung 
BioGenex 
U.S. 
Quantitative IHC; in collaboration with University of Rochester and 
Konica-Minolta 
Dako 
Denmark 
Cell Signaling Technology antibodies 
Dako 
Denmark 
immunohistochemistry products 
Dako/Agilent 
Denmark 
FLEX Human Estrogen Receptor alpha 
Empire Diagnostics 
U.S. 
nCounter multiplex digital immunohistochemistry 
IncellDx, Inc. 
U.S. 
OncoBreast 3Dx, mRNA, DNA cell ploidy, biopsy 
Leica Biosystems 
Germany 
Novocastra HD, immunohistochemistry 
Leica Biosystems 
Germany 
Novocastra HD IHC panel head and neck pathology 
Leica Biosystems 
Germany 
Novocastra HD IHC breast pathology 
NanoString Technologies 
U.S. 
nCounter Vantage products for 3D Biology analysis 
NanoString Technologies 
U.S. 
Dako’s PD-L1 IHC 22C3 PharmDx IHC 
Quest Diagnostics 
U.S. 
Cell Marque Corp's IHC stains 
Sigma-Aldrich 
U.S. 
ALK IHC companion diagnostic for Pfizer's Xalkori 
Theracode GmbH 
Germany 
CLAUDETECT 18.2, IHC for CLDN18.2 protein 
Source: Kalorama Information, company reports 

 
 
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Pharmacodiagnostic Histology 
Growth in specialized histology diagnostics is being driven by the expanding number of 
clinically relevant biomarkers, including molecular assays used for diagnosis, prognosis, and 
therapy selection, as well as the continued expansion of targets evaluated by IHC and ISH in 
tissue samples. Advances in genomics and pharmacogenomics have enabled more precise 
characterization of tumors, supporting the shift toward individualized therapy based on the 
molecular profile of a patient’s cancer. 
The concept of personalized medicine is well established in oncology. Physicians 
increasingly rely on tissue-based biomarker testing to guide treatment decisions, aiming to 
match each patient to the most effective therapy for their specific tumor type and molecular 
profile. Rather than a single uniform disease, cancer is now understood as a collection of 
biologically distinct subtypes, and treatment strategies reflect this growing level of precision. 
Tumor-agnostic biomarkers are also gaining importance, allowing certain therapies to be 
applied across multiple cancer types based on shared molecular features rather than tissue of 
origin. 
Advances in cancer management have facilitated significant changes in histopathology 
workflows. Histology now integrates protein expression, gene alterations, and, in some cases, 
RNA-based data, allowing pathologists to evaluate multiple biomarkers in the context of 
tissue architecture. Tissue biomarkers are important to personalized cancer care, and many 
therapies are developed alongside companion diagnostic tests that identify patients most 
likely to benefit from a specific drug. This approach has improved patient selection and 
treatment outcomes across a range of cancers. 
A range of technologies reinforce this approach, including PCR-based assays, next-
generation sequencing, and in situ hybridization techniques applied to formalin-fixed 
paraffin-embedded tissue. Improvements in extraction methods and assay design have 
enabled the reliable generation of molecular data from archived tissue samples, supporting 
both retrospective studies and routine clinical testing. At the same time, integration of tissue-
based testing with liquid biopsy is becoming more common, allowing clinicians to combine 
detailed tumor characterization with real-time monitoring of disease progression and 
treatment response. 
Tissue-based diagnostic testing is the gold standard for cancer diagnosis because it preserves 
the biological and spatial context of the disease. From a biopsy, pathologists determine tumor 

 
 
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type, grade, and extent of invasion, and support biomarker analysis that guides therapy. FFPE 
tissue remains the dominant sample type in oncology diagnostics and underpins the majority 
of histology-based testing. 
Advances in spatial biology and multiplex analysis are providing deeper insight into the 
tumor microenvironment, particularly in the context of immunotherapy. In addition, artificial 
intelligence is increasingly being incorporated into pathology workflows to improve 
biomarker quantification, reduce variability in interpretation, and offer more consistent 
diagnostic outcomes. These innovations reinforce the central role of histology while 
extending its capabilities in precision oncology. 
The foundation of targeted cancer therapy was established with early biomarker–drug 
relationships such as HER2 testing for trastuzumab therapy. This model has expanded 
significantly, with numerous clinically relevant biomarkers now used to guide treatment 
decisions, including EGFR mutations in lung cancer, HER2 alterations across multiple tumor 
types, and BCR-ABL in hematologic malignancies. As cancer incidence continues to rise 
and treatment options become more complex, demand for integrated tissue-based diagnostics 
is expected to remain strong, driven by ongoing biomarker discovery, expansion of 
companion diagnostics, and increasing use of multiplex and molecularly informed testing 
within routine pathology workflows. 

 
 
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Table 13-14: Major Pharmacodiagnostic Markers 
Marker 
ALK 
BCR/ABL 
BRAF 
BRCA1/BRCA2 
Claudin 18.2 
Epidermal growth factor (EGF) and its receptor (EGFR) 
Estrogen receptor (ER) 
Her-2/neu oncogene/c-erb-B2 protein 
KRAS 
Markers of angiogenesis 
Progesterone Receptors (PR) 
Source: Kalorama Information 
The application of pharmacodiagnostic histology continues to become more sophisticated. In 
addition to standard IHC and ISH staining procedures, DNA and RNA extracted from tissue 
samples are now routinely analyzed using PCR, next-generation sequencing, and other 
molecular techniques. More advanced approaches, including multiplex analysis and spatial 
profiling, are expanding the amount of information that can be derived from a single tissue 
section. While liquid biopsy testing has grown rapidly and provides a less invasive method 
for molecular analysis, it is generally complementary to tissue-based testing rather than a 
replacement, as tissue remains essential for diagnosis and full tumor characterization. 
As understanding of cancer biology and treatment response improves, additional tests have 
been developed to evaluate factors such as tumor biology and, in some cases, radiosensitivity, 
although clinical adoption of radiosensitivity assays remains limited and varies by 
application. The pharmacodiagnostic market remains highly dynamic, with a mix of FDA-
approved companion diagnostics and laboratory-based testing services. 

 
 
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Immune checkpoint biomarkers have become a major area of growth. PD-L1 assays are 
widely used to guide immunotherapy decisions across multiple tumor types. For example, 
the VENTANA PD-L1 (SP263) assay from Roche Diagnostics is performed on the 
BenchMark ULTRA platform and evaluates PD-L1 expression in both tumor and immune 
cells within the tumor microenvironment. PD-L1 testing is now established across multiple 
indications and therapies, with ongoing expansion into additional tumor types and treatment 
settings. 
Companion diagnostics linked to targeted therapies continue to expand. HER2 testing is 
increasing in breast cancer and has recently been extended to include HER2-low 
classification, supporting treatment selection for newer therapies. Molecular assays detecting 
mutations such as IDH1, KRAS G12C, and PDGFRA are now routinely used to guide 
therapy selection in cancers such as acute myeloid leukemia, lung cancer, and gastrointestinal 
tumors. These assays are performed using PCR or sequencing-based platforms and are 
increasingly integrated into broader genomic testing workflows. 
Several important regulatory developments have occurred in recent years. Companion 
diagnostics for immunotherapy and targeted therapy continue to receive expanded approvals 
across multiple tumor types. Liquid biopsy–based companion diagnostics, including next-
generation sequencing assays, have also gained regulatory acceptance and are being used to 
identify actionable mutations when tissue is limited or unavailable. At the same time, multi-
gene panel tests, such as comprehensive genomic profiling assays, are increasingly used to 
support treatment decisions across a range of cancers. 
The trend to personalized medicine (PGx) is expected to create a huge market for histology 
diagnostics.  The market leaders are Agilent, Illumina, and Roche/Ventana Medical that have 
collaborations with pharmaceutical companies to develop companion tests along with 
therapeutics. 
A 
listing 
of 
companion 
tests 
cleared 
by 
the 
FDA 
can 
be 
found 
at 
https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-
companion-diagnostic-devices-in-vitro-and-imaging-tools#CDx_Table.   
 
 

 
 
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Table 13-15: Selected Pharmacodiagnostic Histology Tests 
Company 
Location 
Details 
Abbott Diagnostics 
U.S. 
Vysis ALK Break Apart FISH Probes 
Abbott Diagnostics 
U.S. 
PathVysion HER-2 DNA FISH Probe Kit 
Abbott Diagnostics 
U.S. 
Abbott RealTime IDH-1 
Advanced Cell 
Diagnostics 
U.S. 
Partnership with Leica Biosciences; Bayer companion Dx on RNAscope-
based BOND systems 
ARUP Laboratories, Inc. 
U.S. 
PDGFRB FISH Assay for Gleevec eligibility in myelodysplastic 
syndrome/myeloproliferative disease 
BioGenex 
U.S. 
InSite Her-2/neu  
BioView Ltd. 
Israel 
Abbott Vysis ALK Break Apart FISH on DUET 
Dako/Agilent 
Denmark 
automated HER2 IQFISH pharmDx 
Dako/Agilent 
Denmark 
Ono Pharma PD-L1 companion test 
Dako/Agilent 
Denmark 
HER2 IQFISH pharmDx automated on Dako Omnis 
Dako/Agilent 
Denmark 
collaborations with top pharma companies 
Dako/Agilent 
Denmark 
PD-L1 companion tests various lung cancer and melanoma drugs 
Dako/Agilent 
Denmark 
Dako HER assays companion to Roche/Genentech's Kadcyla 
DiaCarta Inc. 
U.S. 
QClamp KRAS, NRAS, EGFR, BRAF, PIK3CA 
GeneCentric Diagnostics 
U.S. 
Lung Subtype Platform, tumor genome 
GeneCentric Diagnostics 
U.S. 
Bladder, Colorectal, Prostate, and Renal Subtype Platforms, tumor 
genome 
Inspirata 
U.S. 
Image-based breast cancer companion diagnostic; collaboration with Case 
Western Reserve University 
Labcorp 
U.S. 
Dako’s PD-L1 IHC 22C3 pharmDx assay 
Leica Biosystems 
Germany 
BMS automated companion Dx on BOND system 
Leica Biosystems 
Germany 
Synthon Biopharmaceuticals companion Dx 
QIAGEN 
U.S. 
Therascreen FGFR RGQ RT-PCR Kit 

 
 
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Company 
Location 
Details 
QIAGEN  
U.S.  
Therascreen PIK3CA RGQ PCR 
Quest Diagnostics 
U.S. 
Dako PD-L1 IHC 28-8 pharmDx, lung cancer/melanoma 
Quest Diagnostics 
U.S. 
Dako’s PD-L1 IHC 22C3 PharmDx IHC 
Ventana Medical/Roche 
U.S. 
Ventana ALK (D5F3) CDx Assay, lung cancer 
Ventana Medical/Roche 
U.S. 
PD-L1 (SP142) IHC companion diagnostic for Roche’s Tecentriq, for lung 
and bladder cancer 
Ventana Medical/Roche 
U.S. 
PD-L1 (SP263) IHC companion diagnostic for AstraZeneca’s Imfinzi, for 
urothelial carcinoma 
Ventana Medical/Roche 
U.S. 
ALK IHC companion diagnostic for Pfizer's Xalkori 
Source: Kalorama Information 
Digital Imaging and Computational Pathology 
Microscopy has been the mainstay of 
digital pathology, as well. Advances in 
digital photography and the decreasing 
cost 
of 
digital 
cameras 
are 
revolutionizing traditional ways of 
documenting 
pathology 
findings, 
collaborating on slide review, and 
analyzing images. More and more 
histology laboratories are going digital. 
The primary reason is to simplify the 
microscopy task and allow more 
widespread dissemination of histological analyses, even in smaller hospitals and in countries 
that lack skilled oncology pathologists. There is considerable skill involved in the processing 
and staining of tissues and fluids for investigation. But the real art is in reading the slides. 
Digital histology allows pathologists to collaborate in reviewing slides or send images to 
experts for a first reading. 
Advancements in digital imaging combined with bioinformatics tools are reshaping the 
practice of pathology. Although digital workflows are expanding, glass slides remain 

 
 
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essential in current laboratory processes, as tissue must still be collected, processed, and 
mounted before it can be digitized. Whole-slide imaging systems allow slides to be scanned 
at high resolution and integrated into digital platforms for storage, analysis, and remote 
review. 
Automation in histology has been evolving for decades, but recent progress has focused on 
linking sample preparation, staining, imaging, and reporting into more unified workflows. 
Advances in digital optics, high-capacity computing, and artificial intelligence have enabled 
more effective deployment of these systems in routine laboratory settings. As a result, digital 
pathology is moving from early adoption into broader clinical use. 
Staining procedures provide critical information about protein expression and, increasingly, 
molecular characteristics that help distinguish tissue and cell attributes associated with 
disease progression and therapeutic response. The goal is to identify clinically relevant 
biomarkers in tissue samples to guide diagnosis and treatment. While oncology remains the 
primary focus, these techniques are also used in applications such as chromosome analysis, 
infectious disease detection, and molecular characterization of tissue samples. 
Histology slide analysis has traditionally been labor-intensive, relying on microscopic 
examination by trained technologists and pathologists. Digital image capture and analysis 
have begun to change this model. Laboratories are increasingly adopting integrated solutions 
that span slide preparation, image analysis, and reporting. These systems support faster 
turnaround times, improved workflow efficiency, and greater consistency in results. 
Artificial intelligence is becoming an important component of digital pathology, assisting 
with tasks such as tumor detection, biomarker quantification, and case prioritization. While 
these tools do not replace the pathologist, they are increasingly used to support decision-
making and improve reproducibility. 

 
 
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Table 13-16: Selected Digital Pathology Image Capture and Viewing Solutions  
Company 
Location 
Details 
Status 
Applied Spectral Imaging 
USA 
GenASIs Scan & Analysis automated microscopy 
FDA 
Applied Spectral Imaging 
USA 
Version 7.2 of GenASIs, cytogenetic/pathology imaging 
RUO 
Applied Spectral Imaging 
USA 
GenASIs HiPath IHC image capture/analysis on 
microscopes  
FDA 
Bioevopeak Co., Ltd. 
China 
Digital Pathology Slide Scanner 
FDA 
Fluxion Biosciences 
USA 
CytoFlux System for imaging cytometry and analysis 
RUO 
Inspirata, Inc. (Omnyx, LLC) 
USA 
Omnyx Precision Integrated Digital Pathology Solution, 
scanner and IT 
CE 
Inspirata, Inc. (Omnyx, LLC) 
USA 
Dynamax Digital Pathology Software 
FDA 
Leica Biosystems 
Germany 
Aperio AT2 high throughput digital slide scanner 
CE 
Leica Biosystems 
Germany 
Aperio VERSA, automated digital slide scanner FISH 
RUO 
Leica Biosystems 
Germany 
Aperio LV1 digital pathology system  
RUO 
Leica Biosystems 
Germany 
mobile APiQ (Anatomic Pathology with Extra 
Intelligence)   
RUO 
Paige 
USA 
FullFocus Viewer 
FDA 
PerkinElmer 
USA 
Lamina multilabel slide scanner 
RUO 
PerkinElmer 
USA 
Panoramic P250 Flash II digital slide scanner 
RUO 
Philips 
Netherlands 
IntelliSite digital pathology solution 
CE, FDA 
Roche Diagnostics 
USA 
VENTANA iScan HT & DP 200 scanner 
CE 
Sectra AB 
Sweden 
Sectra Digital Pathology Module 
CE, FDA 
Source: Kalorama Information, company reports 
Philips expanded its digital pathology portfolio with its IntelliSite platform, which offers 
high-resolution slide scanning, image management, and workflow integration. The system is 
designed to improve efficiency and diagnostic consistency while supporting remote review 
and integration with artificial intelligence tools as pathology workloads continue to grow. 

 
 
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Clarapath acquired Crosscope, combining automated tissue sectioning and transfer with 
digital imaging and computational pathology capabilities. The integration aims to create a 
more complete, automated workflow from tissue preparation through digital analysis, 
although full end-to-end automation is still evolving. 
Leica Biosystems offers the Aperio GT 450 DX digital pathology system, a high-throughput 
whole-slide imaging platform designed for primary diagnosis. This clearance reflects the 
continued transition of digital pathology from research and archival use into routine clinical 
practice. 
Partnerships with companies such as PathAI, Proscia, and Lumea are accelerating the 
integration of artificial intelligence, advanced image analysis, and emerging techniques such 
as virtual staining into core pathology workflows. These collaborations are helping 
laboratories improve efficiency, standardization, and diagnostic support. 
Recent developments are also being driven by regulatory progress and broader healthcare 
trends. Increasing numbers of digital pathology systems are now cleared for primary 
diagnosis, enabling broader clinical adoption. At the same time, laboratories are 
implementing cloud-based and enterprise-level platforms that allow remote case review and 
collaboration across multiple sites. Workforce shortages in pathology are further accelerating 
adoption, as digital workflows enable more efficient case distribution and access to 
subspecialty expertise. Artificial intelligence is moving beyond pilot use into routine 
workflow, particularly for biomarker quantification and case prioritization. Vendors are 
developing open-platform systems that enable the integration of third-party analytical tools, 
supporting more flexible and scalable digital pathology environments. 
Market growth in digital pathology remains steady. The global market for digital imaging 
systems in histology and cytology is estimated at just over $1,275 million in 2025, with 
10.1% CAGR through 2030. North America remains the largest market, accounting for a 
significant share of adoption, while Europe and Asia are experiencing faster growth as 
regulatory approvals expand and infrastructure improves. 
The competitive landscape is led by major diagnostics and imaging companies, including 
Danaher Corporation (through Leica Biosystems), Philips, and Roche Diagnostics. Other 
important participants include Sectra, Menarini Group, Indica Labs, and Visiopharm, as well 
as a growing number of software- and AI-focused developers. 

 
 
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Table 13-17: Selected Digital Imaging Innovations 
Company 
Location 
Details 
Applied Spectral Imaging  
U.S. 
GenASIs Scan & Analysis automated microscopy 
Applied Spectral Imaging 
U.S. 
Version 7.2 of GenASIs, cytogenetic/pathology imaging 
Applied Spectral Imaging 
U.S. 
GenASIs HiPath IHC image capture/analysis on microscopes 
Cernostics (Castle 
Biosciences) 
U.S. 
TissueCypher Barrett’s Esophagus Assay, digital slide image analysis 
Clarient Diagnostic Services 
(GE Healthcare) 
U.S. 
Definiens automated image analysis software 
ClearLight Diagnostics 
U.S. 
tissue processing and imaging platform for 3D analysis 
Corista 
U.S. 
Digital Pathology Network Platform 
Dako/Agilent 
Denmark 
Omnyx image analysis with Dako HercepTest 
Fluxion Biosciences 
U.S. 
CytoFlux System for imaging cytometry and analysis 
Inspirata 
U.S. 
with Philips automated image analytics, Solution-as-a-Service 
Leica Biosystems 
Germany 
Aperio AT2 high throughput digital slide scanner 
Leica Biosystems 
Germany 
Aperio VERSA, automated digital slide scanner FISH 
Leica Biosystems 
Germany 
Aperio LV1 digital pathology system 
Leica Biosystems 
Germany 
mobile APiQ (Anatomic Pathology with Extra Intelligence)  
Leica Biosystems 
Germany 
with Mayo Clinic, fast cytogenetics imaging software 
Revvity 
U.S. 
Lamina multilabel slide scanner 
Revvity 
U.S. 
Panoramic P250 Flash II digital slide scanner 
Royal Philips 
Netherlands 
IntelliSite digital pathology solution 
TissueGnostics 
Austria 
TissueFaxs 200 scanner slides and TMAs 
Sectra Group 
Sweden 
Sectra Digital Pathology Module (for use with Leica scanner AT2 Dx) 
Source: Kalorama Information, company reports 

 
 
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Circulating Tumor Cells 
Circulating tumor cells (CTCs) are cells that detach from a primary or metastatic tumor and 
enter the bloodstream. They are thought to play a role in metastasis and are of interest as 
potential biomarkers of disease progression. Detection of CTCs offers a noninvasive 
approach to monitoring cancer, and these cells may provide insight into baseline disease 
status, treatment response, and the biology of metastasis. 
Evaluation of cancer biomarkers in blood and other accessible tissues has enabled the 
development of liquid biopsy approaches that complement traditional tissue biopsy. CTCs 
represent one component of liquid biopsy testing, alongside circulating tumor DNA (ctDNA) 
and other analytes. While blood-based sampling is less invasive and allows for repeat testing, 
tissue biopsy remains essential for initial diagnosis and comprehensive tumor 
characterization. 
Interest in CTCs has been ongoing for more than two decades. Early commercial systems, 
such as the CellSearch platform, originally developed by Veridex (now part of Johnson & 
Johnson), were the first to receive FDA clearance for monitoring patients with metastatic 
breast, colorectal, and prostate cancer. These systems primarily focused on measuring CTCs 
as a prognostic indicator, and their clinical use has remained limited to specific settings. 
Subsequent generations of CTC technologies have expanded beyond simple cell counting to 
include molecular and phenotypic characterization of captured cells. Advances in enrichment 
methods, imaging, and single-cell analysis have improved the ability to study tumor 
heterogeneity and identify clinically relevant mutations. Newer approaches enable genomic 
and transcriptomic profiling at the single-cell level, providing deeper insight into tumor 
biology and mechanisms of treatment resistance. Improved capture technologies, including 
microfluidic systems, label-free enrichment methods, and AI-based imaging, are making 
inroads, increasing detection sensitivity for these rare cells, which may occur at extremely 
low concentrations in blood. 
Recent research has also highlighted the importance of circulating tumor cell clusters, which 
may have greater metastatic potential than individual cells. In addition, CTC analysis is 
increasingly being combined with other liquid biopsy markers, such as ctDNA, to provide a 
more comprehensive assessment of disease. This multi-analyte approach reflects a broader 
shift in liquid biopsy toward integrated testing strategies. 
 

 
 
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Compared with ctDNA-based liquid biopsy approaches, CTC testing has seen slower clinical 
adoption. ctDNA assays are more widely used for mutation detection and treatment selection, 
whereas CTCs are more commonly used in research and select clinical applications. The 
clinical value of CTCs is mixed. 
Several companies continue to invest in liquid biopsy technologies, including CTC-based 
approaches, although many commercial offerings now focus more heavily on ctDNA and 
multi-analyte testing. For example, blood-based cancer detection tests such as the Avantect 
assay from ClearNote Health rely on analysis of cell-free DNA rather than CTCs, reflecting 
a broader market shift. 
Nevertheless, the market for commercial CTC tests is estimated to have grown from $100 
million in 2016 to $152 million in 2025.  CTC test services are expected to grow at a 4.0% 
compound rate. 
 
 

 
 
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 Table 13-18: Innovations in CTC Technology 
Company 
Location 
Area 
Details 
Abnova 
Taiwan 
capture 
Clear Cell CTChip 
Affymetrix 
U.S. 
cell enrich 
ScreenCells CTC isolation 
Agena Bioscience 
U.S. 
analysis 
UltraSEEK for rare cell analysis, mass spec 
Angle plc 
UK 
analysis 
cancer detection: ovarian, pr, br 
Angle plc 
UK 
capture 
Parsortix cell separation 
ApoCell (Precision for 
Medicine) 
U.S. 
capture 
ApoStream technology 
Bioaffinity Technologies 
U.S. 
analysis 
CyPath cell stain 
Biocartis 
Switzerland 
analysis 
Idylla liquid biopsy RAS biomarker, PCR 
Celsee Diagnostics 
(BioRad) 
U.S. 
analysis 
Celsee ANALYZER CTC downstream analysis 
Celsee Diagnostics 
(BioRad) 
U.S. 
smpl prep 
Celsee PREP400 CTC downstream prep 
Clearbridge BioMedics 
Singapore 
capture 
ClearCell FX System, automated CTChip 
Cynvenio Biosystems 
U.S. 
analysis 
ClearID Breast Cancer recurrence monitoring, CTC 
Cynvenio Biosystems 
(LungLife AI) 
U.S. 
analysis 
Liquid Biopsy DNA in CTC & ctDNA 
Cynvenio Biosystems 
(LungLife AI) 
U.S. 
capture 
ClearID SCORE, CTC 
DestiNA Genomics 
Scotland 
analysis 
with Master Diagnostica, Spain colon cancer liq biopsy 
EKF Molecular Diagnostics 
UK 
analysis 
CTC and cfDNA assays 
Epic Sciences 
U.S. 
analysis 
metastatic bladder cancers, CTC 
Epic Sciences 
U.S. 
analysis 
high-definition CTC microscopy 
Epic Sciences 
U.S. 
analysis 
35th collaboration pharmaceutical companies 
Exosome Diagnostics 
U.S. 
analysis 
prostate cancer predictive score, exoRNA 
Fluxion Biosciences 
U.S. 
cell enrich 
IsoFlux EMT, epithelial 

 
 
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Company 
Location 
Area 
Details 
Fluxion Biosciences (Cell 
Microsytems) 
U.S. 
Analysis 
CTC isolation IsoFlux System 
Fluxion Biosciences (Cell 
Microsystems) 
U.S. 
cell enrich 
IsoFlux System NGS sample prep 
Fraunhofer Institute 
Germany 
capture 
PoCyton cytometer miniature CTC counter 
Genomic Health 
U.S. 
analysis 
line of liquid biopsy tests 
Genyo 
Spain 
analysis 
MishCTC, miRNA in situ hybridization in CTC 
Guardant Health 
U.S. 
analysis 
Guardant360 biopsy-free cancer, CTC 
Horizon Discovery 
UK 
QC 
standards for circulating DNA tests 
IncellDx 
U.S. 
smpl prep 
IncellPrep Liquid Biopsy cell suspension: FFPE 
NeoGenomics 
UK 
analysis 
with Biodesix, Tam-Seq lung cancer, cfDNA 
NeoGenomics 
UK 
analysis 
TAm-Seq, cell free DNA: sequencing 
Janssen Diagnostics 
U.S. 
analysis 
PD-L1 immune marker 
Janssen Diagnostics 
U.S. 
analysis 
CellSearch technology for breast cancer analysis 
Janssen Diagnostics 
U.S. 
capture 
CTC-iChip CTC isolation, cytology 
Janssen Diagnostics 
U.S. 
cell enrich 
Cellsearch with Asuragen's SuraSeq panels  
Kindstar Global 
China 
analysis 
Advanced Cell CTCscope, ISH 
Labcorp 
U.S. 
analysis 
Sysmex Inostics' OncoBEAM CTC technology 
Leica Biosystems 
Germany 
analysis 
Leica's Bond RX IHC and RareCyte's AccuCyte CyteFinder  
MDxHealth 
Belgium 
analysis 
DNA methylation markers, liquid biopsy test for bladder 
cancer 
Menarini Diagnostics 
Italy 
analysis 
GluCyte, liquid biopsy processing & analysis 
Menarini Silicon 
Biosystems 
U.S. 
capture 
DEPArray NxT digital cell-sorting system 
NeoGenomics 
U.S. 
analysis 
RaDaR ST 
OvaGene Oncology 
U.S. 
POC 
rapid, POC molecular diagnostic tests microfluidic 

 
 
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Company 
Location 
Area 
Details 
ProKyma Technologies 
UK 
capture 
KymaSep POC CTC isolation 
QIAGEN 
Netherlands 
analysis 
AdnaTest Breast Cancer/ Prostate Cancer relapse 
monitor 
QIAGEN 
Netherlands 
analysis 
therascreen EGFR RGQ Plasma PCR, cfDNA 
QIAGEN 
Netherlands 
cell enrich 
AdnaGen's enrichment and molecular analysis 
QIAGEN Hanover 
Germany 
analysis 
AdnaTest Cancer kits, RNA PCR 
Rarecells Diagnostics 
France 
analysis 
ISET test, cell sizing 
RareCyte 
U.S. 
analysis 
AccuCyteSystem, CTC microscopy 
Revvity 
U.S. 
analysis 
Advanced Cell RNAscope portfolio, CTC 
Roche Diagnostics 
U.S. 
analysis 
cell-free DNA (cfDNA) technology 
Savran Technologies 
U.S. 
capture 
tumor cell detection 
ScreenCell 
France 
capture 
ScreenCell MB, DNA or RNA extraction from CTCs 
SeraCare Life Sciences 
U.S. 
QC 
cell-free circulating tumor DNA (ctDNA), NGS 
 Silicon Biosystems 
(Menarini) 
Italy 
analysis 
DEPArray, CTC molecular characterization 
Streck 
U.S. 
QC 
Cell-Free DNA BCT 
Swift Biosciences 
U.S. 
analysis 
Swift’s Accel-Amplicon panel with Fluxion IsoFlux 
Sysmex Inostics 
Germany 
analysis 
BEAMing: digital PCR and flow cytometry for CTCs 
Sysmex Inostics 
Germany 
analysis 
OncoBEAM companion tests, CTC 
Thermo Fisher Scientific 
U.S. 
smpl prep 
Cynvenio's LiquidBiopsy with Ion Chef & AmpliSeq 
Cancer Hotspot 
Source: Kalorama Information, company reports 
Flow Cytometry 
Flow cytometry has made significant advancements over the past decade, evolving from a 
tool primarily used for cell counting and basic immunophenotyping into a highly 
sophisticated platform capable of high-dimensional, multiparametric analysis and sensitive 

 
 
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detection of rare cell populations. Modern systems can analyze multiple physical and 
chemical characteristics of thousands of cells per second, with many platforms 
simultaneously detecting dozens of parameters. Flow cytometry is routinely used in the 
diagnosis and classification of hematologic malignancies, immune monitoring, such as 
CD4/CD8 testing in HIV, minimal residual disease (MRD) detection, stem cell analysis, and 
cell sorting for both clinical and research applications. 
Technology is expanding into additional applications, including advanced immune profiling, 
cell therapy development, and selected areas of infectious disease and translational research. 
While flow cytometry has potential applications in areas such as urinalysis and prenatal 
testing, its primary clinical role remains in hematology and immunology rather than solid 
tumor diagnostics. 
IHC and FISH are widely used to detect protein expression, gene alterations, and 
chromosomal abnormalities in tissue samples. However, these techniques are less suited for 
rapid, high-throughput detection of rare cells in suspension, where flow cytometry offers 
clear advantages. Flow cytometry enables analysis of large numbers of individual cells and 
can identify rare subpopulations using panels of labeled antibodies or probes. 
For applications such as minimal residual disease detection in leukemia, highly sensitive 
assays are required. Modern flow cytometry methods can detect very low levels of disease, 
often at frequencies of one abnormal cell among tens of thousands or more normal cells, 
depending on the assay design and instrumentation. 
Flow cytometry is extensively used in hematologic malignancies for diagnosis, classification, 
and disease monitoring. While there is ongoing research into its use for detecting circulating 
tumor cells in solid tumors, these applications are less established clinically compared with 
other technologies, such as molecular assays 
The global market for flow cytometry (not used exclusively in histology) is estimated at 
$1,765 million in 2025, and with 4.8% annual growth will reach $2,230 by 2030. It is beyond 
the scope of this research to estimate the share of the flow cytometry market used for cancer 
analysis.  Two companies dominate the flow cytometry industry. BD and Beckman Coulter 
together hold almost 86% of the flow market. BD is the clear leader with product sales 
estimated at roughly around $1,139 million in 2025. Both companies continue to update their 
systems and test kits to maintain complete dominance of this market.  

 
 
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Other major companies active in flow cytometry are Bio-Rad Laboratories, Sysmex, 
Diagnostics, Agilent, Diasorin and Miltenyi Biotec. 
In flow cytometry, BD's success derives from continuous product developments that make 
flow cytometry more user-friendly and flexible. BD's future strength is found in the mix of 
bead array, image and flow cytometry technologies that are now part of its holdings.  
Becton Dickinson (BD) is a leading player in the global flow cytometry market, focusing on 
simplifying workflows and expanding access to high-dimensional cell analysis. The 
company has long offered a broad portfolio of antibodies, reagents, and fluorochromes, 
including its Horizon Brilliant dye series, which supports increasingly complex multicolor 
and spectral assays. 
BD’s installed base still includes systems such as FACSCalibur and FACSCanto II, although 
newer platforms have largely replaced these in current purchasing decisions. More recent 
instruments include the FACSLyric clinical system, often paired with the FACSDuet 
automated sample preparation module, which improves workflow efficiency and 
standardization in clinical laboratories. BD also continues to expand its high-parameter 
systems, such as the FACSymphony platform, which enables the simultaneous measurement 
of dozens of cellular parameters and is widely used in advanced research and immunology 
applications. 
In recent years, BD has introduced next-generation platforms such as the FACSDiscover 
series, which combines spectral flow cytometry with real-time cell imaging capabilities. 
These systems allow cells to be analyzed not only by fluorescence but also by spatial and 
morphological characteristics, representing a significant advancement toward imaging-
enabled cytometry. 
Beckman Coulter is another major competitor, with platforms such as the CytoFLEX series 
supporting both research and clinical applications. Recent developments include spectral 
upgrade modules that expand detection capabilities and allow laboratories to enhance 
existing systems without full instrument replacement. 
Agilent Technologies has expanded its NovoCyte portfolio, including high-parameter 
systems such as the NovoCyte Penteon and newer spectral-enabled platforms such as the 
NovoCyte Opteon, which provide increasingly complex multicolor assays with expanded 
detection channels. 

 
 
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Thermo Fisher Scientific continues to offer the Attune platform, which uses acoustic focusing 
technology for high-throughput sample analysis, along with advanced sorting systems 
designed for complex and large-cell applications. 
Other key participants include Cytek Biosciences, a leader in full-spectrum cytometry with 
platforms such as the Aurora and newer Aurora Evo systems, which offer enhanced 
throughput, automation, and improved detection of small particles such as extracellular 
vesicles. Standard BioTools (formerly Fluidigm) offers mass cytometry systems such as 
CyTOF for high-dimensional single-cell analysis. 
Product development in the market has focused on spectral cytometry, higher parameter 
counts, and integration with imaging and automation. Many modern systems provide the 
simultaneous measurement of dozens of parameters, and in some cases more than 50, 
enabling detailed single-cell analysis. In addition, newer platforms are being designed to 
detect smaller particles, including extracellular vesicles and viruses, expanding the 
application range of flow cytometry beyond traditional cell analysis. 
Automation and standardization are also focal areas of innovation, with vendors introducing 
features that streamline instrument setup, quality control, and data acquisition. Integration 
with advanced computational tools and artificial intelligence is becoming increasingly 
important for managing and interpreting high-dimensional datasets. 

 
 
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The Commercial Outlook for Histology and Cytology Tests 
Histology and cytology have been fundamental components of the pathology laboratory, 
providing critical insight into the structure and function of cells, tissues, and organs. Through 
histopathological examination, a wide range of diseases, including cancer, can be identified. 
Physicians rely heavily on pathologists' diagnostic findings to determine the presence of 
malignancy and other pathological conditions, thereby guiding treatment decisions and 
prognostic evaluation. 
Recent technological advances have significantly expanded the understanding of tissue 
biology and its relationship to disease. Innovations in digital imaging, quantitative 
microscopy, artificial intelligence, and virtual histology are transforming the field. These 
tools are improving diagnostic consistency, enabling automation, and enhancing workflow 
efficiency across pathology laboratories. 
Drivers of the histology and cytology testing market include the rising global burden of 
cancer and increasing demand for automation and standardization. In addition, changes 
introduced during the COVID-19 period accelerated the adoption of digital pathology and 
remote review, supporting broader use of advanced diagnostic workflows. 
Automation of histology and cytology processes is now well established in developed 
markets and continues to expand into emerging regions, particularly in large urban centers. 
While elements of automation and digital imaging have been available for many years, recent 
advances in computing power, digital optics, and artificial intelligence have enabled more 
integrated and scalable solutions. These systems are increasingly capable of providing end-
to-end workflows from sample preparation through image analysis and reporting. 
As seen in other laboratory segments, consolidation and workflow integration are expected 
to drive adoption of platforms that can automate multiple traditional manual processes. 
However, a single platform capable of fully integrating all microscopic procedures remains 
a goal rather than a current reality, as different applications such as hematology, cytology, 
and histology often require specialized systems. 
Advances in tissue analysis techniques have also expanded the ability to isolate and study 
specific cell populations. Technologies such as laser capture microdissection allow precise 
extraction of selected cells from tissue sections, enabling downstream molecular analysis 

 
 
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using PCR, sequencing, and mass spectrometry. These approaches support a more detailed 
investigation of tumor biology and early disease changes. 
Recent developments are further expanding the capabilities of histology and cytology 
through the integration of spatial biology and multiplex analysis. New techniques allow 
simultaneous evaluation of protein and RNA expression within the same tissue section, 
providing deeper insight into tumor biology and the surrounding microenvironment. This is 
particularly important in immuno-oncology, where spatial relationships between tumor and 
immune cells can influence treatment response. In addition, histology is increasingly being 
integrated with genomic and molecular data, creating a more comprehensive diagnostic 
framework that combines morphology with molecular profiling. 
Despite the maturity of the histology and cytology segment, ongoing advances in cancer 
diagnostics continue to reshape traditional workflows. New approaches are enabling the 
detection of multiple biomarkers within a single tissue section and improving the integration 
of molecular and morphological data. Workforce constraints and the need for greater 
efficiency are also accelerating the adoption of digital and automated solutions, although cost 
and reimbursement considerations continue to influence the pace of implementation. 

 
 
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Chapter 14: Company Profiles: The Top Tier 
Scope 
These top competitors are presented in alphabetical order.  The profiles include events 
that have occurred in the past few years; they are not a comprehensive review or history 
of the companies selected to appear in the section. For this update, all companies and 
product segments were reviewed for any innovative products. New and innovative 
information was gleaned for 2025 and the first half of 2026 to help industry participants 
to see what is trending in product and company releases.   However, some company 
segments revealed no significant new product developments.  
 
 

 
 
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Abbott Diagnostics 
Abbott Park, IL 60064 
www.abbott.com 
Table 14-1: Abbott Diagnostics Revenue History, 2023-2025 ($ million) 
 
2023 
2024 
2025 
Total Dx 
15,749 
15,426 
16,935 
Source: company reports, Kalorama Information 
The United States garnered about 40% of sales and the other 60% was garnered by non-
United States areas.  
The following is Kalorama’s estimated breakdown of Abbott's revenue in selected test 
segments: 
Table 14-2: Abbott Diagnostic Revenues, by Segment, 2023-2025 ($ million, estimated) 
Segment 
2023 
2024 
2025 
YoY Growth  
2024-2025 
Diabetes 
5,761 
6,085 
7,998 
31.4% 
Core Laboratory 
5,159 
5,235 
5,360 
2.4% 
Rapid & Alere 
3,692 
2,997 
2,454 
-18.1% 
Molecular 
995 
521 
517 
-0.8% 
Point of Care 
525 
588 
606 
3.1% 
Total 
16,132 
15,426 
16,935 
9.8% 
Source: Kalorama Information 
 

 
 
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Abbott Diagnostics focuses on infectious disease testing, with a significant portion of its sales 
generated in the European Union, emerging markets, and the U.S. The company is preparing 
for the future with the development of next-generation systems, informatics to help labs 
manage and retrieve test data, new infectious disease diagnostics, and gene-based oncology 
tests for targeted therapeutics. Abbott's diabetes care attained worldwide sales of $7,998 
million in 2025.  
The core lab revenues increased 2.4%. Rapid diagnostics decreased 18.1% due to lower 
COVID-19 sales and challenging market conditions in China, while molecular increased 
0.7%. 
Abbott entered into a partnership with Medtronic to develop an integrated CGM system based 
on FreeStyle Libre technology that will connect with Medtronic’s automated insulin-delivery 
and smart insulin-pen systems.  
In November 2025, Abbott Laboratories announced a definitive agreement to acquire Exact 
Sciences, expanding Abbott’s diagnostic portfolio in oncology and cancer screening. The 
acquisition is expected to strengthen Abbott’s precision diagnostics segment by integrating 
Exact Sciences' cancer screening and precision oncology diagnostic portfolio. Exact Sciences 
announced in mid-2025 that it exceeded 20 million cumulative Cologuard tests. This 
acquisition, completed in March 2026, will add a robust oncology franchise to Abbott's 
diagnostic segment, creating new growth opportunities. Exact Sciences will benefit from 
Abbott’s deep global commercial infrastructure and broad international presence in the IVD 
market. 
Core Lab 
Abbott Laboratories maintains a comprehensive core laboratory diagnostics portfolio 
spanning clinical chemistry, immunoassay, hematology, molecular diagnostics, and blood 
screening systems. The company’s ARCHITECT family of instruments continues to be 
widely used globally for clinical chemistry and immunoassay testing across multiple disease 
areas, including cardiovascular, infectious disease, oncology, endocrine, fertility, and 
metabolic disorders. A substantial installed base of ARCHITECT systems remains in 
operation, often alongside Abbott’s newer platforms. 
Abbott’s core laboratory focus is the Alinity family of harmonized diagnostic systems, 
designed to improve laboratory efficiency through higher throughput, faster turnaround 

 
 
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times, and streamlined workflows. The Alinity platform features standardized system 
architecture and a common user interface across disciplines, enabling laboratories to simplify 
operations, training, and instrument management. 
The Alinity ci-series integrates clinical chemistry and immunoassay testing through the 
Alinity c clinical chemistry analyzer and the Alinity i immunoassay analyzer. These systems 
can operate independently or as a modular, integrated solution, allowing laboratories to scale 
testing capacity while optimizing space and workflow. 
Abbott’s hematology portfolio includes the Alinity h-series, which combines automated 
hematology analysis with slide preparation and staining capabilities. These systems support 
complete blood count testing with advanced multi-parameter analysis and rapid turnaround 
times, thereby improving laboratory productivity and diagnostic consistency. 
In molecular diagnostics, the Alinity m system provides a fully automated, real-time PCR–
based platform for high-throughput, random-access testing. The system supports continuous 
sample loading, STAT prioritization, and an expanding menu of molecular assays, including 
infectious disease testing for viruses and sexually transmitted infections. 
Abbott’s core laboratory portfolio also includes blood and plasma screening systems under 
the Alinity s platform, supporting high-volume donor screening, as well as integrated 
informatics and workflow solutions. AlinIQ and Alinity PRO software provide centralized 
system monitoring, data analytics, and workflow optimization, enabling laboratories to 
improve operational efficiency and instrument utilization across networks. 
Abbott continues to expand assay menus across its core platforms, particularly in 
immunoassay and clinical chemistry, including advanced cardiac biomarkers such as high-
sensitivity troponin I assays used for early detection and risk assessment of myocardial 
infarction. These assays are broadly available across both ARCHITECT and Alinity systems. 
Hematology 
Abbott’s Alinity h-series is a next-generation hematology solution that integrates high-
throughput complete blood count (CBC) testing with automated slide preparation and 
staining. The system combines the Alinity hq hematology analyzer with the Alinity hs slide 
maker and stainer, creating a harmonized workflow that improves laboratory efficiency while 
reducing manual intervention. 

 
 
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The Alinity hq analyzer delivers a complete blood count with a 6-part white blood cell 
differential, reticulocyte testing capability, and multiple advanced hematologic parameters. 
The analyzer uses Abbott’s proprietary Advanced Multi-Angle Polarized Scatter Separation 
technology, which applies multiple light-scatter measurements at additional angular intervals 
to improve differentiation and classification of white blood cells, red blood cells, and platelets 
as cells pass through the optical detection chamber. 
Abbott’s hematology technology also incorporates advanced computational analysis, 
including machine-learning-based cell classification algorithms, Gaussian Mixture 
Modeling, and Graph Adaptive Clustering to improve abnormal cell recognition, flagging 
performance, and analytical precision. These digital classification tools enhance cell 
population separation and support improved detection of clinically significant abnormalities. 
The integrated Alinity hs module automates blood smear preparation and staining, enabling 
a fully connected hematology workflow from sample loading through slide production. 
Combined, the Alinity h-series system can process approximately 119 CBC tests per hour, 
supporting medium- to high-volume laboratories. 
For selected international markets, Abbott also offers the CELL-DYN Emerald 22 AL, a 
compact automated hematology analyzer designed for small- to mid-sized laboratories. This 
analyzer provides a 5-part differential and remains available in certain regions, although 
commercial availability varies by country, and the system is not broadly positioned in the 
U.S. market. 
Blood Banking 
Abbott markets its Alinity s blood and plasma screening system, which has become a major 
component of the company’s transfusion diagnostics portfolio. The Alinity s System is 
designed to improve blood and plasma screening efficiency through a compact footprint, high 
assay throughput, and increased automation compared with earlier-generation blood 
screening platforms. The system supports continuous loading of samples and reagents, 
automated maintenance functions, and reduced operator intervention, helping blood centers 
and plasma collection laboratories improve workflow productivity while maintaining high 
analytical accuracy and traceability. 
The Alinity platform uses chemiluminescent immunoassay technology for screening donated 
blood and plasma for infectious disease markers, including HIV, hepatitis B, hepatitis C, 

 
 
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HTLV, syphilis, and other transfusion-transmissible infections, depending on regional 
regulatory approvals. Abbott positions the system as part of an integrated blood screening 
solution, alongside its molecular screening platforms, enabling blood centers to standardize 
operations across serology and nucleic acid testing workflows. 
Abbott has also explored digital donor engagement technologies, including immersive 
mixed-reality and virtual reality experiences designed to improve donor comfort and 
engagement during blood donation sessions, particularly to encourage participation among 
younger donor populations. These programs have been introduced in selected blood donation 
initiatives and pilot collaborations as part of broader efforts to improve donor recruitment 
and retention, although they are not a primary commercial product within Abbott’s 
diagnostics portfolio. 
 Infectious Diseases – Molecular 
Abbott is a global leader in immunoassay diagnostics and has extended this expertise into 
molecular diagnostics through a broad portfolio of nucleic acid amplification technologies. 
The company has expanded its molecular testing menu, with strategic emphasis on infectious 
disease, sexual health, oncology, transplant monitoring, and blood screening. Abbott 
Molecular develops assays that analyze DNA and RNA targets at the molecular level, 
supporting clinical decision-making in infectious disease management, women’s health, 
transplantation, and selected genetic applications. 
Abbott’s molecular portfolio includes the widely installed m2000 RealTime system, which 
supports real-time PCR assays for HIV-1, HBV, HCV, Chlamydia trachomatis/Neisseria 
gonorrhea, CMV, and other infectious disease targets. Abbott also markets sequencing-based 
products, including the ViroSeq HIV-1 Genotyping System, which historically played an 
important role in antiretroviral resistance testing, although sequencing strategies in many 
laboratories have increasingly shifted toward next-generation sequencing technologies. 
The company also offers the m2000 platform with its Alinity m molecular diagnostics 
system. Alinity m uses fully automated real-time PCR technology with ReadiFlex random-
access sample handling, continuous loading, and STAT prioritization, allowing laboratories 
to run multiple assay types simultaneously with high workflow flexibility. 
Abbott continues to offer molecular viral load assays for HIV-1, HBV, HCV, and CMV, 
including the Abbott RealTime CMV assay, which remains important in transplant medicine. 

 
 
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The CMV assay amplifies two conserved genomic regions of cytomegalovirus to reduce the 
risk of under-quantification due to viral mutations and is standardized to the World Health 
Organization International Standard for CMV nucleic acid testing, thereby supporting the 
management of transplant patients undergoing antiviral therapy. 
A major area of Abbott’s molecular expansion is sexual health testing. The Alinity m STI 
assay simultaneously detects Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas 
vaginalis, and Mycoplasma genitalium in a single multiplex molecular assay, enabling 
comprehensive sexually transmitted infection screening from a single sample and improving 
laboratory efficiency. 
Abbott also markets the Alinity m high-risk HPV assay; a molecular test used for cervical 
cancer screening and detection of high-risk human papillomavirus genotypes associated with 
cervical cancer. The assay identifies HPV 16 and HPV 18 individually while simultaneously 
detecting 12 additional high-risk HPV genotypes in pooled groups, supporting primary HPV 
screening, co-testing with cytology, and triage of atypical cervical cytology results. The assay 
is approved in multiple global markets, including the U.S. and Europe. 
Abbott continues to expand the Alinity m menu with assays across infectious disease, 
virology, blood screening, and women’s health, positioning molecular diagnostics as a major 
long-term growth driver within its core laboratory business.  
Diabetes 
Abbott’s advanced continuous glucose monitoring portfolio is led by the FreeStyle Libre 
family of biosensor systems, which has become one of the world’s largest continuous glucose 
monitoring franchises. The system uses a small wearable sensor applied to the back of the 
upper arm to continuously measure interstitial glucose levels without routine fingerstick 
calibration. Abbott’s factory-calibrated sensor technology remains a major differentiator, 
eliminating the need for routine finger-prick calibration while providing continuous glucose 
data for diabetes management. 
Abbott’s current CGM portfolio includes FreeStyle Libre 2, FreeStyle Libre 2 Plus, FreeStyle 
Libre 3, and next-generation expanded Libre platforms, with sensors designed to provide up 
to 14 days of continuous wear. The FreeStyle Libre 3 system delivers glucose readings 
automatically to a smartphone every minute and remains one of the smallest and thinnest 

 
 
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commercially available CGM sensors. Abbott continues to position Libre 3 as a high-
accuracy, low-profile sensor priced comparably to earlier Libre generations. 
The FreeStyle LibreLink mobile application remains central to Abbott’s digital diabetes 
ecosystem, allowing users to view current glucose readings, trend arrows, historical glucose 
patterns, and alarms directly on smartphones. Smartphone connectivity is now standard 
across Abbott’s current Libre systems, and users can share glucose data with caregivers and 
healthcare professionals through Abbott’s connected digital platforms. 
Abbott’s FreeStyle Libre 2 and Libre 3 systems include optional real-time low- and high-
glucose alarms and are widely reimbursed across major markets, including Medicare in the 
United States for eligible patients with insulin-treated diabetes. The Libre systems are 
broadly distributed through retail pharmacy channels and diabetes care providers worldwide. 
Abbott has expanded Libre integration into automated insulin delivery systems through 
partnerships with insulin pump manufacturers. In the United States, FreeStyle Libre 2 Plus 
is integrated with the Tandem Diabetes Care t:slim X2 insulin pump, marking Abbott’s first 
U.S. automated insulin-delivery integration. Abbott also maintains an integration partnership 
with Insulet Corporation for future automated insulin-delivery applications. In Europe, 
FreeStyle Libre 3 sensors are compatible with Ypsomed mylife Loop and CamDiab systems, 
supporting closed-loop insulin delivery. 
 The company offers Lingo, an over-the-counter consumer glucose biosensor designed for 
adults seeking metabolic insights, personalized coaching, and wellness monitoring. Abbott 
also introduced Libre Rio, an over-the-counter CGM designed for adults with Type 2 diabetes 
who are not using insulin and manage their glucose through diet, exercise, and oral therapies. 
Abbott also markets the Libre Sense Glucose Sport Biosensor, developed for athletes seeking 
real-time glucose monitoring during exercise and performance training. 
Abbott continues to develop next-generation biosensors, including dual-analyte sensors 
capable of monitoring glucose together with ketones, reflecting the company’s long-term 
strategy to expand beyond glucose monitoring into broader metabolic and chronic disease 
management. 

 
 
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HIV Point of Care 
Abbott introduced one of the world’s first licensed HIV blood screening tests in 1985, 
establishing an early leadership position in HIV diagnostics that continues today across 
laboratory, blood screening, molecular, and point-of-care testing. Abbott’s current HIV 
portfolio includes assays for screening, diagnosis, viral load monitoring, treatment 
management, and digital connectivity, with products designed for both centralized 
laboratories and decentralized care settings. The company continues to invest in HIV testing 
as part of its broader infectious disease diagnostics strategy, particularly in support of global 
HIV treatment programs and underserved healthcare regions. 
Abbott’s laboratory HIV portfolio includes high-throughput immunoassays on its 
ARCHITECT, Alinity i, and Alinity s platforms, as well as molecular viral load assays on 
the Alinity m system for monitoring treatment response and disease progression. Abbott’s 
molecular HIV assays are widely used for viral load quantification and support antiretroviral 
therapy monitoring in both developed and emerging healthcare markets. 
A major component of Abbott’s POC HIV strategy is the m-PIMA HIV-1/2 VL, a portable 
molecular point-of-care viral load test designed for use in remote and underserved 
communities. The m-PIMA HIV-1/2 VL is a quantitative nucleic acid amplification test that 
measures viral load for HIV-1 groups M, N, and O, as well as HIV-2, directly from plasma 
samples. 
The system is designed for POC testing and can deliver quantitative viral load results in less 
than 70 minutes, allowing healthcare providers to make treatment decisions during the same 
patient visit. Abbott positions the platform as an important tool for reducing patient loss to 
follow-up, improving treatment adherence, and expanding viral load monitoring access in 
decentralized healthcare environments. 
The m-PIMA platform is particularly important in global HIV programs supported by 
international public health organizations, where rapid viral load monitoring is essential for 
treatment management in resource-limited settings. 
i-STAT Business 
Abbott’s point-of-care diagnostics portfolio is designed to provide healthcare professionals 
with immediate access to rapid, clinically actionable test results directly at the site of patient 

 
 
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care. The company’s flagship point-of-care platform is the i-STAT Alinity System, a 
handheld blood analysis system that delivers laboratory-quality results within minutes using 
small whole blood samples obtained at the bedside. 
The i-STAT Alinity System uses single-use, test-specific cartridges that require only two to 
three drops of whole blood. After sample application, the cartridge is inserted into the 
handheld analyzer, where fully self-contained microfluidic and biosensor technology 
performs the test without additional preparation. Results are typically available in two to ten 
minutes, depending on the assay. 
Abbott’s cartridge menu includes tests for blood gases, electrolytes, chemistries, cardiac 
markers, coagulation, hematology, lactate, glucose, and renal function, supporting use in 
emergency medicine, critical care, operating rooms, ambulances, urgent care settings, and 
hospital bedside testing. The system remains widely used where rapid decision-making is 
critical. 
The i-STAT Alinity platform also incorporates wireless connectivity and data integration 
capabilities, allowing results to be transmitted directly into hospital information systems and 
electronic medical records, improving workflow efficiency and reducing transcription errors. 
Abbott has expanded beyond traditional bedside chemistry testing with specialized rapid 
assays such as the i-STAT TBI Plasma, a plasma-based test used to assist in evaluating mild 
traumatic brain injury. The assay measures brain injury biomarkers and provides results in 
approximately 15–18 minutes, helping clinicians assess whether CT imaging may be 
necessary. 
Unlike i-STAT cartridge-based bedside assays, the i-STAT TBI Plasma test is performed on 
Abbott’s central laboratory immunoassay platforms, including the ARCHITECT and Alinity 
i systems, linking Abbott’s point-of-care and core laboratory strategies in acute care 
diagnostics. 
Abbott continues to expand its point-of-care testing portfolio by integrating rapid diagnostics, 
connectivity, and handheld testing across acute care, outpatient, and decentralized healthcare 
environments. 
Abbott markets the STAT TBI  test to be used with whole blood. This will enable testing to 
be performed in a variety of healthcare settings including on the sidelines of  sporting events. 

 
 
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The test is run on the i-Stat Alinity analyzer and measures two biomarkers – UCH-L1 and 
GFAP.  
 
 

 
 
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Agilent Technologies 
Santa Clara, CA 
www.agilent.com 
Table 14-3: Agilent Revenue History, 2023-2025 ($ million) 
  
2023 
2024 
2025 
Total Life Sciences and Diagnostics 
2,780 
2,466 
2,726 
Source: company reports, Kalorama Information 
Agilent operates three principal business segments: Life Sciences and Diagnostics Markets, 
Agilent CrossLab, and Applied Markets. This reporting structure replaced the earlier 
segmentation that included a separate Diagnostics and Genomics business, with the 
reorganization beginning in fiscal 2025 to align diagnostics, genomics, and life science 
activities more closely within a single operating segment. In fiscal 2025, Life Sciences and 
Diagnostics Markets became one of Agilent’s strongest growth areas, supported by 
pathology, companion diagnostics, genomics, and biopharma-related demand. 
The Life Sciences and Diagnostics Markets segment includes a broad portfolio of clinical, 
genomic, and analytical technologies supporting pharmaceutical development, clinical 
diagnostics, and biomedical research. Major product areas include pathology products, 
specific proteins and flow reagents, companion diagnostics, target enrichment technologies, 
cytogenetic research solutions and microarrays, PCR and qPCR instrumentation and 
molecular biology reagents, nucleic acid analysis solutions, and automated electrophoresis 
and microfluidics platforms. 
Agilent’s pathology business, largely derived from Dako, includes routine and advanced 
clinical solutions for tissue-based cancer diagnostics. These solutions comprise antibodies, 
reagents, staining instruments, image analysis software, and workflow systems used in both 
primary and advanced oncology diagnostics. The CoverStainer and Artisan product families 
support primary cancer diagnostics through hematoxylin and eosin (H&E) staining and 
special stains used for tissue characterization and identification of abnormal or malignant 

 
 
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tissue. Agilent’s pathology portfolio also includes immunohistochemistry (IHC), in situ 
hybridization (ISH), and companion diagnostic assays used in precision oncology. 
Agilent remains a leader in commercial lab-on-a-chip microfluidics technology, an area 
established through its early development of integrated microfluidic platforms. Lab-on-a-
chip systems enable sample handling, mixing, dilution, electrophoresis, chromatographic 
separation, staining, and detection on miniaturized integrated systems. Agilent’s chips are 
processed using the Agilent 2100 Bioanalyzer platform and continue to be widely used for 
DNA, RNA, protein, and cell analysis in research, translational medicine, and selected 
clinical laboratory workflows. 
Agilent’s microfluidic and array technologies continue to support molecular diagnostics. For 
example, Agendia uses Agilent microarray technology in its MammaPrint breast cancer 
recurrence assay, which remains an FDA-cleared genomic profiling test used in oncology 
decision support. 
Through a series of mergers and acquisitions, Agilent expanded into a diversified life 
sciences and diagnostics company serving analytical laboratories and clinical markets 
through technology platforms that include automation, bioreagents, fluorescence in situ 
hybridization 
probes, 
chromatography, 
immunohistochemistry, 
informatics, 
mass 
spectrometry, microarrays, sequencing support technologies, and spectroscopy. 
Agilent’s CrossLab business provides laboratory services and consumables including 
enterprise asset management, laboratory informatics, equipment service, software 
maintenance, regulatory compliance support, sample preparation products, genomics 
reagents, chromatography columns, spectroscopy supplies, and general laboratory 
consumables. CrossLab is important because it provides recurring revenue and broad 
customer penetration across pharmaceutical, academic, and clinical laboratory markets. 
Mergers and acquisitions continue to support Agilent’s long-term strategy. Recent important 
acquisitions include Advanced Analytical Technologies, Lasergen, Genohm, ACEA 
Biosciences, and Avida Biomed, which strengthened Agilent’s genomics and target 
enrichment capabilities. 
In diagnostics and clinical markets, Agilent offers pathology laboratories globally, with 
strongest penetration in North America, Western Europe, and Japan. Emerging markets 
continue to increase investment in pathology, oncology testing, and molecular diagnostics. 

 
 
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Agilent’s genomics business includes arrays for DNA mutation detection, genotyping, copy 
number analysis, gene rearrangement analysis, methylation profiling, gene expression 
profiling, and next-generation sequencing target enrichment. These technologies support 
translational research, biomarker development, and clinical laboratory testing for inherited 
disease and oncology. 
Its nucleic acid solutions business provides equipment and expertise for synthesis of 
oligonucleotides under pharmaceutical GMP conditions for use as active pharmaceutical 
ingredients in nucleic acid therapeutics, including siRNA, antisense, and gene editing 
applications. 
Agilent collaborates with pharmaceutical companies to develop companion diagnostics. The 
company continues partnerships in precision oncology and digital pathology, including work 
with PathAI to integrate AI algorithms into companion diagnostic assay development and 
with Theragen Bio to support comprehensive genomic profiling using Agilent’s SureSelect 
Cancer CGP Assay platform. 
Agilent also markets an on-deck thermal cycler integrated with the Agilent Bravo automated 
liquid handling system to support next-generation sequencing workflows, improving 
automation in molecular biology and genomic sample preparation. 
The company has a collaboration with Incyte to develop advanced companion diagnostics in 
hematology and oncology. This allows Agilent to expand its companion diagnostic portfolio 
with novel biomarkers.  
In March 2026, Agilent entered into an agreement to acquire Biocare Medical. Biocare is a 
pathology antibody provider. The acquisition will strengthen Agilent’s pathology portfolio 
and expand its footprint in the United States. The transaction is expected to be final by Q4 
2026.  
Genomics 
Agilent’s genomics business includes arrays for DNA mutation detection, genotyping, gene 
copy number determination, identification of gene rearrangements, DNA methylation 
profiling, gene expression profiling, and next-generation sequencing (NGS) target 
enrichment. Agilent remains a major supplier of target-enrichment technologies for research, 

 
 
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translational genomics, and clinical oncology workflows, with its SureSelect portfolio 
continuing to be one of the company’s strongest genomics franchises. 
SureSelect target-enrichment solutions enable highly focused sequencing of genomic regions 
of interest through custom-designed oligonucleotide capture chemistry. The platform 
supports somatic oncology testing, inherited disease analysis, whole-exome sequencing, and 
comprehensive genomic profiling. Agilent has increasingly positioned SureSelect for both 
translational research and clinical laboratory use, with workflows optimized for high-
throughput sequencing and automation. 
The older HaloPlex chemistry is part of Agilent’s historical targeted sequencing portfolio, 
but SureSelect has become the dominant platform in current commercial genomics strategy, 
particularly for higher-complexity oncology and precision medicine applications. SureSelect 
workflows generate sequencing-ready libraries with streamlined sample preparation and 
compatibility across major sequencing platforms. 
Agilent’s microarray portfolio continues to include SurePrint technology for genome-wide 
gene expression analysis, copy number variation studies, and cytogenetic research 
applications. Array-based offerings support copy number assessment, SNP analysis, 
methylation studies, and cytogenomic interpretation in both research and selected clinical 
laboratory settings. 
Agilent also maintains a strong fluorescence in situ hybridization portfolio through 
SureFISH, which uses synthetic oligonucleotide probe technology for highly specific 
chromosomal analysis. SureFISH probes are widely used in cytogenetics, oncology research, 
and pathology workflows requiring targeted gene rearrangement detection. 
Agilent SureFISH probes are marketed as Class I analyte specific reagents (ASRs) in the 
United States and are supported by complementary arrays, scanners, and Agilent 
CytoGenomics software for chromosomal analysis and interpretation. The probe menu 
includes break-apart assays targeting clinically important oncology markers such as ALK, 
ROS1, and RET, which remain relevant in lung cancer biomarker assessment and 
translational oncology research. 
For nucleic acid quality assessment and workflow control, Agilent markets the Agilent 2100 
Bioanalyzer and TapeStation systems, both of which are widely used for DNA and RNA 
quantitation, integrity assessment, and sequencing library quality control in genomics 
laboratories. 

 
 
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Cytogenetic Analysis 
Agilent is a leading provider of microarray-based cytogenetic solutions, particularly for 
comparative genomic hybridization (CGH) and single nucleotide polymorphism (SNP)-
based chromosomal analysis used in cytogenetics laboratories, reproductive genetics, and 
research settings. Agilent arrays enable genome-wide detection of copy number alterations 
at high resolution, ranging from whole chromosome abnormalities to microdeletions and 
microduplications associated with constitutional and oncologic disorders. 
The company’s array portfolio supports multiple array formats, allowing laboratories to 
select different probe densities, resolutions, and sample throughput configurations depending 
on clinical or research requirements. Arrays can also be customized using SureDesign, which 
allows laboratories and researchers to design targeted probe content for specialized genomic 
applications. 
In addition to microarrays, Agilent provides a full cytogenetics workflow that includes 
sample preparation reagents, labeling kits, hybridization systems, scanning hardware, and 
interpretation software. This integrated workflow includes Agilent CytoGenomics for 
visualization, copy number analysis, and chromosomal interpretation. 
Agilent’s cytogenetics portfolio also includes SureFISH, a line of synthetic oligonucleotide 
fluorescence in situ hybridization probes used in cytogenetics, cancer research, and 
pathology laboratories. SureFISH probes remain important for targeted gene rearrangement 
analysis and chromosomal localization studies, with probe menus including clinically 
important oncology targets such as ALK, ROS1, and RET. 
SureScan Dx Microarray Scanner remains an important regulated platform in Agilent’s 
cytogenetics offering. The CE-marked system is intended for use in clinical laboratory 
environments for measuring fluorescence signals of labeled DNA or RNA hybridized to 
microarrays used within validated diagnostic workflows. The scanner continues to support 
both cytogenetics and translational genomic applications. 
Agilent also continues to market GenetiSure Dx Postnatal Assay for detection of genomic 
aberrations associated with developmental delay, intellectual disability, congenital 
anomalies, and unexplained dysmorphic features. The assay is performed on the SureScan 
Dx platform and remains one of Agilent’s primary regulated chromosomal microarray 
offerings for postnatal constitutional testing. 

 
 
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In reproductive genomics, Agilent continues to offer OnePGT, a genome-wide next-
generation sequencing solution for preimplantation genetic testing (PGT). OnePGT supports 
simultaneous detection of monogenic disorders (PGT-M), structural rearrangements (PGT-
SR), and aneuploidies (PGT-A) from a single embryo biopsy, enabling embryo prioritization 
and reproductive decision support in assisted reproduction laboratories. 
While microarrays remain important in cytogenetics, Agilent’s strategic growth emphasis in 
2026 increasingly centers on NGS target enrichment, reproductive genomics, oncology 
profiling, and integrated cytogenomic interpretation workflows, where array and sequencing 
technologies increasingly complement one another. 
Sequencing 
Agilent entered into several licensing and strategic technology agreements over the last 
several years to strengthen its portfolio of clinical next-generation sequencing products, 
particularly in target enrichment, molecular barcoding, and ultra-sensitive variant detection. 
These agreements expanded Agilent’s ability to support high-sensitivity somatic mutation 
analysis, liquid biopsy workflows, and comprehensive genomic profiling applications. 
SureSelect XT HS remains one of Agilent’s core advanced target-enrichment platforms. The 
SureSelect XT HS workflow incorporates molecular barcode technology (unique molecular 
identifiers, UMIs) that improve detection of low-frequency variants by reducing sequencing 
artifacts and increasing confidence in rare mutation calling. This molecular barcode 
capability was strengthened through licensing agreements involving patented barcode 
technologies used in population genetics and precision oncology workflows. 
Agilent continues to market the SureSelect Cancer CGP Assay as a major oncology 
sequencing solution for somatic variant profiling of solid tumors. The assay is designed for 
comprehensive genomic profiling and includes a broad hybrid-capture NGS panel covering 
hundreds of cancer-related genes for detection of SNVs, indels, CNVs, and gene 
rearrangements. Agilent has continued refining this platform for translational oncology, 
biomarker discovery, and companion diagnostic development, including collaborations with 
pharmaceutical and software partners. 
Agilent no longer owns Resolution Bioscience. Agilent divested Resolution Bioscience to 
Exact Sciences, allowing Exact Sciences to expand its precision oncology and liquid biopsy 
portfolio. Resolution Bioscience had developed next-generation sequencing oncology 

 
 
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solutions focused on liquid biopsy, fusion detection, and targeted cancer profiling, and these 
technologies now contribute to Exact Sciences’ oncology testing strategy. 
The divestiture reflects Agilent’s broader strategy to focus internal genomics growth on 
SureSelect target enrichment, companion diagnostics partnerships, cytogenomics, and 
clinical laboratory workflow technologies, rather than directly operating a standalone 
oncology testing business. 
CRISPR 
Agilent provides a sophisticated suite of CRISPR research tools through its SureGuide 
CRISPR portfolio, designed to support genome editing, functional genomics, and high-
throughput screening applications. The SureGuide offering includes custom and pre-
designed CRISPR libraries for gene knockout, gene activation, and gene repression studies 
used in oncology research, drug discovery, and broader life sciences applications. 
Every SureGuide CRISPR library is synthesized using Agilent’s SurePrint DNA synthesis 
platform, which enables highly parallel production of complex oligonucleotide pools with 
very high sequence fidelity and uniform library representation. SurePrint technology allows 
simultaneous synthesis of billions of DNA bases, supporting accurate guide RNA library 
construction with strong reproducibility across large-scale screening experiments. 
Agilent continues to position SureGuide within its broader genomics workflow by integrating 
CRISPR library synthesis with target enrichment, oligonucleotide manufacturing, and 
nucleic acid quality-control platforms, allowing researchers to move efficiently from guide 
design through downstream sequencing validation 
Flow Cytometry 
Agilent’s flow cytometry business has limited direct participation in routine clinical 
diagnostics compared with major clinical flow cytometry suppliers, but its platforms 
increasingly support clinical diagnostic development, translational pathology, and 
laboratory-developed testing environments, particularly in oncology and hematology. 
The flow cytometry portfolio, developed through the acquisition of ACEA Biosciences, is 
marketed under the NovoCyte brand and includes systems used in hospital-based specialty 

 
 
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laboratories, cancer centers, and reference laboratories where advanced cellular analysis 
supports diagnostic decision-making and biomarker evaluation. 
NovoCyte Opteon Spectral Flow Cytometer provides spectral flow cytometry with 
configurations ranging from three to five lasers and support for up to 73 detection channels, 
allowing detailed cellular characterization in complex hematology and immunology 
applications. In clinical diagnostic environments, spectral flow cytometry is increasingly 
valuable for high-complexity immunophenotyping, rare-cell analysis, and expanded marker 
panels used in hematologic malignancy assessment. 
Agilent’s flow systems are most relevant clinically in: 
• leukemia and lymphoma immunophenotyping 
• minimal residual disease assessment 
• immune status monitoring 
• transplant-related immune analysis 
• oncology biomarker validation 
• cellular characterization for advanced laboratory-developed tests 
NovoCyte Penteon and NovoCyte Quanteon also support multiparameter cellular assays in 
specialty clinical laboratories where laboratories require flexible panel design and high 
analytical sensitivity. 
Although Agilent does not currently dominate the regulated clinical flow cytometry segment 
led by Becton Dickinson and Beckman Coulter, its instruments increasingly support clinical 
research and diagnostic assay development linked to precision medicine, particularly where 
high-dimensional cell analysis is needed alongside molecular and pathology workflows. 
Agilent’s broader clinical diagnostics strategy positions flow cytometry as a complementary 
technology to its pathology, genomics, and companion diagnostic businesses, especially in 
oncology where cellular phenotyping and genomic profiling increasingly converge. 

 
 
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Companion Diagnostics - Dako 
Agilent acquired Dako for $2.2 billion in 2012, and the acquisition remains one of the most 
important strategic moves in Agilent’s expansion into clinical pathology and companion 
diagnostics. Dako is now fully integrated into Agilent’s pathology and diagnostics business 
rather than operating as a separate subsidiary, and it continues to serve as the foundation of 
Agilent’s tissue-based cancer diagnostics franchise. 
Dako established a leadership position in tissue-based cancer diagnostics and companion 
diagnostics through early innovation in immunohistochemistry, including introduction of 
some of the first conjugated antibodies used in pathology workflows. Over time, the portfolio 
expanded into immunohistochemistry (IHC), in situ hybridization (ISH), fluorescence in situ 
hybridization (FISH), chromogenic in situ hybridization (CISH), special stains, image 
analysis, and automated pathology workflow systems. 
The pharmDx brand remains Agilent’s core companion diagnostic platform for tissue-based 
oncology assays. pharmDx assays are designed to identify patients eligible for targeted 
therapies or immunotherapies and remain central to Agilent’s precision oncology strategy. 
Agilent’s pathology portfolio includes antibodies, ISH probes, staining systems, and 
automation platforms. Older systems such as TechMate and ChemMate are largely legacy 
technologies, while the current core automation platform is Dako Omnis, which serves as 
Agilent’s flagship high-throughput pathology staining and companion diagnostics 
instrument. Dako Omnis supports integrated immunohistochemistry, ISH, and advanced 
tissue staining workflows in clinical pathology laboratories. 
Agilent continues to market major PD-L1 companion diagnostic assays under the pharmDx 
portfolio. PD-L1 IHC 22C3 pharmDx remains one of the most widely used companion 
diagnostics globally and supports multiple indications linked to Merck & Co.’s Keytruda 
across non-small cell lung cancer, urothelial carcinoma, gastroesophageal cancers, and 
additional solid tumor indications. 
PD-L1 IHC 28-8 pharmDx is an important complementary diagnostic linked to Bristol Myers 
Squibb’s Opdivo and supports expanded use in multiple oncology indications including 
urothelial carcinoma, esophageal squamous cell carcinoma, and head and neck cancers. 
Agilent also expanded its in situ hybridization portfolio. SureFISH probes offer oncology 
and cytogenetic applications with break-apart and dual-fusion assays targeting clinically 

 
 
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important markers including MALT1, BCL2, BCL6, CCND1, MYC, and IGH 
rearrangements. Agilent also maintains chromogenic ISH offerings, including EBER RNA 
CISH and kappa/lambda mRNA probes for tissue-based hematopathology applications. 
The company markets accessory systems that extend Dako Omnis workflow flexibility, 
allowing combined IHC and ISH workflows on a single platform. These technologies support 
increasingly complex pathology workflows that require multiplex biomarker assessment. 
Agilent strengthened digital pathology collaboration through its agreement with Visiopharm, 
under which both companies co-market AI-driven pathology image analysis solutions. This 
partnership supports the adoption of digital pathology, biomarker quantification, and 
companion diagnostic interpretation in oncology laboratories. 
Agilent’s companion diagnostic strategy also includes pharmaceutical collaborations beyond 
checkpoint inhibitors. The company maintains development agreements with oncology drug 
developers, including Incyte, to expand biomarker-driven companion diagnostics in 
hematology and oncology. 
Agilent no longer owns Resolution Bioscience following divestiture to Exact Sciences, so 
liquid biopsy products such as Resolution ctDx FIRST are no longer core Agilent products. 
Agilent’s present precision oncology focus remains centered on tissue-based companion 
diagnostics, SureSelect genomic profiling, and digital pathology integration. 
Agilent markets the MME HIC pharmaDx companion diagnostic test for colorectal cancer. 
The test identifies mismatch repair-deficient colorectal cancer patients who are eligible for 
treatment with BMS’s Opdivo.  
In February 2026, Agilent released its PD-L1 IHC 22C3 pharmDx as a companion diagnostic 
to help identify patients with epithelial ovarian, fallopian tube, or primary peritoneal 
carcinoma whose tumors express PD-L1 and may benefit from treatment with Keytruda.  
Digital Pathology 
Agilent has expanded its role in digital pathology by combining tissue diagnostics, automated 
staining, slide scanning, image analysis, and artificial intelligence into a more integrated 
pathology workflow. Its digital pathology strategy centers on helping pathology laboratories 

 
 
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transition from conventional microscopy to digital slide review, remote collaboration, and 
AI-assisted interpretation. 
The company’s digital pathology portfolio is anchored by the Dako Omnis platform, which 
supports automated immunohistochemistry (IHC) and in situ hybridization (ISH) staining for 
tissue-based cancer diagnostics. Agilent has also strengthened its digital workflow through 
slide scanning systems and software partnerships that support whole-slide imaging, digital 
case management, and quantitative biomarker assessment. 
Agilent collaborates with digital pathology companies to expand AI-based image analysis 
and improve the interpretation of companion diagnostic assays. These efforts are particularly 
important in oncology, where digital pathology supports more consistent biomarker scoring, 
improved workflow efficiency, and broader adoption of precision medicine in clinical 
pathology laboratories. 
 
 
 
 

 
 
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Beckman Coulter / Danaher 
Brea, CA 
www.beckmancoulter.com 
Beckman Coulter, Inc., a subsidiary of Danaher Corporation (DHR), develops, manufactures 
and markets IVD tests for more than 80 years.  The company reports that more than 275,000 
Beckman Coulter systems operate in both diagnostics and life sciences laboratories on six 
continents.   
With an 80-year history, Beckman Coulter’s scalable instruments, comprehensive diagnostic 
test portfolio and business management services are used by hospitals, laboratories and other 
critical care settings around the world. 
Beckman Coulter partnered with Biogen and Fujirebio to advance the development of blood-
based biomarkers for Alzheimer’s disease, particularly assays targeting phosphorylated tau 
proteins associated with neurodegeneration. These efforts have progressed from early 
development into the commercialization of automated immunoassays designed for use on 
high-throughput laboratory platforms. The collaboration supports the growing adoption of 
blood-based testing as a less invasive alternative to cerebrospinal fluid analysis and imaging, 
enabling broader access to Alzheimer’s disease assessment in routine clinical practice. 
Hematology 
Beckman Coulter was the long-time global leader in hematology, but in recent years Sysmex 
has strengthened its global position through aggressive instrument placement, workflow 
expansion, and strong penetration in high-volume laboratories, leaving the two companies 
closely matched, with Sysmex leading in several major markets. 
Beckman Coulter maintains a strong hematology position through a broad analyzer portfolio 
spanning low-, mid-, and high-volume laboratories, supported by workflow automation, 
digital morphology integration, and advanced clinical parameters. Its hematology line 
continues to emphasize first-pass accuracy, workflow efficiency, and expanded clinical 
decision support in a mature but highly competitive market. 

 
 
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The company’s hematology portfolio includes systems ranging from the DxH 500 for lower-
volume laboratories to the DxH 900 for high-throughput clinical laboratories. The DxH 500 
remains designed for smaller laboratories and near-patient environments, offering CBC plus 
5-part differential testing with low sample volume requirements, including capillary blood 
collection suitable for pediatric and geriatric patients. 
Beckman Coulter markets the DxH 520, which provides 5-part differential testing in low-
volume laboratories using small blood sample volumes and rapid turnaround times. The 
system remains important in physician office laboratories, outpatient clinics, and smaller 
hospital laboratories. 
For mid- and high-volume laboratories, the DxH 900 and DxH 690T incorporate Beckman 
Coulter’s core hematology technologies, including the enhanced Coulter Principle, VCS 360 
cellular analysis, and DataFusion analytics. These systems are designed to reduce repeat 
testing, improve flagging accuracy, and provide detailed cellular analysis in near-native cell 
states. 
A key differentiator for Beckman Coulter is its Early Sepsis Indicator, which is available on 
select DxH hematology systems. This parameter uses monocyte morphological analysis to 
detect early cellular changes associated with sepsis risk as part of a routine complete blood 
count with differential. It provides clinicians with earlier insight into potential sepsis without 
the need for separate, dedicated testing. 
Beckman Coulter has expanded hematology workflow automation through integrated 
workcell solutions that combine analyzers, slide preparation, staining, and digital 
morphology. Its hematology automation platforms connect analyzers with slidemaker-
stainers and digital cell morphology through collaboration with Scopio Labs, allowing 
laboratories to integrate automated blood smear preparation with AI-assisted digital review. 
This digital workflow strategy strengthens Beckman Coulter’s position in high-throughput 
hematology laboratories where labor shortages, standardization, and remote review are 
increasingly important. 
Hematology IT 
Beckman Coulter Diagnostics continues to offer both new and installed DxH 500 systems 
through upgraded software designed to improve analytical performance and workflow 

 
 
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efficiency in small-volume clinical laboratories. The software enhancements strengthen 
flagging performance, quality control functions, and user workflow management for 
laboratories performing routine complete blood count and 5-part differential testing. 
The updated software incorporates Beckman Coulter’s proprietary dynamic-gating 
methodology, which improves cell population discrimination by adjusting thresholds 
between cellular clusters. This approach enhances differential accuracy, particularly for 
challenging cell populations, and helps reduce unnecessary slide reviews that can slow 
laboratory workflow. 
Quality control functions have also been expanded, allowing laboratories greater flexibility 
in QC management and documentation. Enhanced QC file capacity and improved reporting 
tools help laboratories support accreditation requirements and maintain more efficient daily 
instrument monitoring. 
Additional software refinements include simplified system setup, expanded user access 
controls, backup and restore capabilities, and access to research-use-only parameters in 
selected markets that support broader laboratory evaluation. 
The DxH 500 remains designed for low-volume laboratory settings where simplicity, small 
sample volume requirements, and rapid turnaround are important. Its compact footprint, 
simplified reagent system, and low maintenance requirements continue to make it suitable 
for physician office laboratories, outpatient settings, and smaller hospital laboratories. 
Clinical Chemistry 
 In clinical chemistry, Beckman Coulter continues to offer a broad test menu of more than 
150 chemistry, immunochemistry, and specific protein assays, supporting routine chemistry, 
therapeutic drug monitoring, drugs of abuse testing, and specialty protein analysis across 
low-, mid-, and high-volume laboratories. 
The company has strengthened its integrated chemistry and immunoassay workflow through 
scalable analyzer families and workcell automation. Earlier UniCel branding has largely 
transitioned to the current DxC and DxI platform families, with automation focused on 
improving throughput, sample handling, and operational efficiency in core laboratories. 

 
 
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DxC 700 AU remains a major mid- to high-volume chemistry platform, combining Beckman 
Coulter DxC workflow design with the proven analytical performance of the Olympus AU 
chemistry architecture. The analyzer continues to serve laboratories requiring high 
throughput, menu breadth, and strong reliability in routine chemistry testing. 
Beckman Coulter also continues to market the DxC 500 AU, designed for mid-volume 
laboratories seeking a compact clinical chemistry system with broad assay capability and 
workflow flexibility. 
Integrated chemistry and immunoassay automation remains a major focus through DxC 500i 
and higher-volume workcell solutions. The DxC 500i combines chemistry and immunoassay 
testing on a single platform and uses FlexMode operation, allowing laboratories to prioritize 
either chemistry or immunoassay workload depending on demand. 
At the high-volume end, Beckman Coulter has positioned the DxC 880i as a flagship 
integrated clinical chemistry and immunoassay platform for large core laboratories, designed 
for high throughput, reduced manual intervention, and advanced workflow connectivity. 
In urinalysis, DxU Iris Workcell is an important automated solution. The workcell integrates 
particle imaging and urine chemistry analysis by combining the DxU 850m Iris with urine 
chemistry instrumentation to support high-throughput automated urinalysis. 
Immunoassays 
Beckman Coulter remains a major supplier of immunoassay and protein testing systems, with 
an immunoassay menu that now exceeds 60 assays covering cardiac disease, cancer markers, 
thyroid function, reproductive endocrinology, anemia, autoimmune conditions, diabetes, 
infectious disease, inflammatory markers, therapeutic drug monitoring, toxicology, and 
specialty proteins. 
The company’s immunoassay portfolio is focused on the Access family and the high-
throughput DxI 9000 Access Immunoassay Analyzer, which has become Beckman Coulter’s 
flagship immunoassay platform for high-volume laboratories. The DxI 9000 delivers high 
throughput, simplified maintenance, and expanded menu capability for large core 
laboratories, while older systems such as Access 2 and UniCel DxI 800 remain widely 
installed in routine laboratory settings. 

 
 
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Beckman Coulter offers its cardiac marker portfolio through Access hsTnI assay, which 
supports early myocardial infarction assessment and cardiovascular risk stratification across 
the Access immunoassay family. The assay remains important because it offers flexibility 
for testing in both serum and plasma. 
The company also maintains strong positioning in heart failure testing through its Access 
NT-proBNP assay, which provides a rapid assessment of acute and chronic heart failure and 
is increasingly used on high-throughput immunoassay platforms. 
In sepsis and inflammatory testing, Beckman Coulter markets both Access PCT and IL-6 
assays. Access PCT provides sepsis risk assessment and septic shock evaluation, while 
procalcitonin integration through middleware allows laboratories to incorporate sepsis 
testing directly into routine core laboratory workflows. 
The company has strengthened its reproductive endocrinology with Access AMH and 
sensitive estradiol assays, maintaining one of the strongest reproductive hormone menus in 
automated immunoassay testing. Beckman Coulter remains a leader in AMH testing, where 
its antibody technology continues to support broad clinical adoption in fertility assessment 
and ovarian reserve evaluation. 
In toxicology and therapeutic monitoring, Beckman Coulter supports drugs-of-abuse testing 
through Syva EMIT assays on AU chemistry platforms, including buprenorphine and 6-
acetylmorphine testing. 
Beckman Coulter also continues to strengthen quality control and data management through 
collaboration with Technopath, expanding use of external QC materials and automated QC 
data management in chemistry and immunoassay laboratories. 
A major emerging area is neurodegenerative disease biomarkers. In 2025, Beckman Coulter 
received FDA Breakthrough Device Designation for its plasma-based Access p-Tau217/β-
Amyloid 1-42 Plasma Ratio, designed to support identification of amyloid pathology 
associated with Alzheimer’s disease. This positions Beckman Coulter among the first major 
core laboratory companies advancing automated blood-based Alzheimer biomarker testing. 

 
 
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Microbiology 
DxM 6100 Autoplak Advanced System markets automated microbiology specimen 
processing steps, including plate inoculation, streaking, Gram stain slide preparation, and 
enrichment broth inoculation. The system is designed to improve laboratory standardization, 
reduce manual handling, and support higher specimen throughput in clinical microbiology 
laboratories. 
The open-platform design is an important differentiator, allowing laboratories to use liquid 
transport tubes and consumables from multiple suppliers while customizing protocols to fit 
existing laboratory workflows. This flexibility helps laboratories integrate automation 
without major workflow redesign. 
The DxM 6100 competes in microbiology automation with systems from Copan Diagnostics 
and other automated specimen-processing providers, particularly in laboratories seeking to 
improve efficiency amid staffing shortages and rising specimen volumes. 
Beckman Coulter markets the DxM MicroScan WalkAway for bacterial identification and 
antimicrobial susceptibility testing. The system supports organism identification and 
susceptibility determination using direct minimum inhibitory concentration (MIC) 
methodology, which remains important for detecting antimicrobial resistance patterns and 
emerging resistant organisms. 
MicroScan WalkAway is especially helpful in routine hospital microbiology laboratories, 
where standardized antimicrobial susceptibility testing and resistance surveillance remain 
essential components of the clinical microbiology workflow. 
IT Clinical 
Beckman Coulter provides its laboratory informatics and remote service strategy through the 
DxONE digital platform, which supports instrument connectivity, workflow optimization, 
predictive service, and operational analytics across chemistry, immunoassay, hematology, 
and automation systems. 
DxONE PROService is the company’s remote monitoring and predictive service application, 
enabling continuous monitoring of instrument performance and early identification of 
potential system issues that could affect turnaround time or laboratory workflow. The 

 
 
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platform securely transmits instrument performance data through Beckman Coulter’s cloud 
infrastructure, enabling service teams to provide remote diagnostics and faster intervention 
when needed. 
Beckman Coulter also offers middleware capabilities through REMISOL Advance, which 
remains a core middleware platform for mid- and high-volume laboratories. REMISOL 
Advance supports real-time sample tracking, autoverification, quality control monitoring, 
and consolidated analyzer connectivity, helping laboratories improve result delivery and 
operational visibility. 
Within the DxONE portfolio, DxONE Workflow Manager enables laboratories to 
standardize workflow rules, automate sample routing, and manage exceptions across multiple 
analytical systems. Cloud-based deployment reduces local IT burden while supporting 
broader laboratory integration across Beckman Coulter chemistry, immunoassay, and 
hematology platforms. 
A major part of Beckman Coulter’s automation strategy is the DxA 5000, which automates 
preanalytical sample handling and quality assessment. The system rapidly evaluates tube 
identification, sample type, pending orders, and specimen integrity while helping laboratories 
reduce preanalytical errors and improve sample workflow before analysis begins. The DxA 
5000 remains especially important in high-volume laboratories where automation, specimen 
integrity control, and labor efficiency are increasingly critical. 
Flow Cytometry 
Beckman Coulter has been active in flow cytometry since the 1970s and is one of the major 
suppliers in the global flow cytometry market alongside Becton Dickinson. Flow cytometry 
remains an important part of Beckman Coulter’s Life Sciences and clinical diagnostics 
strategy, with the company maintaining both research and clinical platforms for cellular 
analysis, immunophenotyping, and hematologic disease assessment. 
For clinical applications, AQUIOS CL Flow Cytometer is a key automated clinical flow 
cytometry platform. The system combines sample preparation and flow cytometric analysis 
within a single instrument using load-and-go automation, supporting routine 
immunophenotyping with minimal operator intervention and first results in approximately 
20 minutes. 

 
 
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The AQUIOS platform supports laboratory-developed and standardized assays through 
AQUIOS Designer Software, which allows laboratories to create customized applications 
beyond predefined CD4 and basic immunophenotyping workflows. This flexibility has 
increased its usefulness in hospital laboratories performing specialized immune monitoring 
and hematology testing. 
Beckman Coulter offers the ClearLLab 10C System, a standardized clinical flow cytometry 
solution designed for hematologic malignancy analysis. ClearLLab panels provide 
multiparameter immunophenotyping for lymphoid and myeloid disorders, including chronic 
leukemia, acute leukemia, non-Hodgkin lymphoma, myelodysplastic syndromes, 
myeloproliferative neoplasms, and plasma cell disorders. 
The ClearLLab system includes standardized reagent panels, control materials, and 
integrated software designed to reduce manual validation requirements and improve 
consistency in clinical hematology laboratories. 
Beckman Coulter’s ClearLLab analysis through Kaluza C, provides clinical data analysis, 
compensation, and reporting designed to support standardized interpretation and quality 
control. 
For higher-complexity laboratories, Navios EX remains an important clinical platform 
supporting advanced multicolor immunophenotyping and standardized hematologic 
malignancy workflows. 
Beckman Coulter’s clinical flow cytometry is focused on leukemia and lymphoma testing, 
automation, and workflow simplification, while research systems continue to support higher-
dimensional cell analysis in translational medicine. 
Blood Banking 
Beckman Coulter continues to provide the PK7400 Automated Microplate System for blood 
donor centers, plasma collection facilities, and reference immunohematology laboratories. 
The system remains a high-throughput, automated microplate platform designed for blood 
grouping, antibody screening, and donor testing workflows in which large sample volumes 
require reliable automation and standardized processing. 

 
 
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The PK7400 continues to support high-volume testing, processing up to 300 samples per 
hour and performing multiple assays per specimen within a single automated workflow. The 
platform integrates reagent handling, incubation, centrifugation, and result interpretation, 
helping blood centers improve throughput and consistency in donor screening operations. 
Beckman Coulter markets reagents and consumables for the PK7400 to donor testing 
laboratories where high-capacity microplate automation remains important. 
Beckman Coulter Life Sciences 
Beckman Coulter Life Sciences strengthened its sample preparation and automation portfolio 
through the acquisition of Labcyte, whose Echo technology introduced acoustic droplet 
ejection for highly precise, contactless transfer of samples and reagents. Echo uses sound 
energy to transfer nanoliter-scale liquid volumes without physical contact, reducing 
contamination risk and improving precision in genomics, drug discovery, and high-
throughput laboratory workflows. 
Beckman Coulter Life Sciences expanded liquid biopsy sample preparation through 
collaboration with Apostle Inc. The partnership provides for the use of the Apostle MiniMax 
High Efficiency Cell-Free DNA Isolation Kit, a magnetic nanoparticle-based system for 
extracting circulating cell-free DNA from plasma in both manual and automated workflows. 
The technology is used for liquid biopsy applications, including oncology, prenatal testing, 
and infectious disease analysis. 
In 2025, Beckman Coulter expanded its spectral flow cytometry portfolio with the launch of 
the CytoFLEX mosaic Spectral Detection Module, which allows laboratories to upgrade 
selected CytoFLEX systems for spectral detection and higher-dimensional cellular analysis. 
This launch strengthened Beckman Coulter’s position in advanced cell analysis by enabling 
broader fluorochrome discrimination and more flexible panel design. 
The company also markets cell-preparation tools, including the OptiMATE Gradient Maker, 
designed to improve reproducibility in density-gradient workflows for cell isolation and 
sample preparation. 
Beckman Coulter additionally offers the NGS Basophil Activation Test for allergy research 
applications, supporting advanced immune response analysis and expanding the company’s 
role in specialized translational research workflows. 

 
 
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Becton, Dickinson and Company (BD) 
Franklin Lakes, NJ 
www.bd.com 
Table 14-4: BD Revenue History, 2023-2025 ($ million, estimated) FYE Sept 30 
 
2023 
2024 
2025 
Total Revenues 
19,372 
20,178 
21,840 
Source: company reports, Kalorama Information 
Geographically, BD's clinical diagnostic IVD product sales were generated 53% 
internationally and 47% in United States.  
Becton, Dickinson and Company (BD) is a global medical technology company that 
develops, manufactures, and markets medical devices, diagnostic systems, laboratory 
instruments, and reagents for healthcare providers, life science researchers, pharmaceutical 
companies, and clinical laboratories worldwide. Founded in 1897 and headquartered in 
Franklin Lakes, BD employs approximately 72,000 people and serves customers in more 
than 61 countries. The company has maintained a long-standing international presence, 
including operations in China since the mid-1990s and India since 1996. 
BD operates through three major business segments: BD Medical, BD Life Sciences, and BD 
Interventional. The Interventional segment includes most of the product portfolio acquired 
through the 2017 purchase of C. R. Bard. BD Medical now also includes the former critical 
care assets acquired from Edwards Lifesciences, which were integrated into BD Advanced 
Patient Monitoring following the acquisition in 2024. 
In 2025, BD announced plans to separate its Biosciences and Diagnostic Solutions business 
to create two independent companies: a streamlined BD focused on core medical technology 
and a second company centered on diagnostics and life sciences. That strategy evolved in 
July 2025 when BD entered into a definitive agreement to combine its Biosciences and 

 
 
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Diagnostic Solutions business with Waters Corporation. BD announced the completion of 
the spin-off with Waters, which was finalized on February 6, 2026.  
BD’s diagnostics portfolio includes specimen collection and transport systems, microbiology 
media, automated blood culture systems, molecular diagnostics, rapid immunoassays, 
cervical cancer screening systems, HPV testing platforms, microorganism identification and 
antimicrobial susceptibility testing, and laboratory automation solutions. Its diagnostic 
technologies support infectious disease testing, healthcare-associated infection monitoring, 
women’s health, and oncology applications. 
Within life sciences, BD Biosciences, based in San Jose, continues to market the FACSCanto, 
FACSLyric, FACSymphony, and related flow cytometry systems, maintaining BD’s strong 
position in clinical and research flow cytometry. 
BD previously separated its diabetes care business, completing the spin-off of Embecta in 
2022. BD retained no ownership stake after the transaction, allowing Embecta to operate 
independently in insulin delivery and diabetes management products. 
Cytology 
Becton, Dickinson and Company markets a comprehensive cervical cancer screening 
portfolio built around the BD Onclarity HPV Assay, BD SurePath Liquid-Based Pap Test, 
and automated laboratory workflow systems, including the BD COR System and legacy BD 
Totalys platform. The company’s cervical screening solutions support primary HPV testing, 
co-testing, cytology preparation, and high-volume laboratory automation. 
BD Onclarity HPV Assay detects 14 high-risk human papillomavirus genotypes in a single 
assay, with extended genotyping that individually identifies several clinically important HPV 
types while grouping others by risk category. The assay remains widely used for primary 
cervical cancer screening and reflex testing and is performed primarily on the BD COR 
molecular automation platform, which has increasingly replaced the earlier BD Viper LT 
System in many laboratories. The assay also remains compatible with selected installed Viper 
systems in existing workflows. 
BD SurePath Liquid-Based Pap Test remains a major cytology collection method in the U.S. 
market and is integrated with BD’s automated sample-preparation and slide-processing 
systems. BD originally developed the BD Totalys System to automate specimen preparation, 

 
 
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imaging, and slide review, including aliquoting for molecular follow-up testing. While legacy 
Totalys and Viper LT systems remain in some laboratories, newer is focused on BD’s 
consolidated molecular workflow platforms. 
The Onclarity assay is approved for use with both BD SurePath specimens and certain 
samples collected in Hologic ThinPrep PreservCyt media, allowing laboratories greater 
flexibility in specimen processing and improving compatibility across existing cervical 
screening programs. 
BD has also expanded Onclarity's role in self-collected screening. In 2025–2026, self-
collection received increased clinical attention as healthcare systems sought to improve 
access to screening for underserved populations, rural patients, and individuals less likely to 
attend traditional pelvic examination visits. This expansion supports broader cervical cancer 
prevention efforts by increasing access while maintaining the sensitivity of molecular tests. 
Molecular Microbiology 
The company offers the BD MAX System platform as part of its molecular microbiology 
portfolio. BD MAX System is a fully integrated molecular instrument that performs nucleic 
acid extraction, amplification, and real-time PCR detection in a single workflow, delivering 
results for up to 24 samples in under 3 hours, depending on the assay type. The platform 
remains widely used in hospitals and clinical laboratories for medium-throughput molecular 
testing across multiple infectious disease categories. 
The BD MAX assay menu includes tests for healthcare-associated infections, antimicrobial 
resistance markers, gastrointestinal pathogens, respiratory infections, reproductive health, 
and sexually transmitted infections. Available assays include panels for MRSA, CPO 
detection, enteric bacterial pathogens, vaginitis, group B streptococcus, and CT/GC testing, 
as well as respiratory panels that include SARS-CoV-2, influenza A/B, and RSV. The 
combined COVID-19, influenza A/B, and RSV molecular assay continues to support 
respiratory testing demand, with results typically available in approximately two hours. 
A key advantage of BD MAX remains its open-system capability, which allows laboratories 
to develop and automate laboratory-developed tests and integrate additional assays through 
BD collaboration partners. This flexibility has helped maintain the platform’s relevance in 
laboratories requiring both commercial and customized molecular workflows. 

 
 
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BD expanded its respiratory and STI diagnostics offerings in Europe with the certification of 
two VIASURE assays developed by Certest Biotec for use on the BD MAX System. This 
allows clinical laboratories to detect a broad range of pathogens quickly and accurately. The 
assays include VIASURE Respiratory Virus Extended Mix Real Time PCR Detection Kit 
for BD MAX and the VIASURE HSV-1, HSV-2 & Treponema pallidum Assay for BD MAX 
System.  
For higher-volume molecular testing, BD increasingly emphasizes the BD COR System, 
which supports expanded automation and assay consolidation. The BD Vaginal Panel, 
performed on the BD COR System, directly detects the three most common infectious causes 
of vaginitis—bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis, and is part 
of BD’s broader women’s health molecular strategy. In Europe. The company offers its 
Enteric Bacterial Panel and Enteric Bacterial Panel plus for the BD COR System.  
In microbiology automation, BD Kiestra remains BD’s flagship laboratory automation 
solution. The Kiestra platform includes robotic specimen processing, smart incubation, 
digital imaging, and track-based automation, enabling laboratories to configure customized 
workflows for culture setup, plate transport, incubation, and reading. BD continues to expand 
Kiestra adoption as laboratories seek greater efficiency, standardization, and integration with 
digital microbiology. 
Traditional Microbiology - ID/AST 
 Becton Dickinson markets a broad microbiology portfolio designed as an integrated 
laboratory workflow spanning specimen collection, culture, organism identification, 
antimicrobial susceptibility testing, and informatics. Its microbiology strategy emphasizes 
connected laboratory solutions that improve turnaround time, standardization, and 
antimicrobial identification. 
BD BACTEC is BD’s flagship blood culture platform, providing automated blood culture 
incubation, detection, and continuous monitoring to diagnose bacteremia and fungemia. The 
BD BACTEC portfolio supports all major stages of blood culture testing, from specimen 
collection and transport through culture analysis, and remains widely used in hospital 
microbiology laboratories worldwide. 

 
 
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BD markets a large culture media portfolio through its longstanding BD Difco and BD BBL 
brands, supplying prepared plated media, dehydrated media, selective media, and specialized 
microbiology reagents used in clinical, industrial, and research laboratories. 
For organism identification and antimicrobial susceptibility testing, BD Phoenix M50 
remains a core platform. The system delivers automated microbial identification and AST 
for a broad range of gram-positive, gram-negative, and yeast organisms. BD also continues 
its commercial collaboration with Bruker Corporation to offer MALDI-TOF identification 
workflows integrated with microbiology laboratory operations. BD BBL Sensi-Disc products 
remain in use for manual antimicrobial susceptibility testing. 
BD has expanded microbiology informatics through the BD Synapsys Informatics Solution, 
which connects instruments, including Phoenix M50, and supports laboratory workflow 
management, result interpretation, and antimicrobial stewardship decision support. The 
system incorporates advanced rules-based analysis to help laboratories interpret complex 
susceptibility patterns and improve reporting efficiency. 
In near-patient microbiology testing, BD Veritor Plus System provides rapid antigen-based 
testing for respiratory syncytial virus (RSV), influenza A and B, group A streptococcus, and 
SARS-CoV-2. The platform is widely used in physician offices, urgent care, and 
decentralized healthcare settings, delivering digital point-of-care results within minutes. 
BD also maintains selected rapid immunoassay and serology offerings, including legacy BD 
Directigen rapid antigen tests and traditional microbiology reagents used for syphilis testing, 
such as RPR and VDRL reagents, fluorescent treponemal reagents, antisera, and specialty 
microbiology diagnostics. 
Specimen collection is also an important part of BD’s microbiology business, with swab-
based transport systems, collection devices, and preservation media designed to optimize 
organism recovery and maintain specimen integrity across laboratory workflows. 
Blood Culture 
Despite continued expansion of molecular syndromic testing for bloodstream infections and 
hospital-acquired pathogens, blood culture remains the foundation of sepsis diagnosis and 
antimicrobial management.  BD is one of the key vendors in the blood culture market. 

 
 
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BD BACTEC FX remains BD’s core blood culture platform for detecting bloodstream 
infections. The system is designed for continuous monitoring of blood culture bottles and 
supports broad microorganism recovery, including aerobic bacteria, anaerobes, and yeast. 
BD offers a full blood culture workflow that spans specimen collection, incubation, detection, 
reporting, and informatics integration. 
BD’s blood culture portfolio includes: 
• Preanalytical collection products for standardized blood culture collection and 
contamination reduction 
• BD BACTEC FX instrumentation, with modular configurations that support small 
laboratories through high-volume hospital networks 
• BD BACTEC blood culture media, including aerobic, anaerobic, pediatric, mycosis, 
and specialty formulations designed to improve microorganism recovery 
• BD Synapsys Informatics Solution, which provides browser-based workflow 
management, result reporting, analytics, and blood culture tracking across 
microbiology operations 
• Integrated data support tools that help laboratories monitor positivity trends, 
contamination rates, and turnaround performance 
BD Synapsys Informatics Solution has become increasingly important as laboratories seek 
integrated microbiology decision support, antimicrobial stewardship connectivity, and multi-
instrument workflow coordination. Synapsys connects blood culture, susceptibility testing, 
and microbiology automation platforms into a unified digital environment. 
BD also expanded its specialty blood safety applications. Its FDA-cleared and CE-marked 
BD BACTEC platelet quality control media is important for detecting bacterial 
contamination in platelet products used by microbiology laboratories, blood banks, and 
transfusion services. These culture-based media support testing of leukocyte-reduced 
apheresis platelet units and pooled whole-blood platelet concentrates, thereby reducing the 
risk of transfusion-associated sepsis. 
An addition to BD is broader laboratory integration between BD blood culture systems and 
downstream organism identification workflows, including BD Phoenix M50 AST/ID, 
MALDI-TOF partnerships, and microbiology automation under BD Kiestra, allowing faster 
movement from positive blood culture to organism identification and antimicrobial 

 
 
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susceptibility reporting. BD also continues promoting culture-based platelet testing as 
laboratories face tighter transfusion safety requirements and expanded pathogen surveillance 
protocols. 
Hospital Acquired Infections 
BD continues to market its antimicrobial resistance portfolio by combining molecular 
diagnostics, chromogenic media, automated susceptibility testing, and digital microbiology 
tools to support hospital infection prevention and antimicrobial stewardship programs. 
BD MAX System is the main offering in BD’s resistance testing strategy. The platform 
provides rapid molecular screening for major antimicrobial resistance markers, including 
carbapenemase-producing organisms (CPO), MRSA, and other healthcare-associated 
pathogens. The BD MAX Check-Points CPO Assay, developed with Check-Points Health, 
detects the five most clinically important carbapenemase genes—KPC, NDM, VIM, IMP, 
and OXA-48-like—in approximately 2.5 hours. The assay is CE-marked and widely used for 
rapid screening of colonized patients and for infection control surveillance. 
BD also markets BD BBL CHROMagar CPE chromogenic plated media for phenotypic 
screening of carbapenemase-producing Enterobacterales. These media support direct culture-
based detection and are commonly used alongside molecular testing to streamline laboratory 
workflows and confirm the growth of resistant organisms. 
BD Phoenix M50 provides resistance characterization through the BD Phoenix CPO Detect 
panel, a phenotypic test that identifies carbapenemase-producing organisms while 
simultaneously performing organism identification and antimicrobial susceptibility testing. 
The system typically delivers CPO detection within 24–36 hours, helping laboratories rapidly 
distinguish resistance mechanisms while preserving phenotypic susceptibility data critical 
for treatment decisions. 
BD has strengthened this workflow by integrating Phoenix data with BD Synapsys 
Informatics Solution, allowing faster interpretation of complex resistance patterns and 
improved reporting for antimicrobial stewardship teams. 
In laboratory automation, BD Kiestra has expanded AI-assisted microbiology reading. BD’s 
Kiestra MRSA Imaging Application uses artificial intelligence algorithms to analyze colony 
growth patterns on BD BBL CHROMagar MRSA II plates, helping laboratories automate 

 
 
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the detection of methicillin-resistant Staphylococcus aureus. The AI application improves 
standardization, reduces manual plate review time, and supports digital microbiology 
workflows. 
Newer additions to BD’s resistance-focused microbiology strategy also include expanded use 
of Kiestra digital imaging, automated plate transport, and integration of resistance screening 
into broader microbiology automation systems, allowing laboratories to connect molecular, 
phenotypic, and AI-supported workflows in a single environment. 
Blood Collection 
PreAnalytiX, the joint venture between BD and QIAGEN, continues in 2026 to develop and 
market integrated systems for the collection, stabilization, and purification of high-quality 
RNA, microRNA, cell-free DNA, and genomic DNA from human blood, bone marrow, and 
tissue specimens. Its core portfolio includes the PAXgene Blood RNA Tube, PAXgene Blood 
DNA Tube, PAXgene Blood cfDNA Tube, and PAXgene Tissue System, which are widely 
used in molecular diagnostics, liquid biopsy, translational research, and pharmaceutical 
development because they preserve specimen integrity during transport and storage and 
support both manual and automated downstream extraction workflows. 
BD also continues expanding decentralized blood collection through its collaboration with 
Babson Diagnostics, with the goal of making laboratory-quality blood testing more 
accessible in retail and outpatient settings. The partnership integrates BD MiniDraw 
Capillary Blood Collection System with Babson’s BetterWay automated sample-handling 
and analytical technology, enabling small fingertip blood samples to be processed for routine 
laboratory testing. This strategy enables the expansion of convenient, low-volume blood 
collection outside traditional phlebotomy settings and complements BD’s broader specimen 
collection portfolio, which also includes Vacutainer blood tubes, Microtainer capillary 
collection systems, Vacutainer Barricor plasma tubes, and CPT cell preparation tubes for 
clinical laboratory and molecular applications. 
Mass Spectrometry 
BD continues its long-standing collaboration with Bruker Corporation, combining MALDI-
TOF mass spectrometry–based organism identification with automated antimicrobial 
susceptibility testing and laboratory informatics. The co-marketing relationship remains 

 
 
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centered on integration of the MALDI Biotyper platform with BD’s BD Phoenix M50, 
enabling laboratories to move efficiently from rapid organism identification to susceptibility 
testing within a streamlined microbiology workflow. BD supports the global distribution of 
co-branded MALDI systems and continues to expand access to newer Bruker technologies, 
including the MALDI Biotyper Sirius and MALDI Biotyper Smart platforms, as well as 
supporting solutions such as the Sepsityper workflow and MBT Compass software, which 
enhance speed, throughput, and data interpretation. The Sepsityper workflow remains 
particularly important in sepsis management, enabling direct identification of pathogens from 
positive blood culture samples and reducing the time to actionable results compared with 
conventional subculture methods. BD also provides consumables, calibration materials, and 
workflow components supporting routine MALDI operations. Integration across the MALDI 
Biotyper platform, BD Phoenix systems, and BD Synapsys Informatics Solution has 
continued to advance, increasingly replacing legacy middleware approaches and enabling 
more unified identification, susceptibility reporting, resistance interpretation, and 
antimicrobial stewardship support across modern microbiology laboratories. 
Flow Cytometry 
Becton Dickinson holds a leading global position in clinical and research flow cytometry, 
building on more than four decades of innovation in single-cell analysis. Its flow cytometry 
portfolio spans clinical diagnostics, cell sorting, immune monitoring, and high-parameter 
research applications, with continued expansion into automation, multi-omics, and software-
driven workflow integration. In clinical diagnostics, the BD FACSVia System is an 
established platform for blood banking applications using the BD Leucocount Kit to identify 
and quantify residual white blood cells in leuko-reduced blood products. BD FACSLyric id 
BD’s flagship IVD flow cytometer for immune monitoring and supports BD Multitest 4-
Color and BD Multitest 6-Color TBNK assays for determining T-cell, B-cell, natural killer 
cell, CD4, and CD8 populations in patients with immune deficiency or immune dysfunction. 
BD has expanded the FACSLyric menu with additional standardized IVD assays and reagent 
panels, while the BD FACSDuet and BD FACSDuet Premium Sample Preparation System 
automate sample preparation, staining, washing, and acquisition workflows through 
integrated liquid-handling robotics and bidirectional connectivity via BD FACSLink 
middleware and laboratory information systems. 

 
 
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Immunoassay 
BD offers its rapid near-patient infectious disease testing portfolio through the BD Veritor 
Plus System platform, a CLIA-waived digital immunoassay system for decentralized testing 
in physician offices, urgent care centers, pharmacies, and outpatient clinics. The BD Veritor 
System for SARS-CoV-2 is a rapid, digital, chromatographic lateral flow antigen test 
designed to detect COVID-19 antigens in symptomatic and selected asymptomatic 
individuals, delivering results in approximately 15 minutes. BD has broadened the Veritor 
respiratory menu to include combination assays such as BD Veritor System for Rapid 
Detection of SARS-CoV-2 & Flu A+B, which simultaneously detects COVID-19 and 
influenza A/B from a single specimen, and continued respiratory testing options for RSV, 
influenza A+B, and group A streptococcus. The platform uses digital optical reading to 
improve result interpretation and reduce subjective visual reading errors. BD also integrates 
the Veritor platform with simplified workflow features and connectivity options for result 
reporting, while maintaining its role as an important near-patient testing solution for 
respiratory infection screening during seasonal respiratory surges and routine outpatient 
infectious disease management. 

 
 
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bioMérieux Inc. 
Marcy-l'Étoile, France 
www.bioMérieux.com 
Table 14-5: bioMérieux Revenue History, 2023-2025 (€ million) 
 
2023 
2024 
2025 
Total  
3,675 
3,980 
4,070 
Source: company reports, Kalorama Information 
bioMérieux is one of the world’s leading microbiology and infectious disease diagnostics 
companies, with operations in more than 160 countries supported by over 45 subsidiaries and 
an extensive distributor network. Headquartered in Marcy-l'Étoile, the company is focused 
on clinical microbiology, molecular diagnostics, syndromic infectious disease testing, 
antimicrobial resistance management, and industrial microbiological control. In clinical 
diagnostics, bioMérieux provides integrated reagent, instrument, and software solutions used 
for infectious disease diagnosis, blood culture, sepsis management, antimicrobial 
susceptibility testing, syndromic molecular testing, selected cancer-related applications, and 
emergency biomarker testing. 
In 2025/2026, bioMérieux reported annual sales above €4.1 billion, with continued growth 
driven primarily by microbiology and molecular infectious disease testing. Clinical 
applications continue to account for approximately 85% of total revenue, while industrial 
applications contribute about 15%, reflecting the company’s strong concentration in clinical 
laboratory diagnostics. Microbiology remains the largest growth engine, supported by blood 
culture systems, identification and susceptibility testing, and syndromic molecular 
diagnostics. 
BIOFIRE FilmArray is one of bioMérieux’s strongest growth drivers, accounting for a major 
share of molecular diagnostics revenue. The BIOFIRE menu includes respiratory, 
gastrointestinal, 
meningitis/encephalitis, 
bloodstream 
infection, 
pneumonia, 
and 
antimicrobial resistance panels, with continued menu expansion and strong adoption in 
hospital laboratories. BIOFIRE SPOTFIRE has expanded rapidly and is now installed 

 
 
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broadly across hospitals, urgent care settings, and decentralized laboratories. SPOTFIRE 
availability has expanded beyond its initial 24-country rollout, with thousands of systems 
installed globally as bioMérieux continues to target faster near-patient molecular respiratory 
testing. 
Traditional Microbiology 
bioMérieux is a global leader in routine bacterial identification and antimicrobial 
susceptibility testing, with VITEK 2 continuing as one of the most widely installed ID/AST 
platforms in clinical microbiology laboratories. The VITEK 2 system identifies more than 
300 clinically relevant microorganisms and delivers routine identification and susceptibility 
results in as little as 3 to 8 hours, depending on organism type and workflow. Its miniaturized 
reagent card technology offers broad antibiotic panels covering Gram-positive bacteria, 
Gram-negative bacteria, yeast, and selected resistant organisms. bioMérieux has 
strengthened this platform through software upgrades, expanded susceptibility algorithms, 
and integration with advanced laboratory informatics for antimicrobial stewardship. 
For laboratories requiring faster and decentralized ID/AST workflows, VITEK Compact Pro 
is an important addition, designed for small- and medium-volume laboratories with 
simplified operation, faster turnaround, and connectivity to centralized microbiology data 
systems. bioMérieux also offers the VITEK REVEAL, which uses sensor-based detection of 
bacterial growth metabolites to deliver rapid phenotypic susceptibility results directly from 
positive blood cultures, supporting earlier antimicrobial decisions in sepsis management. 
Sepsis is a major strategic area for bioMérieux, where the company combines blood culture, 
rapid identification, susceptibility testing, biomarkers, and syndromic molecular diagnostics. 
Its sepsis workflow centers on BacT/ALERT VIRTUO for blood culture detection, BIOFIRE 
molecular panels for bloodstream infection syndromic testing, VITEK MS MALDI-TOF for 
organism identification, and VITEK REVEAL for rapid AST. This integrated approach 
competes with offerings from Roche Diagnostics, T2 Biosystems, OpGen, Accelerate 
Diagnostics, and other emerging sepsis technology developers. 
bioMérieux markets antimicrobial resistance testing through ETEST products, including 
strips for newer antibiotics such as ceftolozane/tazobactam and ceftazidime/avibactam, used 
for multidrug-resistant gram-negative organisms including Enterobacterales and 
Pseudomonas aeruginosa. The ETEST portfolio includes additional strips for newer beta-
lactam/beta-lactamase inhibitor combinations and difficult-to-treat resistant pathogens. 

 
 
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For carbapenemase detection, RAPIDEC CARBA NP is an important manual confirmatory 
test, providing results in under two hours directly from agar culture isolates. bioMérieux also 
continues to market chromID CARBA, chromID ESBL, and expanded chromogenic media 
products for resistance surveillance and screening of carbapenemase-producing organisms, 
ESBL producers, MRSA, and VRE. 
In addition, bioMérieux offers the VITEK MS PRIME, its newer MALDI-TOF microbial 
identification platform, which offers improved throughput, simplified maintenance, and 
enhanced workflow integration with VITEK ID/AST systems and microbiology informatics, 
further strengthening the company’s position in fully connected microbiology laboratories. 
Blood Culture 
bioMérieux and BD are the major venders of blood culture systems.  bioMérieux has been a 
major player in microbiology and has put together a comprehensive menu to tackle sepsis 
and hospital acquired infections, one of the most pressing problems in healthcare.  The 
toolbox includes the BacT/ALERT VIRTUO blood culture platform, the procalcitonin 
immunoassay, and a toolbox of molecular testing tools including the BIOFIRE 
FILMARRAY Blood Culture Identification (BCID) assay test menu and the VITEK MS 
MALDI-TOF mass spec system, which performs automated identification testing within 
minutes.  The goal is to aid in the rapid pathogen identification and appropriate antibiotic 
therapy. 
bioMérieux offers the BacT/ALERT VIRTUO for blood culture detection.  The company 
indicated that the system could fit into any-sized lab, even beyond the routine microbiology 
lab.  Linked to the Myla software BacT/ALERT VIRTUO integrates the blood culture 
workflow to the lab information system.  bioMérieux reports that the BACT/ALERT 
technology is in routine use by blood collection and transfusion facilities in over 25 countries 
worldwide and has a long-proven track record for testing platelets.  
BACT/ALERT VIRTUO is a fully automated microbial detection system with motion-
activated bottle loading and unloading.  It offers proprietary algorithms, high thermal stability 
and sensitive optics, which enhance performance for more rapid time to detection if microbial 
contaminants are present.   
bioMérieux provides the BacT/ALERT VIRTUO, a fully automated blood culture microbial 
system.  According to bioMérieux it is a continuously monitoring blood culture microbial 

 
 
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detection system to offer “Load & Go” technology.  Personnel of all skill levels can easily 
load bottles on the instrument at any time throughout the day or night, enabling prompt 
incubation and reducing hands-on time. Bottle unloading is fully automated with visual and 
audible alarms and alerts, helping laboratories to streamline their workflow. 
bioMérieux also provides culture bottles BACT/ALERT BPA and BPN for quality control 
testing of leukocyte-reduced apheresis platelet units with the BACT/ALERT VIRTUO fully 
automated blood culture system.  These bioMérieux quality control solutions can be used to 
extend platelet shelf life up to a total of seven days.  
Immunoassays 
bioMérieux markets the VIDAS family as one of the world’s most established automated 
immunoassay platforms, including VIDAS 3, mini VIDAS, and legacy VIDAS systems. The 
installed base remains very large globally—estimated at well over 30,000 instruments—with 
strong use in hospitals, emergency laboratories, microbiology laboratories, and decentralized 
clinical settings. The VIDAS range uses ELFA (enzyme-linked fluorescent assay) 
technology and supports both random-access and batch testing through single-test ready-to-
use reagent strips. The menu now includes well over 100 assays covering infectious disease 
serology, emergency biomarkers, endocrine testing, inflammatory markers, oncology 
markers, coagulation, and selected specialty assays. 
The VIDAS portfolio is especially strong in acute care and infectious disease applications. 
VIDAS B.R.A.H.M.S PCT continues to be bioMérieux’s flagship sepsis biomarker and is 
FDA-cleared for assisting antibiotic initiation and discontinuation decisions in lower 
respiratory tract infections and sepsis. It remains one of the few procalcitonin assays in the 
U.S. specifically cleared to support antibiotic stewardship and continues to be widely used in 
emergency departments, ICUs, and hospital antimicrobial stewardship programs. bioMérieux 
has also expanded emergency biomarker testing through VIDAS D-Dimer Exclusion II, 
which is widely used to help exclude deep vein thrombosis and pulmonary embolism when 
combined with clinical pre-test probability models, and through the continued growth of 
cardiac and inflammatory markers. 
Following its acquisition of Banyan Biomarkers, bioMérieux expanded its traumatic brain 
injury diagnostics with VIDAS TBI, which measures GFAP and UCH-L1 in serum to aid 
assessment of mild traumatic brain injury and concussion. The assay is one of the few 

 
 
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commercially available blood-based TBI tests and continues to gain clinical attention in 
emergency medicine. 
Kidney injury testing is another important specialty area offered by NEPHROCHECK, which 
measures the TIMP-2 and IGFBP7 biomarkers to identify kidney stress before overt acute 
kidney injury develops. The assay remains FDA-cleared and continues to appear in 
perioperative and critical care guidelines for cardiac surgery and ICU risk management. 
The infectious disease VIDAS menu has expanded to include hepatitis serology assays for 
hepatitis A, B, C, and E, HIV testing, TORCH testing, and selected parasitology markers. 
Hepatitis E assays is important in regions where HEV testing demand is increasing. 
Additional newer VIDAS assays include expanded gastrointestinal markers, inflammatory 
markers such as VIDAS Calprotectin, and specialty assays supporting hospital acute care 
testing. 
The company’s routine chemistry-related immunoassays include VIDAS Vitamin B12 Total, 
which supports quantitative vitamin B12 assessment, along with ferritin, folate, thyroid, 
fertility, and hormone assays. bioMérieux continues to position VIDAS as a flexible mid-
volume immunoassay platform where rapid single-test access remains valuable compared 
with large high-throughput analyzers. 
Mass Spectrometry 
bioMérieux expanded its MALDI-TOF microbial identification portfolio through VITEK 
MS PRIME, which has become the company’s current flagship MALDI-TOF system for 
rapid organism identification in clinical microbiology laboratories. The platform provides 
rapid identification of bacteria, yeast, filamentous fungi, mycobacteria, and selected difficult-
to-identify organisms within minutes, significantly accelerating organism identification 
compared with conventional biochemical methods. bioMérieux has continued to strengthen 
its mycobacteria and mold identification capabilities, including clinically important 
Mycobacterium tuberculosis complex, major non-tuberculous mycobacteria (NTM), 
Nocardia, and medically significant molds that are increasingly important in 
immunocompromised patient populations. 
 

 
 
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The current VITEK MS database includes tens of thousands of validated spectra derived from 
one of the world’s largest private clinical strain collections and supports broad identification 
coverage for clinically relevant bacterial and fungal pathogens. The database continues to 
expand to improve differentiation of closely related organisms and emerging resistant 
pathogens. Database updates include identification of high-priority organisms such as 
Candida auris, Elizabethkingia anophelis, improved discrimination within the Acinetobacter 
baumannii complex, and continued support for highly pathogenic species, including 
Brucella, under controlled laboratory conditions. 
bioMérieux has also expanded direct workflow integration between VITEK MS PRIME and 
its ID/AST platforms, allowing MALDI-TOF identification to connect directly with VITEK 
2, VITEK Compact Pro, and VITEK REVEAL to accelerate antimicrobial decisions. Newer 
software enhancements improve database management, confidence scoring, and workflow 
standardization while supporting high-throughput microbiology laboratories. 
In addition to organism identification, VITEK MS PRIME is an important component of 
bioMérieux’s broader sepsis and antimicrobial resistance strategy, where rapid MALDI-TOF 
identification is increasingly combined with positive blood culture workflows, syndromic 
molecular testing, and rapid AST to shorten time to optimized therapy. 
BIOFIRE Diagnostics Business 
 bioMérieux has significantly expanded the BIOFIRE FilmArray portfolio since acquiring 
BIOFIRE Diagnostics, transforming it into one of the broadest syndromic PCR menus in 
clinical diagnostics. The original FILMARRAY menu included respiratory, blood culture 
identification, gastrointestinal, and meningitis/encephalitis panels, but the current 2026 
portfolio is substantially larger, featuring multiple updated generations and newer 
decentralized platforms. The current respiratory menu concentrates on BIOFIRE Respiratory 
Panel 2.1 and Respiratory Panel 2.1plus, which detect a broad set of respiratory viruses and 
bacteria, including SARS-CoV-2, influenza A/B, RSV, adenovirus, coronaviruses, and 
atypical bacteria, with results in about 45 minutes. These panels expanded earlier RP2 and 
RP2plus versions by incorporating COVID-19 testing and maintaining broad respiratory 
pathogen coverage. The earlier RP2plus addition of MERS-CoV remains relevant primarily 
in international markets. 
 

 
 
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For bloodstream infections, BIOFIRE FilmArray Blood Culture Identification 2 Panel has 
replaced the original BCID panel and detects a broader range of gram-positive bacteria, 
gram-negative bacteria, yeast, and key antimicrobial resistance genes directly from positive 
blood cultures, improving early sepsis management and antimicrobial stewardship. In lower 
respiratory infection testing, the BIOFIRE Pneumonia Panel and Pneumonia Panel plus are 
major products, detecting bacterial pathogens, respiratory viruses, and resistance markers 
directly from sputum, bronchoalveolar lavage, and endotracheal aspirates, while continuing 
to provide semi-quantitative bacterial results that help distinguish colonization from likely 
infection. 
The gastrointestinal menu includes both the full BIOFIRE Gastrointestinal Panel and 
BIOFIRE Gastrointestinal Panel Mid, with the Mid version targeting a smaller set of common 
bacterial, viral, and parasitic pathogens for laboratories seeking narrower syndromic 
coverage. The meningitis/encephalitis panel is a major cerebrospinal fluid testing product 
that detects the principal bacterial, viral, and fungal pathogens associated with CNS 
infections. 
Additions to the platform have expanded beyond traditional hospital syndromic testing. 
BIOFIRE SPOTFIRE is bioMérieux’s faster decentralized multiplex PCR platform designed 
for urgent care, emergency departments, and near-patient settings. Current SPOTFIRE 
menus include respiratory panels, sore throat testing, and mini respiratory/sore throat panels 
that detect major viral and bacterial pathogens in approximately 15 minutes. Newer 
specialized assays also include the BIOFIRE Tropical Fever Panel, which detects pathogens 
associated with tropical febrile illnesses, including dengue, chikungunya, malaria species, 
leptospirosis, and related targets important in travel medicine and tropical disease diagnosis. 
Additionally, FILMARRAY products include the Joint Infection Panel for prosthetic joint 
infections and expanded menu development in antimicrobial resistance and hospital-acquired 
infection testing. The FILMARRAY 2.0 and Torch systems remain the core installed 
platforms in hospital laboratories, while SPOTFIRE is driving newer decentralized growth.  
Expansion 
bioMérieux expanded its diagnostic portfolio through targeted acquisitions, strategic 
partnerships, and technology investments to strengthen acute care testing, molecular 
microbiology, and next-generation diagnostics. An earlier acquisition was Astute Medical, 
which brought the NEPHROCHECK platform into bioMérieux’s acute care biomarker 

 
 
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portfolio. NEPHROCHECK measures TIMP-2 and IGFBP7 to assess kidney stress and 
predict acute kidney injury before overt renal damage develops. The acquisition expanded 
bioMérieux’s critical care diagnostics business and complemented earlier commercialization 
of NEPHROCHECK on both the Astute140 Meter and adapted VIDAS workflows. 
A major new move came in 2025 with the acquisition of SpinChip Diagnostics, adding a 
rapid immunoassay platform designed for POC testing. SpinChip’s compact benchtop 
analyzer uses centrifugal microfluidics and high-sensitivity immunoassay technology to 
deliver laboratory-quality results in approximately 10 minutes. Initial menu priorities include 
high-sensitivity cardiac troponin I, NT-proBNP, and D-dimer, positioning bioMérieux to 
expand into rapid decentralized emergency diagnostics and acute cardiovascular testing. 
bioMérieux also strengthened its sequencing and rapid pathogen characterization strategy 
through the 2025 acquisition of Day Zero Diagnostics. Day Zero developed technologies that 
combine direct-from-whole-blood sample preparation, genomic sequencing, and advanced 
bioinformatics to enable rapid pathogen identification and antimicrobial susceptibility 
prediction. This acquisition supports bioMérieux’s longer-term strategy to integrate 
sequencing-based infectious-disease diagnostics into sepsis and antimicrobial-resistance 
workflows. 
Additional strategic expansion includes continued integration of Banyan Biomarkers for 
traumatic brain injury diagnostics through VIDAS TBI, expansion of the BIOFIRE 
SPOTFIRE decentralized PCR platform, and continued investment in rapid microbiology 
solutions such as VITEK REVEAL and VITEK MS PRIME. 
bioMérieux offers its BIOFIE SPOT FIRE for bioMérieux launched its BIOFIRE SPOTFIRE 
for pharmaceutical mycoplasma QC. Mycoplasma contamination in pharmaceutical 
production can compromise the quality of an entire batch, resulting in significant loss of 
product and time. The BIOFIRE SPOTFIRE Mycoplasma panel ensures continuity and helps 
manufacturers to improve operations.  

 
 
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Bio-Rad Laboratories, Inc. 
Hercules, CA 
www.bio-rad.com 
Table 14-6: Bio-Rad Revenue History, 2023-2025 ($ million, estimated) 
 
2023 
2024 
2025 
All Diagnostics 
1,489  
1,538 
1,562 
Source: company reports, Kalorama Information 
Bio-Rad Laboratories reported 0.8% growth in full-year 2025 Clinical Diagnostics revenues, 
which reached $1,562 million, compared with $1,538 million in 2024. Growth was primarily 
driven by increased demand for quality control products, blood typing reagents, and diabetes 
testing products, partially offset by weaker sales of certain infectious disease assays. 
Founded in 1952, Bio-Rad Laboratories, Inc. markets a broad range of products for the life 
science research and clinical diagnostics markets. The company offers more than 3,000 
products covering over 300 clinical diagnostic tests that are used by hospital laboratories, 
reference laboratories, transfusion laboratories, and physician office laboratories worldwide. 
Bio-Rad’s clinical diagnostics business offers a number of specialized diagnostic niches, 
including infectious disease immunoassays, diabetes HbA1c testing, autoimmune 
immunoassays, neonatal screening, allergy testing, blood typing, microbiology media, 
pathogen identification assays, quality control products for clinical laboratories. 
Bio-Rad acquired Curiosity Diagnostics, a developer of rapid PCR molecular testing 
systems. Curiosity’s PCR|ONE platform is designed to perform rapid multiplex PCR 
detection of infectious diseases directly at the point of care. 
Bio-Rad expanded its presence in oncology research through a licensing and product 
development agreement with NuProbe, a genomics and molecular diagnostics company 
focused on high-sensitivity mutation-detection technologies for liquid biopsy and precision 
oncology applications. 

 
 
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In February 2025, Bio-Rad announced a binding offer to acquire Stilla Technologies, a 
developer of digital PCR instruments and assays. The acquisition was completed in June 
2025. Stilla’s Nio digital PCR system is integrated into Bio-Rad’s portfolio and rebranded as 
part of the QX700 series, expanding the company’s droplet digital PCR platform capabilities. 
The addition strengthens Bio-Rad’s position in high-sensitivity molecular analysis for 
oncology, infectious disease testing, genetic research, and cell- and gene-therapy 
applications. 
Bio-Rad continues to expand its digital PCR and molecular diagnostics portfolio, which has 
become an important growth area for the company. The integration of Stilla’s technology 
complements Bio-Rad’s established QX200 and QX600 droplet digital PCR systems, 
enabling higher multiplexing capability and improved sensitivity for research and clinical 
applications. 
Quality Control 
Bio-Rad is a global leader in quality control (QC) products for clinical laboratories, offering 
one of the broadest QC portfolios in the diagnostics industry. Its controls cover analytes used 
in immunoassay, therapeutic drug monitoring (TDM), clinical chemistry, cardiac assessment, 
immunology, diabetes, coagulation, hematology, blood gas analysis, drugs-of-abuse testing, 
molecular diagnostics, and infectious disease testing. The company’s External Quality 
Assurance Services (EQAS) programs enable laboratories to independently assess their 
performance by comparing their results with those of peer laboratories that use similar 
methodologies, instruments, and reagents. These programs include specimen packs, 
statistical reports, and peer comparison tools that support regulatory compliance and 
laboratory accreditation. 
Bio-Rad’s laboratory informatics and QC connectivity platform uses its Unity Quality 
Control and Unity Interlaboratory Programs, which connect laboratories globally and allow 
real-time comparison of QC data across large peer groups. The network includes more than 
25,000 laboratories worldwide, helping laboratories identify shifts, trends, and instrument 
performance issues across multiple assay platforms. 
In molecular diagnostics quality control, Bio-Rad has expanded its Amplichek product 
family to include Amplichek STI Control, a multi-analyte molecular quality control designed 
to monitor nucleic acid testing workflows for sexually transmitted infections. The control 
provides detection processes for Chlamydia trachomatis, Neisseria gonorrhoeae, and high-

 
 
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risk HPV targets, covering both extraction and amplification steps in molecular workflows. 
Bio-Rad has expanded its molecular QC product line to include multiplex PCR systems for 
infectious disease testing, oncology, and transplant diagnostics. 
Bio-Rad also has a strong oncology quality control portfolio, including products such as 
Liquichek Tumor Marker Control, which offers expanded analyte coverage for 
immunoassay-based tumor marker testing. Key analytes include HE4, HER-2/neu, low-
concentration PSA, ferritin, and multiple cancer antigen markers, supporting performance 
verification across major automated immunoassay platforms. Expanded compatibility with 
high-throughput analyzers, including multiple Abbott Laboratories Alinity platforms, has 
strengthened Bio-Rad’s role in third-party QC across large core laboratories. 
Bio-Rad has continued to expand assay coverage across major instrument platforms, 
including additional QC assignments for Abbott Laboratories Alinity ci-series, Roche cobas 
systems, and Siemens Healthineers immunoassay and chemistry analyzers, reflecting 
ongoing demand for independent controls as laboratories consolidate onto larger automated 
systems. 
For urinalysis testing, Bio-Rad offers qUAntify Advance Control, an independent QC 
product designed for routine monitoring. The control uses a human urine matrix and provides 
extended open-vial stability, supporting consistency in analytes such as glucose, protein, 
ketones, and other routine urine chemistry parameters used in clinical laboratories. 
In molecular instrumentation, Bio-Rad markets the CFX Opus 96 Dx System and CFX Opus 
384 Dx System, which are real-time PCR detection systems designed for high-performance 
amplification and quantification. These systems provide multiplex testing of up to five targets 
and are used for assay development, laboratory-developed tests, and regulated molecular 
workflows. Bio-Rad has increasingly positioned these systems alongside its digital PCR 
portfolio, including the expanding QX series and newly integrated QX700 platform, 
following the 2025 acquisition of Stilla Technologies, strengthening its position in high-
sensitivity molecular quantification for oncology, infectious disease, and cell and gene 
therapy applications. 
Blood Bank 
Bio-Rad offers a broad transfusion diagnostics portfolio that includes automated and semi-
automated platforms, gel reagents, software, and connectivity solutions for blood grouping, 

 
 
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phenotyping, crossmatching, antibody screening and identification, direct antiglobulin 
testing (DAT), and single-antigen typing. The company’s blood banking portfolio remains 
centered on its IH-System gel card technology, which supports both automated and manual 
workflows used in hospital transfusion laboratories, blood centers, and reference 
laboratories. 
Bio-Rad’s automated blood bank systems include the IH-500 and IH-1000, along with 
connectivity solutions that enable laboratories to standardize blood typing workflows across 
varying testing volumes. The IH-500 is designed for small- to medium-volume laboratories 
and performs automated ABO/Rh grouping, reverse typing, phenotyping, antibody 
screening, antibody identification, DAT, crossmatching, and single-antigen testing using 
Bio-Rad’s full range of gel cards. The system minimizes manual handling while supporting 
continuous loading and flexible test management. 
The IH-1000 is Bio-Rad’s higher-throughput automated blood typing platform for larger 
transfusion laboratories. It supports full automation of immunohematology workflows and 
integrates with the company’s IH-Com patient data management software, which 
consolidates current and historical patient results, performs interpretation crosschecks, and 
supports secure transmission of results to laboratory information systems (LIS). IH-Com also 
enables instrument networking across multiple laboratory sites, improving traceability and 
standardization within hospital systems and blood networks. 
Bio-Rad continues to enhance digital workflow integration through IH-Web remote results 
management, allowing authorized users to review and validate blood bank results remotely 
across connected instruments. These connectivity tools support increasing laboratory demand 
for centralized oversight, data traceability, and compliance with transfusion safety 
requirements. 
For manual and semi-automated workflows, Bio-Rad markets the IH-Reader 24, a semi-
automated centrifuge and reader designed for small- and medium-volume laboratories. The 
system automatically reads gel cards, standardizes interpretation of agglutination reactions, 
and transfers results directly into IH-Com software, reducing operator subjectivity and 
improving consistency in transfusion medicine testing. 
Bio-Rad also offers the IH-Incubator L and IH-Centrifuge L, which support manual gel card 
testing using the full IH-System reagent menu. These instruments remain widely used in 

 
 
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laboratories that require flexible manual processing while maintaining compatibility with 
Bio-Rad’s automated blood bank systems. 
Blood typing is one of Bio-Rad’s strongest growth areas in clinical diagnostics. In 2025, the 
company reported ongoing demand for transfusion diagnostics products, particularly in 
Europe, Latin America, and selected Asia Pacific markets, where gel-based 
immunohematology systems continue to maintain strong installed bases. 
Bio-Rad has continued expanding reagent availability for extended phenotype testing and 
antibody investigation, while strengthening compatibility across its installed blood bank 
platform base. The company’s transfusion diagnostics strategy remains focused on workflow 
standardization, data connectivity, and incremental automation to support laboratory 
efficiency and transfusion safety. 
Diabetes 
Bio-Rad has more than 40 years of experience in diabetes testing and is one of the 
longstanding leaders in high-performance liquid chromatography-based HbA1c testing for 
clinical laboratories. The company established an early market position through benchtop 
HPLC systems used for both glycated hemoglobin measurement and hemoglobin variant 
detection, and it continues to maintain a strong installed base in hospital and reference 
laboratories worldwide. 
The company’s principal HbA1c platform is the D-100 Hemoglobin Testing System, a high-
throughput HPLC analyzer designed for laboratories requiring standardized HbA1c testing 
for diabetes diagnosis and long-term glucose monitoring. The D-100 incorporates Smart 
HPLC technology, automated calibration management, onboard quality monitoring, and Bio-
Rad’s integrated Advisor software, which automatically reviews chromatograms, flags 
abnormal patterns, and helps laboratories identify potential hemoglobin variants that may 
affect HbA1c interpretation. The system is widely used because it combines high analytical 
precision, reduced operator intervention, and strong alignment with international HbA1c 
standardization programs. 
Bio-Rad also continues to market the D-10 Hemoglobin Testing System, which remains 
widely used in moderate-volume laboratories. The D-10 Hemoglobin A1c Program supports 
HbA1c measurement as an aid in both diagnosing diabetes and identifying individuals at 
increased risk of developing diabetes (prediabetes). The system provides laboratories with 

 
 
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automated HPLC-based analysis while maintaining compatibility with established diabetes 
diagnostic guidelines. 
A major strength of Bio-Rad’s diabetes portfolio is its ability to deliver high analytical 
specificity in patient populations with hemoglobin variants, an important advantage over 
some immunoassay-based HbA1c methods. This has helped sustain Bio-Rad’s position in 
laboratories serving diverse patient populations where variant hemoglobins may affect test 
accuracy. 
Bio-Rad supports diabetes laboratories through its strong quality-control portfolio, including 
HbA1c controls, calibrators, and external quality-assurance programs that are widely used 
across both HPLC and immunoassay testing platforms. 
Although the global HbA1c market increasingly includes large, chemistry-based systems 
from Abbott Laboratories, Roche, and Siemens Healthineers, Bio-Rad maintains a 
differentiated position through specialized HPLC performance, variant-detection capability, 
and laboratory-standardization expertise. 
Immunoassays 
 Bio-Rad’s Bio-Plex assay portfolio is built around multiplex immunoassay technology 
derived from Luminex Corporation xMAP bead-based multiplex detection, allowing 
simultaneous measurement of multiple analytes in a single sample. In research applications, 
Bio-Rad continues to offer a broad menu of Bio-Plex multiplex assays for cytokines, 
chemokines, growth factors, cancer biomarkers, diabetes markers, and inflammatory 
mediators across multiple species. These assays remain widely used in translational research, 
immunology, oncology, and biomarker discovery. 
For clinical diagnostics, Bio-Rad’s principal multiplex immunoassay platform remains the 
BioPlex 2200 System, which is designed for automated high-throughput serology and 
autoimmune testing. The platform enables laboratories to perform multiplex or multiple 
individual immunoassays that would traditionally require separate analyzers, improving 
workflow efficiency while maintaining broad assay menus for infectious disease and 
autoimmune testing. 
Bio-Rad markets the BioPlex 2200 Syphilis Total & RPR assay, which is one of the few fully 
automated dual syphilis testing solutions that combine treponemal and non-treponemal 

 
 
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testing in a single assay. The test simultaneously detects antibodies to Treponema pallidum, 
measures reagin antibodies, and determines the RPR titer, supporting both diagnosis and 
treatment monitoring in a single automated workflow. This dual approach remains attractive 
to laboratories seeking to reduce the number of manual reflex testing steps. 
The company also offers the BioPlex 2200 ToRC IgM and IgG assays, multiplex prenatal 
screening panels for Toxoplasma gondii, rubella, and cytomegalovirus (CMV). These assays 
provide comprehensive serologic profiling for first-trimester prenatal screening and remain 
important in laboratories that perform maternal infectious disease testing. 
Bio-Rad’s BioPlex 2200 Lyme Total Assay is designed to detect multiple antibody targets 
associated with Lyme disease in a multiplex format. The assay supports automated first-line 
serologic screening and is positioned to improve consistency compared with traditional 
multi-step Lyme testing workflows. 
In autoimmune diagnostics, the BioPlex 2200 platform supports multiplex autoimmune 
testing through assays for ANA screening, anti-dsDNA, and multiple extractable nuclear 
antigens (ENA). Multiplex autoimmune testing remains one of Bio-Rad’s most differentiated 
immunoassay strengths, particularly in medium- and high-volume specialty laboratories. 
Although Bio-Rad maintains the BioPlex 2200 installed base, growth in immunoassays has 
become more selective as many high-volume infectious disease laboratories increasingly 
migrate toward larger chemiluminescent systems from Abbott Laboratories, Roche, and 
Siemens Healthineers. Bio-Rad’s competitive advantage remains strongest in specialized 
multiplex serology, autoimmune diagnostics, and niche infectious disease assays where 
multiplex efficiency and broad analyte coverage continue to offer workflow advantages. 
Liquid Biopsy 
Bio-Rad strengthens its position in digital PCR through its droplet digital PCR (ddPCR) 
portfolio, which is widely used for highly sensitive nucleic acid quantification in oncology, 
infectious disease, transplant monitoring, and genetic analysis. The company offers a ddPCR 
assay for the detection of BCR::ABL1 gene fusion transcripts, used to monitor treatment 
response in patients with chronic myeloid leukemia. This assay was Bio-Rad’s first clinical 
ddPCR assay to receive CE marking and remains an important application for measuring 
very low levels of residual disease with greater sensitivity than many conventional molecular 
methods. 

 
 
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Bio-Rad’s digital PCR business has expanded significantly with its QX200, QX600, and 
newer QX700 series platforms. The addition of higher multiplexing capability broadens Bio-
Rad’s ability to support oncology mutation detection, rare variant analysis, liquid biopsy 
research, measurable residual disease monitoring, and advanced molecular testing 
applications. The company increasingly positions ddPCR as a complementary technology to 
next-generation sequencing by providing precise absolute quantification and high sensitivity 
for targeted assays. 
Bio-Rad also developed the Genesis Cell Isolation System and Celselect Slides for 
circulating tumor cell (CTC) enrichment and analysis in liquid biopsy workflows. Celselect 
Slides were designed to improve the enumeration and downstream characterization of 
circulating tumor cells for genomic analysis, digital PCR, and immunofluorescence staining. 
While these products remain part of Bio-Rad’s broader oncology technology portfolio, the 
company’s recent commercial emphasis has shifted more strongly toward digital PCR and 
molecular quantification, where demand continues to expand across both research and 
emerging clinical applications. 
Droplet Digital PCR 
Bio-Rad introduced droplet digital PCR in 2012, establishing one of the first commercially 
successful platforms for absolute nucleic acid quantification by partitioning samples into 
thousands of nanoliter-sized droplets. This partitioning approach allows each droplet to 
function as an individual PCR reaction, significantly improving sensitivity, precision, and 
reproducibility compared with conventional quantitative PCR, particularly when detecting 
very low-abundance targets. 
Since its introduction, ddPCR has become widely adopted in oncology research, especially 
for liquid biopsy, rare mutation detection, measurable residual disease monitoring, copy 
number variation analysis, and low-frequency allele detection, where conventional PCR 
methods may lack sufficient analytical sensitivity. Bio-Rad’s ddPCR technology is widely 
used in translational cancer research, infectious disease studies, cell and gene therapy 
development, and advanced molecular assay validation. 
Bio-Rad strengthened its digital PCR capabilities through the acquisition of RainDance 
Technologies. RainDance Technologies droplet-based systems expanded Bio-Rad’s 
intellectual property and technical reach in ultra-sensitive molecular analysis. RainDance 
contributed technologies such as RainDrop Digital PCR and targeted enrichment systems 

 
 
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designed for rare mutation analysis, inherited disease studies, and oncology applications. 
Although the RainDance brand has largely been integrated into Bio-Rad’s broader digital 
PCR strategy, the acquisition helped accelerate Bio-Rad’s expansion in highly sensitive 
liquid biopsy workflows and rare variant detection. 
Bio-Rad advanced digital PCR into regulated clinical diagnostics through the QXDx 
AutoDG ddPCR System and the QXDx BCR-ABL %IS Kit, which became the first digital 
PCR system and assay combination to receive FDA clearance for clinical diagnostic use. The 
system is used to monitor molecular response in patients with Chronic Myeloid Leukemia 
chronic myeloid leukemia by quantifying BCR:ABL1 transcript levels with very high 
precision. The assay monitors residual disease during tyrosine kinase inhibitor therapy and 
helps guide long-term treatment management. 
The QXDx AutoDG system also provides laboratories seeking flexibility between FDA-
cleared assays and laboratory-developed molecular applications. Automated droplet 
generation improves workflow standardization and reduces hands-on variability, which has 
increased adoption in clinical molecular laboratories. 
Bio-Rad has expanded its multiplex capabilities through the QX600 Droplet Digital PCR 
System, which enables the detection of multiple targets within a single reaction and is widely 
used for oncology biomarker research, gene expression analysis, orthogonal validation of 
next-generation sequencing results, and mutation profiling. The company has further 
advanced its digital PCR portfolio with the introduction of the QX700 series, which 
incorporates enhanced multiplexing and workflow improvements. This newer platform 
strengthens Bio-Rad’s position in high-precision molecular quantification across oncology, 
infectious disease, and emerging applications such as cell and gene therapy 
Bio-Rad entered into a partnership with Gencurix  as the exclusive distributor of Gencurix’ 
Droplex digital PCR oncology testing kits throughout Europe. The partnership builds on the 
companies’ existing relationship and will provide physicians with enhanced biomarker 
testing.  
Sequencing 
Bio-Rad and Illumina previously collaborated to introduce the Illumina Bio-Rad Single-Cell 
Sequencing Solution, one of the early integrated next-generation sequencing workflows 
designed for single-cell transcriptomic analysis. The workflow combined Bio-Rad’s droplet-

 
 
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partitioning technology with Illumina sequencing platforms, enabling researchers to study 
gene expression at the single-cell level and supporting investigations into tissue 
heterogeneity, disease progression, immune response, and therapeutic mechanisms. 
The original solution used Bio-Rad’s ddSEQ Single-Cell Isolator together with the SureCell 
WTA 3’ Library Prep Kit, allowing individual cells to be isolated, barcoded, and prepared 
for downstream sequencing. Bio-Rad’s droplet technology generated microdroplet partitions 
containing single cells and molecular barcodes, enabling transcript capture before sequencing 
on Illumina instruments. Data analysis was performed in Illumina’s BaseSpace environment, 
with downstream visualization supported by SeqGeq software developed by FlowJo. 
Although this collaboration helped establish early commercial single-cell sequencing 
workflows, the market has since evolved rapidly, with broader adoption of higher-throughput 
single-cell platforms led by specialized providers such as 10x Genomics. Bio-Rad’s more 
recent strategic emphasis has shifted toward digital PCR, molecular quantification, and 
advanced genomics tools rather than expanding the ddSEQ platform aggressively. 
The collaboration is significant because it demonstrated Bio-Rad’s ability to extend droplet-
partitioning expertise beyond digital PCR into genomics workflows. Many of the underlying 
droplet handling principles developed through these single-cell efforts continue to 
complement Bio-Rad’s broader molecular technologies 

 
 
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Bruker Corporation 
Billerica, MA 
www.bruker.com 
Table 14-7: Bruker Revenue History Product Revenue, 2023-2025 ($ million) 
 
2023 
2024 
2025 
BSI CALID Group 
960 
1,094 
1,210 
Total Revenues 
2,964 
3,364 
3,437 
Source: company reports, Kalorama Information 
In 2025, Bruker Corporation reported total revenues of approximately $3.4 billion, 
representing modest growth over 2024. Within the company’s diagnostics-related business, 
the CALID Group (Cell Biology, Automation, Life Science and In Vitro Diagnostics) 
remained one of the stronger growth contributors, supported by continued expansion in 
microbiology and infectious disease diagnostics. Growth was driven primarily by strong 
global demand for MALDI Biotyper systems, increased molecular diagnostics sales from 
ELITechGroup, and expanding installed-base utilization in clinical microbiology 
laboratories. 
Bruker’s microbiology and diagnostics portfolio is concentrated within the CALID segment 
and includes activities from ELITechGroup ELITechGroup, Bruker Daltonics Bruker 
Daltonics, and selected optical and molecular technologies from Bruker Optics Bruker 
Optics. These businesses collectively support mass spectrometry-based microbiology, 
molecular infectious disease testing, sample-preparation systems, and specialty diagnostic 
instrumentation. 
The strongest growth in clinical diagnostics continues to come from the MALDI Biotyper 
platform, which remains one of the leading mass spectrometry systems for rapid microbial 
identification in clinical microbiology laboratories. Bruker has continued to expand its assay 
menu and workflow capabilities in MALDI-based diagnostics, including applications for 
blood culture identification, antimicrobial resistance detection, and direct specimen analysis. 

 
 
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A major growth area for Bruker is the Sepsityper workflow, which enables rapid 
identification of pathogens directly from positive blood cultures. The product has achieved 
strong adoption in Europe and other international markets because it shortens time to 
organism identification in bloodstream infections and supports earlier antimicrobial decision-
making. Bruker continues to pursue broader regulatory expansion of Sepsityper-based 
workflows and additional blood culture applications. 
Bruker is also advancing the integration of susceptibility testing through new MALDI-based 
antimicrobial resistance solutions, aiming to expand beyond organism identification to more 
comprehensive microbiology workflows. This strategy supports the company’s long-term 
goal of increasing recurring consumables revenue, since instrument sales still account for the 
majority of total microbiology revenues while assay and reagent pull-through remain growth 
priorities. 
In molecular diagnostics, ELITechGroup offers syndromic infectious disease testing, 
sample-preparation systems, and transplant-related molecular assays. Bruker has continued 
to integrate ELITech molecular technologies into its broader microbiology strategy to 
strengthen infectious disease diagnostics across hospital and specialty laboratories. 
Geographically, Bruker generates balanced revenue across major regions, with Europe 
remaining particularly strong in microbiology adoption, while the United States and Asia 
Pacific continue to expand through growing MALDI installed bases and rising demand for 
molecular testing. 
Bruker Daltonics is the company’s central mass spectrometry division and continues to 
supply a broad range of analytical systems including MALDI-TOF, MALDI-TOF/TOF, LC-
MS, FTMS, and QTOF systems used across pharmaceutical research, clinical microbiology, 
proteomics, and applied markets. In clinical diagnostics, Bruker’s strongest competitive 
advantage remains its early and sustained leadership in MALDI mass spectrometry for 
microbial identification, where it continues to compete primarily with bioMérieux. 
More recently, Bruker has also expanded development in tuberculosis testing, fungal 
identification, and resistance marker detection, reflecting growing demand for faster 
microbiology workflows and improved antimicrobial stewardship support in hospital 
laboratories. 

 
 
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Acquisitions and Collaborations 
Bruker uses acquisitions as a key strategy to expand its capabilities in clinical diagnostics, 
microbiology, molecular testing, and laboratory informatics. Over the past several years, the 
company has increasingly targeted businesses that strengthen assay development, 
consumables manufacturing, molecular diagnostics, antimicrobial resistance testing, and 
software integration, supporting its broader goal of building a more complete clinical 
diagnostics platform beyond core instrument sales. 
Bruker acquired InVivo Biotech Services in Germany to add expertise in consumables 
development and manufacturing, particularly in monoclonal antibodies, recombinant 
proteins, and immunoassay component production. This acquisition strengthened Bruker’s 
internal capacity for assay development and supports continued expansion of consumables 
for the MALDI Biotyper platform as well as future infectious disease assay development, 
including molecular and syndromic testing products. 
The acquisition of MERLIN Diagnostika added specialized expertise in antimicrobial 
susceptibility testing (AST) and antibiotic resistance testing (ART). MERLIN’s 
MICRONAUT platform remains important in Bruker’s effort to expand beyond microbial 
identification into susceptibility testing. MICRONAUT supports phenotypic detection of 
microbial growth inhibition across major resistance phenotypes, including MRSA, VRE, 
ESBL, carbapenemases, and antifungal susceptibility testing, while software integration with 
MALDI Biotyper supports broader microbiology workflow development. 
A major diagnostics expansion came through the acquisition of Hain Lifescience Hain 
Lifescience, which formed the basis for Bruker-Hain Diagnostics. This acquisition added a 
well-established molecular assay menu, including GenoType assays for tuberculosis, 
antimicrobial resistance, sexually transmitted infections, and HIV. Hain’s tuberculosis 
molecular assays remain strategically important because they complement Bruker’s 
microbiology portfolio and strengthen its presence in high-burden infectious disease testing 
markets. 
Bruker acquired Arxspan Arxspan, a provider of cloud-based scientific software for 
chemistry, pharmaceutical, and analytical laboratory workflows. This reflects Bruker’s 
broader effort to strengthen informatics and digital laboratory integration across its analytical 
and diagnostic businesses. 

 
 
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The company acquired PreOmics, IonSense, and other specialty businesses supporting 
proteomics and mass spectrometry workflows. These additions strengthen Bruker’s CALID 
segment by improving automation and sample preparation for high-performance analytical 
workflows. 
Bruker completed the acquisition of ELITechGroup, which significantly expanded its 
molecular diagnostics portfolio. ELITech adds sample-preparation systems, specialty PCR 
assays, transplant testing, and infectious-disease molecular solutions that complement 
Bruker’s MALDI-based microbial-identification systems. 
Bruker acquired NanoString Technologies, adding the nCounter, GeoMx, CosMx, and 
AtoMx product lines. This acquisition expands Bruker’s position in spatial biology, 
transcriptomics, and advanced biomarker analysis, areas increasingly relevant to translational 
medicine and oncology research. 
In June 2025, Bruker acquired Biocrates Life Sciences, a mass spectrometry-based 
metabolomics company that provides standardized kits covering more than 1,000 metabolites 
across over 40 metabolite classes. This acquisition strengthens Bruker’s metabolomics 
capabilities and supports growing interest in biomarker discovery, precision medicine, and 
clinical translational research. 
Bruker has increasingly aligned these acquisitions around a long-term strategy that combines 
microbiology, molecular diagnostics, metabolomics, spatial biology, and laboratory 
informatics, positioning the company to expand recurring revenue from assays, software, and 
consumables alongside its established instrument business. 
Mass Spectrometry 
Bruker offers the DART-EVOQ triple quadrupole mass spectrometer for high-throughput 
quantitative analyses at the POC. Bruker sells the timsTOF Ultra Mass Spectrometer with 
transformative Sensitivity. It incorporates a new Captive Spray Ionization Ultra ion source.  
Additionally, Bruker offers the EVOQ DART-TQ+ system for chromatography-free triple 
quadrupole mass spectrometry for POC analysis.  

 
 
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The company markets the MALDI-TOF/TOF system-neoflex Imaging Profiler for mass 
spectrometry-based tissue imaging.  It comes with a proprietary smartbeam 3D laser and fits 
on a bench top.  
Additionally, Bruker markets its Omni Mass Spectrometer system – timsTOF-based mass 
spectrometer.  
Microbiology 
Antimicrobial identification and susceptibility testing (ID/AST) in clinical microbiology 
continues to rely heavily on established automated phenotypic systems such as the Becton 
Dickinson BD Phoenix platform and bioMérieux VITEK systems, but mass spectrometry has 
now become a firmly established component of routine microbial identification in major 
laboratories worldwide. Over the past decade, matrix-assisted laser desorption ionization 
time-of-flight (MALDI-TOF) mass spectrometry has moved from early adoption into broad 
routine use because of its speed, lower cost per test, and high species-level identification 
performance. MALDI-TOF works by generating characteristic protein spectral fingerprints 
that act as unique signatures for microorganisms. These spectral patterns are matched against 
curated reference libraries to identify bacteria, yeasts, fungi, and selected mycobacteria 
within minutes, allowing organism identification often in less than an hour once microbial 
growth is available. 
Bruker Corporation pioneered MALDI-TOF adoption in clinical microbiology through the 
MALDI Biotyper MALDI Biotyper, which remains one of the leading microbial 
identification systems globally. The platform identifies bacteria, yeasts, fungi, and 
mycobacteria by matching protein fingerprints from cultured colonies against Bruker’s 
continuously expanding microbial reference database, which now includes thousands of 
clinically relevant bacterial and fungal species, including expanded coverage for rare 
organisms, filamentous fungi, and non-tuberculous mycobacteria. Bruker has continued 
expanding the MALDI Biotyper family through newer systems including the MALDI 
Biotyper sirius MALDI Biotyper sirius and the compact MALDI Biotyper sirius one MALDI 
Biotyper sirius one, which broaden access to MALDI identification across both large and 
smaller microbiology laboratories. 
 

 
 
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Rapid bloodstream infection testing is a major Bruker growth area through the Sepsityper 
Sepsityper workflow, which enables direct identification of pathogens from positive blood 
cultures without overnight subculture, significantly shortening time to organism 
identification in sepsis management. Bruker has further expanded this workflow with 
functional resistance assays, such as MBT STAR-Carba for carbapenem resistance detection 
and MBT STAR-Cepha for third-generation cephalosporin resistance testing, enabling 
laboratories to obtain early antimicrobial resistance information alongside organism 
identification.  
Molecular PCR 
In addition to its mass spectrometry portfolio, Bruker Corporation has continued expanding 
its clinical molecular diagnostics business through PCR-based assay systems largely built on 
technologies obtained through the acquisition of Hain Lifescience. That acquisition 
established Bruker-Hain Diagnostics within the company’s microbiology and diagnostics 
operations and added a strong menu of molecular infectious disease assays focused on 
tuberculosis, antimicrobial resistance, mycobacteria, and selected viral infections. 
The company offers the FluoroCycler XT, a high-performance PCR thermal cycler and 
reader designed for Bruker’s LiquidArray molecular assay family. The system is designed 
for mid-plex molecular testing with high analytical sensitivity and relatively rapid turnaround 
times, allowing laboratories to perform direct molecular detection from patient samples 
without prolonged culture steps in selected applications. 
Bruker’s FluoroType MTBDR assay family is one of its most important molecular offerings 
for tuberculosis testing. The FluoroType MTBDR 2.0 assay is designed for rapid detection 
of Mycobacterium tuberculosis and major drug-resistance mutations directly from patient 
samples, reducing time to resistance profiling compared with conventional culture-based 
workflows. The assay detects multiple mutations associated with resistance to rifampicin and 
isoniazid and remains particularly important in regions with high tuberculosis burden and 
multidrug-resistant TB prevalence. 
The company has also expanded its mycobacteria testing menu through the FluoroType 
Mycobacteria assay, which differentiates a broad range of clinically relevant non-tuberculous 
mycobacteria species. This addresses growing clinical demand for faster identification of 
non-tuberculous mycobacterial infections, especially in immunocompromised patients and 
chronic pulmonary disease cases. 

 
 
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Bruker offers multiplex infectious disease assays based on its LiquidArray technology, 
including the LiquidArray Gastrointestinal panel, which enables simultaneous detection of 
multiple bacterial, viral, and parasitic pathogens associated with gastrointestinal infections. 
The syndromic panel is designed to improve laboratory efficiency by consolidating multiple 
targets into a single workflow. 
Additional molecular development has focused on invasive fungal disease testing and 
selected transplant-related infectious disease assays, where Bruker aims to build 
differentiated specialty menus rather than compete directly in broad high-volume syndromic 
PCR markets dominated by larger molecular diagnostics companies. 
Bruker’s molecular diagnostics complement its MALDI microbiology franchise by 
combining rapid organism identification, resistance characterization, and targeted molecular 
confirmation within specialized microbiology workflows. 

 
 
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Cepheid / Danaher 
Sunnyvale, CA 
www.cepheid.com 
Cepheid is one of the leading molecular diagnostics companies, focused on highly automated 
cartridge-based PCR systems designed for use across decentralized point-of-care settings, 
hospital laboratories, and high-volume reference centers. As part of Danaher Corporation, 
Cepheid continues to expand the global installed base of its GeneXpert systems, with tens of 
thousands of instruments deployed across more than 180 countries. The platform is widely 
used in both low-resource healthcare settings and advanced clinical laboratories because it 
combines automated sample preparation, nucleic acid extraction, amplification, and detection 
in a fully enclosed cartridge, minimizing contamination risk and simplifying molecular 
testing workflows. 
The GeneXpert System is Cepheid’s core platform and features one of the broadest 
decentralized molecular menus in diagnostics, spanning tuberculosis, respiratory infections, 
sexually transmitted infections, antimicrobial resistance, blood virology, hospital-acquired 
infections, and oncology. The menu offers more assays available globally than in the U.S., 
including products for HIV viral load, hepatitis B and C monitoring, tuberculosis resistance 
testing, women’s health, and leukemia monitoring. The platform’s ability to deliver results 
directly from minimally processed specimens differentiates it from conventional PCR 
systems that require more manual laboratory steps. 
Cepheid’s Xpert HCV Viral Load Fingerstick is one of its most important decentralized 
hepatitis products. The assay quantifies hepatitis C virus RNA directly from capillary whole 
blood obtained by finger stick and produces results in about one hour, allowing diagnosis and 
treatment decisions during a single clinic visit. The test reduces dependence on centralized 
laboratory infrastructure and improves access in outreach clinics, addiction treatment 
programs, and underserved settings. Its broad genotype coverage supports use across 
multiple geographic regions where genotype diversity remains clinically important. 
In 2025 and continuing into 2026, Cepheid also advanced strategic collaboration with Oxford 
Nanopore Technologies to develop integrated sequencing-based workflows that combine 
Cepheid’s cartridge-based automated sample preparation with nanopore sequencing 

 
 
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technology. This collaboration is designed to extend Cepheid’s reach beyond rapid PCR into 
future sequencing-enabled clinical applications, including infectious disease characterization 
and genomic analysis. 
New product offerings include expanded use of Xpert HBV Viral Load, broader deployment 
of Xpert HIV-1 Viral Load XC, continued adoption of Xpert MTB/XDR for extended 
tuberculosis drug resistance detection, and growth in rapid syndromic respiratory panels that 
combine COVID-19, influenza, and RSV detection. Cepheid’s strategy remains centered on 
delivering laboratory-quality molecular results closer to the patient while expanding into 
higher-complexity molecular applications beyond traditional PCR. 
GeneXpert/ Xpress Line 
Cepheid markets its rapid near-patient molecular testing menu through the GeneXpert Xpress 
family, available in single-, two-, and four-module configurations for decentralized 
laboratories, urgent care centers, physician offices, and hospital near-patient settings. The 
GeneXpert Xpress II and GeneXpert Xpress IV platforms are FDA-cleared and CLIA-
waived multi-module systems, allowing multiple rapid PCR tests to be run simultaneously 
while maintaining the same cartridge-based workflow used across the broader GeneXpert 
portfolio. The Xpress systems provide faster turnaround by using optimized cartridge 
chemistry that shortens amplification time compared with standard GeneXpert assays. 
Within respiratory diagnostics, Xpert Xpress Flu, Xpert Xpress Flu/RSV, and Xpert Xpress 
SARS-CoV-2/Flu/RSV combinations remain core products in Cepheid’s near-patient menu. 
Xpert Xpress Flu/RSV detects influenza A, influenza B, and RSV using multiple molecular 
targets to improve strain coverage and maintain sensitivity as circulating viruses evolve, with 
results typically available in about 20 to 30 minutes. Cepheid has also continued to emphasize 
broader use of multiplex respiratory assays that combine COVID-19, influenza, and RSV 
detection in a single cartridge to support emergency department and outpatient respiratory 
triage during seasonal surges. 
For streptococcal testing, Xpert Xpress Strep A is a CLIA-waived molecular assay that 
detects Streptococcus pyogenes directly from throat swabs in as little as 18 minutes. The test 
is valuable because negative molecular results generally eliminate the need for reflex culture 
in many clinical settings, allowing faster treatment decisions for suspected Group A 
streptococcal infections. 

 
 
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Cepheid offers additions to its women’s health portfolio. Its multiplex vaginal PCR panel 
provides simultaneous molecular detection of organisms associated with bacterial vaginosis, 
vulvovaginal candidiasis, and trichomoniasis, supporting syndromic diagnosis from a single 
specimen. This panel improves diagnostic accuracy compared with microscopy and 
conventional microbiology while reducing time to treatment. 
In virology, Xpert Xpress CoV-2 plus offers an additional conserved genetic target to 
improve SARS-CoV-2 detection as variants continue to emerge. Cepheid has also maintained 
broader global placement of its COVID assays alongside multiplex respiratory panels that 
provide continued hospital and outpatient respiratory testing. 
For hematologic oncology, Xpert NPM1 Mutation enables measurable residual disease 
monitoring in acute myeloid leukemia by rapidly quantifying mutant NPM1 mRNA 
transcripts directly from peripheral blood or bone marrow specimens. In infectious disease 
monitoring, Xpert HIV-1 Viral Load XC is an important next-generation assay for viral load 
measurement, designed to provide broader subtype coverage and improved performance 
across diverse HIV strains while supporting decentralized viral load testing in both developed 
and resource-limited settings. 
Newer menu expansion in 2026 also includes broader global adoption of Cepheid’s rapid 
antimicrobial resistance assays, expanded hepatitis testing, and continued rollout of 
syndromic molecular panels, strengthening the company’s position in decentralized PCR 
testing across respiratory disease, sexual health, oncology, and chronic infectious disease 
monitoring. 
Tuberculosis 
Cepheid plays a major role in rapid molecular diagnosis of tuberculosis through its Xpert 
MTB/RIF and Xpert MTB/RIF Ultra assays on the GeneXpert platform. Xpert MTB/RIF is 
one of the most widely adopted rapid molecular tuberculosis tests globally because it 
simultaneously detects Mycobacterium tuberculosis complex DNA and rpoB mutations 
associated with rifampin resistance, directly from clinical specimens. The assay produces 
results in approximately two hours and has become a standard frontline molecular tool in 
many national tuberculosis control programs because it significantly shortens the time to 
diagnosis compared with smear microscopy and conventional culture. 
 

 
 
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Cepheid’s Xpert MTB/RIF Ultra is the company’s most sensitive second-generation 
tuberculosis assay and is increasingly preferred in many clinical settings, particularly for 
patients with low bacterial burden, such as children, HIV-positive individuals, and those with 
extrapulmonary tuberculosis. The assay was redesigned to improve analytical sensitivity by 
more than tenfold compared with the original MTB/RIF test through enhanced molecular 
targets and automated melt curve analysis that improves detection of rifampin resistance 
mutations. This expanded sensitivity has improved identification of smear-negative 
tuberculosis while maintaining rapid turnaround on the GeneXpert system. 
The Ultra assay was developed through collaboration involving Cepheid, academic partners, 
and global tuberculosis organizations, and it offers international tuberculosis elimination 
efforts through widespread deployment in both centralized and decentralized testing 
environments. In 2026, GeneXpert tuberculosis testing remains central to global TB 
programs, with Cepheid continuing to support high-burden countries through broad 
instrument deployment, cartridge supply agreements, and expanded access initiatives to 
improve early diagnosis of drug-resistant tuberculosis. 
Microbiology 
The Xpert Carba-R assay is an important rapid molecular test for infection control because it 
detects five major carbapenemase resistance genes commonly associated with carbapenem-
resistant organisms, including KPC, NDM, VIM, OXA-48, and IMP. Rather than identifying 
the organism itself, the assay detects the resistance genes directly from rectal swabs or 
cultured isolates, enabling hospitals to rapidly identify patients carrying highly drug-resistant 
organisms and strengthen infection prevention measures within hours rather than days. 
In sexually transmitted infection testing, Cepheid markets the Xpert TV assay, a rapid 
molecular urine-based and swab-based test for detection of Trichomonas vaginalis. The assay 
remains widely used because it provides highly sensitive molecular results in approximately 
35 minutes, allowing same-visit diagnosis and treatment in women’s health clinics, urgent 
care settings, and decentralized laboratories. Cepheid’s sexually transmitted infection menu 
continues to benefit from increasing demand for rapid syndromic molecular testing. 
For healthcare-associated infection control, Cepheid’s Xpert MRSA NxG is a key product 
for rapid methicillin-resistant Staphylococcus aureus screening. This next-generation assay 
detects MRSA colonization directly from nasal swabs with improved target design for 

 
 
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broader strain coverage and delivers actionable molecular results in about one hour, 
supporting faster patient isolation decisions and hospital infection control workflows. 
Cepheid offers a strong maternal and neonatal testing portfolio through its Group B 
Streptococcus assays. Xpert GBS LB XC is used for qualitative molecular detection of Group 
B Streptococcus from enriched Lim broth cultures and supports prenatal screening programs 
with fast PCR-based confirmation on GeneXpert systems. Additionally, Xpert Xpress GBS 
is an important rapid intrapartum test because it uses dual molecular targets to improve 
sensitivity and strain detection directly during labor, producing results in approximately 30 
minutes. These assays are valued because rapid identification of maternal GBS colonization 
helps guide antibiotic prophylaxis and reduce the risk of early-onset neonatal sepsis. 
POC Testing 
Cepheid expanded its molecular diagnostics portfolio with a strong emphasis on rapid 
infectious disease testing on the GeneXpert platform. Its Xpert HCV Viral Load Fingerstick 
assay remains one of the company’s most important decentralized hepatitis products because 
it detects hepatitis C virus RNA directly from a fingerstick capillary whole-blood sample 
without requiring plasma preparation. The assay produces results in about one hour, allowing 
clinicians to diagnose active HCV infection and potentially begin treatment during a single 
patient visit, which is especially valuable in outreach clinics, emergency settings, and 
community screening programs. This product was the first CLIA-waived molecular test in 
the U.S. capable of directly detecting HCV RNA from fingerstick blood. 
Cepheid markets its broader Xpert HCV viral load test menu, which offers quantitative 
hepatitis C monitoring on GeneXpert systems used in hospitals, laboratories, and 
decentralized testing sites. In sexual health diagnostics, the Xpert CT/NG assay is an 
important product following its expansion to include throat and rectal specimen testing, 
enabling rapid molecular detection of chlamydia and gonorrhea across multiple specimen 
types with high sensitivity and a fast turnaround time. 
For emerging infectious diseases, Cepheid offers the Xpert Mpox test, designed for rapid 
molecular detection of monkeypox virus on GeneXpert instruments, supporting public health 
and hospital-based outbreak response. The company has also strengthened its respiratory 
testing menu with updated SARS-CoV-2 assays, including multi-target COVID molecular 
tests designed to maintain detection performance as viral variants evolve. 

 
 
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Additional menu expansion includes continued global rollout of Xpert HBV Viral Load for 
hepatitis B viral monitoring, broader use of Xpert Xpress combination respiratory panels 
covering COVID-19, influenza, RSV, and strep testing, and growing adoption of hospital-
based syndromic panels that support faster infectious disease triage.  
Cancer 
Cepheid markets the Xpert Bladder Cancer Monitor in Europe as a noninvasive molecular 
assay for the surveillance of recurrent bladder cancer, using urine samples on the GeneXpert 
platform. The test delivers results in about 90 minutes and remains positioned as a 
complementary tool to cystoscopy, particularly for follow-up monitoring of patients with 
non-muscle invasive bladder cancer. Its strong negative predictive performance has been 
important in reducing unnecessary invasive procedures in selected surveillance settings, 
especially where rapid outpatient molecular assessment is needed. 
In hematologic oncology, Cepheid offers Xpert NPM1 Mutation, a quantitative molecular 
assay that measures mutant NPM1 mRNA transcripts in peripheral blood or bone marrow 
from patients with acute myeloid leukemia. The test detects the major exon 12 mutation 
subtypes, including A, B, and D, and supports monitoring of measurable residual disease by 
providing standardized molecular quantification on GeneXpert systems. This assay is 
important in leukemia follow-up because it enables faster, decentralized molecular 
assessment compared with traditional reference-laboratory PCR workflows. 
Cepheid’s oncology menu has expanded through broader adoption of rapid molecular cancer 
assays on GeneXpert, including products used for hematologic malignancy monitoring, while 
its overall strategy remains focused on bringing fast PCR-based oncology and infectious 
disease testing closer to routine hospital workflows and decentralized care settings. 

 
 
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Danaher Corporation 
Washington, DC 
www.danaher.com 
Table 14-8: Danaher Revenue History, Diagnostics Segment, 2023-2025 ($ million, estimated) 
 
2023 
2024 
2025 
Total Diagnostics 
9,577 
9,787 
9,941 
Source: company reports, Kalorama Information 
Danaher reported modest growth in diagnostics revenue in 2025, reaching approximately 
$9.9 billion compared with $9.8 billion in 2024. Growth was supported mainly by stronger 
performance in pathology diagnostics and acute care testing, particularly within Leica 
Biosystems, Radiometer, and Beckman Coulter Diagnostics. Geographic distribution of 
diagnostic sales remained broad, with North America representing the largest share, followed 
by Western Europe, high-growth markets, and other international regions. 
Danaher has built one of the broadest diagnostics portfolios in the industry through a long 
series of acquisitions and internal expansion. Its major diagnostic businesses include 
Beckman Coulter Diagnostics, Cepheid, Leica Biosystems, Radiometer, and HemoCue, 
while related businesses such as SCIEX support analytical and clinical laboratory workflows. 
The company began developing its modern diagnostics platform with the acquisition of 
Radiometer in 2004 and expanded through additional acquisitions including Leica 
Microsystems, Beckman Coulter, Iris International, Aperio Technologies, HemoCue, and 
Cepheid. These businesses now serve core laboratory diagnostics, molecular diagnostics, 
pathology, urinalysis, and acute care testing markets. 
Beckman Coulter is a leading provider of clinical diagnostics systems with a strong emphasis 
on automated core laboratory and high-throughput immunoassay testing. Its Access and 
UniCel DxI platforms, including the DxI 9000, support rapid and highly sensitive testing in 
hospital and reference laboratories, particularly in acute care environments. The company’s 
cardiac marker menu includes high-sensitivity troponin I (hsTnI), which enables earlier and 
more precise detection of myocardial infarction, along with established troponin assays. For 

 
 
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heart failure assessment, Beckman Coulter offers BNP and next-generation NT-proBNP 
assays, the latter enhanced with improved antibody design, rapid turnaround times, and age-
specific clinical interpretation. Additional markers such as CK-MB support evaluation of 
myocardial injury. These assays are optimized for speed, analytical performance, and 
integration into automated workflows, supporting timely clinical decision-making in 
cardiovascular care. 
Cepheid is one of Danaher’s most important molecular diagnostics assets. Since joining 
Danaher in 2016, Cepheid has continued expanding the GeneXpert platform, which is widely 
used for rapid molecular testing in infectious disease detection, hospital-acquired infections, 
tuberculosis, respiratory disease, sexual health testing, and selected oncology applications. 
The GeneXpert installed base remains one of the largest global molecular diagnostic 
footprints, supporting both hospital laboratories and decentralized testing environments. 
Iris International strengthened Danaher’s urinalysis business through advanced automated 
urine microscopy and chemistry systems. Its iRICELL platform integrates urine chemistry 
and digital microscopy into a fully automated workflow designed for high-volume 
laboratories. Proprietary digital flow morphology technology and auto-particle recognition 
software allow automated classification of urine particles while reducing manual microscopic 
review and improving consistency of results.  
Danaher has also expanded through targeted acquisitions outside core diagnostics. Integrated 
DNA Technologies strengthened the company’s molecular and genomic reagent capabilities, 
supplying oligonucleotides and nucleic acid components used in PCR, sequencing, gene 
editing, and diagnostic assay manufacturing. IDBS added scientific data management and 
laboratory informatics capabilities, while the acquisition of Abcam expanded Danaher’s life 
sciences portfolio with antibodies, reagents, biomarkers, and assay technologies used in 
research and translational medicine. Danaher uses selective acquisitions to strengthen both 
its diagnostics and life sciences businesses while maintaining broad exposure across clinical, 
research, and applied markets. 

 
 
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Dexcom  
San Diego, CA 
www.dexcom.com 
 Table 14-9: Dexcom Revenue History, 2023-2025 ($ million) 
 
2023 
2024 
2025 
Total Revenues 
3,622 
4,033 
4,662 
Source: company reports, Kalorama Information 
Dexcom continued strong expansion in 2025, adding approximately 600,000 to 700,000 net 
new users during the year, excluding users of its over-the-counter Stelo platform. Total 
company revenue reached approximately $4.66 billion in 2025, up about 16% from $4.03 
billion in 2024, driven primarily by higher disposable sensor volume, expanding international 
adoption, broader reimbursement coverage, and continued penetration in both intensive 
insulin and non-intensive insulin markets. Growth was supported by strong uptake of the 
Dexcom G7 platform, increasing pharmacy channel sales, and expanding direct consumer 
access. 
Dexcom is focused exclusively on continuous glucose monitoring technology and 
manufactures products primarily in San Diego, California and Mesa, Arizona. Its CGM 
systems consist of a wearable sensor, transmitter, and display platform integrated with either 
a dedicated receiver, smartphone, or smartwatch. The sensor continuously measures 
interstitial glucose and transmits readings in real time, while software provides trend data, 
alerts, and predictive insights for hypoglycemia and hyperglycemia. 
The company’s legacy Dexcom G5 and G6 systems have largely been superseded 
commercially by the Dexcom G7, although G6 remains important because of compatibility 
with several installed insulin pump systems. Dexcom G6 provides factory-calibrated glucose 
monitoring without fingerstick calibration and remains widely used in automated insulin 
delivery platforms, including pump integrations. Dexcom G6 Pro also remains available for 
professional use, offering both blinded and unblinded clinical glucose monitoring over a 10-
day wear period for physician-guided diabetes assessment. 

 
 
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Dexcom’s principal growth platform is the Dexcom G7, which combines sensor and 
transmitter into a smaller all-in-one disposable device with a significantly shorter warm-up 
period, simplified insertion, and improved comfort. The G7 is available across North 
America, Europe, Asia Pacific, and selected Latin American markets, with reimbursement 
continuing to expand in both public and private payer channels. The system is integrated with 
multiple insulin delivery platforms, including Tandem’s t:slim X2 pump, and supports direct 
connectivity to smartphones and Apple Watch without requiring smartphone relay.  
In 2025 and early 2026, Dexcom also expanded availability of the Dexcom G7 15 Day system 
for adults, extending wear time and improving convenience for long-term users. 
Dexcom also continues to expand beyond prescription diabetes care. Its Dexcom ONE+ 
platform, launched in multiple European markets including Spain, Belgium, and Poland, uses 
the G7 sensor architecture in a simplified lower-cost format designed for broader access. The 
company’s over-the-counter platform, Stelo, became a major strategic addition as the first 
non-prescription glucose biosensor designed for people with type 2 diabetes not using insulin 
and for wellness-focused consumers seeking metabolic insights. Stelo sends glucose data 
directly to smartphones and has opened an entirely new commercial category for Dexcom in 
consumer biosensing. 
The company’s software is a major competitive strength. Dexcom CLARITY provides 
remote glucose pattern reporting for clinicians and patients, while newer digital tools now 
incorporate generative AI-based analytics that identify individualized glucose responses 
linked to meals, activity, sleep, and daily habits. This emerging software layer is designed to 
move Dexcom beyond glucose monitoring toward broader metabolic decision support. 
Dexcom STUDIO, the older reporting platform, has largely been replaced by CLARITY and 
app-based cloud reporting in most markets. 
Dexcom positions itself for growth through expansion into hospital monitoring, non-
intensive type 2 diabetes, international reimbursement gains, and broader biosensor 
applications beyond traditional diabetes management. 

 
 
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Exact Sciences 
Madison, WI 
www.exactsciences.com 
Table 14-10: Exact Sciences Revenue History, 2023-2025 ($ million) 
 
2023 
2024 
2025 
Total revenue 
2,499 
2,759 
3,247 
Source: company reports, Kalorama Information 
Revenues increased in 2025 reached $3,247 million, demonstrating a 17.7% increase over 
2024’s $2,759 million.  The company has continued to increase its revenues for its lead 
product, Cologuard.  For 2025, the Cologuard test revenues grew to $2,530 million from 
2024’s $2,104 million. Revenues increased in 2025 due to an increase in the number of 
completed Cologuard tests and from new products. Precision Oncology revenues reached 
$717 million in 2025 up from $655 million in 2024.  
Abbott Laboratories announced in late 2025 its agreement to acquire Exact Sciences in a 
transaction valued at approximately $21 billion, making it one of the largest diagnostics 
acquisitions in recent years. The acquisition closed in March 2026 following final regulatory 
review and completion of integration planning. Abbott will incorporate Exact Sciences into 
its diagnostics business to strengthen its position in cancer screening, molecular oncology, 
and precision medicine, adding major franchises such as Cologuard, Oncotype DX, 
hereditary cancer testing, and liquid biopsy assets. In 2026, the combined business is 
expected to focus on expanding colorectal cancer screening globally, accelerating 
development of blood-based cancer screening assays, broadening oncology menu integration 
across Abbott’s global commercial infrastructure, and generating cross-platform growth 
through Abbott’s large hospital and physician office customer base. 
Exact Sciences was founded in 1995 following technology developed in collaboration with 
Mayo Clinic and has evolved into one of the leading molecular cancer diagnostics companies 
focused on screening, early detection, precision oncology, and minimal residual disease 

 
 
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monitoring. The company’s initial breakthrough came with stool DNA testing for colorectal 
cancer, culminating in regulatory approval of Cologuard, which established a new 
noninvasive colorectal screening category. Exact Sciences has expanded Cologuard 
eligibility to average-risk adults beginning at age 45 and is now advancing its next-generation 
Cologuard Plus platform, designed to improve sensitivity for advanced precancerous lesions 
while maintaining strong specificity. Cologuard remains the company’s largest revenue 
driver, supported by broad physician adoption, direct consumer awareness campaigns, and 
growing payer coverage. 
Exact Sciences has a long-standing biomarker collaboration with Mayo Clinic across 
multiple cancer types, including pancreatic cancer, liver cancer, and other high-mortality 
malignancies. Earlier work demonstrated promising blood-based methylated DNA marker 
performance for pancreatic cancer detection, and this research has contributed to the 
company’s broader multi-cancer early detection strategy. Although its hepatocellular 
carcinoma blood test program evolved more slowly than originally anticipated, Exact 
Sciences continues to develop blood-based screening and surveillance assays using combined 
genomic, epigenomic, and proteomic technologies. 
A major strategic turning point came with the acquisition of Genomic Health, which added 
the globally established Oncotype DX franchise and significantly expanded Exact Sciences’ 
international oncology presence. Oncotype DX is a major growth driver in breast, colon, and 
prostate cancer decision support, while the company continues expanding into therapy 
selection and genomic profiling. Its OncoExTra assay serves as a comprehensive tumor 
profiling platform using combined DNA and RNA sequencing to support therapy selection 
across solid tumors. The acquisition of OmicEra Diagnostics strengthened proteomic 
biomarker discovery capabilities, while the acquisition of Resolution Bioscience added liquid 
biopsy and circulating tumor DNA expertise that supports advanced precision oncology 
development. 
Exact Sciences has broadened its hereditary and residual disease portfolio through products 
such as Riskguard hereditary cancer testing and Oncodetect, which supports recurrence 
monitoring after treatment using circulating tumor DNA. In 2025 and early 2026, the 
company continued integrating tissue profiling, liquid biopsy, hereditary testing, and 
recurrence monitoring into a unified oncology platform. It also maintains a licensing 
relationship with Freenome to support blood-based colorectal cancer screening development, 
reflecting continued strategic interest in blood-based screening beyond stool diagnostics.  

 
 
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Hologic, Inc. 
Bedford, MA 
www.hologic.com 
Table 14-11: Hologic Revenue History, Diagnostic Product Revenue, 2023-2025 ($ million) 
 
2023 
2024 
2025 
Total Dx  
1,769 
1,658 
1,693 
Source: company reports, Kalorama Information 
Hologic diagnostic sales reached approximately $1,693 million in 2025. Diagnostic revenues 
increased 2.1% compared to 2024 due to an increase in the molecular diagnostics business 
which was driven by an increase in sales for BV/CV assays.  
Hologic’s diagnostics revenues are approximately 41.2% of the company’s total sales with 
some 72.0% generated in the U.S., Europe 15.8%, Asia Pacific 6.1% and rest of world 6.1%. 
Hologic, Inc. is active in several markets: diagnostic products, medical imaging systems, and 
surgical products. The company operates four core business units focused on diagnostics, 
breast health, gynecological surgical and skeletal health.  
Hologic derives most of its diagnostics revenue from molecular testing platforms originally 
built through the acquisition of Gen-Probe, while maintaining global leadership in cervical 
cancer screening through the ThinPrep franchise. ThinPrep remains one of the most widely 
used liquid-based cytology systems worldwide, and the business has expanded further 
through integration with Aptima HPV molecular testing and digital cytology. Hologic’s 
newer cytology strategy centers on the Genius Digital Diagnostics System, an AI-enabled 
platform that combines volumetric imaging and deep-learning analysis to improve cervical 
cancer screening efficiency and lesion detection. The system is increasingly being positioned 
alongside ThinPrep Pap testing and Aptima HPV assays as part of a fully integrated cervical 
screening workflow, particularly in higher-volume cytology laboratories. 

 
 
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PANTHER Molecular System 
The PANTHER molecular platform is Hologic’s molecular diagnostics portfolio. Originally 
developed to complement the higher-volume Tigris platform, PANTHER was designed for 
low- to mid-volume laboratories while retaining the same core target capture and 
transcription-mediated amplification technologies that became hallmarks of Gen-Probe 
systems. PANTHER uses capture oligomers, magnetic microparticles, and isothermal 
transcription-mediated amplification to deliver highly sensitive nucleic acid detection with 
full automation. The system offers primary tube sampling, random access loading, 
continuous sample and reagent loading, and the ability to run multiple assays from one 
specimen. Its compact design and broad menu have made PANTHER one of the most widely 
installed molecular systems in women’s health and sexually transmitted infection testing 
globally. PANTHER can process large assay volumes with minimal hands-on labor while 
running multiple assay types simultaneously. 
Sexually Transmitted Infections 
Aptima remains the flagship assay brand on PANTHER. The assay menu includes 
chlamydia, gonorrhea, trichomoniasis, human papillomavirus, HPV genotyping, HIV viral 
load, hepatitis viral load assays, herpes simplex virus testing, and other sexually transmitted 
infection targets. Aptima Combo 2 remains one of the leading molecular assays for 
simultaneous detection of chlamydia and gonorrhea, and Hologic has expanded specimen 
claims to include clinician-collected and patient-collected throat and rectal swabs. Aptima 
Mycoplasma genitalium is an important differentiator because M. genitalium is difficult to 
culture and increasingly recognized as a clinically significant sexually transmitted pathogen. 
Hologic also markets Group B Streptococcus assays on PANTHER Fusion, expanding 
molecular testing for maternal and neonatal care. 
Infectious Diseases 
Hologic maintains a strong virology business through viral load assays on PANTHER. 
Aptima HIV-1 Quant and Aptima HIV-1 Quant Dx provide highly sensitive viral load 
monitoring and diagnostic capabilities, including dried blood spot testing that supports infant 
HIV diagnosis and decentralized testing programs in Africa and other international markets. 
Aptima HIV-1 Quant Dx remains notable because it supports both viral load monitoring and 
early infant diagnosis on one assay platform. Hologic also markets Aptima HCV Quant Dx 

 
 
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for hepatitis C viral load monitoring and confirmation of active infection, Aptima HBV 
Quant for hepatitis B viral load across genotypes A through H, and Aptima CMV Quant for 
transplant patient monitoring. These viral load assays allow laboratories to run HIV, HBV, 
HCV, and CMV in parallel on PANTHER, strengthening Hologic’s position in centralized 
virology laboratories. Hologic offers its Aptima HCV Quant Dx assay on the PANTHER 
system to quantify hepatitis C viral load and confirm active HCV infection.  The assay uses 
real-time transcription-mediated amplification to provide quantitative determination of 
sustained antiviral response across all major genotypes.   
 Hologic markets the Aptima Herpes Simplex Virus 1 & 2 molecular assay on the PANTHER 
system.  The test, when used with swab specimens from anogenital skin lesions, can 
qualitatively detect and differentiate HSV-1 from HSV-2.  Clinicians collect samples using 
a new Aptima Multitest Swab Specimen Collection Kit or commercially available viral 
transport media. 
Hologic also provides additional marketing for the Aptima Combo 2 Assay for Chlamydia 
trachomatis and Neisseria gonorrhoeae.  These additional claims allow for testing of both 
clinician- and patient-collected throat and rectal swabs. 
Hologic offers the PANTHER Fusion Gastrointestinal bacterial assay and the expanded 
bacterial assay. The tests are designed to detect bacterial pathogens responsible for infectious 
gastroenteritis rapidly. The new GI pathogen detection test leverages rapid molecular 
technology and covers common bacterial causes of infectious gastroenteritis, including 
Salmonella, Campylobacter, Shigella, E. coli, Vibrio, Yersinia and Plesiomonas. The tests 
are run on the Panther Fusion System. 
PANTHER Fusion 
Hologic offers the PANTHER Fusion platform as a flexible molecular system that combines 
high-throughput automation with modular PCR testing. PANTHER Fusion extends existing 
PANTHER instruments by adding cartridge-based PCR capability to the high-volume liquid-
reagent PANTHER workflow, allowing laboratories to run both large routine molecular 
workloads and lower-volume specialty assays on a single integrated platform. The 
PANTHER side is optimized for high-volume Aptima assays using transcription-mediated 
amplification, while the Fusion side uses real-time PCR cartridges for syndromic respiratory 
testing, hospital-acquired infection assays, transplant monitoring, and custom laboratory-

 
 
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developed tests. This dual architecture is one of the platform’s major advantages because 
laboratories can match test format to workload without adding separate instrumentation. 
PANTHER Fusion respiratory testing is one of Hologic’s strongest Fusion growth areas. The 
PANTHER Fusion SARS-CoV-2/Flu A/B/RSV assay provides simultaneous detection and 
differentiation of four major respiratory viruses from a single patient specimen using fully 
automated molecular testing. Hologic also expanded its respiratory workflow with the 
RespDirect collection kit, which simplifies sample preparation and enables direct specimen 
loading. Laboratories can run one, two, or all respiratory targets depending on clinical need, 
giving PANTHER Fusion a modular syndromic testing approach rather than requiring full 
fixed respiratory panels. This flexibility is important as respiratory testing volumes normalize 
after peak pandemic demand but continue to favor multiplex molecular workflows. 
Outside North America, Hologic also offers respiratory testing through the Novodiag 
platform, where the Novodiag RESP-4 assay continues to detect SARS-CoV-2, influenza A, 
influenza B, and RSV in a fully automated format. The Novodiag system is particularly active 
in decentralized and near-patient molecular settings where lower throughput is needed. 
Together, PANTHER Fusion and Novodiag allow Hologic to serve both centralized and 
smaller laboratory respiratory testing markets. 
A major strategic advantage of PANTHER Fusion is Open Access functionality, which 
continues to attract advanced molecular laboratories. Open Access allows CLIA-certified 
laboratories to develop and validate laboratory-developed tests directly on the fully 
automated PANTHER Fusion platform while running FDA-cleared or CE-marked assays 
simultaneously. The myAccess software supports protocol development, threshold setting, 
data interpretation, and automatic reporting to laboratory information systems. This 
capability has become increasingly valuable as laboratories seek flexible automation without 
purchasing separate open PCR systems. 
PANTHER Fusion also remains important in transplant virology. The PANTHER Fusion 
EBV Quant assay supports Epstein-Barr virus monitoring in transplant patients using plasma 
and whole blood, while PANTHER Fusion BKV Quant measures BK virus in plasma and 
urine to help monitor transplant-associated viral complications. These assays strengthen 
Hologic’s role in transplant monitoring, where quantitative viral load testing remains 
clinically important for immunocompromised patients. 

 
 
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The platform offers broad laboratory efficiency. Laboratories can combine women’s health 
assays, virology, respiratory testing, hospital-acquired infection assays, transplant 
monitoring, and Open Access assays on a single system, capable of running up to 32 assay 
types simultaneously. Hologic’s PANTHER Fusion is capable of processing up to 500 
combined PANTHER Fusion and Aptima assays during a single 8-hour shift, which remains 
attractive for consolidated molecular laboratories. 
Hologic’s PANTHER Fusion strategy increasingly emphasizes menu expansion, respiratory 
flexibility, transplant virology, and laboratory consolidation, while future growth is expected 
from additional respiratory syndromic targets, broader adoption in hospital microbiology, 
and further expansion of laboratory-developed testing on automated PANTHER Fusion 
systems. 
Cytology  
Cytology is one of Hologic’s strongest long-term franchises. ThinPrep continues to dominate 
liquid-based cervical cytology, especially when combined with Aptima HPV molecular 
assays. Hologic is a leading supplier in both Pap testing and HPV testing across Europe and 
North America. Clinical screening guidelines continue to support Pap testing in younger 
women and HPV co-testing in women aged 30 to 65. These guidelines support the strong 
utilization of ThinPrep and Aptima together. A major strategic development is the Genius 
Digital Diagnostics System, which adds AI-powered digital cytology analysis to the 
ThinPrep franchise. Genius combines volumetric imaging with deep-learning algorithms to 
identify clinically relevant abnormal cells and prioritize suspicious areas for cytotechnologist 
review. It is the first FDA-cleared digital cytology system combining artificial intelligence 
with volumetric imaging for cervical screening and is increasingly central to Hologic’s digital 
cytology growth strategy. 

 
 
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Illumina 
San Diego, CA 
www.illumina.com 
Table 14-12: Illumina Revenue History, 2023-2025 ($ million, not all revenues are for clinical products and 
services; estimated) 
 
2023 
2024 
2025 
Total Revenues 
4,504 
4,372 
4,343 
Source: company reports, Kalorama Information 
Illumina reported 2025 revenue of $4,343 million compared to $4,372 million in 2024. Core 
Illumina consumables increased in 2025 due to demand for high-throughput consumables 
from the transition to NovaSeq X, although core Illumina instruments decreased in 2025 due 
to lower demand.  
Illumina offers its sequencing franchise, with a portfolio spanning benchtop, mid-throughput, 
and ultra-high-throughput platforms that support whole-genome sequencing, targeted 
resequencing, amplicon sequencing, copy-number analysis, structural variant detection, 
methylation studies, transcriptomics, and increasingly integrated multiomics applications. Its 
sequencing-by-synthesis (SBS) chemistry is the company’s core competitive advantage, 
particularly against Thermo Fisher Scientific platforms and emerging long-read competitors. 
Illumina’s installed base now spans research, clinical, public health, biopharma, and 
population genomics laboratories worldwide, with the company increasingly positioning its 
systems not only for sequencing output but also for integrated software, informatics, and AI-
enabled genomic interpretation. Recent growth has been driven by the  expansion of the 
NovaSeq X Series family, which offers significantly higher throughput, lower reagent 
consumption, reduced waste, and lower cost per genome than previous-generation systems, 
while the NovaSeq X Plus is capable of producing more than 20,000 whole genomes annually 
in large-scale genomic centers. 
At the benchtop level, MiSeq is widely used for smaller laboratories requiring rapid 
turnaround and flexible low-volume sequencing, particularly for microbial genomics, 

 
 
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amplicon sequencing, and targeted oncology panels. The MiSeqDx is Illumina’s flagship 
regulated benchtop clinical sequencer, featuring diagnostic workflows through integrated 
software for sample tracking, audit trails, user management, and clinical reporting. 
Regulatory availability has expanded across major global markets, including the United 
States, Europe, China, Canada, Australia, South Korea, Singapore, Thailand, and other Asia 
Pacific regions, supporting a growing ecosystem of in vitro diagnostic assay developers. 
Illumina’s companion diagnostic leadership is growing, including extended RAS testing 
capabilities developed with Amgen for KRAS and NRAS mutation detection, which help 
oncology laboratories implement local precision oncology workflows. 
Illumina offers the TruSight Oncology Comprehensive assay, one of the company’s most 
strategically important clinical genomic products. The assay evaluates more than 500 genes 
and supports identification of actionable biomarkers, including NTRK fusions, RET 
alterations, MSI, and TMB, helping determine eligibility for targeted therapies such as 
Vitrakvi and Retevmo. In Japan, Illumina expanded the commercialization of TruSight 
Oncology following approval by the Ministry of Health, Labor and Welfare, strengthening 
its position in decentralized oncology testing. While TruSight Oncology 500 remains widely 
used in translational and pharmaceutical research, Illumina converts elements of this content 
into regulated clinical offerings across multiple geographies. Earlier assays, such as TruSight 
Tumor 170, are important in selected regional and laboratory-developed testing 
environments, particularly on the NextSeq 550Dx system. 
In reproductive health, VeriSeq NIPT Solution v2 is a major CE-marked offering for 
noninvasive prenatal testing, allowing expanded screening for chromosomal and 
subchromosomal abnormalities beyond standard trisomy panels. The assay continues to gain 
adoption in Europe, the Middle East, Africa, and selected Asia Pacific markets as laboratories 
seek more automated high-throughput prenatal screening solutions. Illumina has a strong 
position in reproductive genomics through embryo screening and carrier screening 
workflows that are tied to its broader sequencing ecosystem. 
The company’s technology emphasizes multiomics. Illumina’s Illumina Complete Long 
Reads provides synthetic long-read capability compatible with NovaSeq X, NovaSeq X Plus, 
and NovaSeq 6000 systems, enabling improved structural variant detection and phasing 
without requiring dedicated long-read instrumentation. This approach supports users seeking 
long-read genomic information while remaining within Illumina’s SBS ecosystem. In single-
cell biology, the 2024 acquisition of Fluent BioSciences strengthened Illumina’s direct 
participation in simplified single-cell workflows by adding technology that reduces 

 
 
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instrument complexity and microfluidic dependence. Earlier collaborations with Bio-Rad 
Laboratories on single-cell sequencing also remain influential in laboratories that combine 
droplet partitioning with Illumina sequencing. 
Illumina expanded its software and informatics partnerships to strengthen clinical 
interpretation and AI capabilities. Collaborations with QIAGEN provide the development of 
IVD kits on MiSeqDx and NextSeq 550Dx systems, while earlier oncology reporting 
partnerships with PierianDx helped establish structured variant interpretation workflows. In 
2025, Illumina deepened its AI strategy through a partnership with Tempus AI to integrate 
genomic data generation with multimodal clinical data and machine-learning models to 
accelerate precision medicine adoption. 
Strategically, Illumina has moved beyond pure sequencing toward proteomics and broader 
molecular profiling. The spin-off of GRAIL in 2024 marked a major restructuring after 
prolonged regulatory pressure surrounding the acquisition, allowing Illumina to refocus 
capital deployment. In 2025, Illumina advanced its multiomics strategy through the 
acquisition of SomaLogic, bringing high-plex proteomic analysis to its portfolio and 
strengthening its platform for integrated genomics-proteomics workflows. This complements 
the company’s oncology and translational medicine strategy, where combined genomic and 
proteomic signatures are increasingly important for biomarker discovery. 
Additional commercial expansion includes the partnership with Pillar Biosciences, enabling 
broader access to targeted oncology assays across Illumina sequencers. These assays 
strengthen decentralized oncology testing and support laboratories seeking faster targeted 
mutation analysis without requiring large comprehensive profiling runs.  
China 
Illumina is the leading global supplier of DNA sequencing systems, with its sequencing-by-
synthesis technology continuing to dominate many research and clinical genomics 
laboratories worldwide. Its platforms are widely used in pharmaceutical research, drug 
discovery, translational medicine, oncology profiling, reproductive health, infectious disease 
surveillance, agricultural genomics, and consumer genomics. Although growth in China has 
become more complex because of procurement policies favoring domestic sequencing 
suppliers and rising competition from Chinese genomic instrument manufacturers, China is 
an important strategic market for Illumina, particularly in academic genomics, hospital-based 
oncology testing, reproductive health, and large-scale population sequencing programs. 

 
 
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Demand is strongest in oncology research, hereditary disease screening, reproductive testing, 
and noninvasive prenatal testing, although direct-to-consumer DNA testing has moderated 
compared with earlier years due to tighter regulatory oversight. 
In China, Illumina’s sequencing systems remain widely used in major reference laboratories 
and university hospitals for cancer genomics, inherited disease testing, and prenatal 
screening. The company has a large installed base of NovaSeq, NextSeq, and benchtop 
systems such as MiniSeq and MiSeq, which are frequently used in hereditary disease research 
and smaller clinical sequencing programs. Noninvasive prenatal testing remains one of the 
most established applications for Illumina technology in China, with many local laboratories 
using Illumina workflows for chromosomal aneuploidy screening and expanded reproductive 
genomics services. 
Illumina’s earlier collaboration with Boai NKY Medical Holdings is one of its notable China-
focused initiatives in hereditary disease. The partnership was designed to combine Illumina 
sequencing hardware with NKY’s local library-preparation chemistry and bioinformatics 
software to develop next-generation sequencing-based hereditary disease assays, particularly 
for inherited kidney disorders, aligned with the regulatory requirements of China’s National 
Medical Products Administration. While no major public commercial launch from that 
collaboration has been highlighted, the program appears to have remained relevant as part of 
broader efforts to localize sequencing workflows for regulatory acceptance in China. 
Illumina’s strategy in China increasingly emphasizes enabling local assay developers, 
integrating software, and supporting regulated diagnostic pathways rather than solely selling 
imported sequencing instruments. 
More recently, Illumina has had to navigate stronger domestic competition from Chinese 
sequencing companies, especially as hospitals and public institutions increasingly evaluate 
locally manufactured alternatives for cost and procurement reasons. Even so, Illumina retains 
strong technical credibility in high-complexity oncology sequencing, reproductive genomics, 
and translational research, particularly where standardized global workflows and large 
international data compatibility remain important. The company’s longer-term strategy in 
China now focuses on maintaining leadership in premium clinical sequencing applications, 
advanced oncology profiling, and multiomics research rather than relying solely on broad 
instrument expansion. 

 
 
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Leica Biosystems/Danaher 
Buffalo Grove, IL  
www.leicabiosystems.com 
Leica Biosystems is a cancer diagnostics company and one of the global leaders in 
histopathology workflow solutions, with a portfolio that covers tissue processing, 
embedding, microtomy, staining, digital pathology, image analysis, and workflow software 
from biopsy through diagnosis. As part of Danaher Corporation, Leica Biosystems positions 
itself as a major integrated pathology provider focused on linking pathology more closely 
with radiology, surgery, and oncology, particularly as digital pathology adoption expands 
across clinical laboratories and cancer centers. Its strategy emphasizes workflow 
connectivity, automation, and AI-enabled pathology interpretation to support precision 
oncology and higher laboratory productivity. 
Digital Pathology 
Leica Biosystems markets a comprehensive digital pathology portfolio under its Aperio 
platform, including high-throughput systems such as the Aperio AT2 and Aperio GT 450, 
compact scanners such as the Aperio CS2 and Aperio LV1, and advanced multimodal 
systems such as the Aperio VERSA, which supports both brightfield and fluorescence 
imaging. The current commercial focus is on the Aperio GT 450 and GT 450 DX platforms, 
which are designed for high-volume clinical environments, offering faster scan speeds, large 
slide capacity, and scalable deployment across enterprise pathology networks. Leica has 
expanded its digital pathology system through Aperio eSlide Manager and associated 
viewing platforms, enabling remote case access, centralized workflow management, and 
interoperability with laboratory and hospital information systems. These capabilities support 
multi-site pathology operations and provide a foundation for integration of image analysis 
and AI-assisted workflows. 
Tissue Staining 
In tissue staining and advanced biomarker analysis, Leica Biosystems’ acquisition of Cell 
IDx is important. The acquisition brought Cell IDx’s UltraPlex multiplex staining technology 

 
 
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into Leica’s research and translational pathology portfolio, allowing simultaneous 
visualization of multiple biomarkers on a single tissue section using both fluorescent and 
chromogenic multiplex immunohistochemistry. UltraPlex is designed to integrate directly 
with Leica’s BOND RX automated staining platform, enabling high-throughput multiplex 
biomarker workflows that are increasingly important in immuno-oncology, tumor 
microenvironment analysis, and translational biomarker discovery. 
The combination of UltraPlex and BOND RX allows researchers to detect three or more 
chromogenic markers on a single slide within a pathology workflow that remains compatible 
with standard laboratory practice. This has become increasingly relevant as pharmaceutical 
companies and cancer research centers demand multiplex tissue characterization to support 
companion diagnostics and immunotherapy development. Leica continues to  expand this 
strategy through stronger integration of staining, imaging, and digital analysis so that 
multiplex workflows can move more efficiently from research into future clinical 
applications. 
Lab Systems 
Leica Biosystems focuses on histopathology workflow solutions through a product portfolio 
that spans specimen preparation, staining, imaging, and digital diagnosis. The company 
concentrates on integrating tissue processing, advanced staining, digital pathology, and 
workflow software into a unified pathology platform for cancer diagnostics. BOND-III is one 
of the company’s core advanced staining systems, widely used for immunohistochemistry 
(IHC), in situ hybridization (ISH), and companion diagnostic workflows. The platform is 
valued for its high-throughput automation, assay consistency, and flexible menu support, 
particularly in oncology laboratories where standardized biomarker testing is critical for 
therapeutic decision-making. 
For routine histology automation, Leica Biosystems markets the HistoCore SPECTRA 
Workstation, which integrates the HistoCore SPECTRA ST stainer and the HistoCore 
SPECTRA CV coverslipper into a single platform for medium- and high-volume pathology 
laboratories. The workstation facilitates continuous loading, automated reagent handling, and 
rapid slide throughput. Its integrated drying oven offers a major workflow advantage, 
allowing glass slides to dry in approximately five minutes, enabling them to move quickly to 
pathologist review and helping laboratories reduce turnaround time and improve daily 
workflow efficiency. 

 
 
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In digital pathology, Aperio LV1, a compact digital pathology platform designed for low-
volume scanning, rapid consultation, and telepathology applications. The Aperio LV1 holds 
four slides and offers microscope-like navigation, along with live digital viewing, remote 
robotic control, and rapid slide access. Live View enables near-real-time telepathology, 
allowing remote slide viewing in under 15 seconds, making the system particularly useful 
for frozen-section support, satellite laboratories, and remote pathology consultation. It also 
functions as a low-volume whole-slide scanner, making it valuable in settings where 
laboratory space is limited but access to digital pathology is increasingly required. 
More recently, Leica Biosystems expanded integration among its staining systems, digital 
scanners, and pathology software, enabling laboratories to move more seamlessly from slide 
preparation to digital review and AI-assisted analysis. This broader workflow integration is 
one of Leica’s strongest competitive advantages as pathology laboratories increasingly adopt 
digital and computational pathology solutions. 

 
 
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Natera  
Austin, TX 
www.natera.com 
Table 14-13: Natera Revenue History, 2023-2025 ($ million) 
 
2023 
2024 
2025 
Total Natera Sales 
1,078 
1,697 
2,306 
Source: company reports, Kalorama Information 
Natera reported very strong growth in 2025, with total revenues reaching approximately 
$2.31 billion, up from about $1.70 billion in 2024, reflecting continued progress in oncology, 
women’s health, and transplant diagnostics. The strongest growth driver remained oncology, 
particularly the rising adoption of Signatera for molecular residual disease (MRD) 
assessment, recurrence monitoring, and treatment response tracking across multiple solid 
tumors. Natera, originally founded in 2003 as Gene Security Network and publicly listed on 
NASDAQ in 2015, has evolved from a reproductive genetics company into one of the most 
influential liquid biopsy and cell-free DNA diagnostics companies, while still maintaining a 
major position in non-invasive prenatal testing and transplant surveillance. 
The company’s core foundation is its proprietary multiplex PCR (mmPCR) platform, which 
enables simultaneous interrogation of thousands of genomic loci in a single reaction with 
very high analytical sensitivity. This platform is designed to detect both copy-number 
variants and single-nucleotide variants at very low circulating DNA concentrations, enabling 
detection of variants at approximately 0.01% variant allele frequency in plasma. Natera’s 
bioinformatics segment, based on maximum-likelihood statistical modeling and 
individualized genomic interpretation, is paramount to its ability to generate highly sensitive, 
patient-specific assays. Together, these technologies support oncology MRD testing, 
transplant rejection surveillance, and reproductive genomics, while also helping assay 
customization for research and biopharma applications. 
Signatera is Natera’s flagship oncology product and differentiates itself from fixed-panel 
liquid biopsy assays by creating a personalized assay for each patient based on sequencing 

 
 
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of the individual tumor. Rather than using a generic mutation panel, Signatera typically tracks 
16 or more patient-specific tumor variants and can expand to larger mutation sets for research 
applications. This personalized approach has made Signatera increasingly important in 
colorectal cancer, breast cancer, bladder cancer, lung cancer, and immunotherapy 
monitoring, with growing use in treatment selection and post-surgical surveillance. More 
recently, Natera introduced the ultra-sensitive Signatera Genome, which expands genomic 
coverage to improve sensitivity in very low disease burden settings and supports earlier 
molecular detection of recurrence. 
In women’s health, Natera is a major contributor in prenatal and reproductive genetics 
through its established prenatal portfolio. Panorama Prenatal Test is one of the leading non-
invasive prenatal tests for fetal aneuploidy detection, screening chromosomes 13, 18, 21, X, 
and Y, while also supporting triploidy and selected microdeletion analysis.  Natera’s Vistara 
expands prenatal screening to include monogenic disease detection by analyzing fetal cfDNA 
for selected dominant single-gene disorders. Horizon Carrier Screen is a major carrier 
screening platform with a broad menu aligned with evolving clinical guidelines, covering 
hundreds of inherited disorders including cystic fibrosis, spinal muscular atrophy, fragile X 
syndrome, hemoglobinopathies, metabolic disorders, and many rare autosomal recessive 
conditions. 
Natera strengthened this reproductive business significantly through its 2024 acquisition of 
reproductive health assets from Invitae, expanding both carrier screening and prenatal testing 
market share. Additional reproductive offerings include Anora for miscarriage analysis using 
SNP-based parental support technology, which detects aneuploidy, triploidy, copy number 
changes, uniparental disomy, and maternal cell contamination. Natera also offers 
preimplantation testing and prenatal paternity testing in selected markets The company has 
expanded into specialized prenatal assays such as Fetal Focus, designed for targeted inherited 
disease assessment covering cystic fibrosis, spinal muscular atrophy, alpha-thalassemia, 
beta-hemoglobinopathies, and sickle cell disease. 
In transplant diagnostics, Prospera remains an important growth area. The assay measures 
donor-derived cell-free DNA to detect active organ rejection in transplant recipients. Its 
expanded cardiac transplant version, Prospera Heart with Donor Quantity Score, adds Donor 
Quantity Score (DQS) to improve discrimination of antibody-mediated and acute cellular 
rejection. Natera’s distribution collaboration with One Lambda continues to augment 
transplant market penetration, especially in kidney transplantation, and there has been no 
major public indication that this arrangement has ended. 

 
 
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Internationally, Natera is engaged in strategic expansion through its collaboration with BGI 
Genomics, which includes the commercialization of Signatera in China and the development 
of reproductive health assays on BGI’s DNBseq sequencing platform. This partnership is 
strategically relevant as China continues to expand oncology liquid biopsy and prenatal 
testing capacity. Natera has also expanded into early cancer detection research, although this 
remains earlier-stage compared with its highly commercialized MRD business. 
Additionally, the company offers Natera’s cfDNA-based fetal RhD assay, which is relevant 
in prenatal blood group management, and its collaboration with MyOme for integrated 
polygenic breast cancer risk assessment combining monogenic and polygenic risk factors.  
Natera provides Zenith genomics, a next-generation whole genome sequencing assay that is 
designed to detect rare diseases. Zenith genomics was developed through a partnership with 
Natera and MyOme. The product provides enhanced resolution of hard-to-detect features that 
may indicate the presence of a rare disease through advanced sequencing and interpretation 
technology. 
 Natera’s next phase of development is Signatera CDx, which is being positioned as a 
companion diagnostic intended to guide treatment decisions rather than only track disease 
status. In early 2026, Natera submitted the test for FDA premarket approval, marking a 
significant step toward regulatory clearance. The assay is designed to identify patients who 
are most likely to benefit from specific therapies, particularly in settings such as bladder 
cancer where MRD status can inform the use of immunotherapy. While it is not yet FDA-
approved, the move toward a regulated companion diagnostic reflects a broader shift in 
molecular oncology, where liquid biopsy tests are evolving from monitoring tools into 
decision-making instruments that can directly influence treatment selection. 

 
 
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QIAGEN 
Venlo, Netherlands 
www.QIAGEN.com 
Table 14-14: QIAGEN Revenue History, 2023-2025 ($ million) 
 
2023 
2024 
2025 
Total Revenue 
1,965 
1,978 
2,090 
Source: company reports, Kalorama Information 
QIAGEN reports total revenue of $2,090 million in 2025, compared with $1,978 million in 
2024. 
QIAGEN has expanded its global presence as part of a long-term growth strategy, with 
operations across Europe, North America, Asia, and other key international markets. The 
company offers a broad portfolio of consumable kits, instruments, and automation systems 
serving molecular diagnostics, applied testing, pharmaceutical development, biotechnology, 
and academic research. QIAGEN is widely recognized as a pioneer in DNA and RNA 
extraction technologies and continues to build on this foundation with integrated molecular 
workflow solutions. 
QIAGEN has evolved into a leading molecular diagnostics company through a combination 
of internal innovation and strategic acquisitions. While historically focused on infectious 
disease testing, the company has expanded into oncology, precision medicine, and immune 
monitoring. Its clinical portfolio now offers applications including screening, diagnosis, 
prognosis, therapy selection, and disease monitoring. 
QIAGEN maintains a strong position in immune response testing through its QuantiFERON 
platform, which is widely used in tuberculosis detection and is being expanded into broader 
immune-monitoring applications. The company continues to develop new assays and 
applications that leverage this technology, supporting both infectious disease and 
immunology-related testing. 

 
 
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In precision medicine, QIAGEN offers a growing portfolio of companion diagnostics and 
biomarker assays designed to guide targeted therapies. The company collaborates with 
numerous pharmaceutical and biotechnology partners to co-develop companion and 
complementary diagnostics that support treatment decisions across multiple cancer types. Its 
solutions include both tissue- and liquid biopsy–based approaches for molecular profiling. 
QIAGEN’s technology portfolio spans multiple molecular platforms, including PCR-based 
workflows, digital PCR, next-generation sequencing solutions through partnerships, 
universal reagent systems, and rapid syndromic testing with the QIAstat-Dx platform. These 
systems are designed to deliver flexible, scalable solutions for both centralized laboratories 
and near-patient settings. 
As a leader in “Sample to Insight” solutions, QIAGEN integrates sample preparation, 
molecular analysis, and data interpretation into end-to-end workflows.  
Tuberculosis. 
 QIAGEN has expanded its tuberculosis testing portfolio with the offering of the QIAreach 
QuantiFERON-TB test, a portable and decentralized solution designed to improve access to 
interferon-gamma release assay (IGRA) testing. The system uses whole blood samples to 
detect immune responses to Mycobacterium tuberculosis infection by measuring interferon-
gamma produced by sensitized T cells. The QIAreach platform incorporates a digital lateral 
flow–based detection system that simplifies workflow and enables faster, easy-to-interpret 
results compared to traditional laboratory-based IGRA testing, for use in decentralized and 
resource-limited settings. 
In addition, QIAGEN has expanded its molecular tuberculosis testing capabilities with the 
introduction of the QIAseq xHYB Mycobacterium tuberculosis panel. This next-generation 
sequencing–based assay enables targeted analysis of TB genetic material, supporting 
applications such as strain characterization and detection of drug resistance–associated 
mutations. The panel reflects QIAGEN’s broader strategy to integrate sequencing 
technologies into infectious disease diagnostics and epidemiological surveillance. 

 
 
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Molecular Expansion 
QIAGEN offers a broad molecular diagnostics portfolio centered on integrated “Sample to 
Insight” workflows that combine sample preparation, amplification, and analysis across 
multiple platforms. The company’s portfolio includes automation systems such as 
QIAsymphony for sample preparation and assay setup, and QIAstat-Dx for rapid, multiplex 
syndromic testing in clinical and near-patient settings. QIAGEN continues to position these 
platforms as complementary solutions that address a wide range of laboratory needs, from 
centralized high-throughput testing to decentralized molecular diagnostics. 
QIAGEN expanded its syndromic testing capabilities through the acquisition of STAT-Dx, 
whose cartridge-based molecular testing system was rebranded as QIAstat-Dx. This platform 
enables fully integrated, sample-to-answer molecular analysis using real-time PCR 
technology, with single-use cartridges that incorporate all necessary reagents and sample 
processing steps. The system is designed for ease of use and can deliver results in 
approximately one hour, supporting rapid diagnosis of infectious diseases in both laboratory 
and near-patient environments. The modular analyzer can be configured with multiple 
independent testing modules, allowing flexible throughput and workflow optimization. 
The QIAstat-Dx portfolio has expanded with new panels and system enhancements, 
including higher-capacity configurations such as QIAstat-Dx Rise, which is designed to 
support increased testing volumes in mid- to high-throughput settings. The platform now 
includes multiplex respiratory panels capable of detecting a broad range of viral and bacterial 
pathogens, supporting syndromic testing for respiratory infections and improving clinical 
decision-making. 
QIAGEN has also developed molecular testing solutions for viral load monitoring and 
transplant-related infections through its PCR-based assay portfolio. These assays are 
designed to support management of immunocompromised patients by enabling detection and 
quantification of clinically relevant viruses. 
As part of its portfolio optimization strategy, QIAGEN has decided to discontinue its 
NeuMoDx integrated PCR systems, shifting its focus toward higher-growth areas such as 
syndromic testing with QIAstat-Dx, digital PCR with QIAcuity, and bioinformatics 
solutions. The company continues to support existing NeuMoDx customers while 
reallocating resources to its core molecular platforms. 

 
 
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Recent developments include regulatory clearance of expanded QIAstat-Dx respiratory 
panels, which enable multiplex detection of more than 20 pathogens, including SARS-CoV-
2, in a single, fully integrated assay with results available in approximately one hour. 
Precision Medicine / Companion Diagnostics 
QIAGEN is a leader in precision medicine and has established a strong position through 
extensive collaborations with pharmaceutical and biotechnology companies to co-develop 
companion diagnostics. The company is engaged in numerous partnerships with major 
industry players, supporting the development of biomarker-driven tests that guide targeted 
therapies across oncology and other disease areas. These collaborations enable QIAGEN to 
expand its portfolio of companion and complementary diagnostics aligned with emerging 
precision therapies. 
QIAGEN offers a broad menu of molecular diagnostics for cancer, including companion 
diagnostics designed to support therapy selection and disease management. Its solutions are 
supported by integrated molecular workflows, including automated sample preparation using 
the QIAsymphony platform and downstream PCR-based testing on systems such as the 
Rotor-Gene Q. The company has increasingly focused on flexible workflows that support 
both PCR and next-generation sequencing–based applications through universal reagent 
systems and partnerships. 
QIAGEN has continued to expand its therascreen portfolio of PCR-based companion 
diagnostics. Recent additions include assays designed to detect clinically relevant mutations 
associated with targeted cancer therapies. These tests support the identification of actionable 
biomarkers in solid tumors, particularly in non-small cell lung cancer, where detecting 
resistance and activating mutations is critical for treatment selection. 
The company has also secured regulatory approvals for companion diagnostics that guide the 
use of targeted therapies in oncology. These include PCR-based assays that detect specific 
gene mutations in tumor tissue samples, enabling the identification of patients who may 
benefit from precision therapies. QIAGEN’s companion diagnostics are designed for use 
with formalin-fixed, paraffin-embedded tissue and integrate with its automated sample 
preparation and molecular testing platform. Recent developments include regulatory 
approvals for additional companion diagnostic assays designed to support targeted oncology 
therapies, as well as continued expansion of testing aligned with KRAS G12C inhibitor 
treatments. QIAGEN is also advancing a multi-platform strategy that integrates PCR-based 

 
 
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assays with broader sequencing workflows, enabling more comprehensive biomarker 
analysis in both tissue and liquid biopsy samples. 
QIAGEN’s QIAstat-Dx Rise is an automated syndromic testing system with automated 
cartridge loading and unloading. The company reports over 4,600 instruments placed 
globally so far.  
Molecular Microbiology 
QIAGEN’s molecular diagnostics business includes its artus product line, originally 
developed through the acquisition of Gesellschaft für molekularbiologische Diagnostik und 
Entwicklung. The artus RealArt assay portfolio was designed for use with a variety of open 
PCR platforms, including Roche LightCycler, ABI TaqMan, and Rotor-Gene instruments. 
The portfolio includes a broad range of assays for detecting viral and bacterial pathogens, as 
well as applications in genotyping and veterinary diagnostics. While these assays established 
QIAGEN’s early presence in molecular testing, the company has shifted its focus toward 
integrated, automated molecular solutions. 
Building on its PCR foundation, QIAGEN has advanced its syndromic testing capabilities 
through the QIAstat-Dx platform, which provides fully integrated sample-to-answer 
molecular diagnostics via real-time PCR. The system enables processing of a wide range of 
sample types, including swabs and respiratory specimens, with minimal hands-on time and 
results available in approximately one hour. QIAstat-Dx is designed for both centralized 
laboratories and near-patient settings, offering flexible throughput through a modular 
analyzer configuration. 
QIAGEN has expanded the QIAstat-Dx platform with new system enhancements and an 
expanding menu of syndromic panels. Recent updates include an enhanced analyzer 
configuration with improved software, connectivity, and workflow flexibility, supporting 
remote data access and integration with laboratory information systems. The platform has 
also expanded geographically, with broader adoption in Asia and other international markets. 
The QIAstat-Dx test menu has grown significantly, with multiple syndromic panels designed 
to provide rapid diagnosis of infectious diseases. These include comprehensive respiratory 
panels that detect a wide range of viral and bacterial pathogens, gastrointestinal panels that 
target common causes of enteric infections, and focused respiratory virus panels to support 
targeted clinical decision-making. In addition, the platform has been expanded to include 

 
 
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panels for central nervous system infections, such as meningitis and encephalitis, further 
broadening its clinical utility. 
Recent regulatory clearances have strengthened QIAGEN’s position in syndromic testing, 
with multiple QIAstat-Dx panels approved for clinical use. These developments reflect the 
company’s strategic focus on expanding rapid, multiplex molecular diagnostics and 
consolidating its leadership in syndromic testing. 
Prenatal Testing 
QIAGEN has collaborated with companies such as Natera to advance cell-free DNA–based 
testing workflows, particularly for applications like non-invasive prenatal testing. These 
efforts focused on integrating technologies for sample collection, preparation, and analysis 
to enable accurate detection of fetal DNA in maternal blood samples. QIAGEN’s PAXgene 
cell-free DNA collection and stabilization technology plays a key role in preserving sample 
integrity and improving the reliability of downstream molecular analysis. While earlier 
collaborations included the development of sequencing-based workflows, QIAGEN’s 
current strategy emphasizes enabling technologies and bioinformatics solutions that support 
flexible use across multiple next-generation sequencing platforms rather than reliance on a 
single proprietary system. 
QIAGEN offers a portfolio of diagnostic solutions focused on reproductive health and 
disease prevention. This includes the PartoSure test, a rapid point-of-care assay used to assess 
the risk of spontaneous preterm birth in symptomatic patients. The test detects placental 
alpha-microglobulin-1 (PAMG-1) and provides rapid results using a noninvasive sampling 
procedure, supporting clinical decision-making in obstetric care. 
PartoSure is part of QIAGEN’s broader sexual and reproductive health portfolio, which also 
includes the AmniSure ROM Test for the detection of rupture of membranes and the Digene 
HC2 HPV Test for cervical cancer screening. In addition, QIAGEN supports non-invasive 
prenatal testing and broader genomic applications through its sample collection technologies 
and bioinformatics capabilities, positioning the company as an enabling partner in molecular 
diagnostics workflows rather than a primary provider of NIPT assays. 

 
 
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Next-Generation Sequencing 
QIAGEN has expanded its next-generation sequencing (NGS) and bioinformatics portfolio 
offering applications in rare and inherited diseases through its QIAGEN Clinical Insight 
(QCI) platform. QCI provides advanced data interpretation and decision-support tools as part 
of an integrated “Sample to Insight” workflow, enabling analysis of genomic data generated 
from sequencing assays. The platform incorporates curated knowledge bases such as the 
Human Gene Mutation Database (HGMD), supporting identification of clinically relevant 
variants and inheritance patterns, and has continued to evolve as a key component of 
QIAGEN’s precision medicine strategy. 
QIAGEN has also developed a range of NGS library preparation and enrichment solutions 
under its QIAseq portfolio. These include technologies such as QIAseq FastSelect for 
efficient removal of ribosomal RNA, as well as expanded targeted DNA and RNA panels 
designed for oncology and rare disease applications. The company has introduced workflow-
enhancing solutions such as normalization kits that simplify library preparation and improve 
consistency across samples, supporting automation and high-throughput sequencing 
environments. 
More recently, QIAGEN has expanded its capabilities in advanced sequencing applications 
with the introduction of QIAseq xHYB Long Read Panels, designed to support long-read 
sequencing technologies and enable more comprehensive analysis of complex genomic 
regions and structural variants. In addition, RNA sequencing solutions such as the UPXome 
library kits support transcriptome analysis and gene expression profiling, further broadening 
the company’s NGS portfolio.                 
Liquid Biopsy 
QIAGEN has established a strong position in liquid biopsy by focusing on enabling 
technologies that support non-invasive genomic profiling of cancer. The company provides 
a comprehensive portfolio of solutions for the analysis of circulating biomarkers, including 
cell-free DNA (cfDNA), RNA, and extracellular vesicles. Rather than offering a single end-
to-end diagnostic test, QIAGEN’s strategy centers on providing integrated workflows that 
support sample collection, stabilization, purification, and downstream molecular analysis 
across multiple platforms. 

 
 
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A core component of QIAGEN’s liquid biopsy portfolio is its sample preparation technology, 
including the QIAamp Circulating Nucleic Acid Kit, which is widely used for the isolation 
of circulating DNA and RNA from plasma. This is complemented by the PAXgene Blood 
ccfDNA Tube, which enables the collection and stabilization of whole blood samples while 
preserving circulating nucleic acid profiles during transport and storage. The continued 
expansion of PAXgene technology into both oncology and prenatal applications underscores 
its role as a key pre-analytical solution for liquid biopsy workflows. Together with automated 
processing on platforms such as QIAsymphony, these technologies provide a standardized 
workflow that supports reliable downstream molecular testing. 
QIAGEN has also developed integrated solutions for next-generation sequencing–based 
liquid biopsy analysis. These include workflows that combine cfDNA extraction, library 
preparation, and targeted sequencing using QIAseq technologies, along with associated 
bioinformatics tools for data analysis and interpretation. Recent developments include 
expanded support for advanced sequencing approaches, such as long-read technologies, 
which enable improved analysis of complex genomic regions and structural variants. 
In addition to cfDNA-based approaches, QIAGEN offers solutions for the analysis of 
extracellular vesicles and RNA biomarkers, including kits for exosome isolation and total 
RNA purification from biofluids such as plasma and urine. These technologies support 
emerging multi-analyte liquid biopsy applications in cancer research and biomarker 
discovery. 
Cervical Cancer 
QIAGEN is a global provider of HPV screening technologies, with a portfolio that spans both 
established and emerging molecular approaches to cervical cancer screening. The company 
has developed solutions for use in a wide range of settings, from high-throughput clinical 
laboratories to low-resource environments. Its careHPV test supports cervical cancer 
screening programs in resource-limited regions, while its broader molecular portfolio 
addresses increasing demand for more precise risk stratification and early detection. 
QIAGEN has expanded its HPV testing portfolio with PCR-based assays such as the 
QIAscreen HPV PCR Test, which detects multiple high-risk HPV genotypes associated with 
cervical cancer. The assay supports both screening and genotyping and is designed for use 
with clinician-collected and self-collected samples, reflecting growing adoption of self-
sampling approaches in cervical cancer screening programs. The test is compatible with 

 
 
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QIAGEN’s PCR workflows, including Rotor-Gene Q systems and other open-platform 
configurations. 
In addition, QIAGEN offers advanced molecular solutions, such as methylation-based 
assays, to support risk stratification following a positive HPV test. These technologies enable 
the identification of patients at higher risk of progressing to cervical cancer, supporting more 
personalized screening and follow-up strategies. 
The company’s established digene Hybrid Capture 2 (HC2) HPV Test remains widely used 
in screening programs, particularly in settings where established workflows are in place. 
However, QIAGEN’s strategy has shifted toward expanding PCR-based and molecular 
testing solutions that offer improved sensitivity, specificity, and genotyping capabilities. 
Expansion 
QIAGEN continues to expand its portfolio through a combination of internal development 
and strategic partnerships, particularly in precision medicine and immuno-oncology. The 
company has entered into collaborations to advance companion diagnostics and biomarker 
discovery, including agreements granting access to technologies for profiling T-cell and B-
cell receptor repertoires via next-generation sequencing. These capabilities augment the 
development of immune-based diagnostics and enhance QIAGEN’s position in immuno-
oncology research. 
QIAGEN has also strengthened its global infrastructure, including by expanding its 
development and manufacturing footprint. The establishment of advanced facilities in the 
United Kingdom supports ongoing innovation in molecular diagnostics and assay 
development, reinforcing the company’s role in global diagnostic innovation. 
The company is building partnerships in precision oncology, including collaborations to 
advance companion diagnostics and integrated testing solutions. These efforts include the 
development of assays for use in both laboratory-developed and kit-based formats, 
supporting broader adoption of biomarker-driven therapies. 
QIAGEN has also expanded its geographic presence, including initiatives to strengthen its 
footprint in the Middle East, where it supports public health programs such as tuberculosis 
screening through the deployment of QuantiFERON-based testing solutions. 

 
 
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Recent product developments include continued expansion of the QIAstat-Dx syndromic 
testing platform, including the introduction of targeted gastrointestinal panels designed to 
detect a defined set of clinically relevant pathogens. These smaller panel configurations 
complement broader multiplex assays and reflect increasing demand for flexible, cost-
effective syndromic testing. 
In addition, QIAGEN has expanded its collaborations in molecular diagnostics and precision 
oncology, including partnerships to develop next-generation sequencing–based panels for 
hematologic malignancies and to advance digital PCR–based oncology assays. These efforts 
combine QIAGEN’s expertise in sample preparation, molecular technologies, and digital 
PCR platforms with partner capabilities in assay development, supporting both tissue- and 
liquid biopsy–based applications. 
 
 

 
 
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QuidelOrtho Corporation  
San Diego, CA 
www.quidelortho.com 
Table 14-15: QuidelOrtho Revenue History, 2023-2025 ($ million) 
 
2023 
2024 
2025 
Total revenues 
2,999 
2,782 
2,732 
Source: company reports, Kalorama Information 
Labs revenue increased 6% compared to 2024 due to growth in reagents, consumables and 
services. However, instrument revenue declined. Immunohistology revenues increased due 
to reagent growth. Donor screening decreased 54% due to the wind-down of the U.S. donor 
screening business. POC revenue decreased 13% due to the decrease in sales of QuikVue 
SARS and Sofia SARS Antigen assays. Molecular diagnostics increased 10%, driven by 
higher SAVANNA revenue.  
The following is a breakdown of QuidelOrtho’s revenues as provided by the company. 
Table 14-16: QuidelOrtho Diagnostic Revenues, by Segment, 2023-2025 ($ million, estimated) 
Segment 
2023 
2024 
2025 
YoY Growth  
2024-2025 
Core Lab 
1,426 
1,427 
1,506 
5.6% 
Point of Care 
892 
694 
602 
-13.3% 
Donor Screening 
136 
115 
53 
-53.9% 
Immunohematology 
512 
522 
544 
4.2% 
Molecular 
33 
24 
27 
12.5% 
Total 
2,999 
2,782 
2,732 
-1.8% 
Source: Kalorama Information 

 
 
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QuidelOrtho Corporation markets a broad portfolio of diagnostic products spanning 
infectious disease, women’s health, cardiac biomarkers, gastrointestinal testing, 
immunohematology, and clinical laboratory diagnostics. Since the merger of Quidel and 
Ortho Clinical Diagnostics, the company has expanded from a primarily rapid-test business 
into a diversified diagnostics supplier serving physician offices, hospitals, urgent care 
centers, clinical laboratories, reference laboratories, retail clinics, and wellness screening 
programs. Its strongest region is the United States through direct sales and distributor 
networks, while international sales continue across Europe, Japan, Latin America, and 
selected Asia Pacific markets, with respiratory testing, cardiac biomarkers, and laboratory 
automation remaining major growth drivers. 
In 2025, QuidelOrtho announced a strategic shift in its molecular diagnostics strategy, 
discontinuing development of its Savanna platform and instead planning to acquire LEX 
Diagnostics following FDA clearance. The LEX system is designed to deliver ultra-fast PCR-
based molecular testing for respiratory infections in decentralized healthcare settings. At the 
same time, the company continues to expand the test menu available on its VITROS 
laboratory platforms and strengthen its position across point-of-care testing, core laboratory 
diagnostics, and transfusion medicine. 
Immunoassays 
 QuidelOrtho Corporation markets a broad mix of point-of-care and laboratory 
immunoassays across rapid-testing and core laboratory platforms. Its rapid immunoassay 
brands include QuikVue, Sofia 2, D3 Direct Detection, and Thyretain. These tests for 
influenza, RSV, SARS-CoV-2, Group A Strep, fecal occult blood, pregnancy, thyroid 
disease, bacterial vaginosis, infectious mononucleosis, HSV, H. pylori, and selected sexually 
transmitted infections. The Sofia platform is the company’s leading POC patient 
immunoassay system, with respiratory testing continuing to drive major volume. 
QuidelOrtho offers VITROS XT 7600, VITROS 5600, VITROS 4600, and VITROS 3600 in 
the core laboratories for chemistry, immunodiagnostics, and integrated testing. The VITROS 
menu provides routine chemistry, special chemistry, proteins, therapeutic drug monitoring, 
toxicology, endocrine assays, infectious disease serology, cardiology markers, and oncology 
immunoassays. Enhanced chemiluminescence is paramount to the immunodiagnostic 
systems, supporting tests in thyroid function, reproductive endocrinology, anemia, 

 
 
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metabolism, infectious disease, and tumor markers, including CA125, CEA, alpha-
fetoprotein, and CA15-3. 
The company is expanding through its MicroTip Partnership Assay program, which allows 
third-party assays to run on VITROS analyzers through collaborations with Diazyme 
Laboratories, ARK Diagnostics, and Sekisui Diagnostics. This program adds esoteric assays 
such as free light chains for plasma cell disorders, D-dimer, toxicology assays including 
fentanyl, and specialty chemistry assays without requiring QuidelOrtho to internally develop 
every assay. 
QuidelOrtho offers the VITROS High Sensitivity Troponin I Assay, which supports rapid 
rule-out and rule-in of myocardial infarction across multiple VITROS systems. The VITROS 
NT-proBNP II Assay is designed for heart failure assessment, while the VITROS 
NEPHROCHECK is an automated urinary biomarker test for acute kidney injury risk using 
TIMP-2 and IGFBP-7 biomarkers. Infectious disease immunoassays remain broad and 
include hepatitis B markers, HIV combination testing, syphilis serology, and other blood-
borne infection assays across automated VITROS systems. 
Rapid Immunoassays 
QuidelOrtho markets a broad point-of-care immunoassay portfolio built around the Sofia 2 
platform, which is one of the company’s most important near-patient testing systems. Earlier 
acquisitions, such as the ocular diagnostics products acquired from RPS Diagnostics, remain 
part of QuidelOrtho’s specialty rapid test portfolio, including InflammaDry, which detects 
elevated MMP-9 as an inflammatory marker associated with dry eye disease, and AdenoPlus, 
which helps differentiate adenoviral conjunctivitis from other causes of acute conjunctivitis. 
These products are FDA-cleared and support ophthalmology office testing, although they 
represent a smaller specialty segment compared with respiratory diagnostics. 
The Sofia platform has evolved into QuidelOrtho’s core fluorescent immunoassay system for 
POC testing, combining fluorescent lateral flow chemistry, automated interpretation, 
connectivity, barcode scanning, and electronic reporting. Compared with visually read lateral 
flow assays, Sofia provides instrument-read results that reduce subjective interpretation and 
improve consistency. Virena continues to provide real-time de-identified reporting from 
connected Sofia analyzers, supporting infectious disease surveillance across healthcare 
networks. 

 
 
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Current Sofia testing is heavily concentrated in respiratory disease, including influenza A+B, 
RSV, SARS-CoV-2, Group A Strep, and combination respiratory panels. The Sofia 2 SARS 
Antigen FIA is one of the best-known antigen assays on the platform and was notable as the 
first COVID-19 antigen assay to receive de novo authorization through the FDA’s traditional 
review pathway. QuidelOrtho also markets the CLIA-waived QuickVue COVID-19 Test, 
which received expanded FDA clearance for both home and professional use and remains 
part of its OTC respiratory strategy. 
Additionally, Sofia provides specialty assays, including Lyme disease testing through Sofia 
Lyme FIA and Sofia 2 Lyme+ FIA, as well as Sofia Vitamin D FIA, which is one of the few 
quantitative assays on the Sofia platform. Earlier menus also included Legionella and 
pneumococcal antigen testing, supporting decentralized infectious disease diagnosis. 
QuidelOrtho offers the Triage MeterPro business, including the Triage True High-Sensitivity 
Troponin I Test for rapid assessment of myocardial infarction in emergency and POC 
settings. This fluorescence immunoassay provides results in approximately 20 minutes and 
strengthens QuidelOrtho’s position in acute care diagnostics. 
 The company has continued to integrate specialty assay collaborations into its broader menu. 
The 2025 collaboration with BÜHLMANN Laboratories added fecal assays, including fCAL 
turbo and fecal pancreatic elastase testing, to automated laboratory systems to support 
inflammatory bowel disease differentiation and pancreatic insufficiency assessment.  
The Solana Business 
QuidelOrtho offers the AmpliVue non-instrumented system for lower-volume, moderately 
complex labs, and Lyra reagents for higher throughput, highly complex laboratories that are 
compatible with existing PCR infrastructure. 
The Solana molecular platform leverages QuidelOrtho's Helicase-Dependent Amplification 
(HDA) technology, and in some tests a Reverse-Transcriptase HDA that is resident in 
QuidelOrtho's AmpliVue molecular product line to generate a fast test result. Solana can 
process up to 12 patient samples in each 45-minute run. 
 The Solana molecular platform processes up to 12 different assays or samples in each 
batched run, and the menu for the instrument also includes Quidel's Influenza A+B, Strep 

 
 
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Complete (Groups A+C/G), RSV+hMPV, HSV 1+2/VZV, Trichomonas, and C. difficile 
tests.   
QuidelOrtho provides the Solana RSV + hMPV assay, which can detect and differentiate 
between respiratory syncytial virus and human metapneumovirus.  The assay detects viral 
RNA from nasal and nasopharyngeal swabs and runs on the firm's Solana molecular testing 
instrument. It requires no upfront RNA extraction and yields results in approximately 45 
minutes. The RSV and hMPV assay also uses a novel reverse-transcriptase HDA that is used 
in Quidel’s AmpliVue molecular product line to generate fast and accurate test results 
QuidelOrtho markets its Solana GBS Assay for the direct, qualitative detection of Group B 
Streptococcus from enriched broth cultures of specimens from antepartum women.  The 
Solana GBS Assay is an easy-to-use molecular diagnostic test that generates accurate results 
from either LIM or Carrot enrichment broth cultures of vaginal/rectal swabs from antepartum 
women after 18 to 24 hours of incubation. 
QuidelOrtho also markets the Solana Bordetella Complete Assay, a molecular diagnostic 
assay to detect bacterial strains that cause whooping cough.  The assay also detects and 
differentiates Bordetella pertussis and Bordetella parapertussis in nasopharyngeal swabs. The 
test runs on QuidelOrtho's Solana system, which uses helicase-dependent amplification and 
processes up to 12 samples per batched run. 
Blood Bank 
 QuidelOrtho is one of the major global suppliers in transfusion medicine, building on more 
than 75 years of immunohematology development dating back to early blood typing 
innovations under the Ortho Clinical Diagnostics legacy. The company provides blood bank 
automation, serology reagents, and transfusion workflow software, serving hospitals, donor 
centers, and reference laboratories worldwide. Its transfusion medicine portfolio focuses on 
blood grouping, antibody screening, compatibility testing, donor typing, and extended 
antigen phenotyping, with ongoing emphasis on laboratory automation, workflow 
standardization, and blood safety. 
The company markets ORTHO Sera blood-grouping reagents for extended-phenotype 
testing, maintaining one of the broadest antisera menus available to immunohematology 
laboratories in the United States. These reagents support detailed antigen characterization 
beyond routine ABO/Rh typing and remain important in complex transfusion cases, antibody 

 
 
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investigations, and rare donor matching. Extended phenotyping is increasingly relevant as 
laboratories seek better compatibility for chronically transfused patients, including oncology 
and sickle cell populations. 
ORTHO VISION and ORTHO VISION Max are flagship immunohematology analyzers for 
blood typing, antibody screening, crossmatching, and donor testing. These systems support 
gel-based automation, reduce manual handling, and improve consistency in transfusion 
laboratories. QuidelOrtho continues to expand software integration through ORTHO 
CONNECT, which centralizes workflows across multiple instruments and hospital sites 
while enabling a single, validated integration with laboratory information systems. ORTHO 
CONNECT remains strategically important because blood bank laboratories increasingly 
require centralized oversight, remote result review, and standardized data handling across 
healthcare networks. 
 QuidelOrtho is focusing on strengthening automation in rare antigen phenotyping and 
advanced blood bank workflow efficiency. These areas expected to remain important as 
transfusion services face staffing shortages and increasing complexity of compatibility 
testing.  

 
 
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Radiometer A/S / Danaher 
Copenhagen, Denmark 
www.radiometer.com 
Radiometer, founded in 1935, is a global pioneer in acute care diagnostics and blood gas 
analysis. The company introduced the world’s first commercially available blood gas 
analyzer in 1954, and it continues to be one of the strongest global suppliers of acute care 
testing systems used in hospitals, emergency departments, intensive care units, operating 
rooms, and clinical laboratories in more than 130 countries.  
Radiometer develops, manufactures, and markets solutions for blood gas analysis, blood 
sampling, acute care immunoassays, transcutaneous monitoring, and related IT management 
systems. Its major brands include ABL90 FLEX PLUS, ABL800 FLEX, AQT90 FLEX, 
TCM5 FLEX, AQURE, PICO, CLINITUBES, and QUALICHECK. Through ownership of 
HemoCue, Radiometer also provides decentralized hemoglobin and glucose testing. 
The company is a leader in acute care workflow automation, with its ABL analyzers designed 
to rapidly deliver blood gas, electrolytes, metabolites, and co-oximetry parameters directly 
at the point of care. Ongoing development has focused on faster cartridge handling, enhanced 
usability, and improved connectivity, as well as tighter integration with hospital information 
systems via the established AQURE platform. AQURE provides centralized management of 
quality control, operator competency, and device oversight across distributed testing 
environments, supporting compliance and standardization. These capabilities have become 
increasingly important as hospitals seek to manage growing networks of point-of-care 
devices under unified quality and data governance frameworks. 
Radiometer offers transcutaneous monitoring through its TCM platform, which enables 
noninvasive measurement of oxygen and carbon dioxide using skin-based sensors. These 
systems remain particularly important in neonatal intensive care, as well as in respiratory and 
selected critical care applications where continuous monitoring is required without repeated 
blood sampling. Ongoing enhancements focus on improving connectivity and 
interoperability with bedside monitoring systems and the hospital information infrastructure, 
enabling transcutaneous data to be more effectively integrated into patient monitoring 
workflows and clinical decision-making. 

 
 
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The AQT platform is offered for rapid cardiac and inflammatory markers in emergency 
settings, including troponin, D-dimer, CRP, and NT-proBNP. 
Critical Care 
Radiometer focuses on delivering laboratory-quality acute-care testing at the point of care 
through cassette-based analyzers, integrated blood-sampling systems, and centralized IT 
connectivity. Radiometer’s operations in Denmark are through Radiometer Medical ApS.  
The company’s strategy emphasizes rapid critical care testing with minimal operator 
complexity, especially in ICUs, NICUs, emergency departments, operating rooms, and 
decentralized hospital testing sites. 
Its flagship blood gas systems is the ABL90 FLEX PLUS and ABL800 FLEX platforms. The 
ABL90 FLEX PLUS continues to be one of the most advanced compact blood gas analyzers 
in acute care, measuring up to 19 parameters from only 65 µL of whole blood in 
approximately 35 seconds. Its menu includes blood gases, electrolytes, metabolites, co-
oximetry, bilirubin, creatinine, and urea, making it one of the broadest compact critical care 
menus available. This wide panel is especially valuable because clinicians can obtain renal 
function markers such as creatinine and urea directly at the bedside, together with immediate 
blood gas results, reducing delays in acute decision-making. 
The ABL800 FLEX PLUS is Radiometer’s major platform, providing up to 18 STAT 
parameters on a single sample with high-throughput automated handling and Drop’n Go 
functionality that allows staff to load samples and go. This is highly valuable in emergency 
departments and larger critical care laboratories where rapid throughput and minimal staff 
interruption are important. Smaller systems such as ABL80 FLEX and ABL9 are used by 
lower-volume departments and satellite testing locations, with ABL9 particularly suited to 
critical care units that perform only limited daily blood gas volumes. 
The company’s TCM5 is a product for neonatal, pediatric, adult, sleep, and respiratory 
monitoring. The system continuously measures transcutaneous oxygen and carbon dioxide 
along with pulse oximetry, perfusion index, and pulse rate using integrated Masimo 
technology. The TCM5 FLEX version is particularly important in neonatal intensive care 
because it allows continuous respiratory assessment without repeated blood draws, while the 
TCM5 BASIC version is used more frequently in sleep clinics and home respiratory care. 

 
 
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Radiometer has expanded digital clinical support through collaboration with Etiometry. The 
partnership, first launched in 2022 and expanded commercially in 2024, remains active and 
focuses on integrating acute care analyzer data with predictive clinical decision-support tools, 
especially in neonatal intensive care and other high-acuity hospital settings. This reflects 
Radiometer’s broader strategy of moving beyond analyzers alone toward integrated acute 
care decision support and workflow optimization. 
Immunoassays 
Radiometer entered the immunoassay market through its 2006 acquisition of Innotrac 
Diagnostics, which provided the core technology behind Radiometer’s acute care 
immunoassay platform. That acquisition introduced proprietary dry chemistry and time-
resolved fluorescence capabilities that remain central to the AQT90 FLEX system. Since its 
launch, AQT90 FLEX has become one of the company’s most important acute care 
immunoassay platforms, designed for both near-patient and laboratory use where rapid 
quantitative biomarker testing is needed. 
The AQT90 FLEX fully automates the immunoassay process from whole blood aspiration 
through reagent handling, incubation, fluorescence detection, and result generation, 
minimizing manual preparation and allowing quantitative results directly from whole blood 
in approximately 11 to 21 minutes, depending on the assay. The analyzer remains widely 
used in emergency departments, chest pain units, and critical care settings because it delivers 
laboratory-quality quantitative results without requiring centrifugation or extensive sample 
preparation. 
The current test menu includes major acute care biomarkers such as troponin I, CK-MB, 
myoglobin, NT-proBNP, CRP, β-hCG, D-dimer, procalcitonin, and creatinine. These assays 
support rapid assessment of myocardial infarction, heart failure, thromboembolic disease, 
infection, pregnancy-related emergencies, and renal function in acute care environments. 
Recent clinical emphasis has increasingly centered on cardiac biomarkers, inflammatory 
markers, and sepsis support, where rapid decision-making is essential. 
The AQT90 FLEX PCT remains particularly important because it provides quantitative 
procalcitonin measurement directly from whole blood or plasma without prehandling, 
supporting early sepsis evaluation and antibiotic stewardship programs. Results are available 
in under 21 minutes, allowing faster clinical intervention in emergency and intensive care 
settings. Creatinine testing on the AQT90 FLEX also adds renal assessment capability, 

 
 
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helping broaden the analyzer’s role in acute care decision-making beyond traditional cardiac 
testing. Overall, Radiometer’s immunoassay business continues to complement its blood gas 
franchise by adding rapid biomarker analysis to critical care workflows. 
HemoCue 
HemoCue is a global provider of point-of-care hemoglobin testing, particularly through the 
widely used HemoCue Hb 201+ Analyzer, which remains extensively deployed in hospitals, 
blood donation centers, maternal health programs, field screening initiatives, and community 
anemia programs worldwide. As part of Radiometer, HemoCue offers decentralized testing 
that delivers laboratory-quality hemoglobin results from capillary, venous, or arterial blood 
within seconds, supporting both clinical diagnosis and public health screening. 
To strengthen digital anemia management, HemoCue offers HealthTrender Anemia, a 
connected solution designed for real-time population monitoring and program management. 
The system uses the HemoCue BT Connect, attached to the Hb 201+ Analyzer, enabling 
Bluetooth transfer of hemoglobin results to a mobile application. Users can add demographic 
and anthropometric information such as age, gender, location, weight, and height, after which 
data are uploaded securely to a cloud-based platform. Offline functionality remains important 
for rural and field programs because results are stored locally until connectivity is restored, 
preventing loss of screening data. 
The HealthTrender web platform provides dashboards, statistical reporting, and program 
analytics, making it especially valuable for ministries of health, NGOs, and large anemia 
surveillance programs where rapid field data aggregation is essential. This digital integration 
has strengthened HemoCue’s role beyond single-patient testing by supporting broader 
anemia intervention programs, particularly in maternal and child health and nutritional 
surveillance. 
HemoCue’s 2024 collaboration with Novo Nordisk, provided placement of HemoCue’s 
HbA1c 501 systems in more than 400 clinics across approximately 30 countries in Africa, 
Latin America, and Southeast Asia. This initiative focuses on improving access to point-of-
care HbA1c testing for children with type 1 diabetes, expanding HemoCue’s role from 
anemia screening into diabetes monitoring in underserved healthcare settings. Together, 
these developments reinforce HemoCue’s position as a major provider of decentralized 
hematology and metabolic point-of-care diagnostics 

 
 
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Transcutaneous Monitoring 
Radiometer Medical ApS partnered with Perimed AB to accelerate and expand the 
distribution of the Perimed PeriFlux 6000 tcp02 standalone system.  The PeriFlux 6000 tcp02 
standalone system is the latest generation of transcutaneous monitoring systems and will be 
an addition to Radiometer’s portfolio, designed to provide non-invasive measurements of 
oxygenation status.  The PeriFlux 6000 tcp02 standalone system provides health care 
professionals with a reliable, easy-to-use tool to support wound-healing predictions and will 
replace Radiometer’s TCM400. The partnership is active and longstanding. 

 
 
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Revvity 
Waltham, MA 
www.revvity.com 
Table 14-17: Revvity Revenue History, 2023-2025 ($ million, estimated) 
 
2023 
2024 
2025 
Total Diagnostics 
1,458 
1,356 
1,431 
Source: company reports, Kalorama Information 
Diagnostic revenue for 2025 increased $75 million due to an increase in immunodiagnostics 
and an increase in reproductive health revenue.  
Revvity, Inc. is a global provider of health science technologies and services headquartered 
in Waltham, Massachusetts, with approximately 11,000 employees. The company operates 
through two primary segments, Life Sciences and Diagnostics, following the strategic 
transformation of its legacy PerkinElmer portfolio. Revvity’s Diagnostics business is focused 
on reproductive health, newborn screening, infectious disease testing, autoimmune 
diagnostics, and selected genomic applications, supported by a broad portfolio of 
instruments, reagents, assay platforms, and informatics solutions. The company maintains a 
strong leadership position in prenatal and newborn screening, with platforms such as the 
DELFIA Xpress system that support first- and second-trimester screening workflows and are 
integrated with LifeCycle software for data interpretation and laboratory management. 
Revvity continues to expand this leadership in 2026 through growth in multiplex newborn 
screening, particularly with assays such as the EONIS SCID-SMA test and the EONIS Q 
system, which streamline high-throughput molecular screening in public health laboratories. 
Through its EUROIMMUN business, Revvity has strengthened its position in autoimmune 
and infectious disease diagnostics by offering advanced immunofluorescence and 
immunoassay solutions. The EUROPattern system, used with IFA Mosaic assays, enables 
automated digital interpretation of antibody patterns such as ANCA, supporting the diagnosis 
of autoimmune diseases, including vasculitis. EUROIMMUN’s BIOCHIP technology 

 
 
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enables multiplex detection in a single reaction field, allowing simultaneous pattern 
recognition and monospecific confirmation of antibodies such as PR3, MPO, and GBM. 
These capabilities are further enhanced by automation and AI-assisted image analysis, 
reflecting Revvity’s broader 2026 strategy of embedding artificial intelligence into diagnostic 
workflows to improve accuracy, standardization, and laboratory efficiency. Additionally,  the 
company continues to expand its specialty immunodiagnostics portfolio through 
chemiluminescence and ELISA-based assays across endocrinology, autoimmune disease, 
infectious disease, and neurology, supported by platforms such as the IDS i20 random-access 
analyzer, which enables multi-disciplinary testing on a single system. 
In molecular and genomics workflows, Revvity offers automated sample preparation 
solutions through its Chemagic platform portfolio, including the Chemagic 360 and the 
integrated Chemagic Prime system. These platforms automate nucleic acid for PCR and next-
generation sequencing applications, utilizing magnetic rod-based separation to improve yield 
and consistency across a wide range of sample types. In 2026, Revvity has further expanded 
its automation strategy by introducing new intelligent liquid-handling and workflow 
solutions, including compact systems designed to increase flexibility, reduce manual 
intervention, and support scalable laboratory operations. These developments reinforce the 
company’s focus on fully automated, sample-to-answer workflows aligned with the needs of 
high-throughput and decentralized testing environments. 
Revvity also maintains a strong presence in infectious disease diagnostics through products 
such as the T-SPOT.TB test, an interferon-gamma release assay used for the detection of 
latent tuberculosis infection. The company has enhanced automation of this workflow with 
liquid-handling platforms such as the Auto-Pure 2400 system, improving throughput and 
reproducibility in clinical laboratories. Across its diagnostics portfolio, Revvity is 
increasingly aligning with precision medicine by expanding into companion diagnostics and 
collaborating with biopharmaceutical partners, while also advancing digital and informatics 
capabilities through its software platform.  

 
 
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Roche Diagnostics 
Indianapolis, IN 
www.roche.com 
Table 14-18: Roche Revenue History, 2023-2025 (CHF million) 
 
2023 
2024 
2025 
Roche Diagnostics 
14,451 
14,324 
13,847 
Source: company reports, Kalorama Information 
In 2025, Roche Diagnostics reached revenues of CHF 13,847 million.   
Table 14-19: Roche Diagnostic Revenues, by Segment, 2023-2025 (CHF million) 
Segment 
2023 
2024 
2025 
YoY Growth  
2024-2025 
Core Lab 
7,750 
8,004 
7,614 
-4.9% 
Molecular Lab 
2,567 
2,590 
2,527 
-2.4% 
Near Patient Care 
2,746 
2,167 
1,983 
-8.5% 
Pathology Lab 
1,388 
1,563 
1,723 
10.2% 
Total 
14,451 
14,324 
13,847 
-3.3% 
Source: company reports, Kalorama Information 
For the full year of 2025, Roche Diagnostics revenues decreased by -3% in CHF. North 
American sales increased 9% in 2025; EMEA sales increased 6% in 2025. Asia Pacific sales 
decreased by 12%, and Latin American sales increased by 11% in 2025.  
Roche is the global leader in clinical diagnostics, maintaining a significant lead over 
competitors with revenues that continue to exceed those of other major IVD companies by a 

 
 
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wide margin. The company holds a dominant position across core laboratory diagnostics, 
molecular testing, and tissue-based cancer diagnostics through its Roche Diagnostics and 
Roche Tissue Diagnostics divisions. Roche is also a key player in personalized healthcare, 
integrating diagnostics with therapeutics to support targeted treatment strategies, particularly 
in oncology and chronic disease management. Its long-standing leadership in diabetes care, 
despite increased competition from continuous glucose monitoring (CGM) specialists, is 
supported by its Accu-Chek franchise and ongoing investments in next-generation glucose 
monitoring technologies. 
In point-of-care testing, Roche strengthened its decentralized diagnostics strategy through 
the acquisition of select assets from LumiraDx, focused on POC platform technology. This 
move enhances Roche’s ability to deliver rapid, near-patient testing solutions across 
immunoassay and clinical chemistry applications, aligning with the broader industry shift 
toward decentralized care and faster clinical decision-making. The integration of LumiraDx’s 
technology is expected to expand Roche’s footprint in urgent care settings, physician offices, 
and community-based testing environments. 
Roche is investing in its diagnostics and diabetes care infrastructure, including its established 
manufacturing and operations in Indianapolis, a key North American hub. The company 
maintains large-scale production of Accu-Chek blood glucose monitoring products and 
continues to enhance its capabilities through investments in automation, digital connectivity, 
and integrated diabetes management solutions. While Roche is actively developing and 
evaluating continuous glucose monitoring technologies through partnerships and internal 
innovation, it has not established large-scale CGM manufacturing in the United States. Its 
current strategy emphasizes connected care platforms, data integration, and expansion of its 
core glucose monitoring portfolio rather than major standalone CGM production facilities. 
Roche continues to advance its diagnostics portfolio by increasing its focus on automation, 
digital integration, and menu expansion across molecular and immunodiagnostics platforms. 
The company is expanding the use of AI and data-driven tools to enhance workflow 
efficiency, particularly in digital pathology and clinical decision support. Roche’s strategy 
concentrates on connecting diagnostics with therapeutics, reinforcing its leadership in 
personalized medicine while continuing to scale both centralized laboratory systems and 
decentralized testing solutions. 

 
 
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Hematology 
Roche’s cobas m 511 integrated digital hematology analyzer is a system that consolidates 
multiple steps of the complete blood count (CBC) process into a single automated workflow. 
The platform brings together cell counting, digital morphology, and classification, 
minimizing the need for manual slide preparation and microscopic review. Automating smear 
preparation, staining, imaging, and analysis enables laboratories to improve operational 
efficiency while maintaining consistent and reproducible results across routine and more 
complex testing environments. 
The system uses Roche’s digital morphology approach to capture high-resolution images of 
blood cells and apply advanced analytical algorithms to identify and classify white blood 
cells, red blood cells, and platelets. It provides a full CBC with 5-part differential and 
reticulocyte count, along with detailed morphological evaluation that traditionally required 
manual microscopy. This digitized workflow provides remote review, standardized 
interpretation, and improved traceability, which are increasingly important for quality control 
and multi-site laboratory operations. 
Roche continues to advance the cobas m 511 through software and connectivity 
enhancements that align with its broader laboratory automation strategy. Improved 
integration with laboratory information systems and automation solutions provides more 
efficient data handling and workflow coordination within centralized laboratories. Ongoing 
refinement of algorithm-based classification and decision-support tools is further 
strengthening the system’s role in AI-assisted hematology, helping laboratories address 
growing test volumes and staffing challenges while maintaining diagnostic reliability. 
Immunoassays 
 Roche’s cobas and Elecsys immunoassay portfolio sports one of the most comprehensive 
centralized IVD testing platforms, covering a broad range of clinical areas including 
infectious disease, cardiology, oncology, fertility and maternal health, endocrinology, 
neurology, bone and rheumatoid markers, and critical care. The menu is built on Roche’s 
electrochemiluminescence (ECL) technology, which is widely used for its high sensitivity, 
precision, and scalability across laboratory settings. These assays run on Roche’s cobas e 
systems, including the cobas e 402, cobas e 801, and cobas pro integrated solutions, 
supporting testing from mid-volume laboratories to high-throughput core lab environments. 

 
 
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Roche’s infectious disease immunoassays, offers a broad serology and antigen/antibody 
testing menu that includes hepatitis A, B, and C, HIV, syphilis, HSV, CMV, rubella, 
toxoplasma, and HTLV. Advanced assays such as Elecsys HCV Duo and HIV combination 
tests enable simultaneous detection of antigens and antibodies, improving early detection and 
diagnostic accuracy. In critical care, the Elecsys BRAHMS PCT assay continues to provide 
sepsis risk assessment and antibiotic stewardship, while Roche’s cardiac menu includes high-
sensitivity troponin assays designed for rapid and precise detection of myocardial injury. 
Roche’s high-throughput immunoassay capability is represented by systems such as the 
cobas e 801 module, which delivers high testing capacity with a large number of onboard 
reagents, enabling laboratories to consolidate testing and improve operational efficiency. The 
company continues to enhance workflow automation, reagent management, and system 
connectivity, supporting integration into fully automated laboratory environments. 
Roche has expanded its immunoassay portfolio in neurology with the introduction of blood-
based Alzheimer’s biomarkers, including the Elecsys pTau181 plasma assay to identify 
amyloid pathology and the Elecsys ApoE4 test to assess genetic risk.  It tests for These assays 
complement existing cerebrospinal fluid (CSF) tests, such as beta-amyloid and 
phosphorylated tau, and reflect a broader shift toward minimally invasive, high-throughput 
testing that can be performed on existing cobas e platforms. This transition toward blood-
based biomarkers supports earlier detection and wider clinical adoption of neurodegenerative 
disease testing. 
The company also offers the Elecsys Neurofilament Light Chain (NfL) test, a blood test that 
detects neuroaxonal damage associated with neuroinflammation. It is a quantitative 
immunoassay that measures neurofilament light chain protein concentrations in plasma. The 
test is CE marked and is performed on the cobas instruments. The test aims to deliver reliable 
insights into relapsing-remitting multiple sclerosis 
Roche has also strengthened its women’s health testing portfolio, including the Elecsys sFlt-
1/PlGF ratio, which is used to assess the risk of preeclampsia and support clinical decision-
making in pregnancy management. In fertility testing, assays such as anti-Müllerian hormone 
(AMH) continue to be widely used to evaluate ovarian reserve. 

 
 
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HIV 
Roche is focusing on improving access, automation, and clinical monitoring across both 
centralized and decentralized settings. The cobas Plasma Separation Card, an important 
component of this strategy, enables the collection of small blood samples via fingerstick for 
HIV viral load testing without the need for cold-chain transport. This approach provides 
access to quantitative HIV-1 testing in remote and resource-limited settings, while 
maintaining compatibility with Roche’s high-throughput molecular systems, including the 
cobas 6800 and cobas 8800 platforms. The card also provides expanded access to testing 
through global health programs and aligns with ongoing efforts to improve early diagnosis 
and viral load monitoring. 
Roche’s HIV molecular testing portfolio features its automated PCR-based systems, 
particularly the cobas 6800/8800 platforms, which provide high-throughput, fully integrated 
sample-to-result viral load testing. These systems offer large-scale screening and treatment-
monitoring programs, delivering consistent, standardized results across centralized 
laboratories. In 2025 and 2026, Roche has further strengthened this offering with 
enhancements to system performance, workflow flexibility, and connectivity, along with 
continued use of dual-target HIV-1 viral load assays designed to improve detection across 
diverse viral subtypes. 
Roche has also expanded its HIV assay menu by adding a qualitative nucleic acid test that 
detects and differentiates HIV-1 and HIV-2, supporting earlier diagnosis and improved 
clinical decision-making. This complements Roche’s established immunoassay portfolio, 
including combination antigen and antibody tests that enable early detection of infection and 
are widely used in screening and diagnostic settings. 
Roche’s broader HIV strategy emphasizes integrated solutions that combine innovative 
sample collection methods, high-throughput molecular testing, and sensitive immunoassays. 
The company continues to support global access initiatives and public-private partnerships 
aimed at expanding HIV testing, improving linkage to care, and enabling effective 
monitoring of treatment response.  
Molecular Expansion 
Roche has expanded its molecular diagnostics portfolio through the integration of the former 
GenMark ePlex platform, now marketed as the cobas eplex system. The system provides 

 
 
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automated, sample-to-answer multiplex testing with integrated quality control and data 
management, supporting syndromic panels for respiratory and bloodstream infections. Its test 
menu includes panels that can identify a broad range of bacterial and viral pathogens, as well 
as key antimicrobial resistance markers, enabling faster, more targeted treatment decisions, 
particularly in sepsis and acute care settings. 
A major area of innovation in 2025 and 2026 is Roche’s introduction of TAGS (temperature-
activated generation of signal) technology, which enables greater multiplexing within 
existing PCR systems. The first implementation of this technology has been applied to 
respiratory testing with assays such as the cobas Respiratory 4-flex and expanded cobas 
Respiratory flex tests, which allow simultaneous detection of multiple respiratory viruses, 
including SARS-CoV-2, influenza A and B, and RSV, along with additional respiratory 
targets. These assays are designed to run on the cobas 5800, 6800, and 8800 systems, 
allowing laboratories to scale testing from routine to high-throughput environments while 
maintaining consistent assay performance. 
Roche’s current molecular strategy is a move toward flexible, customizable multiplex testing. 
Laboratories can tailor testing panels based on clinical needs, seasonal trends, or patient 
populations, while digital reflex capabilities enable additional targets to be analyzed 
automatically from the same sample, without requiring repeat sample collection or 
processing. This approach improves workflow efficiency, reduces unnecessary testing, and 
supports faster clinical decision-making. 
Additionally, Roche expanded the clinical utility of the cobas eplex system by introducing 
broader syndromic panels and enhanced pathogen coverage, including improved detection of 
bloodstream infections and integrated antimicrobial resistance marker identification. The 
system is positioned to support faster turnaround times in acute care environments, 
complementing Roche’s high-throughput molecular platforms. 
Together, the cobas eplex system and TAGS-enabled assays form part of Roche’s broader 
molecular diagnostics strategy, which spans rapid syndromic testing, scalable high-
throughput PCR, and flexible multiplex assay design.  
Core Molecular 
The cobas 6800 and cobas 8800 systems are Roche’s flagship high-throughput molecular 
platforms, providing fully integrated, automated sample-to-result solutions for routine and 

 
 
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large-scale testing. These systems offer a wide range of applications, including viral load 
monitoring, blood donor screening, women’s health, and infectious disease diagnostics. Built 
on real-time PCR technology, they enable continuous, random-access processing with 
minimal manual intervention, eliminating the need for pre-sorting and allowing multiple 
assays to run simultaneously within the same workflow. The systems are designed for 
extended walk-away operation, supporting several hours of unattended processing while 
maintaining high throughput and consistent performance across centralized laboratory 
environments. Roche’s global installed base has continued to expand, reflecting strong 
adoption in national screening programs and large reference laboratories. 
Roche’s molecular menu on the cobas 6800/8800 platforms includes assays for HIV-1 viral 
load and qualitative HIV-1/HIV-2 detection, hepatitis B and C, cytomegalovirus, human 
papillomavirus, and chlamydia/gonorrhea. The systems also provide blood screening assays 
such as cobas MPX, along with tests for West Nile virus and hepatitis E, enabling 
comprehensive donor screening. Additionally, Roche expanded its infectious disease menu 
to include assays for emerging pathogens such as monkeypox (MPXV) and malaria, 
supporting broader public health and blood safety applications. 
The cobas c 703 is part of Roche’s cobas pro integrated solutions and serves as a high-
throughput clinical chemistry module designed for large core laboratories. It is positioned 
alongside the cobas e 801 immunoassay module to create a consolidated, fully automated 
core lab system capable of handling high sample volumes with minimal manual intervention. 
The cobas c 703 is designed to deliver very high throughput for routine and specialty 
chemistry testing, supporting a broad test menu that includes general chemistry, therapeutic 
drug monitoring, drugs of abuse, and specific proteins. The system emphasizes continuous 
loading, high onboard reagent capacity, and automated maintenance functions, allowing 
laboratories to maintain an uninterrupted workflow and reduce downtime. It also supports 
standardized reagent packaging and calibration processes, helping improve consistency 
across laboratory networks. 
A key strength of the cobas c 703 is its integration within Roche’s overall automation 
ecosystem. When connected to pre-analytical systems and track-based automation, the 
analyzer supports fully automated sample handling from loading through result reporting. 
The platform is also integrated with Roche’s informatics and middleware solutions, enabling 
centralized data management, workflow optimization, and remote monitoring of system 
performance. 

 
 
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In 2025 and 2026, Roche introduced next-generation enhancements to the cobas 6800/8800 
systems that significantly improve throughput, flexibility, and workflow efficiency. Updated 
system configurations and software enable more assays to run within the same workflow and 
support more flexible test scheduling, including the ability to run multiple assay types 
simultaneously from the same sample stream. These enhancements also enable laboratories 
to run both in vitro diagnostic and laboratory-developed tests within a unified workflow, 
improving operational efficiency and resource utilization. 
Roche has also advanced multiplex molecular testing on these platforms by integrating newer 
technologies that enable the detection of multiple targets in a single assay. This enables more 
flexible, customizable testing strategies, particularly in respiratory diagnostics, where 
laboratories can tailor testing to clinical need or seasonal demand. 
 Roche offers rapid molecular testing through the cobas liat platform, including multiplex 
assays for SARS-CoV-2, influenza A/B, and RSV, delivering results in approximately 20 
minutes. Together, these platforms form a tiered molecular testing strategy, with cobas liat 
addressing near-patient needs and cobas 6800/8800 supporting centralized, high-volume 
laboratories.  
Digital PCR 
The digital PCR segment is becoming increasingly competitive, with Roche advancing its 
position alongside established players such as Bio-Rad and Thermo Fisher Scientific. Roche 
has been developing a multi-channel digital PCR platform, designed to expand multiplexing 
capabilities and improve the detection of low-abundance targets, reflecting growing demand 
for highly sensitive nucleic acid quantification in oncology, infectious disease, and 
translational research. 
Roche’s primary entry in this space is the Digital LightCycler System, a digital PCR platform 
designed for precise and absolute quantification of DNA and RNA without the need for 
standard curves. The system supports high-sensitivity detection of rare mutations and low-
level viral loads, making it particularly relevant for applications such as minimal residual 
disease monitoring, liquid biopsy, and infectious disease research. Roche’s system provides 
an enhanced platform with improved multiplexing, workflow automation, and data analysis 
capabilities, positioning it for broader use in both research and, over time, clinical 
environments. 

 
 
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Roche offers  the LightCycler PRO System, a next-generation quantitative PCR platform that 
complements its digital PCR offering. The system is designed to deliver improved thermal 
performance, faster cycling times, and enhanced data precision, supporting a wide range of 
molecular testing applications. While primarily positioned for research and advanced 
laboratory use, it reflects Roche’s continued investment in high-performance PCR 
technologies across both qPCR and digital PCR segments. 
Diabetes Care 
Roche Diabetes Care is an established player in diabetes management, with a long history in 
blood glucose monitoring and a presence across global markets. Under the Accu-Chek brand, 
Roche offers a range of connected solutions that integrate glucose monitoring, data 
management, and digital health tools to support therapy decisions. The company’s strategy 
has increasingly shifted toward connected care, combining devices, software, and services to 
enable more personalized and data-driven diabetes management. 
Roche’s core blood glucose monitoring portfolio centers on systems such as the Accu-Chek 
Guide platform, which remains widely used for self-monitoring. The system includes user-
focused design features such as spill-resistant strip packaging, simplified blood application, 
and automated data capture. Results are transmitted via Bluetooth to Roche’s digital 
platforms, allowing patients, caregivers, and healthcare providers to access and share glucose 
data in real time.  
The mySugr platform was acquired by Roche and is a central component of its digital 
diabetes portfolio. The app supports logging, coaching, and data visualization, and integrates 
with Accu-Chek devices to provide a more comprehensive view of glucose trends and 
therapy management. Roche expanded digital coaching, remote support, and subscription-
style supply models that bundle devices, test strips, and digital services. 
The Accu-Chek SmartGuide CGM system represents a recent product introduction from 
Roche, first launched in 2024 and expanded commercially through 2025. By 2026, the system 
is in the early stages of broader market adoption, positioning it as a next-generation 
continuous glucose monitoring platform rather than a newly introduced product.  This next-
generation platform provides continuous, real-time glucose readings and predictive insights, 
enabling users to anticipate and better manage glucose level fluctuations. The system 
includes a wearable sensor with extended wear time and mobile applications that forecast 
glucose trends, supporting more proactive disease management. Integration of SmartGuide 

 
 
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with Roche’s digital system, particularly the mySugr platform, consolidates glucose data, 
lifestyle inputs, and therapy information into a unified interface, improving usability and 
clinical insight. Roche has also expanded interoperability, enabling its CGM and connected 
devices to integrate with external data platforms, supporting a more flexible and connected 
approach to diabetes management. 
Coagulation 
Since 1993, CoaguChek systems from Roche have set the standard in point-of-care INR 
testing for patients on oral anticoagulant therapy.  According to Roche, CoaguChek is a 
market leader, with over 1 million CoaguChek XS meters in use worldwide and over 250,000 
CoaguChek XS PT test strips used per day.  Nine of the top 10 U.S. integrated health 
networks (IHNs) have chosen CoaguChek technology. 
Roche offers the CoaguChek XS mPOC app for use with the CoaguChek XS meter.  The app 
makes the Bluetooth-enabled PT/INR reporting offered by CoaguChek Patient Services more 
convenient and accessible by allowing patients to use their own iOS device (iPhone or iPad).  
The app is available exclusively to patients who test PT/INR, with support from CoaguChek 
Patient Services.  Wireless-enabled patient self-testing with CoaguChek Patient Services 
enables HCPs to confidently monitor reported PT/INR data remotely. 
Roche markets its multiplex Factor II and Factor V test for use on the Cobas 4800 system, 
which performs real-time PCR analysis for mid- to high-volume labs.  Roche noted that the 
clearance expands the cobas 4800 system's menu and enables labs to consolidate genomics, 
oncology, microbiology, and virology testing on a single platform. Roche added the Cobas t 
511 and Cobas t 711 coagulation analyzers, which are suitable for central labs performing 
coagulation and thrombophilia testing. 
cobas Liat System – POC 
Utilizing PCR technology, the cobas Liat System fully automates the testing process, 
simplifies workflow and enables healthcare professionals to perform molecular testing in a 
variety of settings with minimal training.  The Liat system performs real-time PCR in a tube-
based format, using spatial thermal cycling to enable results in 20 minutes or less.   

 
 
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Roche  offers the CLIA-waived molecular cobas Influenza A/B & RSV test for use on the 
cobas Liat System.  The cobas Influenza A/B & RSV test provides lab-quality PCR results 
for flu and RSV in about 20 minutes, supporting a prompt, confident diagnosis to patients. 
The cobas Influenza A/B & RSV test uses real-time PCR technology to detect and 
differentiate influenza A virus RNA, influenza B virus RNA and respiratory syncytial virus 
(RSV) RNA in about 20 minutes.  
Roche sells the cobas Liat PCR System with four assays into CE-markets, including a 20-
minute real-time PCR nucleic acid test to detect Clostridium difficile (C. diff), the cobas 
Influenza A/B, cobas Strep A, and cobas Influenza A/B & RSV.  These assays have been 
approved by the FDA and are CLIA waived. 
Roche offers the cobas MRSA/SA test for use on the Liat PCR point-of-care platform.  The 
test simultaneously detects MRSA and SA from a single sample in less than 30 minutes.  The 
MRSA/SA test is the fifth Cobas assay for use on the Liat PCR system.  
Roche offers FDA- and CLIA-waived cobas liat sexually transmitted infection multiplex 
assay panels, called the Liat Triplex Point-of-Care STI Test. The panels include tests for 
chlamydia, gonorrhea, and Mycoplasma genitalium, which are identified from a single 
sample. The cobas liat CT, NG, and MG STI assays further expand and complement the 
company’s portfolio of point-of-care diagnostic solutions. 
Roche marketed its first POC test to diagnose Bordetella infections, including whooping 
cough. The test detects Bordetella infections and also differentiates between three key 
species: pertussis, Para pertussis, and B. holmessii. The test is run on the cobas liat system 
and delivers results in about 20 minutes.  
HPV 
In June 2023, the WHO provided prequalification for Roche’s cobas HPV test for use on the 
cobas 6800/8800. This expands the availability of this HPV screening tool in countries that 
rely on the global organization’s list in making purchases.  
Roche markets its HPV self-collection solution. This HPV self-collection solution provides 
easy screening for patients, with samples sent to a laboratory for analysis using Roche’s cobas 
molecular instrument.  

 
 
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Blood Bank 
Roche’s blood banking and donor screening business is a highly automated, integrated 
workflow that combines NAT, serology, pre-analytics, and informatics to support high-
throughput donor screening laboratories. The company has a leading position in global blood 
and plasma molecular screening, with decades of real-time PCR expertise and expanding 
connectivity across molecular and immunoassay platforms to streamline operations and 
improve traceability. Its systems emphasize full sample-to-result automation, bidirectional 
data flow, and scalable throughput suited to national and regional blood services. 
Roche’s cobas MPX assay is a multiplex NAT solution for donor screening on the cobas 
6800 and cobas 8800 Systems, enabling simultaneous detection of HIV-1, HIV-2, HBV, and 
HCV from a single sample using dual-target strategies that enhance sensitivity and reduce 
the need for supplemental discriminatory testing. These systems are among the highest-
throughput molecular platforms, offering extended walk-away times, continuous loading, 
and improved workflow efficiency. Enhancements across the cobas 5800/6800/8800 family 
have focused on expanded menu flexibility, improved automation, and broader adoption of 
high-plex PCR technologies to support evolving screening demands, including preparedness 
for emerging pathogens. 
Roche has expanded its cobas pro integrated solution, which combines clinical chemistry and 
immunoassay capabilities for large-scale infectious disease screening. The platform offers 
high-volume donor testing with assays such as Elecsys HIV Duo, which differentiates HIV 
antigen and antibody responses, along with an expanded menu covering hepatitis, syphilis, 
and other transfusion-relevant infections. Ongoing menu development has emphasized 
improved sensitivity, reduced turnaround times, and harmonization with molecular screening 
workflows. 
Roche has also strengthened its blood screening portfolio through the development of pre-
analytical automation and digital solutions, including sample handling systems, workflow 
optimization software, and connectivity tools that link donor screening instruments with 
laboratory information systems. In addition, the company continues to support dried-blood 
and remote-collection approaches, such as plasma separation cards, to expand access to 
molecular testing in decentralized or resource-limited settings. 

 
 
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Transplant Medicine 
Roche offers a comprehensive cytomegalovirus (CMV) molecular testing portfolio, with 
ongoing transition from legacy platforms to its newer high-throughput cobas systems. The 
cobas AmpliPrep/cobas TaqMan CMV Test established itself as one of the first standardized 
in vitro diagnostic assays aligned to the World Health Organization (WHO) International 
Standard, enabling consistent viral load monitoring across laboratories and supporting 
clinical management of transplant patients. While this system remains in use in some 
laboratories, Roche has increasingly shifted its focus toward its newer-generation platforms. 
Roche’s cobas CMV assay is now positioned on the fully automated cobas 6800 and cobas 
8800 Systems, delivering higher throughput, improved workflow automation, and enhanced 
standardization for quantitative CMV DNA testing. The assay is used to monitor viral load 
in recipients of solid-organ and hematopoietic stem cell transplants undergoing antiviral 
therapy, supporting earlier intervention and more precise treatment management. The system 
allows simultaneous processing of CMV alongside other viral load assays such as HIV-1, 
HBV, and HCV, enabling consolidated testing on a single integrated platform. 
Company updates through 2026 emphasize improved assay sensitivity at low viral loads, 
expanded calibration traceability to international standards, and greater harmonization across 
laboratories. Roche has also enhanced multiplexing efficiency and workflow flexibility on 
the cobas 5800/6800/8800 family, allowing laboratories to balance transplant monitoring 
with infectious disease testing on shared instrumentation. 
In addition, Roche is advancing its broader molecular offerings with the integration of higher-
plex PCR capabilities and the development of digital PCR technologies, which are expected 
to further improve precision in viral load quantification for transplant management over time. 
Connectivity and data management tools have also been strengthened, enabling closer 
integration with hospital information systems and supporting longitudinal patient monitoring.  
Sequencing and Mass Spectrometry 
Roche expanded its presence in mass spectrometry and next-generation sequencing 
workflows, building on earlier introductions while advancing automation, menu 
development, and integration with core laboratory systems. The cobas mass spectrometry 
solution includes the cobas i 601 analyzer, which represents Roche’s entry into routine 
clinical mass spec with an emphasis on standardization, ease of use, and full laboratory 

 
 
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automation. The Ionify reagent packs initially focused on steroid hormone testing, and the 
menu has since expanded to include additional endocrinology and therapeutic drug 
monitoring assays, with ongoing development aimed at bringing more complex mass 
spectrometry applications into routine clinical use without requiring highly specialized 
expertise. 
Roche offers its mass spectrometry platform as part of an integrated core lab system, linking 
sample preparation, analysis, and data management with existing cobas automation and IT 
infrastructure. Enhancements are focused on improving throughput, reducing manual steps, 
and enabling scalable deployment in high-volume laboratories. The company continues to 
emphasize standardized workflows and ready-to-use reagent kits to differentiate its offering 
from traditional, more complex mass spectrometry systems. 
Roche has advanced its SBX technology as part of a broader strategy to enter the next-
generation sequencing market with a differentiated approach. SBX is designed to improve 
sequencing performance by converting nucleic acid sequences into expanded molecular 
constructs, enabling highly accurate signal detection and efficient data generation. The 
technology is in an advanced development phase, with ongoing efforts focused on improving 
read accuracy, scalability, and workflow efficiency for both research and future clinical 
applications, particularly in oncology and infectious disease. Roche is positioning SBX 
alongside its established PCR and digital PCR capabilities to create a multi-technology 
portfolio spanning targeted molecular testing through to high-throughput sequencing. This 
approach reflects a broader strategy to bring advanced genomic technologies into more 
automated, standardized, and clinically accessible laboratory workflows. 
Cancer Companion Testing 
Roche offers its companion diagnostics and precision oncology portfolio, strengthening its 
position in tissue-based diagnostics and targeted therapy selection. The company offers a 
companion diagnostic to identify patients with HER2-low metastatic breast cancer who may 
benefit from treatment with Enhertu, reflecting the growing importance of refined biomarker 
stratification beyond traditional HER2-positive classifications. Roche enhanced its HER2 
testing portfolio with improved assay sensitivity and digital pathology integration to support 
more precise patient identification. 
Roche’s VENTANA CLDN18 RxDx Assay is a valuable addition in gastrointestinal 
oncology as the first immunohistochemistry-based companion diagnostic for determining 

 
 
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CLDN18 expression in gastric and gastroesophageal junction cancers, supporting patient 
selection for targeted therapies such as zolbetuximab. Similarly, the VENTANA FOLR1 
RxDx Assay has expanded access to folate receptor alpha testing in ovarian cancer, enabling 
identification of patients eligible for antibody-drug conjugate therapies such as mirvetuximab 
soravtansine. Roche continues to focus its companion diagnostic menu in solid tumors, with 
ongoing development in lung, breast, and gynecologic cancers. 
Roche markets its digital pathology and AI-enabled diagnostics. The VENTANA TROP2 
RxDx assay, combined with an AI-driven image analysis algorithm, represents a move 
toward integrated companion diagnostics that combine tissue staining with computational 
interpretation. This approach is designed to improve reproducibility and standardization in 
biomarker scoring and is expected to be extended to additional biomarkers and tumor types. 
Further development of AI-assisted companion diagnostics and expanded regulatory 
submissions across multiple oncology indications is expected during the forecast period. 
Roche’s VENTANA MET RxDx Assay identifies patients with non-squamous non-small 
cell lung cancer who are eligible for MET-targeted therapies, reinforcing the company’s 
strong presence in lung oncology biomarker testing. Roche offers a comprehensive lung 
cancer testing portfolio that includes MET, PD-L1, ALK, ROS1, and other biomarkers, often 
integrated with digital pathology workflows. 
Information Technology 
Roche was awarded the CE mark for its Navify Mutation Profiler clinical software that 
provides annotation, interpretation, and clinical reporting of next-generation sequencing tests 
for cancer.  Along with it, Roche launched Navify Therapy Matcher, an optional clinical 
decision support app that helps clinicians link clinically actionable mutations to therapy 
options.  
Roche offers the cobas infinity edge, a secure, cloud-based platform for integrating and 
managing POC data in the clinical setting.  

 
 
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Roche Tissue Diagnostics 
Tucson, AZ 
www.diagnostics.roche.com 
Roche Tissue Diagnostics, a division of Roche, offers a portfolio of automated tissue 
diagnostics systems, reagents, and digital pathology solutions, with a strong emphasis on 
workflow integration, AI-enabled analysis, and precision oncology. The company’s 
VENTANA platform provides automated tissue processing and slide staining for cancer 
diagnostics, supporting both immunohistochemistry (IHC) and in situ hybridization (ISH) 
applications in clinical labs.  
The BenchMark ULTRA and the newer BenchMark ULTRA PLUS systems are now the 
main platforms, offering true random-access processing, enabling laboratories to run STAT 
and routine samples simultaneously without batching. These systems provide enhanced 
throughput, improved reagent management, and greater standardization of staining quality, 
while maintaining flexibility for complex protocols. The BenchMark Special Stains platform 
is a fully automated histochemical staining process with walk-away capability, integrated 
baking through staining, and seamless connectivity to laboratory workflow solutions and 
remote support tools. 
Roche has significantly expanded its digital pathology system, including high-throughput 
slide scanners such as the VENTANA DP 200 and next-generation scanning systems 
designed for higher capacity and faster image acquisition. These are integrated with the uPath 
enterprise software platform, which enables image management, case review, collaboration, 
and remote diagnostics. Roche’s digital pathology offering is enhanced by expanded AI-
powered image analysis algorithms that support biomarkers such as HER2, PD-L1, Ki-67, 
and other oncology markers, improving reproducibility and diagnostic confidence. 
 Roche offers its assay menu across IHC, ISH, and multiplex staining, including companion 
diagnostics aligned with targeted therapies in oncology. Multiplex and advanced staining 
capabilities are being further developed to support more complex biomarker profiling within 
a single tissue sample, reflecting the growing demand for precision medicine. 
 

 
 
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Immunohistochemistry - IHC 
Roche markets the anti-p504s (SP116) Rabbit Monoclonal Primary Antibody2 for prostate 
cancer diagnosis. This antibody has been validated for use in a dual stain with the VENTANA 
Basal Cell Cocktail (34ßE12+p63), on a single slide, to aid in distinguishing morphologically 
difficult cases as benign, atypical or cancerous on a single slide. The assay is an in vitro 
diagnostic (IVD) primary antibody for use on the VENTANA BenchMark IHC/ISH series 
of automated slide stainers. 
Roche Tissue Diagnostics uses its OptiView DAB detection technology to develop new 
immunohistochemistry (IHC)-based diagnostic tests.  Roche Tissue Diagnostics received 
FDA clearance to market the VENTANA MMR IHC Panel, which provides a group of 
immunohistochemistry (IHC) tests for patients diagnosed with colorectal cancer. The tests 
detect specific proteins associated with a DNA repair mechanism called mismatch repair 
(MMR) and help differentiate between sporadic colorectal cancer and probable Lynch 
syndrome, a hereditary form of colorectal cancer. About 3 percent of colorectal cancers are 
associated with Lynch syndrome.  The panel of five assays includes four that target MMR 
proteins MLH1, MSH2, MSH6 and PMS2, as well as the VENTANA BRAF V600E (VE1) 
assay.  According to Roche Tissue Diagnostics, this is the first FDA clearance of an IHC 
panel of this type.   
Roche Tissue Diagnostics offers the VENTANA DP 200 high-speed slide scanner for digital 
pathology.   
Additional features of the VENTANA DP 200 include scan speed of less than 49 seconds for 
15-by-15-millimeter scan area, and the application of a unique International Color 
Consortium (ICC) color profile to each image to ensure that the digital image closely matches 
colors observed under a microscope.  The VENTANA DP 200 is also Digital Imaging and 
Communications in Medicine (DICOM) Standard compatible and integrates with Image 
Management Servers, including VENTANA Virtuoso software.  
Roche has expanded its digital pathology portfolio beyond the VENTANA DP 200 slide 
scanner, a clinical whole slide imaging system designed for routine diagnostic use that 
enables high-resolution digitization of glass slides and supports pathologists in reviewing and 
interpreting cases for primary diagnosis. The portfolio now includes the higher-throughput 
VENTANA DP 600 slide scanner for larger laboratories requiring greater capacity and faster 
turnaround times, along with the navify digital pathology platform, which provides image 

 
 
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management, case workflow, reporting, and integration with laboratory information systems 
to support scalable and remote review environments. Roche has also built out a broader 
digital system that incorporates AI-enabled image analysis for biomarkers such as HER2, 
PD-L1, ER, PR, and Ki-67 and links digital pathology with its companion diagnostics and 
staining platforms, positioning the company toward a more connected, standardized, and 
data-driven pathology workflow. 
Roche also offers the VENTANA HER2 Dual ISH DNA Probe Cocktail assay for the 
detection of the HER2 biomarker in breast and gastric cancer. HER2 - human epidermal 
growth factor receptor 2 - is an important biomarker found in breast and gastric cancers. 
Roche reported that the assay is designed to be completed within the same day, providing 
clinicians the ability to get results back quicker than the most common methods of 
confirmatory testing for HER2.  Results can be read using light microscopy, eliminating the 
need for a specialized fluorescence microscope.  Further, Roche claims to be the only 
provider of a fully automated brightfield Dual ISH solution for the detection of HER2 
amplification.  The brightfield assay is fully automated on the BenchMark IHC/ISH 
instruments.  The test is being launched in Europe, the Middle East, Africa, Latin America 
and Asia Pacific.   
Roche offers the Ventana Kappa and Lambda Dual ISH mRNA Probe Cocktail. The test is 
designed to help pathologists differentiate a B-cell malignancy from a normal response to 
infection. The product was CE marked in June 2024.  
Cervical Cancer Screening 
The CINtec Cytology tests are used in determining which women are at higher risk of 
developing cervical cancer. Roche Tissue Diagnostics offer a complete menu of cervical 
cancer tests the cobas HPV Test for screening, and the CINtec PLUS Cytology and CINtec 
Histology for triage and diagnosis. 
Roche markets the CINtec histology test to detect high-grade cervical disease in women who 
have had a tissue biopsy.  Pathologists can use CINtec test along with hematoxylin & eosin 
(H&E) staining to identify women for providing treatment for cervical pre-cancer. 
CINtec histology test offers conclusive visual confirmation whether the pre-cancerous 
lesions are present or absent.  CINtec histology test adds to the firm’s cervical cancer 
portfolio, which also comprises cobas HPV test and CINtec Plus cytology test. 

 
 
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Companion Diagnostics 
Roche Tissue Diagnostics markets the PD-L1 Assay as a complementary diagnostic for 
Genentech's PD-L1 inhibitor Tecentriq, which was subsequently approved to treat lung 
cancer.  The test gauges PD-L1 expression in tumor and immune cells 
The Ventana PD-L1 assay is run on the Ventana BenchMark Ultra instrument.  It evaluates 
a patient's PD-L1 status using tumor and immune cell staining and scoring within the tumor 
microenvironment.  PD-L1 is a protein involved in the suppression of the immune system 
and understanding its expression in tumors could help with identifying those patients who 
are most appropriate for treatment with an immunotherapy.  Ventana reported it is pursuing 
regulatory approval of the Ventana PD-L1 assay for use with other cancers in the U.S. and 
internationally. 
Roche markets the Ventana ALK CDx assay as a companion diagnostic to identify ALK-
positive (NSCLC patients eligible for treatment with the Roche medicine ALECENSA 
(alectinib).  The Ventana ALK CDx Assay is the only FDA-approved test as a companion 
diagnostic for ALECENSA.  The VENTANA ALK CDx Assay is intended for the qualitative 
detection of the anaplastic lymphoma kinase protein in formalin-fixed, paraffin-embedded 
(FFPE) NSCLC tissue stained with a BenchMark XT or BenchMark ULTRA automated 
staining instrument.  It is also indicated as an aid in identifying patients eligible for treatment 
with XALKORI (crizotinib), ZYKADIA (ceritinib) or ALECENSA (alectinib). 
Roche provides VENTANA PD-L1 Assay in CE markets. It aids in identifying triple-
negative breast cancer patients eligible for treatment with Tecentriq (atezolizumab) plus 
chemotherapy (nab-paclitaxel). Assessment of PD-L1 biomarker status on tumor-infiltrating 
immune cells with the assay is essential for identifying those patients most likely to benefit 
from the treatment. 
Roche offers the Ventana PD-L1 Assay as a companion diagnostic to identify NSCLC 
patients that would benefit from treatment with Libtayo offered by Regeneron.  
Roche, through its Ventana portfolio, continues to expand its leadership in companion 
diagnostics with the introduction of multiple new immunohistochemistry-based assays 
aligned with targeted oncology therapies. The VENTANA CLDN18 (43-14A) RxDx Assay 
is an FDA-approved companion diagnostic designed to identify CLDN18.2 protein 
expression in patients with gastric or gastroesophageal junction adenocarcinoma who may 
be eligible for treatment with zolbetuximab (VYLOY). 

 
 
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Roche also offers an expanded indication of its PATHWAY anti-HER2/neu (4B5) Rabbit 
Monoclonal Primary Antibody assay to support assessment of HER2 status in biliary tract 
cancer, enabling identification of patients eligible for HER2-targeted therapies such as 
zanidatamab (ZIIHERA). 
In addition, Roche offers the VENTANA FOLR1 RxDx Assay, an immunohistochemistry-
based companion diagnostic intended to identify patients with epithelial ovarian cancer who 
may benefit from treatment with mirvetuximab soravtansine (ELAHERE). These 
developments highlight Roche’s continued focus on expanding its companion diagnostic 
portfolio to support precision oncology across multiple tumor types. 

 
 
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Siemens Healthineers (Siemens) 
Deerfield, IL 
www.siemens.com/diagnostics 
Table 14-20: Siemens Healthineers Revenue History, 2023-2025 (€ million) 
 
2023 
2024 
2025 
Total  
€8,286 
€8,678 
€9,156 
Source: company reports, Kalorama Information 
Total revenue for diagnostics was €9,156 million for 2025. There was moderate growth in 
most segments during 2025. The company is still feeling the effects of a reduction in COVID-
19 revenues. However, there was an increased demand for routine tests in 2025. Excluding 
COVID-19 revenues, the diagnostic segment increased 2.1%.  In 2024, Siemens’s revenue 
generated 42% in the Americas, 33% in the EMEA, and 24% in the Asia Pacific including 
China.  
Siemens Healthineers and 24ed beyond its earlier Strategy 2025 framework and is now 
operating under a newer strategic phase focused on expanding leadership in imaging, 
diagnostics, precision therapy, and digitally enabled healthcare. Within this structure, 
Diagnostics continues as a core business with its own operating direction, while the 
company’s broader portfolio increasingly emphasizes artificial intelligence, workflow 
efficiency, and integrated care pathways across the healthcare continuum. Earlier initiatives 
such as the integration of the epoc blood gas portfolio are offered in point-of-care testing, but 
Fast Track Diagnostics is no longer a central growth platform following the company’s 
decision to wind down that unit. Siemens Healthineers’ diagnostics business currently spans 
laboratory diagnostics and point-of-care testing, including clinical chemistry, immunoassay, 
hematology, hemostasis, urinalysis, automation, informatics, and blood gas analysis. The 
company’s overall business is best described today as being organized around imaging, 
diagnostics, cancer care, and minimally invasive therapies, supported by digital technologies 
and AI rather than by the older historical framing that included hearing aids and legacy 
acquisitions as defining elements. 

 
 
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Core Lab 
Siemens offers its complete core lab testing solution the CE Marked and FDA cleared 
Atellica system consists of scalable immunoassay and chemistry analyzers and can operate 
as a stand-alone system or connect to Aptio Automation.  The Atellica Portfolio includes: 
Atellica Solution (automation-ready immunoassay, and clinical chemistry analyzers), 
Atellica 1500 Automated Urinalysis System (fully digital, automated urinalysis system), 
Atellica NEPH 630 System (mid-volume, dedicated nephelometric system for specialty 
protein testing), Atellica COAG 360 System (fully automated high-volume coagulation 
system that unifies five testing methodologies), Atellica MDX 160 System (flexible, 
automated molecular system for multiple sample types), and Atellica PM 1.0 Software 
(process management software to optimize lab operations through data analytics and 
visualization). 
Siemens’ Atellica MDX 160 Molecular System allows users to automate and integrate LDTs 
With IVD Kits on multiple sample types.  Atellica MDX 160 Sample Prep is a flexible, 
automated sample preparation solution with maximum productivity for multiple specimen 
types.  
The company continues to expand the test menu. Siemens Healthineers added two high-
Sensitivity Troponin I assays (TnIH) for Siemens' Atellica (immunoassay and clinical 
chemistry analyzer) and ADVIA Centaur XP/XPT (immunoassay system).  The high-
sensitivity performance of the two TnIH assays enables detection of lower levels of troponin 
at significantly improved precision at the 99th percentile and detects smaller changes in a 
patient’s troponin level during repeated testing. 
Siemens markets the Atellica IM BRAHMS PCT (procalcitonin) Assay for ER and ICU use 
of sepsis assessment, assigning mortality risk and antibiotic therapy decision-making. 
Siemens also markets the Dimension Hemoglobin A1c turbidimetric inhibition assay for 
measuring percentage and mmol/mol measurements of HbA1c in venous whole blood. 
Siemens offers its Atellica CH Enzymatic Hemoglobin A1c Assay to assist clinicians in 
diagnosing and monitoring diabetes.  

 
 
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Lab Automation 
The Atellica automation solution can be used as a stand-alone system or scaled to support 
larger laboratory environments, with flexible configurations that can be adapted to a wide 
range of laboratory layouts, including linear, L-shaped, and U-shaped designs. The system is 
designed to accommodate diverse workflow requirements and can be integrated with Aptio 
Automation to support comprehensive, multidisciplinary laboratory operations. It is 
compatible with a broad range of sample container types, including pediatric and specialty 
tubes, supporting high levels of workflow flexibility. 
Siemens Healthineers supports these automation platforms with Atellica Process Manager 
software, a configurable solution that enables laboratories to monitor and manage workflow, 
instrumentation, and system performance across connected devices. The software provides 
centralized visibility into laboratory operations, allowing staff to oversee processes, track 
system status, and manage daily tasks more efficiently. Features include real-time monitoring 
of reagent and consumable levels, helping laboratories maintain continuity of operations and 
reduce manual intervention. 
The Atellica Diagnostics IT portfolio  extends these capabilities by enabling laboratories to 
leverage operational data to optimize workflow performance and resource utilization. This 
includes user interface enhancements designed to streamline operator interaction, such as 
simplified dashboards and workflow-based task organization that reduce system complexity 
and improve usability. 
Immunoassays 
Siemens became a top player in immunoassays through its 2006 acquisition of DPC.   Since 
its introduction in 1992 by DPC, the IMMULITE family of systems has grown to be a premier 
brand in immunoassay testing. The tests complement Siemens' ADVIA Centaur systems.  
Together, they have a large global installed base in hospital clinical laboratories.  
Siemens offers an FDA-cleared menu of Atellica infectious disease immunoassays, including 
HIV Ag/Ab Combo (CHIV), HBsAg II, HCV, and Syphilis.  The HBsAg II SMART 
algorithm and the hot zone help reduce repeat testing and decrease turnaround time. 

 
 
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Siemens Healthineers sells its automated immunoturbidimetric assay for the quantitative 
determination of the von Willebrand antigen in plasma and an anti-Mullerian hormone 
sandwich immunoassay.  
Additionally, the Atellica CH Diazo Direct Bilirubin assay for bilirubin detection is provided 
for use on the Atellica CH Analyzer.  
Siemens Healthineers markets the Atellica CI Analyzer for immunoassay and clinical 
chemistry testing. 
Siemens Healthineers provides its NfL assay for use on its Atellica IM Analyzer and the 
ADVIA Centaur XP/XPT systems. The test will be used to help predict the risk of MS disease 
activity in patients with RMS.  
Hematology 
Siemens Healthineers’ hematology portfolio is led by its ADVIA systems, which support a 
broad menu of diagnostic assays and incorporate established flow cytometry methodologies 
for high-precision cell analysis. The company has advanced its digital hematology workflow 
through continued integration with the CellaVision DM1200 and next-generation 
morphology platforms, enabling automated slide review, AI-assisted classification, and 
remote hematopathology capabilities that reduce manual microscopy workload and improve 
standardization across laboratory networks. 
The long-standing collaboration between Siemens Healthineers and HORIBA Medical 
remains active in 2026, supporting co-development and distribution of complementary 
hematology solutions. HORIBA Medical continues to expand its Yumizen platform portfolio 
with enhancements in automation, connectivity, and compact systems targeting decentralized 
and mid-volume laboratories, while leveraging Siemens’ broader diagnostic ecosystem. The 
partnership focuses on integrated workflow solutions spanning hematology, chemistry, and 
hemostasis, with no indication of termination. 
In hemostasis, Sysmex Corporation and Siemens Healthineers maintain their strategic 
alliance, with ongoing menu expansion on the CN-series analyzers. Systems such as the CN-
3000 and CN-6000 continue to support advanced assays, including anti-Xa testing for both 
heparin and direct oral anticoagulants, while benefiting from improved throughput, 
automation, and standardized reagent integration. Siemens Healthineers continues to 

 
 
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commercialize these platforms under its brand, alongside the CS-2500, CS-5100, and CA-
600 series, providing a full spectrum of solutions for laboratories ranging from low to high 
volume. 
The Atellica HEMA 570 and Atellica HEMA 580 analyzers offered by Siemens Healthineers 
are part of the high-volume hematology strategy in 2026, offering scalable automation, 
intelligent sample routing, and integrated data management. Recent updates to the Atellica 
HEMA line include enhanced middleware connectivity, expanded digital morphology 
integration, and workflow-optimization features that enable continuous loading, reduce 
turnaround times, and improve flagging algorithms for abnormal cells. These systems are 
increasingly used as part of unified core lab automation tracks, aligning hematology with 
chemistry and immunoassay testing within a single operational framework. 
Urinalysis 
Siemens Healthineers has expanded its digital urinalysis strategy through its collaboration 
with Healthy.io, integrating Siemens’ urinalysis chemistry and reagent expertise with 
Healthy.io’s smartphone-based testing platform. The Dip.io system remains a key component 
of this partnership, combining a dipstick kit with a mobile application that uses image capture 
and AI-driven analysis to interpret results. The platform detects multiple parameters 
associated with kidney disease, urinary tract infections, and metabolic conditions, while 
enabling secure cloud-based data sharing with healthcare providers. Since its initial 
regulatory clearances, the system has been deployed more widely in home testing programs 
and remote patient monitoring initiatives, particularly in chronic kidney disease screening 
pathways and decentralized care models. 
Healthy.io’s digital urinalysis platform is utilized in established programs in Israel and the 
United Kingdom, where it has been incorporated into virtual renal care pathways and 
population health screening efforts. The platform has expanded its role in large-scale home 
testing programs, providing earlier detection of kidney disease and improving patient 
compliance through convenient at-home sample collection and analysis. Integration with 
healthcare systems and electronic medical records has also improved, allowing providers to 
track longitudinal patient data and intervene earlier in disease progression. 
Within its core laboratory portfolio, Siemens Healthineers has advanced its urinalysis 
workflow with the Atellica UAS 60 analyzer, which supports high-resolution digital urine 
microscopy. The system combines automated sample processing with detailed imaging and 

 
 
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particle classification, reducing reliance on manual microscopy while improving consistency 
and throughput. Ongoing enhancements include improved image-analysis algorithms, 
expanded particle-recognition capabilities, and tighter integration with Atellica automation 
and informatics solutions. 
Siemens Healthineers has expanded its urinalysis portfolio beyond the Atellica UAS 60 with 
a fully integrated solution that includes the Atellica UAC 800 urine chemistry analyzer, 
designed for high-throughput dipstick analysis with automated strip handling and 
standardized reading. The company also maintains its CLINITEK line, including the 
CLINITEK Novus automated urine chemistry analyzer and CLINITEK Status+ system, 
which remain widely used in decentralized and physician office settings. Recent updates 
across these platforms focus on improved connectivity, operator-independent workflows, and 
integration with laboratory information systems to support both centralized labs and near-
patient environments. In addition, Siemens Healthineers has enhanced its urinalysis 
automation capabilities through track-based integration with Atellica Automation, enabling 
seamless movement of urine samples between chemistry and sediment analysis systems. 
Digital innovations include expanded use of AI-assisted image analysis in sediment 
microscopy and remote review capabilities, supporting workforce efficiency and 
standardization. Together, these additions strengthen Siemens Healthineers’ position with a 
comprehensive urinalysis system spanning handheld, mid-volume, and high-throughput 
laboratory solutions, as well as emerging digital and home-based testing models. 
Molecular 
Siemens Healthineers continues to expand its molecular IVD portfolio with a strategic shift 
toward rapid, decentralized testing and streamlined workflows. While legacy platforms such 
as the VERSANT and TRUGENE systems established the company’s presence in viral load 
testing and genotyping,  the company offers the Atellica VTLi molecular platform. This 
cartridge-based PCR system delivers fast, sample-to-result testing with minimal hands-on 
time and is being expanded with an evolving menu of infectious disease assays, including 
respiratory and sexually transmitted infection panels designed for near-patient and urgent 
care settings. Enhancements to the VTLi system include improved assay turnaround times, 
expanded multiplex capabilities, and tighter integration with digital informatics for real-time 
result reporting and clinical decision support. Siemens Healthineers offers the VERSANT 
kPCR Molecular System for established applications such as HIV, HBV, and HCV viral load 
testing, while positioning newer molecular workflows around automation, connectivity, and 

 
 
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decentralized access. These developments reflect a broader transition toward flexible, 
distributed molecular diagnostics that complement centralized laboratory testing and enable 
faster, clinically actionable results. 
Sequencing with Artificial Intelligence 
Siemens Healthineers offers sequencing and AI-enabled molecular diagnostics through the 
continued integration of its NEO New Oncology acquisition, which provides advanced next-
generation sequencing capabilities for tumor profiling and precision medicine. The Neo 
platform focuses on targeted sequencing of clinically relevant regions of tumor DNA, 
enabling high-resolution genomic analysis for oncology applications.  Siemens Healthineers 
has also enhanced its offering with improved bioinformatics pipelines, enabling faster 
turnaround times and more standardized interpretation of complex genomic data. AI-driven 
analytics are increasingly embedded in workflows, supporting variant classification, quality 
control, and clinical reporting, and enabling laboratories to scale NGS testing with greater 
consistency and efficiency. 
Additionally, Siemens Healthineers has expanded its molecular workflow solutions with the 
Fast-Track cycler, a compact and flexible thermocycler designed to support a wide range of 
PCR-based applications across laboratories of varying sizes. The FTC system is an accessible 
entry point for molecular testing, offering simplified operation, rapid cycling performance, 
and compatibility with multiplex assay formats. 
A key innovation within the company’s molecular portfolio is the FastFinder software, 
developed in collaboration with UgenTec, which introduces AI-powered automation into 
real-time PCR analysis. FastFinder enables fully automated interpretation of amplification 
data, using machine learning algorithms to evaluate curve kinetics, apply assay-specific 
decision logic, and generate standardized results without manual review. The platform is 
compatible with widely used PCR systems, including Applied Biosystems and LightCycler 
instruments, and supports multiplex workflows by consolidating multiple assay outputs into 
a single, clinically actionable report. 
Acute Care – POC 
Siemens Healthineers expanded its point-of-care portfolio through the acquisition of Epocal 
Inc., which provides the epoc Blood Analysis System, a handheld, wireless solution for near-

 
 
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patient blood testing. The system utilizes single-use, room-temperature-stable BGEM test 
cards that incorporate a broad panel of analytes on a single card, enabling rapid assessment 
of blood gases, electrolytes, and key metabolic parameters. The epoc system delivers results 
for pH, oxygen and carbon dioxide levels, sodium, potassium, ionized calcium, hematocrit, 
glucose, lactate, creatinine, chloride, BUN, and total carbon dioxide in less than a minute, 
supporting fast clinical decision-making in emergency and critical care settings. 
Updates to the epoc platform focus on enhanced connectivity, including support for newer 
host systems and improved data management capabilities, enabling seamless integration with 
hospital and laboratory information systems. These enhancements support real-time data 
transmission, centralized oversight of decentralized testing, and improved workflow 
efficiency across acute care environments. 
Siemens Healthineers offers point-of-care assays for kidney function and metabolic 
assessment on the epoc system, with ongoing menu enhancements and usability 
improvements. In addition, the company maintains its CLINITEST rapid testing portfolio, 
including combination COVID-19 and influenza antigen assays that provide results in 
approximately 15 minutes and support decentralized respiratory testing in clinical and near-
patient settings. 
POC Connectivity 
Siemens Healthineers has expanded its point-of-care connectivity capabilities through an 
integrated informatics strategy that supports centralized oversight of decentralized testing. 
The RAPIDComm Data Management System remains a core component, enabling healthcare 
organizations to manage point-of-care testing programs through a single, configurable 
interface that supports device connectivity, operator management, quality-control tracking, 
and real-time result reporting. 
Building on its acquisition of Conworx Technology, Siemens Healthineers has also 
developed an open point-of-care informatics system that enables connectivity across a broad 
range of POC devices and healthcare IT systems. These solutions allow test results from 
multiple instruments to be automatically transmitted to electronic medical records, reducing 
manual data entry and improving accuracy and workflow efficiency. The system also 
provides centralized management of devices, reagents, and compliance processes, helping 
institutions standardize operations across distributed testing environments. 

 
 
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Siemens Healthineers has enhanced its ability to aggregate data from point-of-care 
instruments, including blood gas, urinalysis, and near-patient testing systems, enabling real-
time visibility into testing performance and patient results across healthcare networks. 
Business Expansion 
Siemens Healthineers has expanded its role in managed laboratory services through long-
term partnerships with healthcare systems, including large-scale public-private initiatives 
such as those established in Turkey. Under these models, Siemens Healthineers provides end-
to-end laboratory solutions, including infrastructure design, instrumentation, consumables, 
maintenance, and operational support across multiple disciplines, including biochemistry, 
microbiology, hematology, immunology, pathology, genetics, and point-of-care testing. 
These agreements reflect the company’s broader strategy to deliver integrated, high-
efficiency laboratory services while supporting standardization and scalability across 
healthcare networks. 
Siemens Healthineers has also advanced its digital health strategy through an integrated 
system that combines data from in vitro diagnostics, imaging, and clinical information 
systems. These platforms enable the aggregation and analysis of large volumes of healthcare 
data, support collaboration across institutions, and provide tools for predictive analytics, 
workflow optimization, and clinical decision support. The company continues to enhance 
these capabilities with cloud-based infrastructure and interoperability across enterprise 
systems. 
The divestment of its microtiter-based ELISA immunodiagnostics business to Diasorin has 
enabled Siemens Healthineers to further streamline its portfolio and focus on higher-growth 
areas, including automation, molecular diagnostics, and advanced immunoassay 
technologies. 
In addition, Siemens Healthineers maintains strategic collaborations with leading laboratory 
service providers such as Unilabs, supporting the modernization of laboratory infrastructure, 
improved workflow efficiency, and standardization across large diagnostic networks. 
The company’s partnership with Sysmex Corporation in hemostasis testing is a key 
component of its diagnostics strategy. Through this collaboration, both companies distribute 

 
 
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a combined portfolio of hemostasis instruments and reagents under their respective brands, 
expanding global reach and strengthening their offerings in coagulation testing, 
anticoagulation monitoring, and bleeding risk assessment. This integrated portfolio continues 
to be marketed across major regions, including the United States and Europe. 

 
 
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Sysmex Corporation 
Kobe, Japan 
www.sysmex.co.jp/ 
Table 14-21: Sysmex Revenue History, 2023-2025 (billions of Yen) FYE March 31 
 
FY2023 
FY2024 
FY2025 
Total Revenues 
¥411 
¥462 
¥503 
Source: company reports, Kalorama Information 
Sysmex’s year-end is March 31, so the company reported 2025 IVD revenues of 503 billion 
yen.  
EMEA - sales grew as a result of higher sales in the hematology and hemostasis  
China - sales grew as instrument sales recovered to previous year levels and reagent sales 
increased 
Asia Pacific – sales grew by double digits for both instruments and reagents due to increased 
activity in India and other countries  
Japan – sales increased by double digits due to an increase in hematology and hemostasis 
segments and an increase in medical robotics 
Sysmex is an integrated manufacturer of laboratory software and diagnostic systems involved 
in the development, production, marketing, and servicing of clinical laboratory testing 
devices and reagents.  Sysmex’s products are used by medical institutions in more than 190 
countries, with a significant portion of sales concentrated in Europe, the Americas, Japan, 
and China. 
Since its establishment in 1968, Sysmex has concentrated on hematology and urinalysis.  
Sysmex has expanded its portfolio and offers clinical laboratory systemization and solutions, 
including clinical diagnostics, automation, and information systems.  The company is 

 
 
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innovating across all of its diagnostic practices, including flow cytometry, urinalysis and 
hematology. 
Hematology 
Sysmex strengthened its position in hematology by combining established high-throughput 
systems with newer analyzers designed for decentralized and mid-volume laboratories. The 
XN-Series remains the flagship of the company’s hematology portfolio, with modular 
configurations that combine analyzers, slide preparation systems, and digital morphology 
solutions for laboratories ranging from major hospital networks to smaller routine testing 
sites. Systems such as the XN-9100, XN-3100, and XN-1500 continue to support automated, 
high-volume workflows with strong standardization and scalability. 
A newer product is the XR-Series Automated Hematology Analyzer, which expands 
Sysmex’s next-generation hematology offering with improved automation, workflow 
efficiency, and advanced clinical parameters. The system is designed to support highly 
automated laboratories seeking greater productivity, enhanced data management, and 
stronger integration across health system networks. Sysmex has also expanded its lower-
volume hematology line with the XQ-320, a compact three-part differential analyzer intended 
for physician office laboratories, stat labs, and smaller hospital settings. This platform 
emphasizes fast turnaround, ease of use, and dependable performance in space-constrained 
environments. 
Sysmex offers decentralized testing needs with the XN-L series, which brings many 
capabilities of the broader XN family into a smaller footprint for lower-volume laboratories. 
These systems, along with the XQ line, are designed  offered by the BeyondCare Quality 
Monitor, a web-based quality management approach that helps laboratories identify shifts 
and trends earlier, reduce manual quality control burden, and standardize performance across 
distributed testing sites. 
The company also offers differentiated products such as the XN-31, which provides 
automated detection and quantification of malaria-infected red blood cells in addition to 
routine CBC parameters, extending hematology into infectious disease applications. Sysmex 
has further advanced digital hematology through its collaborations in automated cell 
morphology and slide review, helping laboratories reduce manual microscopy demands and 
improve workflow consistency. 

 
 
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Coagulation 
Sysmex Corporation and Siemens Healthineers continue to expand their collaboration in 
hemostasis through a global OEM partnership that enables both companies to distribute a 
combined portfolio of coagulation analyzers and reagents under their respective brands. This 
collaboration offers testing for blood clotting disorders, anticoagulant therapy monitoring, 
and perioperative risk assessment, and has been fully commercialized across major markets, 
including the United States and Europe. 
While established systems such as the CS-2500 and CS-5100 remain widely used in high-
volume laboratories, recent product development has focused on newer generation platforms 
within the CN-Series. A key advancement is the CN-6000 Automated Blood Coagulation 
Analyzer, which received U.S. regulatory clearance in 2025. This system is designed for 
high-throughput laboratories and incorporates enhanced automation, continuous sample 
loading, and improved workflow efficiency. The platform is supported by a comprehensive 
reagent menu, including assays for prothrombin time (PT/INR), activated partial 
thromboplastin time (APTT), fibrinogen, antithrombin, and D-dimer using established 
INNOVANCE reagents. 
The CN-3000 system complements the CN-6000 by addressing the needs of mid- to high-
volume laboratories, offering similar automation capabilities in a more compact 
configuration. Together, the CN-Series platforms provide scalable solutions for laboratories 
of all sizes while supporting integration with automated track systems and broader laboratory 
workflows. 
Urinalysis  
Sysmex Corporation expanded its urinalysis portfolio through advanced automation, digital 
imaging, and rapid microbiology solutions. The company’s UN-Series systems represent the 
core of its automated urinalysis offering, combining fluorescence flow cytometry and digital 
imaging to deliver standardized and high-throughput urine sediment analysis. Platforms such 
as the UN-2000 integrate particle counting with imaging capabilities, enabling laboratories 
to reduce manual microscopy while improving consistency and workflow efficiency. 
 

 
 
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Sysmex also provides dedicated urine particle analyzers such as the UF-1500, which offers 
automated sediment analysis using flow cytometry and enables walk-away operation for 
routine laboratory workflows. Digital imaging capabilities are further supported by systems 
such as the UD-130, which capture and store high-resolution images of urine particles, 
enabling automated classification and remote review. Together, these systems create a fully 
integrated urinalysis workflow that enhances accuracy and reduces operator variability. 
A key area of innovation for Sysmex is rapid testing for urinary tract infections, driven by its 
investment in Astrego Diagnostic AB. Sysmex is advancing point-of-care and near-patient 
systems capable of detecting bacterial presence in urine within minutes and determining 
antimicrobial susceptibility in approximately 30 minutes. These systems combine compact 
instrumentation with cartridge-based testing to support faster clinical decision-making and 
improved antimicrobial stewardship. 
Immunoassays 
Sysmex offers its HISCL Series, which utilizes chemiluminescence enzyme immunoassay 
technology to deliver high-sensitivity testing across a broad range of clinical applications. 
Current systems such as the HISCL-5000 and HISCL-800 form the foundation of Sysmex’s 
immunochemistry offering, supporting both routine and specialized assays in areas including 
infectious disease, oncology, metabolic disorders, and inflammatory conditions. 
Sysmex has focused on expanding its assay menu, introducing new parameters that enhance 
the clinical value of the HISCL platform. Notable developments include assays targeting 
amyloid beta biomarkers for Alzheimer’s disease, enabling blood-based assessment of Aβ 
accumulation to support earlier diagnosis and treatment planning. Additional assay 
expansions include panels for gynecologic and gonadal hormones, as well as targeted tests 
such as the HISCL HIT IgG assay for heparin-induced thrombocytopenia and the HISCL C-
peptide assay for diabetes management. 
The company’s established specialty markers, such as M2BPGi for liver fibrosis, TARC for 
atopic dermatitis, and presepsin for sepsis, are reinforcing the HISCL platform’s role in both 
routine and advanced clinical testing. These assays are designed to deliver rapid turnaround 
times with small sample volumes while improving laboratory efficiency and standardization. 
Additionally, Sysmex is advancing next-generation immunoassay technologies through 
systems such as the HI-1000, an ultra-high sensitivity platform intended for research and 

 
 
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emerging clinical applications. This system provides detection of extremely low-abundance 
biomarkers, particularly in liquid biopsy and precision medicine, and reflects Sysmex’s long-
term strategy to expand into high-sensitivity protein analysis. 
Lab Information System 
Sysmex’s digital diagnostics is offered through its Caresphere platform, a networked system 
that connects laboratory instruments, information systems, and operational data in real time. 
Caresphere enables laboratories to standardize workflows across locations, improve 
operational visibility, and support data-driven decision-making through centralized 
monitoring and analytics. 
The Caresphere laboratory workflow system serves as a core component, integrating pre-
analytical, analytical, and post-analytical processes into a unified platform. The system 
provides real-time insight into laboratory operations, including sample tracking, turnaround 
times, and instrument utilization, allowing laboratories to optimize workflow efficiency and 
resource allocation. By linking multiple instruments and systems,  
Sysmex has enhanced the Caresphere system with expanded cloud-based capabilities and 
interoperability, enabling remote access to operational data and improved coordination 
across healthcare networks. Additional modules such as Caresphere QM support quality 
management by providing continuous monitoring of quality control data, trend analysis, and 
compliance support, helping laboratories maintain standardized performance and regulatory 
adherence. 
Sysmex has also introduced new diagnostic assays that integrate with its informatics 
infrastructure. These include immunoassay-based tests for neurological and metabolic 
conditions, such as blood-based amyloid beta assays used to support the evaluation of 
Alzheimer’s disease. More recent additions to the HISCL assay menu include hormone 
panels, HIT antibody testing, and C-peptide assays, reflecting ongoing expansion of clinical 
parameters across its immunoassay systems. 
Flow Cytometry 
In flow cytometry, Sysmex offers its clinical flow cytometry portfolio with integrated 
systems designed to improve workflow standardization, automation, and analytical 

 
 
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performance. The company provides flow cytometry platforms supported by dedicated 
sample-preparation systems, such as the PS-10, along with a broad menu of antibody reagents 
for clinical and research applications. These solutions are designed to streamline sample 
handling, reduce manual preparation steps, and improve reproducibility across laboratories. 
Sysmex offers a flow cytometry system configuration that emphasizes automated sample 
preparation, standardized reagent panels, and enhanced data analysis capabilities. The 
company’s platforms offer a wide range of clinical applications, including hematologic 
malignancy assessment, immune profiling, and monitoring of therapeutic response. 
Recent developments focus on improving integration between flow cytometry systems and 
laboratory information environments, enabling more efficient data management and 
workflow coordination. Sysmex is also expanding its reagent portfolio and panel design to 
support multiparameter analysis and more precise characterization of cell populations. 
Precision Medicine / Companion Test Diagnostics 
In Japan, Sysmex markets the PrismGuide APOE Genotyping Kit, an in vitro diagnostic 
assay that determines APOE genotype from genomic DNA extracted from whole blood and 
identifies six genotype combinations. The test is designed to support clinical decision-making 
by assessing a patient’s risk of developing amyloid-related imaging abnormalities associated 
with anti-amyloid β antibody therapies used in Alzheimer’s disease. While not a traditional 
oncology-style companion diagnostic, the assay serves as a therapy-guiding test, helping 
physicians evaluate treatment suitability and risk before initiating anti-amyloid therapies. 
Sysmex’s companion diagnostic activity remains focused on oncology through its 
OncoGuide NCC Oncopanel System, which continues to be expanded and used to identify 
actionable mutations and guide targeted therapies, including with FGFR inhibitors such as 
futibatinib. In 2025–2026, Sysmex has focused more on expanding the clinical utility of its 
genomic profiling and biomarker platforms rather than launching entirely new standalone 
companion diagnostics, with ongoing development of additional gene panel content, 
biomarker-driven assays, and collaborations to link diagnostics with targeted and precision 
therapies across oncology and neurodegenerative diseases. 

 
 
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Liquid Biopsy 
Sysmex, through its subsidiary RIKEN GENESIS Co., Ltd., established the RIKEN 
GENESIS Innovation Genome Center at the Life Innovation Center within the Kawasaki 
Innovation Gateway at SKYFRONT to support large-scale genomic analysis. The facility 
integrates next-generation sequencing and liquid biopsy technologies to provide high-
throughput gene analysis services and clinical sequencing with quality systems aligned to 
international standards, supporting both research and clinical applications in oncology and 
precision medicine. 
Sysmex markets its blood-based RAS mutation testing in Japan through the OncoBEAM 
RAS CRC Kit, which detects circulating tumor DNA to identify mutations relevant to 
colorectal cancer treatment selection. The assay is used in clinical practice to guide targeted 
therapy decisions and represents one of Sysmex’s key liquid biopsy offerings. 
Sysmex’s collaboration with QIAGEN is paramount to its companion diagnostics strategy, 
combining Sysmex’s expertise in plasma-based testing with QIAGEN’s assay development 
and global commercialization capabilities. The partnership, which has been expanded in 
recent years, continues to support the development and deployment of liquid biopsy-based 
companion diagnostics and therapy-guiding assays, with ongoing efforts focused on 
broadening biomarker coverage, improving sensitivity, and extending applications across 
additional cancer types. 
Sysmex Inostics 
Sysmex acquired Inostics GmbH from Indivumed and renamed the business Sysmex Inostics, 
establishing a foothold in liquid biopsy and molecular oncology. The company maintains its 
headquarters in Hamburg, Germany, and a CLIA-certified laboratory in Baltimore, 
Maryland, which supports clinical testing services and pharmaceutical collaborations. 
Sysmex Inostics specializes in highly sensitive mutation-detection technologies, including 
BEAMing and plasma-based sequencing approaches for analyzing circulating tumor DNA 
in blood samples. 
Sysmex Inostics’ OncoBEAM platform provides quantitative detection of tumor-specific 
somatic mutations for routine testing. These assays are widely used in oncology clinical trials, 
translational research, and therapy selection, particularly where tissue samples are limited or 
unavailable. Sysmex continues to position BEAMing as a core technology for liquid biopsy 

 
 
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applications and for integration into companion diagnostic development programs with 
pharmaceutical partners. 
Sysmex Inostics operates globally across Europe, the United States, and Japan, providing 
assay services and supporting precision medicine initiatives through collaborations with 
academic institutions, research organizations, and biopharmaceutical companies. The 
company’s core focus remains on oncology, specifically the detection of actionable genetic 
alterations in cell-free DNA, rather than broad infectious disease testing as previously 
emphasized. 
The Sysmex Inostics OncoBEAM RAS CRC assay is the flagship product, enabling detection 
of RAS mutations in circulating tumor DNA to guide treatment decisions in metastatic 
colorectal cancer. The test supports the identification of patients unlikely to benefit from anti-
EGFR therapies and provides a non-invasive alternative to tissue-based testing, particularly 
when rapid results are required or tumor samples are unavailable. 
In addition to RAS testing, Sysmex Inostics offers a sequencing-based assay menu that 
includes targeted panels for solid tumors and hematologic malignancies, such as assays for 
head and neck cancer and acute myeloid leukemia. The company has also continued to refine 
its liquid biopsy portfolio by enhancing sensitivity, broadening biomarker coverage, and 
integrating with next-generation sequencing workflows.  
Forging New Markets 
Sysmex is investing heavily in artificial intelligence, data analytics, and digital health 
technologies to strengthen its position in personalized medicine, with a particular focus on 
integrating genomic testing, molecular diagnostics, and data-driven clinical decision support. 
The company has expanded its Cytocell operations by moving to a larger facility at 
Cambridge Science Park in the United Kingdom to accommodate increasing demand for 
fluorescence in situ hybridization (FISH) probes and support continued growth in 
cytogenetics and cancer diagnostics. Sysmex has also expanded into rapid antimicrobial 
susceptibility testing through its acquisition of Astrego Diagnostics AB, aiming to accelerate 
the clinical adoption of fast phenotypic AST solutions for urinary tract infections and to 
address the growing global challenge of antimicrobial resistance. 
In Japan, Sysmex introduced the PrismGuide IRD Panel System, a diagnostic solution 
combining reagents and analysis software to perform comprehensive genomic profiling for 

 
 
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inherited retinal diseases, enabling the detection of mutations across a broad panel of disease-
associated genes and supporting earlier and more precise diagnosis. The company has also 
collaborated with Hitachi High-Tech to advance genetic testing systems based on capillary 
electrophoresis sequencing technologies, reinforcing its capabilities in clinical genomics. 
Geographically, Sysmex continues to expand its global infrastructure by strengthening direct 
sales and service operations in Italy across hematology, urinalysis, and hemostasis; 
establishing Sysmex East Africa in Kenya to support growth in multiple emerging markets; 
and expanding its diagnostic reagent production capacity in Brazil to improve regional supply 
and responsiveness. In addition, Sysmex has announced plans to relocate its headquarters 
functions within Kobe by 2028 to enhance operational integration and support long-term 
growth. 
 
  
 

 
 
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Thermo Fisher Scientific Inc. 
Waltham, MA 
www.thermofisher.com 
Table 14-22: Thermo Fisher Revenue History, Clinical Diagnostics, 2023-2025 ($ million) 
 
2023 
2024 
2025 
Specialty Diagnostics 
$4,405 
$4,512 
$4,676 
Source: company reports, Kalorama Information 
Specialty diagnostics revenues grew in 2025 approximately 3.6% over 2024. The increase 
results from strong growth in sales of immunodiagnostics and transplant diagnostics.  
Thermo Fisher Scientific was formed through the $10.6 billion merger of Thermo Electron 
and Fisher Scientific in 2006 and has since evolved into one of the largest global providers 
of scientific instrumentation, specialty diagnostics, and laboratory services. The company 
offers a broad portfolio spanning analytical instruments, including advanced mass 
spectrometry systems, as well as reagents, chemicals, antibodies, and consumables used 
across biotechnology, pharmaceutical, and clinical laboratory settings. Thermo Fisher serves 
a diverse customer base, including healthcare providers, pharmaceutical and biotech 
companies, academic institutions, and government laboratories, with a strategy focused on 
integrating research, diagnostics, and applied markets.  
Its core brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher 
Scientific, and Unity Lab Services, collectively support end-to-end laboratory workflows 
from discovery through clinical application. The company has transformed from a traditional 
laboratory supply and distribution model into a highly diversified life sciences and 
diagnostics leader through sustained acquisitions and product development. In the in vitro 
diagnostics sector, Thermo Fisher operates primarily through its Thermo Scientific platform, 
with strong capabilities in specialty diagnostics, including immunodiagnostics, clinical 
chemistry, microbiology, and molecular testing, while Fisher Scientific continues to function 
as a global distribution and services channel. The company has emphasized expanding 

 
 
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translational capabilities, aiming to bridge genomic and proteomic research into clinical 
diagnostics and precision medicine applications. 
Thermo Fisher has further strengthened its position in specialty diagnostics and proteomics 
through targeted acquisitions, including The Binding Site Group, which expanded its 
presence in plasma protein testing and hematology diagnostics, particularly in multiple 
myeloma and related disorders, and Olink, which enhances its leadership in high-throughput 
proteomics and biomarker discovery.  
Additionally, the company continues to invest in molecular diagnostics, next-generation 
sequencing workflows, and companion diagnostics, supporting the growing demand for 
personalized medicine and integrated diagnostic solutions. Thermo Fisher has expanded 
beyond its traditional focus on tools and diagnostics into a more comprehensive role across 
clinical research, data, and pharmaceutical services. The acquisition of Clario strengthens its 
capabilities in clinical trial data capture and endpoint analytics, while collaborations in real-
world data integration enhance its ability to support evidence generation and regulatory 
decision-making. The company is also increasing its presence in contract development and 
manufacturing, including investments in sterile drug manufacturing capacity and biologics 
production, aligning with demand for outsourced pharmaceutical development and domestic 
manufacturing. Additional expansion in bioprocessing and filtration technologies further 
supports cell and gene therapy and biologics workflows. 
Immunoassays 
Thermo Fisher Scientific has one of the broadest specialty immunodiagnostic and drugs-of-
abuse testing menus in the market. In toxicology, the company offers assays such as the DRI 
Hydrocodone assay and the CEDIA Buprenorphine II assay, offering urine drug testing with 
sensitivity suited to modern opioid-monitoring requirements. Its drugs-of-abuse portfolio 
also includes the Thermo Scientific CEDIA Mitragynine assay for kratom detection, 
marketed for forensic and criminal justice use, and Thermo Fisher continues to maintain a 
broad menu of assays for prescription drug, opioid, and substance-use monitoring on routine 
clinical chemistry analyzers. In allergy and autoimmunity, Thermo Fisher is a major 
contributor through its ImmunoCAP and EliA product lines and Phadia laboratory systems. 
The company offers EliA anti-thyroglobulin and anti-thyroid peroxidase tests for 
autoimmune thyroid disease, while the Phadia 200 supports a broad menu of ImmunoCAP 
and EliA assays used in the diagnosis of allergic and autoimmune conditions. Its 

 
 
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ImmunoCAP specific IgE menu, including peanut component testing such as Ara h 6, 
remains an important part of component-resolved allergy diagnostics and continues to see 
broader clinical adoption. 
Thermo Fisher also has a strong position in maternal-fetal and specialty protein testing 
through its B·R·A·H·M·S and Binding Site businesses. The B·R·A·H·M·S KRYPTOR 
GOLD system supports assays for prenatal screening and preeclampsia risk assessment, 
including sFlt-1 and PlGF biomarkers, while the company has also expanded its oncology-
supportive immunoassay offerings with products such as the B·R·A·H·M·S CgA II 
KRYPTOR assay. In plasma cell disorder testing, Thermo Fisher strengthened its portfolio 
through the Optilite Freelite assays, which received expanded U.S. clearance in 2024 for 
evaluation of monoclonal gammopathy of undetermined significance. The company further 
advanced this area in 2025 with U.S. clearance for the EXENT system, an automated mass 
spectrometry platform designed to aid in the diagnosis of multiple myeloma and related 
monoclonal gammopathies. These additions broaden Thermo Fisher’s role beyond traditional 
immunoassay testing and reinforce its position in specialty diagnostics across toxicology, 
allergy, autoimmunity, women’s health, oncology-related testing, and hematologic disease 
assessment. 
Microbiology 
Thermo Fisher Scientific offers one of the most comprehensive antimicrobial susceptibility 
testing portfolios in the clinical microbiology market. The company offers its Thermo 
Scientific Sensititre platform. Sensititre systems provide both manual and automated broth 
microdilution testing, delivering standardized minimum inhibitory concentration results that 
remain the gold standard for antimicrobial susceptibility assessment. The platform includes 
a range of workflow solutions, including the Sensititre ARIS 2X automated reading and 
incubation system, the Sensititre Vizion digital MIC viewing system, and supporting 
informatics and barcoding tools designed to streamline laboratory operations. Thermo Fisher 
continues to expand its panel offerings to include clinically relevant antimicrobials, 
particularly those targeting multidrug-resistant Gram-negative organisms, reinforcing its role 
in addressing antimicrobial resistance challenges. 
The Sensititre microbroth dilution plate portfolio includes panels designed for both Gram-
negative and Gram-positive organisms, incorporating newer antimicrobial combinations 
such as beta-lactam/beta-lactamase inhibitor therapies. These plates enable laboratories to 

 
 
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generate precise MIC values across a broad range of antibiotics, supporting optimized 
therapeutic decision-making, antimicrobial stewardship initiatives, and resistance 
surveillance. While individual plate configurations evolve over time to reflect emerging 
therapies and resistance patterns, the overall Sensititre system remains a cornerstone 
technology for standardized AST in clinical laboratories worldwide. 
In addition to AST, Thermo Fisher supports microbiology workflows through its Oxoid 
culture media and chromogenic media portfolio, which are used for organism isolation and 
preliminary identification. Earlier integrations with digital colony counting and chromogenic 
media interpretation systems helped automate portions of the microbiology workflow, and 
more recent efforts have focused on improving laboratory efficiency through enhanced 
workflow connectivity, data management, and compatibility with laboratory information 
systems. The company continues to align its microbiology solutions with broader trends 
toward automation, digital microbiology, and faster turnaround times. 
Thermo Fisher’s AST solutions are also used to support antimicrobial development and 
clinical decision-making, including applications for newer antibiotics targeting resistant 
infections.  
Molecular Test Business 
Thermo Fisher Scientific’s molecular diagnostics business offers a portfolio of PCR, next-
generation sequencing, and genetic analysis platforms that support both research and clinical 
applications. Core systems include the Ion Torrent sequencing platforms, the Applied 
Biosystems 3500 Dx Series genetic analyzers for capillary electrophoresis, and the Applied 
Biosystems QuantStudio Dx family of real-time PCR instruments, which are used in clinical 
and public health laboratories. The company has expanded the clinical utility of these 
platforms through assay menu development, automation, and integration with laboratory 
workflows, with a particular focus on infectious disease, oncology, and genetic testing. While 
Affymetrix microarray technologies historically played a major role in multiplex genomic 
analysis, their importance has declined relative to PCR and NGS-based approaches, although 
they continue to be used in selected research and specialty applications. 
Thermo Fisher’s PCR assay portfolio includes a broad menu of syndromic and targeted 
panels. Products such as the TaqPath enteric testing panels and the TrueMark STI Select 
Panel support multiplex detection of gastrointestinal pathogens and sexually transmitted 
infections, respectively, using streamlined workflows on QuantStudio systems. The company 

 
 
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has also expanded its presence in decentralized molecular testing through the Accula 
platform, which delivers rapid PCR-based results for respiratory infections such as influenza 
at or near the point of care. In infectious disease response, Thermo Fisher provides public 
health testing through assays targeting emerging pathogens, building on earlier test 
development for orthopoxviruses and other high-priority infectious threats. 
In addition to PCR, Thermo Fisher is increasingly positioning its Ion Torrent sequencing 
platforms for clinical applications, including oncology and genetic disease testing, with 
ongoing efforts to simplify workflows and improve turnaround time for clinical laboratories. 
The company is also enhancing its molecular portfolio through automation, sample-
preparation solutions, and data-analysis tools to support higher throughput and more 
standardized testing environments. While earlier collaborations, such as integration efforts 
involving third-party molecular systems, helped expand workflow flexibility, Thermo 
Fisher’s current strategy is more focused on delivering integrated, end-to-end molecular 
solutions across PCR and sequencing.  
In recent years, Thermo Fisher has expanded its molecular diagnostics portfolio beyond 
traditional PCR systems into fully integrated and automated clinical testing solutions. An 
example is the Ion Torrent Genexus Dx system, an automated next-generation sequencing 
platform designed to deliver sample-to-report results with minimal hands-on time. The 
system, paired with the Oncomine Dx Express test, supports oncology applications including 
companion diagnostics, reflecting Thermo Fisher’s growing presence in clinical NGS. 
Additionally, the company has enhanced its PCR system through workflow-integration tools, 
such as Diomni software and automated sample-preparation systems, enabling more efficient 
and standardized molecular testing. These developments highlight Thermo Fisher’s strategic 
shift toward fully integrated molecular diagnostics solutions that combine PCR, sequencing, 
automation, and data management to support precision medicine and decentralized testing 
environments. 
 Next-Generation Sequencing 
Thermo Fisher Scientific’s next-generation sequencing portfolio includes Ion Torrent 
semiconductor technology and a strategic shift toward fully integrated, automated, and 
clinically focused solutions. While earlier workflows relied on systems such as the Ion Chef 
and Ion GeneStudio S5 series, the company’s current emphasis is on the Genexus platform, 
including the Genexus Dx system, which enables automated sample-to-report sequencing 

 
 
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with minimal hands-on time and rapid turnaround, suitable for decentralized clinical 
laboratories. Supporting this platform, the Oncomine Dx Express test and related oncology 
panels provide clinically actionable tumor profiling, including companion diagnostic 
applications, while the Oncomine Precision Assay enables comprehensive genomic profiling 
from both tissue and liquid biopsy samples. Thermo Fisher continues to expand its targeted 
sequencing capabilities through Ion AmpliSeq HD technology, which supports high-
sensitivity detection of low-frequency variants in applications such as liquid biopsy and 
heterogeneous tumor analysis. In parallel, the company is strengthening its integrated NGS 
ecosystem through automation, software, and workflow standardization, aligning its 
sequencing portfolio with the growing demand for precision medicine, decentralized testing, 
and rapid clinical decision-making in oncology and genetic disease. 
Thermo Fisher provides its Oncomine Dx Target test as a companion diagnostic to identify 
patients eligible for treatment with Hernexeos, a tyrosine kinase inhibitor offered by 
Boehringer Ingelheim. The company also provides its Oncomine Dx Express NGS Assay as 
a companion diagnostic for Zegfrovy and for tumor profiling.  
qPCR 
Thermo Fisher Scientific offers the Applied Biosystems QuantStudio 6 and 7 Pro Real-Time 
PCR Systems, advanced connected qPCR platforms designed to improve laboratory 
workflow efficiency, data integrity, and user interaction. These systems incorporate features 
such as user authentication, voice-enabled operation, and RFID-enabled plate recognition to 
streamline assay setup and reduce manual input errors. The instruments support the use of 
TaqMan Array Plates with embedded assay information, enabling automatic upload of plate 
layouts and minimizing setup variability. QuantStudio Pro systems are also integrated with 
cloud-based connectivity through Instrument Connect software, allowing users to monitor 
runs, access data, and perform remote analysis from desktop or mobile devices. In current 
use, these platforms are positioned as part of Thermo Fisher’s broader connected laboratory 
system, offering applications in research, clinical diagnostics, and high-throughput testing 
environments. 
Oncology Companion Diagnostics 
Thermo Fisher offers its Oncomine family of next-generation sequencing assays, with a clear 
transition from earlier platforms such as the Ion PGM Dx system to fully automated, 

 
 
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integrated sequencing solutions. The Oncomine Dx Target Test, originally developed using 
Ion AmpliSeq technology, established Thermo Fisher as an early leader in NGS-based 
companion diagnostics by enabling multiplex detection of clinically relevant genomic 
alterations from limited tissue samples. While this assay remains in use and continues to 
receive expanded indications, the company’s current strategy is focused on more advanced 
platforms. 
The Oncomine Dx Express Test, designed for use on the Genexus Dx system, represents 
Thermo Fisher’s most recent and important advancement in molecular oncology diagnostics. 
This fully automated, sample-to-report sequencing solution enables rapid tumor profiling and 
companion diagnostic testing with turnaround times of approximately one day, supporting 
decentralized clinical laboratories and faster treatment decisions. The assay can detect a 
broad range of genomic alterations, including mutations, insertions and deletions, gene 
fusions, and copy number changes across multiple cancer-related genes, and has received 
expanded regulatory approvals for both tumor profiling and targeted therapy selection in 
oncology. 
Thermo Fisher has expanded its companion diagnostic portfolio through collaborations with 
pharmaceutical companies to support targeted therapies across multiple tumor types, 
including lung cancer and other solid tumors. The company is also advancing multi-
biomarker companion diagnostic systems designed to support a broader range of genomic 
targets within a single assay, reflecting the shift toward comprehensive genomic profiling in 
precision medicine. In addition, Thermo Fisher offers specialized sequencing solutions, such 
as the SeCore HLA system, for immunotherapy applications.  
Transplant Medicine 
 Thermo Fisher Scientific offers its transplant line through the One Lambda brand acquired 
in 2012, and provides a comprehensive portfolio of HLA typing and antibody detection 
assays used to assess donor–recipient compatibility and monitor transplant patients for signs 
of rejection. The company offers testing solutions based on serological, molecular, ELISA, 
flow cytometry, and bead-based multiplex technologies, supporting both pre-transplant 
matching and post-transplant surveillance. One Lambda is a global leader in transplant 
immunology, serving transplant centers worldwide with assays designed to improve graft 
survival and clinical outcomes. Thermo Fisher has expanded its transplant diagnostics 

 
 
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capabilities beyond traditional HLA typing into advanced molecular and genomic 
approaches.  
The company offers next-generation sequencing that is based HLA typing through its Ion 
Torrent platforms and associated workflows, while continuing to provide PCR-based and 
multiplexed assay solutions for comprehensive genetic profiling, including HLA, KIR, and 
platelet antigen testing. In recent years, Thermo Fisher has strengthened its position in 
transplant monitoring by introducing novel molecular assays and services that enable earlier, 
less invasive detection of rejection. These include the CXCL10 testing service, which uses 
urine samples to detect inflammatory signals associated with early kidney transplant 
rejection, and the One Lambda Pre-Transplant Risk Assessment assay, which uses a multi-
gene expression signature to generate a risk score for early acute rejection. 
Thermo Fisher is also advancing its transplant diagnostics portfolio through sequencing and 
PCR approaches for donor-derived cell-free DNA analysis, supporting non-invasive 
monitoring of graft health and expanding its role in next-generation transplant surveillance 
alongside traditional immunological testing.  
Mass Spectrometry 
Thermo Fisher Scientific is one of the leaders in mass spectrometry, with a strong presence 
across research, pharmaceutical development, and applied markets. While mass spectrometry 
has historically been used primarily in research settings, the company continues to advance 
its technologies for use in clinical and translational diagnostics. Thermo Fisher’s current 
strategy focuses on enabling clinical laboratories to adopt liquid chromatography–tandem 
mass spectrometry through improved automation, standardized workflows, and integrated 
software solutions that reduce the need for highly specialized expertise. Earlier efforts to 
introduce fully automated clinical mass spectrometry systems, such as the Cascadion 
platform, demonstrated the potential for broader adoption of MS-based testing in hospital 
laboratories, particularly for small-molecule analysis. However, more recent developments 
have shifted toward high-performance, flexible mass spectrometry systems capable of 
supporting both research and clinical applications. In 2025, Thermo Fisher expanded its 
portfolio with the introduction of advanced Orbitrap-based systems, including the Orbitrap 
Astral Zoom and Orbitrap Excedion Pro mass spectrometers. These systems are designed to 
deliver higher sensitivity, speed, and analytical resolution, supporting applications in 
proteomics, biomarker discovery, and translational research, as well as emerging clinical use 

 
 
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cases. Thermo Fisher also provides integrated mass spectrometry workflows that combine 
high-resolution instrumentation with standardized sample preparation, software, and data 
analysis tools to support clinical research and emerging diagnostic applications.  
 
 

 
 
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Werfen 
Barcelona, Spain 
http://www.werfen.com/en 
Table 14-23: Werfen Recent Revenue History, 2023-2025 (€ billion) 
 
2023 
2024 
2025 est 
Total IVD Revenues 
2.1 
2.2 
2.1 
Source: company reports, Kalorama Information 
Werfen is a family-owned diagnostics company focused on specialized testing segments, 
with core operations built around several key business units including Instrumentation 
Laboratory (hemostasis and acute care), Biokit (immunodiagnostics), and Inova Diagnostics 
(autoimmunity). Instrumentation Laboratory, headquartered in Bedford, Massachusetts, 
serves as the primary R&D, manufacturing, and commercial engine for hemostasis and blood 
gas testing, while Biokit, based in Spain, develops and supplies reagents, and Inova 
Diagnostics, based in San Diego, focuses on autoimmune disease diagnostics. The company 
operates globally with a direct presence in approximately 30 countries and distribution in 
more than 100 territories, employing close to 7,000 people, with manufacturing and research 
activities concentrated in the United States and Europe. 
Werfen generated approximately €2.13 billion in revenue in 2025, down from €2.2 billion in 
2024, reflecting continued underlying growth despite some regional market pressures. 
Revenues are driven by its core segments: hemostasis, acute care diagnostics, and 
autoimmunity, with strength in North America and other key markets. There is a slower 
demand in certain parts of Asia. Across its installed base, Werfen systems and reagents 
continue to process well over a million patient samples per day globally. 
Hemostasis remains the company’s largest business line, supported by its ACL TOP family 
of coagulation analyzers, which continues to expand through ongoing menu development 
and system enhancements. The segment generated roughly €699 million in 2025, driven by 
reagent utilization and analyzer placements. Werfen maintains a strong position in 
specialized coagulation diagnostics, particularly in hospital-based and high-throughput 

 
 
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settings, while expanding its assay menu in areas such as thrombosis risk and anticoagulant 
monitoring. 
In acute care diagnostics, Werfen has strengthened its position in blood gas testing with the 
rollout of the GEM Premier 7000 platform featuring iQM3 intelligent quality management. 
This system represents an advancement in point-of-care blood gas testing, incorporating real-
time quality control and improved detection of pre-analytical issues such as hemolysis. The 
GEM Premier 7000 was launched in the United States in 2024 and expanded into Europe in 
2025, with continued rollout underway. The acute care segment generated approximately 
€649 million in 2025 and continues to grow across all regions outside China. The company 
is placing increasing emphasis on connectivity and data integration, with iQM3 positioned 
as a key differentiator in improving workflow efficiency and reducing errors at the point of 
care. 
In autoimmunity, Inova Diagnostics offers its BIO-FLASH chemiluminescent platform and 
the Aptiva system, which utilizes particle-based multi-analyte technology for autoimmune 
testing. The segment generated approximately €192 million in 2025, achieving 8% growth 
as laboratories shift toward fully automated, random-access systems and multiplex testing 
approaches. Werfen continues to offer assays for conditions such as antiphospholipid 
syndrome, including IgG and IgM antibody testing, while benefiting from broader trends 
toward earlier and more precise diagnosis of autoimmune diseases. 
 Werfen has expanded beyond traditional immunoassay and coagulation testing with the 
acquisition of Omixon, strengthening its position in transplant diagnostics and next-
generation sequencing-based HLA typing. This adds a molecular component to its portfolio 
and is expected to become more important as integration progresses. The company is focused 
on increasing product launches, expanding installed-base utilization, and advancing its 
capabilities in connectivity, automation, and molecular diagnostics.  

 
 
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Chapter 15: Company Profiles: The Second 
Tier 
Scope 
In this section, Kalorama has selected a group of companies that have demonstrated 
longevity, market penetration, and/or contributed important innovations in IVD. The 
profiles are not intended to be comprehensive reviews or histories of the companies 
included in this section, and are listed alphabetically. 
                                        

 
 
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ARKRAY 
Kyoto, Japan 
www.ARKRAY.co.jp/english 
ARKRAY, Inc. was founded in 1960 and has established presence in the global diagnostic 
industry, particularly in diabetes care and clinical laboratory testing. The company develops 
and manufactures a broad range of diagnostic and monitoring solutions, including automated 
systems for urinalysis, HbA1c testing, and clinical chemistry, along with associated reagents 
and consumables. ARKRAY is recognized for early innovation in diabetes diagnostics, 
including the introduction of the EYETONE system in 1971, one of the first portable blood 
glucose analyzers, and the development of an HbA1c analyzer based on HPLC technology 
in the early 1980s. The company remains a significant global supplier of glucose monitoring 
systems, with a strong presence in both professional and self-testing markets. 
ARKRAY has expanded its international footprint, with commercial operations across 
Europe, including offices in Italy, Spain, Portugal, the United Kingdom, and Belgium, and a 
manufacturing facility in Ireland that supports regional distribution and production. In 
clinical diagnostics, ARKRAY markets fully automated urine analyzers and sediment 
analysis systems, as well as dry-chemistry analyzers designed for small- to mid-sized 
laboratories and decentralized testing environments. The company has also strengthened its 
portfolio in HbA1c testing with both laboratory-based and point-of-care systems, supporting 
diabetes management across care settings. 
Updates reflect ongoing operational and portfolio alignment rather than major product 
platform shifts. In 2025, ARKRAY America implemented a labeling update associated with 
the relocation of its U.S. operations office, representing an administrative change without 
impact on product performance or regulatory status 
Dry Chemistry / Immunoassays 
ARKRAY, Inc. has a presence in decentralized clinical chemistry, with its SPOTCHEM 
series of dry-chemistry analyzers supporting near-patient and small-laboratory testing since 
the late 1980s. The SPOTCHEM EZ remains a compact, portable, CLIA-waived benchtop 
chemistry analyzer designed for rapid testing in physician offices and clinics. Utilizing dry 

 
 
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chemistry technology, the system supports flexible testing with panels, single assays, or 
combinations, and accommodates whole blood, serum, or plasma samples. It features 
automated calibration via magnetic card, minimal operator intervention, and walk-away 
operation, eliminating the need for sample pre-treatment. The test menu continues to focus 
on routine chemistry and lipid testing, with a defined panel structure suited to point-of-care 
environments and has been incrementally expanded with additional multi-analyte reagent 
strips targeting liver, renal, and metabolic testing. 
In the United States, ARKRAY’s SPOTCHEM platform is available with CLIA-waived 
testing for lipid panels and general chemistry, while additional moderately complex assays 
extend its capabilities to diabetes-related markers, calcium, proteins, and enzymes, enabling 
broader use in physician office laboratories and decentralized settings. The company also 
offers the SPOTCHEM EL system, which applies similar dry-chemistry principles in 
specialized and veterinary settings, further broadening the platform's reach. Complementing 
its hardware, ARKRAY has continued to enhance connectivity and workflow integration, 
including compatibility with laboratory information systems and simplified data 
management, to support efficient operations in small- and mid-sized clinical environments. 
ARKRAY has continued to refine its dry chemistry offering with updates such as the 
SPOTCHEM D-00 QR, an evolution of the SPOTCHEM D-Concept system. This platform 
integrates dry chemistry with immunoassay measurement capabilities and is configured as a 
modular system comprising a central operating unit and interchangeable measurement 
modules for immunology, biochemistry (including electrolytes), and centrifuge-based 
processing. The SPOTCHEM D-Concept platform remains differentiated by its modular 
design and ability to combine multiple testing modalities within a compact footprint, 
enabling primary screening for kidney function, liver function, metabolic conditions, and 
lifestyle-related diseases through flexible reagent configurations.  
Urinalysis 
ARKRAY, Inc. has a long history in urinalysis dating back to the early 1970s, when it 
introduced one of the first automated urine analyzers in urine chemistry and sediment 
analysis. Since that time, the company has steadily expanded its urinalysis portfolio to 
include fully automated urine chemistry analyzers, test strips, sediment analysis systems, and 
data management solutions. ARKRAY’s development efforts focus on improving laboratory 

 
 
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efficiency, automation, and clinical utility, particularly for the early detection and monitoring 
of kidney disease and metabolic disorders. 
The AUTION ELEVEN series is a main component of ARKRAY’s urine chemistry offering, 
with systems such as the AE-4021 and AE-4022 providing compact, automated analysis for 
low- to mid-volume laboratories. These instruments offer a broad menu of urine dipstick 
tests, including advanced parameters enabled by test strips such as the Uriflet S 11UA, which 
allow measurement of albumin-to-creatinine and protein-to-creatinine ratios in addition to 
standard analytes. These capabilities enhance the clinical value of routine urinalysis by 
supporting early identification of chronic kidney disease and diabetic nephropathy and reflect 
continued expansion of multi-parameter strip offerings. 
ARKRAY has also advanced automation in pre-analytical and analytical workflows with 
systems such as the AUTION DISPENSER UD-9440, which automates sample handling 
processes including barcode identification, mixing, aliquoting, and labeling. This system 
integrates with high-throughput analyzers such as the AUTION MAX AX-4060 and AX-
4061, enabling seamless sample transport and continuous processing. The AUTION MAX 
series is central to ARKRAY’s high-volume urinalysis strategy, offering fully automated 
measurement of routine chemistry parameters, as well as proteinuria and microalbuminuria, 
with flexible sample handling, including small-volume and direct-cup analysis. 
In addition to chemistry-based urinalysis, ARKRAY has expanded its capabilities in 
automated urine sediment analysis through image-based systems such as the AUTION EYE 
AI-4510, which incorporates advanced digital imaging and AI-assisted particle recognition 
to improve standardization, reduce manual microscopy, and enhance workflow efficiency. 
This technology reflects the broader shift toward integrated urine chemistry and sediment 
analysis within a single automated workflow. 
ARKRAY’s collaboration with Beckman Coulter continues to support high-throughput 
laboratory solutions through the iQ Urinalysis Workcell, which combines ARKRAY’s 
AUTION MAX AX-4030 urine chemistry analyzer with Beckman Coulter’s digital flow 
morphology system. Offered in scalable configurations, the system enables automated 
particle classification and harmonized chemistry results across platforms. Together with 
standalone analyzers and integrated systems, ARKRAY now provides a comprehensive 
urinalysis ecosystem that spans pre-analytical automation, chemistry testing, and AI-enabled 
sediment analysis, with ongoing enhancements focused on workflow integration, expanded 
test parameters, and improved laboratory efficiency. 

 
 
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BGI Genomics (formerly Beijing Genome Institute) 
Shenzhen, China 
http://www.genomics.cn/en 
BGI Group (formerly Beijing Genomics Institute), with its publicly listed subsidiary BGI 
Genomics, is a global genomics organization headquartered in Shenzhen, China. Founded in 
1999 to participate in the Human Genome Project, the company has evolved into a major 
provider of sequencing services, clinical genomics, and bioinformatics solutions. BGI 
operates through a network of research, clinical, and service laboratories across China, 
Europe, Asia Pacific, and the United States, supporting applications in healthcare, population 
genomics, agriculture, and pharmaceutical research. Its mission focuses on advancing life 
sciences through large-scale genomics, technology development, and global scientific 
collaboration. 
BGI offers high-throughput sequencing and integrated multi-omics capabilities, supported 
by its proprietary sequencing platforms and bioinformatics infrastructure. Rather than relying 
on older Illumina-based systems, BGI has developed its own sequencing technologies 
through its affiliated platform-development arm, enabling scalable, cost-efficient genomic 
analysis. The company’s clinical diagnostics operations, often referred to as BGI Genomics 
or BGI Diagnostics, provide a broad range of testing services, including non-invasive 
prenatal testing, oncology testing, infectious disease detection, and genetic screening. These 
services are supported by centralized and regional laboratories, reflecting a global service 
model rather than reliance on a single high-capacity sequencing site. 
In recent years, BGI has expanded its focus to include clinical and public health applications, 
such as population-scale screening programs, oncology genomics, and infectious disease 
surveillance. The company continues to integrate sequencing, mass spectrometry, and data 
analytics to support precision medicine initiatives, while also maintaining activity in research 
and industrial applications, including agriculture and synthetic biology. While BGI has 
explored consumer-facing genomics services, its primary strategic direction is concentrated 
on clinical diagnostics, large-scale genomic projects, and partnerships with healthcare 
systems and governments.  

 
 
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MGI Tech Co., Limited, China 
MGI Tech Co., a subsidiary of BGI Group, develops and manufactures sequencing 
instruments, consumables, and reagents designed to support life science research, clinical 
diagnostics, and population genomics. The company’s technology platform provides its 
proprietary DNBSEQ sequencing technology, which enables high-throughput, cost-efficient 
genomic analysis. As the instrumentation arm of BGI, MGI focuses on providing integrated 
sequencing solutions, including automated sample-preparation systems, sequencing 
platforms, and associated reagents, to support applications across healthcare, agriculture, and 
environmental research. MGI’s current product portfolio offers its DNBSEQ and 
CycloneSEQ platforms, which have largely superseded earlier BGISEQ systems. Key 
instruments include mid- to high-throughput sequencers, such as the MGISEQ-2000 series, 
and high-output systems, such as the DNBSEQ-T7, designed for large-scale genomic 
projects and clinical sequencing applications. More recently, MGI introduced the DNBSEQ-
T1+ sequencer, a flexible platform featuring multiple flow cell formats and lane 
configurations to support a wide range of throughput requirements. These systems are 
supported by advances in sequencing chemistry, including HotMPS and CoolMPS 
technologies, which are designed to improve accuracy, reduce duplication rates, and enable 
PCR-free workflows.  
In addition to instrumentation, MGI has expanded its portfolio of targeted sequencing 
solutions and workflow packages. Additional offerings include ATOPlex-based assays for 
infectious disease applications, such as dengue virus and multipathogen panels, as well as 
whole-genome sequencing solutions for microbial isolates that are compatible with newer 
sequencing platforms. The company also offers clinical applications such as circulating 
tumor DNA and minimal residual disease analysis in oncology, reflecting the growing 
importance of liquid biopsy and precision medicine 
Prenatal Testing 
 Founded in 2007, BGI Diagnostics focuses on applying genomic technologies to clinical 
practice, with an emphasis on reproductive health, disease prevention, and precision 
medicine. The company is widely recognized for its leadership in non-invasive prenatal 
testing (NIPT), particularly through its NIFTY test, which uses cell-free DNA sequencing to 
screen for common fetal chromosomal abnormalities such as trisomies 21, 18, and 13 from 
early pregnancy. Over time, the NIFTY test has evolved into a broadly adopted screening 

 
 
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solution with expanded capabilities, including detection of sex chromosome aneuploidies, 
selected microdeletions and microduplications, and, in some markets, more comprehensive 
genome-wide screening options. In addition to its core NIPT offering, BGI Diagnostics has 
expanded its reproductive genomics portfolio to include carrier screening, preimplantation 
genetic testing, and other prenatal and neonatal genetic services, reflecting a more integrated 
approach to reproductive health. 
Test Services 
The following are representative examples of the test services offered by BGI Group. The 
company has processed large volumes of clinical samples globally across a range of 
applications, including noninvasive prenatal testing, human papillomavirus screening, 
newborn screening, hearing impairment testing, and rare disease analysis. BGI has 
established itself as a high-throughput service provider, leveraging large-scale sequencing 
infrastructure to deliver cost-efficient genomic testing across diverse clinical and public 
health programs. 
BGI provides its proprietary sequencing platforms and a global laboratory network, enabling 
the company to offer whole-genome sequencing, targeted sequencing, and population-scale 
genomic analysis. The company continues to pursue cost reduction strategies and high-
volume sequencing capabilities, with long-term goals of making genomic sequencing more 
accessible and affordable for routine clinical use. Rather than focusing on earlier-generation 
platforms, BGI emphasizes its DNBSEQ-based technologies to support scalable sequencing 
services.  
BGI Genomics has established multiple collaborations with healthcare providers, research 
institutions, and industry partners to expand the use of genomic testing in oncology, 
reproductive health, and precision medicine. These partnerships include efforts to apply 
whole genome sequencing and advanced analytics to improve cancer treatment selection, 
support immunotherapy response prediction, and enable personalized healthcare approaches. 
The company is also active in expanding reproductive health services and integrating 
genomic technologies into broader clinical workflows. 
In addition to large-scale sequencing services, BGI has developed targeted testing panels 
such as hereditary cancer assays, which are designed to identify germline variants across 
multiple cancer-associated genes. These offerings are supported by high-throughput 
sequencing platforms and bioinformatics pipelines that enable comprehensive genomic 

 
 
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profiling. BGI continues to expand its presence in precision medicine and public health 
initiatives, including collaborations focused on population genomics and data-driven 
healthcare.  
Whole Genome Sequencing (WGS) 
BGI Genomics has expanded its capabilities in clinical whole-genome sequencing through 
collaborations with diagnostic and bioinformatics partners to improve the analysis, 
interpretation, and reporting of genomic data. These efforts combine BGI’s proprietary 
DNBSEQ sequencing technology with advanced bioinformatics pipelines to support the 
diagnosis of genetic disorders and enable broader adoption of whole-genome sequencing in 
clinical settings. The company’s strategy emphasizes integration of sequencing, artificial 
intelligence, and cloud-based computing to deliver scalable and clinically actionable 
genomic insights.  
BGI has pursued long-term initiatives to reduce sequencing costs and turnaround times, 
focusing on high-throughput whole-genome sequencing supported by advanced computing 
infrastructure. These efforts have evolved into increasingly standardized clinical sequencing 
workflows that support both diagnostic applications and large-scale genomic programs. BGI 
Genomics has developed a range of clinical sequencing-based assays, including tests for 
hereditary conditions and oncology applications. These include homologous recombination 
deficiency detection assays used to support treatment decisions in cancer patients, as well as 
genetic testing panels for inherited disorders such as thalassemia. The company is also 
expanding its oncology portfolio into circulating tumor DNA and minimal residual disease 
applications, as well as targeted sequencing panels for infectious disease detection and public 
health surveillance.  
NGS Sequencing 
BGI Genomics offers its infectious disease and genetic testing portfolio through sequencing-
based diagnostic solutions. The company has introduced metagenomic next-generation 
sequencing tools, such as GPMeta, designed to detect a broad range of pathogens directly 
from clinical samples by analyzing complex sequencing data. These solutions enable 
comprehensive identification of bacteria, viruses, fungi, and other microorganisms, 
supporting clinical microbiology, particularly in cases where conventional methods are 
inconclusive, and are increasingly applied in areas such as sepsis, respiratory infections, and 

 
 
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central nervous system infections. BGI has also expanded targeted sequencing approaches 
for multi-pathogen detection and public health surveillance, supporting rapid response to 
infectious disease outbreaks. 
In addition to infectious disease diagnostics, BGI offers a range of reproductive and genetic 
screening services, including its VISTA Carrier Screening program, which uses next-
generation sequencing to identify individuals or couples at risk of passing on inherited 
genetic conditions. The panel has been expanded to include a large number of genes 
associated with rare disorders and is increasingly positioned alongside broader reproductive 
genomics services. 
BGI has also developed pathogen detection workflows, such as PMseq, designed for rapid, 
sensitive identification of infectious agents across a variety of clinical sample types. These 
tools are being increasingly used in clinical and public health settings, including outbreak 
surveillance and epidemiological monitoring, where rapid and unbiased pathogen detection 
is critical.  

 
 
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Biocartis 
Mechelen, Belgium 
www.biocartis.com 
Biocartis’ flagship Idylla platform is a fully automated, cartridge-based molecular 
diagnostics system designed to process a wide range of biological samples in decentralized 
laboratory settings. The platform integrates sample preparation, nucleic acid extraction, 
amplification, and detection into a single workflow, enabling results in approximately 35 to 
150 minutes with minimal hands-on time. Idylla assays are compatible with formalin-fixed, 
paraffin-embedded (FFPE) tissue and other tumor sample types through onboard liquefaction 
and lysis, and support both DNA and RNA analysis. The system’s compact footprint, ease of 
use, and rapid turnaround time make it well-suited for near-patient and routine pathology 
laboratory environments. 
Biocartis offers a growing menu of molecular assays on the Idylla platform, primarily 
focused on oncology, with additional applications in infectious disease. The oncology 
portfolio includes assays for clinically actionable biomarkers such as EGFR, KRAS, NRAS, 
and BRAF, as well as microsatellite instability (MSI) testing. The Idylla MSI test has 
received regulatory clearance and provides a rapid assessment of MSI status directly from 
tumor tissue. The company has also expanded into liquid biopsy with assays targeting 
circulating tumor DNA, including EGFR mutation detection. 
Recent product development has focused on expanding menu flexibility and oncology 
coverage. The Idylla FLEX technology enables separation of assay-specific reagents from 
core system components, supporting faster development and broader test menus. Using this 
approach, Biocartis offers assays such as the Idylla IDH1-2 Mutation Assay and is expanding 
into breast cancer testing with panels targeting biomarkers including PIK3CA and AKT1, as 
well as gene expression–based subtyping assays. The Idylla GeneFusion Panel supports the 
detection of key gene fusions relevant to non-small cell lung cancer, including ALK, ROS1, 
and MET alterations. 
Biocartis continues to advance its companion diagnostics strategy through collaborations 
with pharmaceutical partners and the development of regulatory-cleared assays. In 2025, the 
company achieved CE marking for its EGFR Mutation Test as a Class C companion 

 
 
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diagnostic, supporting targeted therapy selection in non-small cell lung cancer. Additional 
partnerships and assay development efforts are focused on expanding biomarker testing 
across oncology indications and enabling rapid, decentralized access to molecular 
diagnostics.  
Biocartis offers Idylla CDx MSI Test, which is designed to identify eligible microsatellite 
instability-high colorectal cancer patients who may benefit from treatment with Opdivo. The 
test is run on the Idylla platform and qualitatively detects a panel of seven monomorphic 
biomarkers to detect MSI in a CRC tissue sample. The test runs in a single-use cartridge and 
provides results in about 3 hours.   

 
 
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Diagnostica Stago S.A.S. 
Asnières sur Seine, France 
www.stago.com 
Founded in 1945 and focused exclusively on hemostasis for decades, Diagnostica Stago has 
built a comprehensive portfolio of coagulation diagnostics spanning routine and specialized 
testing. The company offers a broad range of reagents, analyzers, and software solutions 
designed to support clinical laboratories of all sizes, from basic PT/INR testing to advanced 
hemostasis investigations. Stago operates globally through an extensive commercial network 
and affiliated entities, with capabilities that include coagulation testing, platelet function 
analysis, and thrombin generation assays. 
Stago’s product portfolio includes the STA series of hemostasis analyzers, with its latest Max 
Generation 3 systems, including the STA R Max 3 and STA Compact Max 3, representing 
the company’s flagship platforms for high-throughput and mid-sized laboratories. These 
systems incorporate advanced automation, enhanced sample integrity checks such as 
detection of hemolysis, icterus, and lipemia, and full connectivity to laboratory automation 
systems, supporting efficient and standardized workflows.  Stago also provides the ST hemO 
range of analyzers, including the ST hemO 301 for higher-throughput laboratories and the 
ST hemO 201 for smaller laboratories, expanding its offering across different laboratory 
segments. 
Stago markets an extensive menu of reagents for coagulation and anticoagulant monitoring, 
including assays designed to support the management of direct oral anticoagulants and other 
newer therapeutics that are not adequately monitored by traditional PT/INR testing. The 
company continues to expand its specialty testing capabilities through innovations such as 
thrombin generation assays, supported by systems such as ST Genesia, and new reagent kits 
aimed at assessing thrombosis risk in specific patient populations. Stago is enhancing its 
offering with workflow optimization and laboratory support solutions designed to improve 
efficiency and standardization in hemostasis testing. 
Through its acquisition of HemoSonics, Stago entered the point-of-care hemostasis market 
with viscoelastic testing technology, including the Quantra Hemostasis Analyzer, which is 
used for rapid assessment of coagulation status in critical care and surgical settings.  

 
 
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Diasorin S.p.A 
Saluggia, Italy 
www.Diasorin.com 
Diasorin has established a long-standing position in the immunodiagnostics market, with 
over five decades of experience developing and commercializing specialty diagnostic tests 
for clinical laboratories. The company continues to expand beyond its traditional 
immunoassay base into molecular diagnostics and decentralized testing, reflecting broader 
industry trends toward integrated and near-patient solutions. In recent years, Diasorin has 
strengthened its menu through targeted partnerships and internal development, including the 
LIAISON MR-proADM chemiluminescent immunoassay, which assesses infection severity 
and sepsis risk, and a collaboration with Gilead Sciences to develop a fully automated 
hepatitis D assay for the LIAISON XL platform. 
POC 
A significant strategic shift has been Diasorin’s entry into the molecular point-of-care market 
with the LIAISON NES platform, a next-generation system designed to deliver rapid, near-
patient molecular testing with simplified workflow. By 2026, commercialization has 
expanded through distribution agreements, supporting broader access to the platform and its 
initial multiplex respiratory panel for detecting influenza A/B, RSV, and SARS-CoV-2. 
Diasorin continues to build out its molecular portfolio by expanding the LIAISON PLEX 
system, which enables flexible, multiplex syndromic testing. In addition to respiratory 
panels, the platform now includes blood culture assays targeting gram-negative bacteria and 
yeast pathogens, along with associated resistance markers, strengthening its role in sepsis 
and critical care diagnostics. 
Immunoassays 
Diasorin maintains a broad immunoassay portfolio with more than 100 assays spanning 
infectious disease, endocrinology, oncology, cardiovascular markers, and autoimmune 
conditions. The LIAISON analyzer family remains central to its business, offering fully 
automated chemiluminescent testing in a closed-system format. Recent menu additions, 

 
 
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including Streptococcus pneumoniae urinary antigen testing and ongoing Lyme disease assay 
development, further strengthen its infectious disease offering. Overall, Diasorin’s strategy 
through 2026 reflects a transition toward a balanced portfolio that combines high-throughput 
immunoassays, advanced multiplex molecular diagnostics, and emerging point-of-care 
solutions, with a strong focus on infectious diseases, syndromic testing, and rapid diagnostics 
that support clinical decision-making in both centralized and decentralized care settings. 
Diasorin offers the LIAISON QuantiFERRON-TB-Gold Plus II assay through its partnership 
with QIAGEN. The LIAISON QuantiFERRON-TB Gold Plus assay is a next-generation 
automated Interferon Gamma Release Assay designed to increase productivity and workflow 
efficiency, providing a 25% faster turnaround time than the previous-generation assay. The 
new assay enables labs to test up to 75% more patients per hour.  
Molecular 
The company has also expanded its direct molecular testing capabilities through the Simplexa 
platform, including the addition of the Simplexa C. auris Direct assay for rapid detection of 
this emerging multidrug-resistant fungal pathogen. This complements a broader menu of 
assays for respiratory infections, congenital CMV, and other infectious diseases, all designed 
to streamline workflow by eliminating the need for separate nucleic acid extraction. Diasorin 
also continues to advance host-response diagnostics through the LIAISON MeMed BV test, 
which helps differentiate bacterial from viral infections and supports more informed 
treatment decisions. The LIAISON PLEX Gram-Negative Blood Culture Assay detects 27 
targets, including 19 gram-negative bacteria and 8 resistance gene targets.  
Molecular Oncology 
Diasorin offers CE-IVD molecular diagnostic assays for hematologic oncology, including 
tests designed to detect key genetic abnormalities associated with acute myeloid leukemia. 
These include assays targeting common translocations such as AML1-ETO, CBFB-MYH11, 
BCR-ABL, and PML-RARA, which are used to support rapid molecular characterization at 
diagnosis. These assays are designed to provide streamlined workflows and relatively fast 
turnaround times compared to traditional molecular methods, enabling earlier clinical 
decision-making in acute leukemia management 
 

 
 
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Eiken Chemical Co., Ltd 
Tokyo, Japan  
www.eiken.co.jp/en/  
Eiken Chemical’s goal is to establish itself as a leader in the clinical diagnostics market by 
developing molecular diagnostics.  Its products are used primarily in the diagnosis and 
treatment of microbial infections.  Eiken plans to expand into Europe, the U.S., Australia, 
and Latin America.   
Eiken Chemical is a long-established diagnostics company with a portfolio spanning fecal 
testing, urinalysis, microbiology media, and molecular diagnostics. While the company 
offers a range of immunoassay and screening products, its most significant contribution to 
the in vitro diagnostics market has been the development and commercialization of loop-
mediated isothermal amplification (LAMP) technology, which enables rapid, sensitive 
molecular testing without complex thermal cycling. Eiken markets a broad menu of LAMP-
based assays under its Loopamp brand, targeting infectious diseases such as tuberculosis, 
gastrointestinal pathogens, sexually transmitted infections, and respiratory viruses. These 
assays are used in both centralized laboratories and decentralized settings, particularly in 
regions that require rapid, simplified molecular testing, and continue to expand through 
global health initiatives and infectious disease applications. 
Eiken maintains a strong global presence in fecal testing through its OC-Sensor series of 
automated analyzers and OC-Auto reagents for fecal immunochemical testing. More recent 
systems, including the OC-SENSOR Ceres and higher-throughput platforms such as OC-
SENSOR PLEDIA, support multi-parameter stool analysis, including hemoglobin and 
inflammatory markers such as calprotectin, enabling broader use in colorectal cancer 
screening and gastrointestinal disease management. These systems are widely used in 
population screening programs and continue to improve workflow efficiency and test 
integration.  
 

 
 
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Fujirebio Diagnostics, Inc. 
Malvern, PA 
www.fdi.com 
Fujirebio Diagnostics, a subsidiary of H.U. Group Holdings, is a global provider of in vitro 
diagnostics with a strong focus on immunoassays, molecular diagnostics, and biomarker 
development. The company has built a broad portfolio through internal development and 
strategic acquisitions, with particular strength in specialty diagnostics areas such as 
oncology, infectious disease, fertility, and neurodegenerative disorders. Its flagship 
LUMIPULSE platform, based on chemiluminescent enzyme immunoassay technology, 
supports a wide range of automated immunoassay testing in clinical laboratories worldwide. 
Fujirebio is widely recognized for its leadership in biomarker development, particularly in 
neurodegenerative disease diagnostics. A major recent advancement is the marketing of the 
LUMIPULSE G pTau 217/β-Amyloid 1-42 Plasma Ratio test, the first FDA-cleared blood-
based in vitro diagnostic test to aid in the identification of amyloid pathology associated with 
Alzheimer’s disease. This test enables less invasive assessment using a simple blood draw 
and represents a significant step forward in early diagnosis and patient management. The 
company has further expanded its neuro portfolio with additional assays targeting pTau217 
in both plasma and cerebrospinal fluid, supporting earlier and more accurate detection of 
Alzheimer’s disease and differentiation from other dementias. 
The LUMIPULSE system has expanded the company’s assay menu across disease areas. 
Developments include assays targeting cardiac markers, infectious diseases, fertility 
hormones, and metabolic disorders, as well as an expanding range of neurological biomarkers 
such as β-amyloid, tau proteins, and neurofilament light. The company continues to 
strengthen its capabilities through collaborations focused on biomarker discovery and assay 
development. 
The LUMIPULSE G NfL blood assay is a relatively recent addition to the company’s 
automated immunoassay menu for neurological biomarkers. The assay was first introduced 
around 2023 in a research and early-evaluation setting as part of the growing use of blood-
based markers for neurodegenerative disease and brain injury. 

 
 
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Its transition into the clinical diagnostics market occurred in 2026, when the test became 
available in Europe as a CE-marked assay on the LUMIPULSE G platform. This marked an 
important step, moving the test from research use into routine laboratory settings, particularly 
in regions adopting blood-based neurology testing. 
The assay measures neurofilament light chain (NfL) in blood, which reflects neuroaxonal 
damage and is being used to support evaluation and monitoring of conditions such as 
Alzheimer’s disease, multiple sclerosis, and other neurological disorders. Its main advantage 
is that it allows testing from a simple blood sample rather than cerebrospinal fluid, making it 
easier to integrate into routine clinical workflows. 
As of 2026, the LUMIPULSE G NfL blood assay is considered a new clinical product, with 
growing adoption in Europe and ongoing expansion of Fujirebio’s broader neurology menu, 
which includes additional blood-based biomarkers for neurodegenerative disease. 

 
 
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Fulgent Genetics, Inc 
El Monte, CA  
www.fulgentgenetics.com 
Fulgent was founded in 2011 and has developed an impressive line of tests and services. The 
company developed a proprietary technology platform that allows it to offer a flexible test 
menu that can be expanded. The company combines NGS with its technology platform to 
perform full-gene sequencing and deletion analysis in a single test.   
Fulgent Genetics offers molecular diagnostic testing services across infectious disease, 
reproductive health, and oncology. The company introduced testing solutions for emerging 
infectious diseases, including orthopoxvirus detection, supporting public health response 
efforts. In reproductive genetics, Fulgent launched its Beacon expanded carrier screening 
panel, which analyzes hundreds of genes associated with autosomal recessive and X-linked 
conditions, reflecting growing demand for comprehensive carrier screening. 
Fulgent has also strengthened its position in oncology and hereditary disease testing through 
strategic partnerships and contract awards. The company secured agreements to provide 
hereditary cancer and genetic testing services to large healthcare networks, including 
government-related programs, supporting broader access to genomic testing. In addition, 
Fulgent has partnered with pharmaceutical and diagnostics companies to support the 
commercialization of germline cancer testing panels, enabling analysis of clinically relevant 
genetic variants associated with hereditary cancer risk. 
The company continues to advance its testing capabilities through its proprietary sequencing 
and bioinformatics platform, including exome-based testing and integrated data analysis 
solutions. These services support the detection of single-nucleotide variants, copy number 
variations, and other genomic alterations across a range of clinical applications.  
 

 
 
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GeneDx 
www.genedx.com 
GeneDx is a genomic diagnostics company focused on translating complex genetic data into 
clinically actionable insights, with a strong emphasis on rare and pediatric diseases. The 
company offers a broad portfolio spanning whole-genome sequencing, whole-exome 
sequencing, and targeted gene panels, supported by curated variant databases and advanced 
interpretation capabilities.  
GeneDx has shifted its strategy toward exome and genome sequencing as first-line tests, 
particularly in neonatal and pediatric intensive care settings where rapid diagnosis can 
significantly impact clinical management. The company has built one of the largest rare-
disease genomic datasets, which it uses to improve diagnostic yield, variant interpretation, 
and reanalysis over time. GeneDx has also expanded its collaborations with health systems 
and research networks, supporting earlier diagnosis and more precise treatment pathways, 
while increasingly positioning itself as both a diagnostics provider and a data-driven 
precision medicine company. 
 
 

 
 
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Grifols S.A. 
Barcelona, Spain 
www.grifols.com 
Grifols operates as a global healthcare company with core business areas focused on 
Biopharma, Diagnostic, Bio Supplies, and contract manufacturing and services, marketing 
its products in more than 100 countries. The company is a leading producer of plasma-derived 
therapeutics and maintains a strong position in transfusion medicine and in vitro diagnostics. 
Grifols’ Diagnostic division provides a broad portfolio of products for laboratory analysis, 
including blood typing, antibody detection, coagulation testing, and automated immunoassay 
systems, as well as reagents and instrumentation for hospital blood banks and transfusion 
centers. 
Grifols is particularly well established in transfusion medicine, where its product portfolio 
includes nucleic acid amplification testing (NAT) systems for detecting infectious agents in 
blood and plasma donations, as well as solutions for immunohematology and molecular 
blood group typing. These technologies support blood safety by enabling sensitive detection 
of viral pathogens and accurate donor–recipient matching. The company continues to expand 
its molecular testing capabilities in transfusion diagnostics, reinforcing its leadership in blood 
screening and compatibility testing. 
In clinical diagnostics, Grifols offers assays for infectious diseases, autoimmune conditions, 
and specialized therapeutic monitoring, including immunoassay-based and molecular testing 
solutions. The company is also expanding its presence in select areas of personalized 
medicine, particularly in monitoring patients receiving biologic therapies. Additionally,  
Grifols provides specialized clinical laboratory services that integrate molecular and 
proteomic diagnostics to support disease diagnosis, prognosis, and treatment monitoring. 
Blood Transfusion Business 
Grifols expanded its position in molecular blood screening through its longstanding 
partnership with Hologic, ultimately assuming full control of the Procleix diagnostic 
business, including customer service, manufacturing, and product development activities. 
This acquisition strengthened Grifols’ capabilities in nucleic acid amplification testing for 

 
 
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transfusion and transplantation screening and included manufacturing facilities, intellectual 
property rights, and access to key technologies. As a result, Grifols has established a leading 
position in molecular blood screening, with Procleix systems widely used by blood centers 
globally to test donations for major transfusion-transmissible infections. 
The Procleix platform, based on the fully automated PANTHER system, supports high-
throughput, sensitive detection of viral pathogens, including HIV, hepatitis B and C, and 
other emerging infectious agents. The system is widely used in large-scale blood screening 
programs and continues to expand its test menu to address evolving transfusion safety needs. 
Grifols has introduced a range of NAT assays on this platform, including tests for West Nile 
virus, Zika virus, Babesia, and malaria, enabling the detection of pathogens that may not be 
identified through traditional serological screening. 
Grifols has expanded its molecular screening portfolio with multiplex assays, such as the 
Procleix ArboPlex test, which simultaneously detects multiple arboviruses in a single run, 
improving efficiency and throughput in blood screening laboratories. These developments 
reflect a broader shift toward multiplex NAT testing and enhanced preparedness for emerging 
infectious diseases.  
ABO Blood Typing 
 The ABO blood group system classifies human blood based on the presence or absence of 
A and B antigens on the surface of red blood cells. Individuals are categorized as type A, B, 
AB, or O depending on these antigenic properties. First described by Karl Landsteiner in 
1901, the ABO system remains the foundation of transfusion medicine, as it is critical for 
determining compatibility between donor and recipient blood. ABO typing, along with 
antibody screening, forms the basis of pre-transfusion testing and has traditionally been 
performed using manual serological methods, although automation has become increasingly 
common in modern laboratories. 
Grifols offers an immunohematology portfolio through the development and 
commercialization of reagents and automated systems designed for both routine and complex 
blood typing. The company offers a range of antisera reagents and gel card–based 
technologies that support accurate blood grouping and antibody detection in clinical 
laboratories. These products are widely used in transfusion services and blood banks to 
ensure safe and compatible blood transfusions, with ongoing expansion of reagent menus to 
support the detection of rare blood group antibodies and complex cases. 

 
 
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Grifols has also advanced automation in immunohematology with systems such as the Erytra 
Eflexis and Wadiana analyzers, which are designed for pre-transfusion compatibility testing 
using DG Gel technology. These automated platforms improve workflow efficiency, 
standardization, and throughput in blood bank laboratories by integrating sample processing, 
testing, and result interpretation. Recent developments emphasize enhanced connectivity 
with laboratory information systems, improved traceability, and scalability for high-volume 
blood centers and centralized testing environments. The company continues to expand the 
global availability of these systems, including growth in Asia and other emerging markets. 
Molecular ABO Blood Typing 
Serological blood grouping involves testing a blood sample to detect the presence or absence 
of clinically significant blood group antigens on red blood cells. This approach is the standard 
method for routine blood typing and compatibility testing. However, serological results can 
be difficult to interpret in certain patients due to the presence of alloantibodies or 
autoantibodies arising from prior transfusions, pregnancies, or underlying medical 
conditions, complicating antibody identification in complex cases. 
Molecular blood grouping, or genotyping, augments serological testing by analyzing DNA 
to predict blood group antigen profiles. This approach enables more precise identification of 
both common and rare blood group variants and supports improved donor–recipient 
matching, particularly in patients requiring chronic transfusion support, such as those with 
sickle cell disease, thalassemia, or oncology-related anemia. Molecular typing is increasingly 
used in both patient care and donor screening programs to enable extended antigen matching 
and identification of rare donors. 
Grifols has expanded its molecular immunohematology portfolio with assays such as the ID 
Core XT and ID RHD XT, which genotype multiple blood group antigens beyond the ABO 
system. These assays support extended antigen profiling across clinically significant blood 
group systems, improving transfusion compatibility and reducing the risk of 
alloimmunization. The tests are used in both donor screening and patient testing and are 
integrated into laboratory workflows and reference laboratory services, including Grifols’ 
Immunohematology Center. 

 
 
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 Immunoassays 
Revenues in specialty diagnostics have remained stable, with growth expected as Grifols 
continues to expand its clinical diagnostics portfolio. The company’s PROMONITOR 
ELISA assays provide important information on drug levels and immunogenicity in patients 
receiving biologic therapies, particularly for chronic inflammatory diseases. These assays 
support therapeutic drug monitoring by helping clinicians assess treatment response, 
optimize dosing, and detect anti-drug antibodies. The PROMONITOR portfolio continues to 
expand to cover a broader range of biologic therapies, particularly in gastroenterology and 
autoimmune diseases, reflecting the increasing role of personalized medicine and targeted 
therapies in clinical practice. 
Through its subsidiary, Araclon Biotech, Grifols has also developed diagnostic assays 
targeting neurodegenerative diseases, including tests that quantify amyloid-beta biomarkers 
associated with Alzheimer’s disease. These assays measure Aβ40 and Aβ42 proteins using 
both immunoassay and mass spectrometry–based approaches and are intended to support 
early detection and research applications in Alzheimer’s disease. While these tests represent 
innovative developments in blood-based biomarker detection, their use remains primarily in 
specialized and emerging diagnostic settings. 

 
 
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Guardant Health, Inc. 
Redwood City, CA 
www.guardanthealth.com 
Guardant Health, founded in 2013, is a leading developer of liquid biopsy diagnostics based 
on proprietary digital sequencing technology. This approach uses molecular barcoding and 
advanced error-correction methods to enable highly sensitive detection of tumor-derived cell-
free DNA in blood samples. The technology offers comprehensive genomic profiling by 
identifying multiple classes of genomic alterations, including point mutations, insertions and 
deletions, fusions, and copy number changes, allowing for non-invasive tumor 
characterization and disease monitoring. 
The company’s flagship product, Guardant360, is a blood-based comprehensive genomic 
profiling test used to guide treatment selection and monitor disease progression in patients 
with advanced solid tumors. The test has evolved with expanded biomarker identification 
and cancer subtyping capabilities, improving clinical decision-making. Guardant360 is 
complemented by tissue-based profiling solutions, including Guardant360 Tissue and 
TissueNext, with multiomic approaches integrating DNA, RNA, methylation, and protein 
expression data to provide more comprehensive tumor characterization. 
Guardant Health offers Guardant360 CDx as a companion diagnostic to identify advanced 
breast cancer patients with ESR1 mutation who may benefit from Eli Lilly’s Inluriyo. 
Guardant’s CDx was approved in conjunction with Inluriyo for the treatment of patients with 
estrogen receptor-positive ESR1-mutated advanced or metastatic breast cancer.  
Guardant Health markets cancer screening and early detection with its Shield blood test for 
colorectal cancer, which has received regulatory approval as a primary screening option and 
achieved reimbursement milestones. The company also offers Guardant Reveal for minimal 
residual disease detection and recurrence monitoring, extending its portfolio across the 
cancer care continuum. 
More recently, Guardant has expanded into germline testing with the introduction of the 
Guardant Hereditary Cancer Test, a blood-based panel designed to identify inherited cancer 
risk. In addition, the company continues to enhance its platform capabilities through 

 
 
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integration of artificial intelligence and large-scale genomic datasets, supporting more 
advanced biomarker discovery and precision oncology applications. 

 
 
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Haemonetics 
Boston, Mass 
www.haemonetics.com 
Haemonetics, founded in 1971, is an established provider of blood and plasma collection 
technologies and hospital-based solutions that support transfusion medicine and critical care. 
The company operates across three primary segments, plasma, blood center, and hospital, 
reflecting its broad reach from donor collection through to patient care. Its portfolio includes 
systems designed to optimize plasma collection efficiency and quality, including the NexSys 
PCS Plasma Collection System with Persona technology, which enables more personalized 
donation protocols and helps increase average plasma yield while maintaining donor safety 
and consistency. 
In 2024, Haemonetics streamlined its portfolio by divesting its whole-blood product line to 
GVS S.p.A., allowing the company to focus more heavily on higher-growth, higher-margin 
areas such as plasma collection and hospital-based technologies. This shift aligns with 
ongoing global demand for plasma-derived therapies and the need for more efficient 
collection infrastructure. The company continues to invest in software, automation, and data-
driven collection tools that improve operational efficiency for plasma centers and enhance 
traceability and compliance. 
Haemonetics reported revenues of approximately $1.36 billion in 2025, representing 
moderate growth over 2024. Performance was largely driven by the hospital segment, 
supported by recent acquisitions and continued demand for technologies used in surgical 
blood management, cell salvage, and transfusion optimization. At the same time, the plasma 
segment remains a core growth engine, benefiting from sustained demand for 
immunoglobulins and other plasma-derived therapies, while blood center operations continue 
to provide stable, though more mature, revenue contributions.  

 
 
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Horiba  
Kyoto, Japan 
www.horiba.com  
The Horiba Group provides a broad range of analytical and measurement systems across 
multiple industries, including automotive, environmental monitoring, semiconductor 
manufacturing, and in vitro diagnostics. Within healthcare, Horiba Medical focuses on 
hematology and clinical chemistry solutions, offering analyzers, reagents, and associated 
laboratory systems. Hematology remains the company’s core business, accounting for the 
majority of its diagnostics revenue and supported by a global installed base of instruments 
and reagent contracts. 
Horiba’s diagnostic portfolio includes hematology analyzers, clinical chemistry systems, and 
supporting technologies for laboratory testing. The company has expanded its Yumizen 
product line, which serves laboratories of varying sizes with scalable and automated 
solutions. Recent additions include enhancements to the Yumizen H500 and H550 platforms, 
designed to deliver efficient workflows, continuous loading capabilities, and rapid 
turnaround times for routine hematology testing, as well as the integration of erythrocyte 
sedimentation rate estimation via VoRA technology. 
In clinical chemistry, Horiba offers analyzers such as the Yumizen C230, C240, and C560, 
paired with dedicated reagent systems to support routine and specialty testing. In hematology, 
the company has advanced its high-throughput capabilities with the HELO 2.0 platform, a 
modular, automation-ready solution designed for mid- to high-volume laboratories that 
supports integration into core laboratory workflows and connectivity with laboratory 
information systems. 
Horiba has also expanded its mid- to high-throughput hematology offering with systems such 
as the Yumizen H2500, as well as new variants within the Yumizen H500 series, including 
models with autoloading and open- and closed-tube configurations. These systems 
incorporate advanced parameters and workflow efficiencies to reduce manual intervention 
and improve turnaround time. 
 

 
 
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Menarini Diagnostics 
Florence, Italy 
www.menarinidiagnostics.com 
The Menarini Group, founded in 1886 and headquartered in Florence, Italy, is a global 
healthcare company with operations spanning pharmaceuticals, diagnostics, and biomedical 
measurement technologies. The group operates through an extensive international network 
of subsidiaries and partners across Europe and other global markets. A. Menarini 
Diagnostics, established in 1976, represents the group’s diagnostics division and focuses on 
laboratory and near-patient testing across multiple clinical areas, including diabetes, clinical 
chemistry, hematology, autoimmunity, and pathology. 
Menarini Diagnostics offers a broad portfolio of products through a combination of in-house 
development and strategic partnerships. Its products include blood glucose monitoring 
systems, HbA1c testing, clinical chemistry analyzers, hematology systems, urinalysis, and 
immunoassays. The company maintains a strong presence in diabetes diagnostics, with its 
GlucoMen line of blood glucose meters and continuous glucose monitoring solutions 
supporting both self-testing and connected care. Menarini’s strategy relies heavily on 
collaborations with diagnostic manufacturers to expand its product offering and geographic 
reach. 
In molecular diagnostics, Menarini has expanded its PRIME MDx platform, a sample-to-
result real-time PCR system that supports a growing menu of infectious disease assays, 
including respiratory panels. The platform is positioned for decentralized and routine 
laboratory use, enabling flexible processing of multiple sample types. The company has also 
entered into distribution and collaboration agreements to broaden its molecular testing 
portfolio, including point-of-care and syndromic testing solutions. 
Menarini has expanded into specialty diagnostics through partnerships, including 
collaborations in liquid biopsy and oncology. A key example is its agreement to 
commercialize epigenetic-based cancer detection assays, such as bladder cancer tests, that 
support non-invasive diagnosis and recurrence monitoring. 

 
 
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Meridian Bioscience, Inc. 
Cincinnati, OH 
www.meridianbioscience.com 
Meridian Bioscience is a life science company that develops, manufactures, and distributes 
diagnostic test kits, purified reagents, and biopharmaceutical components. The company has 
established strong positions in infectious disease diagnostics, particularly in gastrointestinal 
and respiratory infections, as well as in serology, parasitology, and fungal disease testing. 
Meridian’s products are used by hospitals, reference laboratories, research institutions, 
diagnostics manufacturers, and biotechnology companies in more than 60 countries. 
In addition to its diagnostics business, Meridian is a supplier of specialty biologicals and 
recombinant reagents used in drug discovery, vaccine development, and diagnostic assay 
production. The company’s life science segment provides critical raw materials, including 
antigens, antibodies, and proteins, supporting both research and commercial applications. 
Founded in 1977, Meridian has extensive experience in immunoassay-based diagnostics and 
offers a broad menu of assays for infectious diseases, including Clostridioides difficile, 
Escherichia coli Shiga toxin, and Helicobacter pylori. These tests are widely used in clinical 
laboratories to detect gastrointestinal pathogens and contribute to the company’s strong 
presence in this segment. 
Meridian expanded its diagnostics portfolio through the acquisition of Magellan Diagnostics, 
which develops and markets blood lead testing systems for use in point-of-care and 
laboratory settings. These systems support screening and monitoring of lead exposure in both 
pediatric and adult populations and are widely deployed in physician offices and clinical 
laboratories. 
The acquisition of EUPROTEIN enhanced Meridian’s capabilities in recombinant protein 
production, strengthening its position in life science reagents and enabling the development 
of advanced immunological components. Following its 2023 acquisition by SD Biosensor 
and its investment partners, Meridian has been integrated into a broader global diagnostics 
platform, supporting expanded geographic reach, manufacturing scale, and product 
development capabilities. 

 
 
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Meridian Bioscience has continued to expand its diagnostics portfolio, including 
immunoassays and molecular solutions. The company markets its Curian Shiga Toxin Assay, 
designed for use on the Curian analyzer platform. This assay is a rapid, qualitative fluorescent 
test that enables simultaneous detection and differentiation of Shiga toxins, thereby 
improving the diagnosis of gastrointestinal infections. Meridian also offers its Premier HpSA 
FLEX assay, a non-invasive enzyme immunoassay for the qualitative detection of 
Helicobacter pylori antigens in both preserved and unpreserved stool samples, further 
strengthening its position in gastrointestinal diagnostics. 
Meridian has expanded its portfolio of PCR-based solutions designed to assist high-
throughput and decentralized testing workflows. The company introduced its Lyo-Ready 
range of PCR master mixes, including one-step RT-qPCR formulations optimized for RNA 
virus detection and multiplex applications. These lyophilization-ready reagents are designed 
for stability, rapid rehydration, and compatibility with automated platforms, supporting 
scalable molecular testing. 
Meridian has also developed inhibitor-tolerant qPCR reagents that enable reliable 
amplification from challenging sample types, including crude lysates and inhibitor-rich 
specimens such as blood, saliva, stool, and other clinical matrices. These reagents reduce the 
need for extensive sample preparation and improve workflow efficiency in both research and 
diagnostic settings. 
Additionally, the company introduced a series of sample-specific qPCR master mixes 
tailored for different specimen types, including saliva, blood, and stool. These products are 
designed to enhance sensitivity and simplify molecular workflows, supporting applications 
such as infectious disease testing and liquid biopsy research. 

 
 
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Mindray - Shenzhen Mindray Bio-medical Electronics Co., Ltd.  
Shenzhen, China 
http://mindray.com 
Founded in 1991, Mindray is a global provider of medical devices and diagnostic solutions, 
with a strong presence in in vitro diagnostics, patient monitoring, and medical imaging. 
Headquartered in Shenzhen, China, the company operates in more than 190 countries and 
maintains a global network of research, manufacturing, and service facilities. Mindray’s in 
vitro diagnostics business includes hematology, clinical chemistry, immunoassay, 
coagulation, microbiology, urinalysis, and flow cytometry, supporting a wide range of 
laboratory needs. 
Mindray offers a comprehensive hematology portfolio ranging from compact analyzers for 
small laboratories to high-throughput, fully automated cellular analysis lines. Systems such 
as the BC series analyzers and CAL family platforms provide scalable solutions with 
integrated slide-making and staining capabilities, supporting efficient workflow and high 
sample throughput. Developments include hematology systems that combine complete blood 
count testing with additional parameters such as erythrocyte sedimentation rate, reflecting 
increasing demand for multi-parameter testing in a single platform. 
In immunoassay and clinical chemistry, Mindray provides a range of chemiluminescence and 
biochemistry analyzers, including integrated solutions that combine both technologies into 
unified platforms. These systems are designed to improve laboratory efficiency through 
automation, flexible configuration, and high-throughput processing. Recent product 
introductions include new standalone and integrated analyzers for mid-volume laboratories, 
as well as expanded assay menus in areas such as inflammation and infectious disease. 
Mindray has also advanced its automation strategy by developing integrated laboratory 
solutions and collaborating with automation providers. These efforts support total laboratory 
automation by enabling connectivity across hematology, chemistry, and immunoassay 
systems, improving workflow efficiency and data management in high-volume laboratories. 
 

 
 
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Mindray has expanded into microbiology by introducing automated culture systems that 
support blood culture and pathogen detection workflows. These systems provide automated 
sample handling, detection, and data management capabilities, extending Mindray’s reach 
into microbiology diagnostics and complementing its broader IVD portfolio. 
Recent product developments have expanded Mindray’s presence across multiple diagnostic 
segments. The company introduced the FA-N Series fully automated microbial culture 
system, marking its entry into microbiology diagnostics with automated blood culture 
detection capabilities. In immunoassay and clinical chemistry, Mindray launched  analyzers 
such as the CL-2600i and BS-1000M, along with integrated solutions including the M680 
and M980 systems, which combine immunoassay and chemistry testing in compact, high-
efficiency platforms. These additions reflect Mindray’s focus on integrated core laboratory 
solutions, automation, and expansion into new diagnostic areas. 

 
 
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Myriad Genetics, Inc. 
Salt Lake City, UT 
www.myriad.com 
Myriad Genetics is a publicly traded personalized medicine company focused on the 
development and commercialization of molecular diagnostic tests across oncology, women’s 
health, and mental health. The company’s testing portfolio is based on advanced genomic 
and molecular technologies, including DNA sequencing, RNA expression profiling, and 
biomarker analysis, supporting risk assessment, diagnosis, treatment selection, and disease 
management. 
Myriad’s core oncology offering includes the myRisk Hereditary Cancer test, a 
comprehensive panel designed to assess inherited risk for multiple cancers, including breast, 
ovarian, colorectal, pancreatic, prostate, melanoma, gastric, and endometrial cancers. The 
company has expanded its hereditary testing portfolio to support broader risk assessment and 
preventive care, particularly in women’s health. In addition, Myriad offers Prolaris, a gene 
expression test used to assess the aggressiveness of prostate cancer and guide treatment 
decisions. 
Myriad provides the GeneSight Psychotropic test, which uses pharmacogenomic insights to 
help guide medication selection for patients with depression and other neuropsychiatric 
conditions. The company has demonstrated the test's clinical utility through studies showing 
improved treatment outcomes when gene–drug interactions are considered in therapy 
selection. 
Myriad also plays a significant role in companion diagnostics and targeted therapy selection. 
Its BRCAAnalysis CDx test is an FDA-approved germline companion diagnostic that 
identifies patients with BRCA1 and BRCA2 mutations who may benefit from PARP inhibitor 
therapies across multiple cancer types, including ovarian, breast, pancreatic, and prostate 
cancers. The company has expanded its companion diagnostic partnerships with 
pharmaceutical companies to support precision oncology. 
The company has further broadened its oncology portfolio with integrated testing solutions, 
including its prostate cancer risk and management offerings, which combine hereditary 

 
 
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testing, tumor profiling, and prognostic assessment. Myriad has also expanded its biomarker 
portfolio to include additional targets relevant to ovarian cancer and other malignancies, 
supporting more personalized treatment strategies. 
In women’s health and oncology, Myriad offers its myChoice CDx test to assess homologous 
recombination deficiency (HRD), which helps identify patients who may benefit from 
specific targeted therapies. Recent collaborations have focused on expanding access to HRD 
testing and improving identification of patients eligible for advanced treatments. 
Myriad Genetics offers the MyChoice CDx Test as the companion diagnostic for Zejula, a 
PARP inhibitor from GSK, for patients with advanced ovarian cancer. The MyChoice CDx 
is the only FDA-approved companion diagnostic test in the United States that identifies 
patients with HRD-positive status who are eligible for treatment with Zejula.  
 

 
 
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OraSure Technologies, Inc. 
Bethlehem, PA 
www.orasure.com 
OraSure Technologies is a developer and manufacturer of diagnostic solutions and sample-
collection technologies, with a strong focus on infectious-disease testing and oral-fluid–
based diagnostics. Formed through the merger of STC Technologies and Epitope, the 
company expanded its molecular capabilities by acquiring DNA Genotek, enabling entry into 
genomic sample collection for DNA and RNA analysis. OraSure’s products are used globally 
across public health organizations, clinical laboratories, and decentralized testing 
environments. 
The company’s core diagnostic portfolio is its OraQuick platform, which includes rapid tests 
for HIV and hepatitis C. The OraQuick ADVANCE Rapid HIV-1/2 Antibody Test remains 
a widely used point-of-care assay that utilizes oral fluid samples, while the OraQuick In-
Home HIV Test and OraQuick HIV Self-Test support consumer-directed, decentralized 
testing. Recent updates have expanded the eligible age range for HIV self-testing, supporting 
broader adoption in screening and prevention programs. OraSure also offers rapid HCV 
testing and other infectious disease assays, reinforcing its presence in public health 
diagnostics. 
OraSure maintains a strong position in oral fluid–based toxicology testing through products 
such as the Intercept Oral Fluid Drug Testing System and the Q.E.D. Saliva Alcohol Test. 
These solutions are widely used in workplace testing, clinical toxicology, and forensic 
applications, offering convenient, non-invasive sample collection and reliable laboratory-
based analysis. 
The company has significantly expanded its sample collection portfolio, including the 
Oragene and ORAcollect systems for DNA and RNA collection, as well as specialized 
devices for microbiome and women’s health applications. This includes the Colli-Pee urine 
collection device, developed for non-invasive self-sampling in applications such as HPV 
testing, supporting increased adoption of at-home and decentralized screening approaches. 
These innovations reflect the growing demand for patient-friendly, non-invasive diagnostic 
solutions. 

 
 
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OraSure has also advanced its rapid testing capabilities with lateral flow platforms such as 
the InteliSwab rapid antigen test, while continuing to validate performance against emerging 
variants and explore broader infectious disease applications. In addition, the company has 
strengthened its molecular diagnostics pipeline through the acquisition of Sherlock 
Biosciences, adding CRISPR-based detection technologies that support the development of 
next-generation rapid molecular tests. 

 
 
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Randox Laboratories Ltd. 
Crumlin, N. Ireland 
www.randox.com 
Randox Laboratories Ltd. is a privately held diagnostics company specializing in the 
development and manufacture of diagnostic reagents, instruments, and quality control 
solutions. Founded in 1982, Randox has established a global presence with distribution in 
more than 130 countries and offices across Europe, North America, Asia, Africa, and 
Australia. The company’s core capabilities include its proprietary Biochip Array 
Technology, clinical chemistry analyzers, external quality assessment (EQA) programs, 
quality control materials, antibodies, recombinant proteins, and a broad range of clinical and 
environmental diagnostic reagents. 
Randox has also expanded into laboratory testing services through its Randox Testing 
Services division, which provides drug and alcohol testing and forensic toxicology services. 
These services are widely used by law enforcement agencies and workplace testing programs, 
with capabilities including hair testing that enables long-term monitoring of substance use. 
This complements Randox’s broader diagnostics portfolio by integrating laboratory services 
with its testing technologies. 
The company has strengthened its manufacturing and research capabilities through 
investments in facilities such as Randox Teoranta in Ireland, which supports the production 
of clinical chemistry analyzers and Biochip-based diagnostic products.  
Randox Biosciences represents the company’s focus on advancing scientific discovery, drug 
development, and companion diagnostics. This division integrates capabilities across life 
sciences, pharmaceutical services, molecular diagnostics, and research technologies, 
supporting both internal innovation and external collaborations. 
Strategic developments include the acquisition of Cellix Limited, a company specializing in 
microfluidic technologies and impedance-based flow cytometry. This acquisition enhances 
Randox’s capabilities in cell analysis and supports expansion into advanced diagnostic and 
research applications. 

 
 
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Clinical Chemistries 
Randox offers an extensive portfolio of clinical chemistry reagents, comprising thousands of 
assay procedures designed to support a wide range of automated analyzers. The company’s 
reagent menu covers routine chemistry, specific proteins, lipids, therapeutic drugs, drugs of 
abuse, antioxidants, diabetes testing, autoimmune conditions, cardiac markers, electrolytes, 
anemia markers, liver function, inflammation and infection, neonatal screening, nutritional 
status, and renal function. 
Randox markets the RX series of clinical chemistry analyzers, including the RX daytona+, 
RX imola, and RX modena. These systems are designed to deliver flexible, scalable testing 
solutions for laboratories with varying throughput requirements. The RX series utilizes 
technologies such as latex-enhanced immunoturbidimetry to support a broad range of assays, 
including specific protein testing. 
The platforms offer an expanded test menu that includes assays such as direct HbA1c, 
apolipoproteins (including Apo C-II, Apo C-III, and Apo E), cystatin C, and microalbumin, 
enabling comprehensive evaluation of metabolic, cardiovascular, and renal health. The 
integration of advanced hardware with user-friendly software supports efficient workflow, 
high throughput, and consistent performance across diverse laboratory settings. 
POC and Rapid 
Randox has expanded its molecular diagnostics portfolio through its Vivalytic platform, 
developed in collaboration with Bosch Healthcare Solutions. The company introduced a 
rapid PCR-based MRSA/SA assay for detection and differentiation of methicillin-resistant 
and methicillin-sensitive Staphylococcus aureus, delivering results in under one hour and 
supporting rapid infection control and clinical decision-making. 
The Vivalytic test menu has continued to expand and includes a growing range of multiplex 
panels targeting respiratory, genitourinary, and hospital-acquired infections. More recent 
developments include the introduction of assays for central nervous system infections, such 
as bacterial meningitis panels, which are being evaluated and implemented to support rapid 
diagnosis of severe infectious diseases. The platform combines both low-plex PCR and 
higher-plex multiplexing technologies, enabling flexible testing options depending on 
clinical needs. 

 
 
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 Companion Diagnostics 
In 2025, Randox received U.S. FDA De Novo authorization for its first companion 
diagnostic, the ConcizuTrace ELISA, developed to support treatment monitoring in patients 
receiving concizumab therapy for hemophilia A and B. The assay is designed for the 
quantitative measurement of concizumab concentrations in plasma samples and is used to 
guide dose adjustment decisions following initiation of therapy. The test represents a new 
class of diagnostic systems for monitoring non-factor replacement therapies and reflects the 
growing shift toward precision dosing in hemophilia management. 
Developed in collaboration with Novo Nordisk, the ConcizuTrace ELISA supports the use 
of concizumab, a next-generation therapy targeting the tissue factor pathway inhibitor to 
reduce bleeding risk. The solution is offered as part of a comprehensive service model that 
includes standardized sample collection, transportation, and centralized laboratory analysis, 
with results delivered through an integrated reporting platform. This approach enables 
clinicians to incorporate drug level monitoring into individualized treatment strategies. 
Controls 
Randox’s quality control products and external quality assessment program account for a 
significant share of the company’s revenue.  With more than 30 years of experience 
developing Laboratory Quality Control for the in vitro diagnostics market, Randox is one of 
the largest manufacturers of quality control products worldwide.  The product portfolio 
includes Acusera true third-party quality controls, Acusera 24.7 interlaboratory data 
management software and the RIQAS EQA scheme. 
Introduced in 1990, RIQAS (Randox International Quality Assessment Scheme) has 
developed into one of the world’s largest global External Quality Assessment (EQA / 
Proficiency Testing (PT) schemes serving over 45,000 participants in more than 133 
countries.  Currently, 33 comprehensive EQA programs are available covering a wide range 
of clinical diagnostic testing. 
The Acusera range of Quality Controls and Calibrators covers over 300 parameters for 
clinical chemistry, immunoassay, urine, immunology/proteins, lipids, cardiac, CSF, 
therapeutic drug monitoring, toxicology, urine chemistry, urinalysis, coagulation, blood gas, 
tumor markers, maternal screening, antioxidants, diabetes and a number of research-based 
areas. 

 
 
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A wide range of formats is available, including liquid/lyophilized, assayed/unassayed, and 
human/bovine. Customers can even choose between multi-analyte and single-analyte 
controls, depending on their laboratory needs.  According to Randox, its assay controls are 
the most comprehensive on the world market to date, containing a unique combination of 
proteins, lipids, immunoassays, cardiac markers, blood markers, therapeutic drugs, and 
routine chemistry analytes.  For example, the Acusera Chemistry Premium Plus control 
contains 100 analytes, while the Acusera Chemistry Premium control offers 91. 
Randox also offers Acusera 24.7 Live Online, an interlaboratory peer-group reporting 
software package that extends the capabilities of Internal Quality Controls (IQC) by 
providing a tool to monitor and analyze daily control data and compare results with other 
laboratories using the same control lot.  With Acusera 24.7 users benefit from online access 
anytime, peer group data generated from thousands of laboratories every 24 hours, fully 
interactive charts and reports and automatic import of QC data direct from the Laboratory 
Information Management Systems (LIMs) or instrument via Acusera 24.7 Connect. 
Randox offers the Acusera Infectious Disease Controls. The Infectious Disease Serology 
Internal Quality Controls will include quality control material for Lyme Disease, ToRCH, 
Epstein-Barr virus, HIV, Hepatitis A virus, Human T-lymphotropic virus, Cytomegalovirus, 
and Varicella zoster virus (Chickenpox or Shingles). 
In June 2023, Randox introduced the  Acusera Ultra-low PSA Control, which is designed to 
assist in the quantification and monitoring of ultra-low levels of PSA in post-therapy prostate 
cancer patients.  
Evidence Series - Multistat Biochip Analyzers 
Randox developed its proprietary Biochip Array Technology (BAT) to enable multiplex 
detection of multiple analytes from a single patient sample. This technology underpins the 
company’s Evidence series of immunoassay analyzers, including the Evidence, Evidence 
Evolution, Evidence Investigator, and Evidence MultiSTAT platforms. Unlike traditional 
single-analyte systems, BAT allows simultaneous measurement of multiple biomarkers, 
supporting efficient, high-throughput testing while reducing sample volume requirements. 
The systems support a wide range of sample types, including serum, plasma, whole blood, 
urine, and oral fluid. 
 

 
 
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Ongoing developments have expanded the Evidence series with the introduction of the 
Evidence Random Access Biochip Technology Analyzer, a next-generation platform that 
delivers higher throughput and greater workflow flexibility. The system incorporates 
random-access processing, enabling continuous loading and prioritization of samples, and 
supports rapid turnaround times while maintaining the ability to multiplex dozens of analytes 
from a single sample. 
Randox continues to expand its menu of biochip-based assays across clinical and toxicology 
applications. New multiplex panels have been developed for the rapid detection of drugs of 
abuse and emerging synthetic opioids, supporting both clinical and forensic testing. These 
panels enable simultaneous detection of multiple compounds from a single sample, 
delivering rapid results to support timely decision-making. 
The Evidence Investigator is a compact, semi-automated benchtop analyzer utilizing 
chemiluminescent detection with CCD imaging to quantify analyte concentrations. The 
platform supports a wide range of disease-specific panels, including applications in 
cardiovascular disease, neurology, toxicology, and metabolic disorders. 
Molecular 
Randox has licensed other companies’ multiplex PCR technologies to expand its molecular 
diagnostics portfolio and develop high-throughput screening panels for detection of a wide 
range of pathogens and genetic markers. These technologies are integrated with Randox’s 
Biochip Array Technology, enabling workflows that combine multiplex PCR amplification, 
array-based hybridization, and chemiluminescent detection on platforms such as the 
Evidence Investigator. 
The workflow involves standard nucleic acid extraction followed by amplification using 
multiplex PCR on conventional thermal cyclers. Amplified products are then hybridized to 
biochip arrays, allowing simultaneous detection of multiple targets within a single sample. 
This approach supports efficient, cost-effective testing with turnaround times typically within 
a few hours after extraction. 
Randox’s molecular portfolio includes assays for diagnostic, prognostic, and predictive 
applications across a range of disease areas, including sexually transmitted infections, 
respiratory infections, cardiovascular disease, and inherited conditions. The technology 
supports multiple assay formats, including pathogen detection, single-nucleotide 

 
 
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polymorphism genotyping, and mutation analysis. The company expanded its multiplex 
infectious disease panels, enabling simultaneous detection of multiple bacterial, viral, and 
protozoan targets and supporting identification of co-infections. 
 Randox has developed biochip arrays for genetic and cardiovascular applications, including 
panels targeting mutations in genes such as KRAS, BRAF, and PIK3CA, as well as assays 
for familial hypercholesterolemia. These arrays enable simultaneous detection of multiple 
clinically relevant mutations, supporting precision medicine and treatment selection. 
Randox also offers genetic risk assessment panels, including arrays designed to evaluate 
predisposition to cardiovascular disease through multiplex SNP analysis, as well as 
expanding capabilities in advanced cell analysis through integration of microfluidic 
technologies. 

 
 
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Seegene, Inc. 
Seoul, Korea 
www.seegene.com 
Seegene, Inc. is a global molecular diagnostics company founded in 2000 and headquartered 
in South Korea, with additional operations in the United States and Europe. The company 
specializes in advanced multiplex PCR technologies that enable highly sensitive and specific 
detection of multiple targets in a single assay, supporting applications in infectious disease, 
pharmacogenetics, and oncology. 
Seegene has developed a suite of proprietary PCR chemistries designed to enhance 
multiplexing capability, sensitivity, and specificity. These technologies enable simultaneous 
detection and quantification of multiple pathogens within a single reaction, supporting 
efficient and comprehensive molecular diagnostics. The company offers a broad portfolio of 
multiplex systems, including Allplex, Anyplex, Seeplex, and Magicplex platforms, which 
are widely used in syndromic testing for respiratory infections, gastrointestinal diseases, 
sexually transmitted infections, sepsis, and human papillomavirus. 
Seegene’s assay menu includes a wide range of multiplex panels targeting viral and bacterial 
infections, allowing clinicians to differentiate between pathogens with similar clinical 
presentations and support appropriate treatment decisions. The company has achieved strong 
adoption of its syndromic panels, particularly in international markets, driven by demand for 
rapid and accurate diagnostic solutions. 
The company has also advanced automation and workflow integration by integrating nucleic 
acid extraction, amplification, and result interpretation into streamlined processes for high-
throughput laboratory environments. These systems are designed to reduce manual labor, 
improve reproducibility, and support efficient laboratory operations. 
Seegene has also expanded its capabilities with the availability of CURECA, a fully 
automated molecular diagnostics system that integrates the entire PCR workflow from 
sample preparation through result reporting. The system supports a variety of specimen types 
and is designed to improve laboratory efficiency while minimizing hands-on time. 
Additionally, the company offers STAgora, a digital platform that enables real-time 

 
 
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visualization and analysis of infectious disease data, supporting epidemiological surveillance 
and more informed clinical and public health decision-making. 
Seegene continues to advance its OneSystem strategy, which focuses on expanding access to 
its multiplex PCR technologies through collaborations and platform-agnostic assay 
development. This approach enables broader global distribution and integration of its assays 
across different diagnostic platforms, including decentralized and near-patient testing 
environments. 
The company has also continued to expand its assay portfolio with additional Novaplex tests 
and enhanced Allplex panels, including expanded detection of antimicrobial resistance 
markers and broader coverage of respiratory, gastrointestinal, and sexually transmitted 
infections. At the same time, Seegene has strengthened its software system to support data 
analysis, reporting, and integration with laboratory information systems, complementing its 
digital surveillance capabilities. 

 
 
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Sekisui Diagnostics LLC 
Burlington, MA 
www.sekisuidiagnostics.com 
Formerly Genzyme Diagnostics, Sekisui Diagnostics became part of Sekisui Medical in 2011 
and has since developed a diversified diagnostics portfolio spanning clinical chemistry, 
coagulation, and rapid testing solutions. The company offers a broad range of products, 
including clinical chemistry reagents and analyzers, coagulation systems, ELISA and LINE 
immunoassays, and rapid diagnostic tests for infectious diseases. Sekisui Diagnostics 
maintains a strong presence in coagulation testing and clinical chemistry, particularly in its 
home market and selected international regions. 
The company has also expanded its capabilities in molecular and genetic testing, including 
the development of assays for newborn screening. These include tests designed to 
simultaneously detect conditions such as severe combined immunodeficiency and spinal 
muscular atrophy, enabling early diagnosis and intervention in neonatal populations. 
Sekisui Diagnostics has strengthened its position in point-of-care and near-patient testing 
through strategic partnerships and product launches. The company partnered with Aptitude 
Medical Systems to commercialize molecular testing solutions based on the Metrix platform, 
enabling rapid PCR-based detection of infectious diseases in decentralized settings. Building 
on this collaboration, Sekisui offers molecular assays for respiratory infections, including 
combination COVID-19 and influenza tests designed for point-of-care and at-home use, 
delivering results in approximately 20 minutes. 
In addition to molecular diagnostics, Sekisui expanded its rapid antigen testing portfolio. 
This includes combination assays for detecting influenza A, influenza B, and SARS-CoV-2, 
as well as rapid tests for respiratory syncytial virus. These immunochromatographic assays 
are designed for ease of use in clinical and decentralized settings, with rapid turnaround times 
that support timely clinical decision-making. 

 
 
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Veracyte, Inc. 
South San Francisco, CA 
www.veracyte.com 
Veracyte’s flagship products include the Afirma platform for thyroid nodule assessment, 
which uses genomic analysis to help resolve indeterminate cytology results and reduce 
unnecessary surgeries. The company has expanded this offering with the Afirma Genomic 
Sequencing Classifier and the Afirma Xpression Atlas, which provides insights into gene 
alterations associated with thyroid cancer and supports treatment selection. 
The company also markets a portfolio of genomic classifiers across multiple disease areas, 
including the Percepta Genomic Sequencing Classifier for lung cancer risk assessment, the 
Envisia Genomic Classifier for interstitial lung disease, and the Decipher test portfolio for 
prostate cancer. These tests are primarily offered as laboratory-developed tests in the United 
States, with select international expansion underway. 
Veracyte has continued to invest in expanding its platform capabilities. The acquisition of 
C2i Genomics has added whole-genome minimal residual disease (MRD) capabilities, 
strengthening the company’s oncology portfolio and enabling more comprehensive cancer 
monitoring solutions. In addition, Veracyte has advanced its strategy to decentralize testing 
through collaboration with Illumina to develop in vitro diagnostic versions of its assays for 
use on next-generation sequencing platforms. 
Recent product developments include the introduction of new genomic classifiers within the 
Decipher portfolio, including tests designed to support risk stratification and treatment 
decisions in advanced prostate cancer. These offerings expand Veracyte’s presence in 
oncology and reinforce its focus on precision medicine. 
  
 

 
 
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Chapter 16: Company Profiles: Blood Bank 
Specialists 
Scope 
This section presents a selection of companies that specialize in blood banking and that have 
contributed to test innovation to this segment. This is not a comprehensive review or history 
of the companies selected to appear in the section, listed alphabetically. 

 
 
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AliveDx 
Eysins, Switzerland 
www.alivedx.com  
Quotient, now operating as AliveDx, has more than 30 years of experience in transfusion 
diagnostics, developing and 
manufacturing products for blood grouping and 
immunohematology. The company expanded into the U.S. market in the early 2010s with 
FDA authorization to commercialize conventional liquid reagents and has since built a broad 
portfolio of licensed products for transfusion medicine. AliveDx continues to offer a 
comprehensive range of immunohematology reagents, including its ALBAcyte product line, 
serving blood banks and hospital laboratories worldwide. 
The company’s main product is the MosaiQ platform, a fully automated microarray-based 
system designed to consolidate and streamline diagnostic testing. The platform provides 
multiplex testing across immunohematology, infectious disease, and autoimmune 
applications. The MosaiQ Extended Immunohematology Microarray enables simultaneous 
antibody screening and antigen typing, including ABO forward and reverse grouping, 
improving workflow efficiency and reducing manual processing. 
AliveDx has continued to expand the MosaiQ test menu through internal development and 
partnerships. Collaborations with external partners have supported the development of 
additional assays, particularly in infectious disease testing, broadening the platform’s clinical 
utility. More recently, the company has extended MosaiQ into new application areas, 
including allergy and autoimmune disease testing, with multiplex microarray assays designed 
to deliver automated, sample-to-answer workflows. 
The company offers autoimmune testing panels, including multiplex assays for connective 
tissue diseases and celiac disease, which are designed to simplify laboratory workflows 
through fully automated processing. These assays support detection of multiple biomarkers 
in a single run, improving efficiency and clinical insight. 
 
 

 
 
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Cerus Corporation 
Concord, CA 
www.cerus.com 
Product revenue increased 14% during the year ended December 31, 2025, compared to the 
year ended December 31, 2024, primarily due to the continued expansion of the company's 
platelet products.   
 Cerus Corporation is a biomedical company focused on improving blood transfusion safety 
through pathogen reduction technologies. Its core product, the INTERCEPT Blood System, 
is designed to reduce the risk of transfusion-transmitted infections by inactivating a broad 
spectrum of pathogens, including viruses, bacteria, and parasites that may be present in 
donated blood. The system targets nucleic acids with a proprietary photoactive compound 
that, when activated by ultraviolet A (UVA) light, binds to DNA and RNA, preventing 
replication and thereby rendering pathogens and donor white blood cells inactive. 
Cerus markets the INTERCEPT Blood System for platelets and plasma across the United 
States, Europe, the Middle East, and other international markets. The system is widely used 
as a proactive safety measure to address both established transfusion-transmitted pathogens, 
such as hepatitis viruses and HIV, and emerging infectious threats. The company is also 
advancing its INTERCEPT red blood cell system, which is in late-stage development and 
represents a significant opportunity to extend pathogen reduction technology across the full 
range of transfusable blood components. 
Cerus has strengthened its commercial position through strategic partnerships and supply 
agreements, including long-term collaborations with major blood collection organizations. 
The company has also expanded its manufacturing capabilities through partnerships to 
support global demand for INTERCEPT products. 
Recent product developments include enhancements to the INTERCEPT platform and 
supporting technologies. These include regulatory approvals for the extended shelf life of 
platelet processing sets, improving inventory management, and operational efficiency for 
blood centers. In addition, Cerus has introduced next-generation illumination technology, 

 
 
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including the INT200 system, an LED-based device designed to improve workflow 
efficiency, throughput, and scalability in blood processing operations. 

 
 
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Chapter 17: Company Profiles: Core Lab and 
Other Companies 
Scope 
This section presents a selection of companies that have brought and continue to bring 
innovation to clinical chemistry and the core laboratory. This is not a comprehensive review 
or history of the companies selected to appear in the section and is listed alphabetically. 
 
 
 
 
 

 
 
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SCIEX Pte Ltd. 
Framingham, MA 
www.sciex.com  
A Danaher Corporation company since 2013, SCIEX is a leading provider of mass 
spectrometry solutions serving basic research, drug discovery and development, food and 
environmental testing, forensics, and an expanding role in clinical and translational 
diagnostics. With more than three decades of innovation, SCIEX offers a broad and 
integrated portfolio spanning quadrupole time-of-flight (QTOF), triple quadrupole, hybrid 
QTRAP, capillary electrophoresis, and high-throughput acoustic mass spectrometry 
platforms. Its high-resolution QTOF portfolio includes the TripleTOF series for advanced 
qualitative and quantitative workflows and the X500 family designed for routine and 
biotherapeutic characterization. In quantitative mass spectrometry, SCIEX continues to build 
on its widely adopted triple-quadrupole systems, including the 6500+ and the newer 7500+ 
platforms, which deliver enhanced sensitivity, robustness, and performance for regulated and 
high-throughput laboratories. The QTRAP series extends these capabilities by integrating 
linear ion trap functionality, enabling simultaneous quantitation and confirmation within a 
single workflow, while legacy systems such as the TOF/TOF 5800 have transitioned to 
limited support as the company advances newer technologies. 
SCIEX’s portfolio is increasingly defined by workflow integration and end-to-end solutions. 
The company’s ExionLC and ExionLC AE systems provide optimized front-end separations 
for LC-MS/MS applications, while its software system, including SCIEX OS and cloud-
enabled data platforms, offers instrument control, data acquisition, advanced analytics, and 
multi-omics integration. Product introductions reflect a continued focus on sensitivity, 
throughput, and application breadth. Zeno SWATH DIA has enhanced proteomic depth and 
quantitative performance for biomarker discovery and translational research. The ZenoTOF 
8600 system represents a next-generation high-resolution platform with expanded mass 
range, improved speed, and increased sensitivity. In quantitative analysis, the SCIEX 7500+ 
system enhances performance in demanding applications that require ultra-low detection 
limits. High-throughput innovation is demonstrated by the Echo MS+ system, which 
combines acoustic ejection with open port interface sampling for rapid, label-free analysis 
and is now integrated with high-resolution platforms to enable large-scale screening 
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With increasing demand for mass spectrometry in regulated and clinical laboratory 
environments, SCIEX continues to advance standardized workflows, automation, and service 
capabilities to support routine adoption of LC-MS/MS in areas such as toxicology, 
endocrinology, and therapeutic drug monitoring.  
Diabetes 
ARKRAY, Inc. is a provider of diabetes management solutions and maintains a strong 
presence in the U.S. long-term care market, which is supported by a broad portfolio of 
glucose monitoring systems and HbA1c analyzers. The company has a long history of 
innovation in diabetes diagnostics, including the early development of portable blood glucose 
testing technologies and HbA1c analyzers based on HPLC. Since introducing its early 
glucose testing systems in the 1970s, ARKRAY has continued to expand its diabetes care 
portfolio, with the GLUCOCARD product line serving as a core offering for both 
professional and self-monitoring applications. 
ARKRAY’s blood glucose monitoring systems have placed a strong emphasis on accuracy, 
usability, and connectivity. The GLUCOCARD Shine family, including Bluetooth-enabled 
and accessibility-focused models, supports data sharing, remote monitoring, and integration 
with digital health platforms, making these systems particularly well suited for long-term 
care and home health environments. These meters are designed to meet stringent accuracy 
requirements and incorporate features such as hematocrit correction to improve reliability 
across diverse patient populations. ARKRAY has also expanded its digital health system 
through mobile applications and connected care solutions that enable patients and providers 
to track glucose trends, manage lifestyle factors, and support clinical decision-making. 
In HbA1c testing, ARKRAY maintains a strong position with its ADAMS A1c series, which 
offers a tiered portfolio addressing a range of laboratory needs. Systems such as the HA-
8180V and HA-8180T support routine clinical laboratories, while the compact HA-8380V 
serves smaller facilities and decentralized settings. The HA-8190V platform represents the 
company’s advanced HPLC-based solution, delivering high-precision HbA1c measurement 
with enhanced detection of hemoglobin variants, supporting accurate assessment across 
diverse patient populations. This tiered approach enables ARKRAY to address both high-
throughput central laboratories and near-patient testing environments. 
In addition, ARKRAY has introduced systems such as the ADAMS Glucose GA-1180, a 
laboratory-based analyzer designed to support accurate glucose measurement and integration 

 
 
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with HbA1c testing workflows in centralized laboratory settings. The company has also 
expanded into adjacent diagnostic areas with products such as combination antigen tests for 
respiratory infections, reflecting diversification beyond core diabetes care.  
Molecular 
ARKRAY, Inc. has expanded its presence in molecular diagnostics by improving 
accessibility to genetic testing, with a portfolio designed to support streamlined workflows 
from sample preparation through analysis and reporting. The company’s approach 
emphasizes simplified, cartridge-based systems suitable for hospital laboratories and 
decentralized testing environments. Its offering includes nucleic acid extraction through 
compatible platforms such as the Maxwell RSC system, amplification and detection using 
the i-densy Gene Analyzer series, and data management through connected software 
solutions such as MEQNET iDia, enabling an integrated sample-to-answer workflow. 
The i-densy IS-5320 remains the core platform within ARKRAY’s molecular diagnostics 
portfolio, providing fully automated genetic analysis from sample preparation through 
amplification and detection, with results delivered in a relatively short turnaround time and 
without the need for highly specialized technical expertise. The system is positioned for 
applications in pharmacogenomics, oncology, and infectious disease testing, and reflects the 
broader industry trend toward near-patient molecular diagnostics. ARKRAY has  expanded 
the i-densy reagent menu, including assays targeting cytochrome P450 genotypes such as 
CYP2C19 for drug metabolism, as well as multi-analyte cartridge-based reagents that enable 
simultaneous detection of multiple genetic targets from whole blood or purified nucleic acid 
samples. 
ARKRAY’s molecular strategy focuses on menu expansion and workflow integration rather 
than new instrument platforms. Enhancements include broader assay availability across 
pharmacogenomics and disease-specific applications, improved ease of use through 
cartridge-based testing, and compatibility with laboratory information systems to support 
routine clinical adoption. The company also maintains collaborations with Promega 
Corporation for nucleic acid purification workflows, particularly in applications such as 
circulating cell-free DNA analysis. In addition, ARKRAY offers microfluidics-based 
systems such as the μTAS Wako platform for specific applications, including tuberculosis 
testing, although this remains a more specialized offering. 

 
 
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EKF Diagnostics Holdings Plc 
Cardiff, UK 
www.ekfdiagnostics.com 
EKF Diagnostics Holdings plc develops, manufactures, and distributes point-of-care 
analyzers used in the detection and management of diabetes, anemia, lactate, and renal-
related conditions. The company’s portfolio includes systems for measuring glucose, lactate, 
hemoglobin, hematocrit, and HbA1c across a wide range of settings including physician 
offices, pharmacies, blood banks, sports medicine clinics, hospitals, and laboratories. EKF 
Diagnostics operates internationally, with products distributed in more than 100 countries 
and research, development, and manufacturing capabilities spanning Germany, Ireland, the 
United States, and the United Kingdom. 
Founded in Germany in 1990, EKF has expanded acquisitions, building a diversified near-
patient testing portfolio. Key acquisitions include Quotient Diagnostics, which strengthened 
its HbA1c capabilities, Argutus Medical, which added expertise in kidney biomarkers, and 
Stanbio Laboratory, which expanded its clinical chemistry and distribution footprint. These 
acquisitions have supported EKF’s strategy of combining point-of-care technologies with 
central laboratory capabilities and consumables. 
EKF’s product portfolio includes hemoglobin analyzers such as the Hemo Control and 
DiaSpect Tm systems, which are widely used in hospitals, blood banks, and screening 
programs where rapid and reliable results are essential. The DiaSpect platform has been 
enhanced with connectivity features that enable integration with EKF’s data management 
solutions, supporting traceability and workflow efficiency across decentralized settings. In 
HbA1c testing, the Quo-Test and Quo-Lab analyzers remain central offerings, utilizing 
boronate fluorescence quenching technology to deliver accurate HbA1c measurements from 
small blood samples. These systems are designed for ease of use and affordability, 
particularly in decentralized and resource-limited environments, and can be equipped with 
connectivity solutions that support data transfer, quality control, and integration with 
laboratory information systems. 
In metabolic testing, EKF continues to advance its Biosen line of glucose and lactate 
analyzers, with the Biosen C-Line representing the latest generation of benchtop systems 

 
 
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designed for rapid, precise measurement in clinical, laboratory, and sports medicine settings. 
The company has also expanded its connectivity ecosystem, including EKF Link and related 
middleware solutions, enabling improved data management, remote monitoring, and 
interoperability across its analyzer portfolio. In addition, EKF maintains a broad offering of 
Stanbio-branded reagents, enzymes, calibrators, and controls, supporting both point-of-care 
and central laboratory testing workflows. 
 
 

 
 
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Shimadzu Scientific Instruments 
Columbia, MD 
www.ssi.shimadzu.com/ 
Shimadzu Corporation is a multinational company headquartered in Kyoto, Japan, with a 
long history dating back to 1875. Its operations span analytical instruments, medical systems, 
and industrial technologies. Shimadzu Scientific Instruments serves as the company’s U.S. 
arm, providing sales, service, and technical support through a broad national network. 
Shimadzu maintains a strong presence in analytical instrumentation and has expanded its role 
in clinical diagnostics, particularly through liquid chromatography and mass spectrometry 
platforms that support in vitro diagnostic applications. 
Shimadzu established an important position in clinical microbiology through its collaboration 
with bioMérieux, which led to the development of MALDI-TOF–based identification 
systems used in routine microbiology laboratories. In clinical diagnostics, the company has 
increasingly focused on LC-MS/MS–based workflows to support applications such as 
therapeutic drug monitoring, toxicology, and endocrinology. This includes the development 
of integrated solutions that combine triple-quadrupole mass spectrometry systems with 
automated sample-preparation platforms such as the CLAM series, enabling streamlined, 
sample-to-answer workflows suitable for routine clinical laboratory use. 
Shimadzu’s mass spectrometry portfolio has continued to evolve with systems such as the 
LCMS RX series and high-sensitivity triple quadrupole platforms, which offer improved 
robustness, throughput, and analytical performance for clinical applications. The company 
has also expanded its menu of clinically oriented assay kits, including immunosuppressant 
testing solutions such as the DOSIMMUNE LC-MS/MS kit, which support therapeutic drug 
monitoring in regulated laboratory environments and align with evolving regulatory 
requirements in regions adopting IVDR standards. 
In addition to LC-MS/MS, Shimadzu markets MALDI-TOF–based clinical microbiology and 
maintains a broad analytical portfolio that includes UHPLC systems such as the Nexera 
series, imaging mass spectrometry platforms, and compact analytical instruments designed 
for ease of use and workflow integration. The company also continues to innovate in gas 

 
 
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chromatography and spectrophotometry, with systems such as the Brevis GC platform 
emphasizing compact design and energy efficiency.  

 
 
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Snibe Co. Ltd. (Shenzhen New Industries Biomedical Engineering Co. 
Ltd.) 
Shenzhen, Guangdong, China 
https://www.snibe.com/ 
Snibe (Shenzhen New Industries Biomedical Engineering Co., Ltd.) is a global diagnostics 
company specializing in the development, manufacturing, and commercialization of clinical 
laboratory instruments and in vitro diagnostic reagents, with a primary focus on 
chemiluminescence immunoassay technology. Founded in 1995, the company has built its 
platform around magnetic microbead–based separation technology and proprietary 
chemiluminescent labeling systems, enabling high sensitivity and throughput in 
immunoassay testing. Snibe was among the first Chinese companies to obtain U.S. regulatory 
clearance for a CLIA-based immunoassay system and to expand into regulated international 
markets. 
The company’s MAGLUMI series of automated CLIA analyzers forms the core of its 
portfolio, with a large global installed base across hospitals and clinical laboratories in more 
than 140 countries. The portfolio spans a wide range of throughput levels, from compact 
systems such as the MAGLUMI X3 to mid- and high-throughput platforms, including the 
MAGLUMI X6 and X8, and extends to flagship ultra–high-throughput systems, such as the 
MAGLUMI X10, designed for large core laboratories and high-volume testing environments. 
These systems are continuously expanding their assay menus to cover infectious diseases, 
endocrinology, oncology, cardiovascular markers, and other clinical areas. 
Snibe has expanded beyond standalone immunoassay analyzers into integrated core 
laboratory solutions. Through its Biolumi systems, the company combines immunoassay and 
clinical chemistry platforms into unified workflows, enabling laboratories to streamline 
operations and improve efficiency. In addition, Snibe has introduced total laboratory 
automation solutions such as the SATLARS-T8 system, which incorporates automated 
sample handling, analyzer integration, and workflow management, reflecting a strategic shift 
toward fully automated, high-throughput laboratory environments. 
Snibe has broadened its diagnostic portfolio into molecular diagnostics and additional testing 
segments. The Molecision series supports nucleic acid testing applications with multiple 

 
 
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configurations to meet different throughput needs, while newer product lines also extend into 
coagulation testing, with systems such as the Hemolumi H6 analyzer. The company has also 
expanded its regulatory footprint, including IVDR-certified assays for key infectious disease 
markers in Europe and ongoing regulatory clearances in the United States for selected 
analyzers and assays. 
 

 
 
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Tosoh Bioscience 
Tokyo, Japan 
www.tosohbioscience.com 
Tosoh Bioscience is a subsidiary of Tosoh Corporation, a global group with a strong presence 
in specialty chemicals, materials, and life sciences. Tosoh Bioscience develops and 
manufactures a comprehensive portfolio of chromatographic media, bioseparation systems, 
and in vitro diagnostic analyzers, with a high degree of integration between its diagnostics 
and separation technologies. 
The company’s AIA series represents its core automated immunoassay platform, utilizing 
fluorescent enzyme immunoassay (FEIA) technology and a proprietary AIA-PACK test cup 
format. The portfolio spans a wide range of throughput levels, from the compact AIA-360 
designed for physician office laboratories and small hospital settings, to mid-range systems 
such as the AIA-600II, and higher-throughput analyzers, including the AIA-900 and flagship 
AIA-2000, which supports continuous random-access processing and advanced workflow 
capabilities for large laboratories. These systems provide a broad assay menu covering 
oncology, endocrinology, fertility, cardiac, infectious disease, and metabolic testing. 
Tosoh has expanded its immunoassay technology with the addition of chemiluminescent 
enzyme immunoassay (CLEIA) systems, including the AIA-CL300, which offers enhanced 
analytical sensitivity and supports a broader range of clinical applications in compact, 
decentralized laboratory environments. This expansion reflects a strategic shift toward 
higher-sensitivity immunoassay technologies while maintaining the reliability and workflow 
efficiency of its established AIA platforms. Higher-throughput CLEIA systems further 
extend this capability into larger laboratory settings. 
In hemoglobin testing, Tosoh remains a leader in HPLC-based HbA1c analysis with its HLC-
723 series, including the G8 and G11 systems. These analyzers provide rapid, high-resolution 
separation of hemoglobin fractions, with variant-detection capabilities and scalable sample 
handling, supporting both routine diabetes monitoring and specialized hemoglobinopathy 
analysis. Continued enhancements emphasize faster turnaround times, improved automation, 
and seamless integration into core laboratory workflows. 

 
 
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Tosoh strengthens its position through incremental innovation, including expanded 
immunoassay sensitivity, enhanced HbA1c performance, and increased connectivity with 
laboratory automation systems. Strategic collaborations and workflow integration initiatives 
further support its role in modern core laboratory environments, positioning the company as 
a reliable provider of immunoassay and HbA1c diagnostic solutions. 

 
 
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Trinity Biotech Plc 
Bray, County Wicklow, Ireland 
www.trinitybiotech.com 
Trinity Biotech plc is a developer and manufacturer of diagnostic test kits and instruments 
serving both clinical laboratory and point-of-care markets. Founded in 1992, the company 
has built a broad portfolio spanning infectious disease, autoimmune disorders, 
hemoglobinopathies, and diabetes monitoring. Trinity operates manufacturing facilities in 
Ireland, the United States, and Canada, and also runs Immco Diagnostics, which provides 
specialized testing services for autoimmune and immunological disorders, including 
advanced serology and immunogenetics testing. 
The company offers a wide range of diagnostic technologies, including rapid point-of-care 
immunoassays under the Uni-Gold brand, enzyme immunoassays, Western blot systems, 
indirect fluorescent antibody platforms, and line immunoassays for detecting infectious and 
autoimmune diseases. Its clinical chemistry portfolio includes specialized reagents and assay 
kits for metabolic and enzymatic testing, along with HPLC-based solutions for hemoglobin 
and other analytes. Trinity also develops automated laboratory instruments, including ELISA 
processors, Western blot automation systems, and integrated platforms that combine multiple 
assay technologies to improve laboratory efficiency and workflow standardization. 
Trinity has strengthened its position in hemoglobin testing with automated systems such as 
the Premier Resolution platform, which enables detailed analysis of hemoglobin variants and 
supports the diagnosis of hemoglobinopathies. In point-of-care diagnostics, systems such as 
the Meritas analyzer provide quantitative fluorescence-based testing in a compact, easy-to-
use format designed for decentralized settings. The company maintains a strong presence in 
autoimmune diagnostics through its Immco-branded assays and instrumentation, supported 
by its reference laboratory services. 
In recent years, Trinity has expanded into next-generation diabetes management and data-
driven diagnostics. The company has developed a continuous glucose monitoring platform 
based on advanced biosensor technology, strengthened through acquisitions and further 
advanced with the introduction of its AI-native CGM+ system, a wearable device that 
integrates glucose sensing with additional physiological parameters such as heart activity, 

 
 
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body temperature, and physical activity. This platform reflects a strategic move into digital 
health and multi-parameter monitoring. 
Trinity has also expanded its clinical diagnostics portfolio into women’s health with the 
introduction of the PreClara Ratio test, a biomarker-based assay that assesses the risk of 
preeclampsia. This addition broadens the company’s reach into pregnancy-related 
diagnostics and complements its existing laboratory-based testing capabilities. In parallel, 
recent acquisitions have strengthened Trinity’s position in metabolomics and oncology 
diagnostics, including the development of non-invasive prostate cancer risk assessment 
technologies. 

 
 
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Chapter 18: Company Profiles: CTC & Liquid 
Biopsy Test Providers 
Scope 
In this section, Kalorama has selected a group of companies that provide molecular and 
proteomic tests and technologies that advance the potential of circulating tumor cell (CTC) 
testing and cell-free DNA as liquid biopsy tools to diagnose, monitor, and guide therapy for 
cancer patients. This is not a comprehensive review or history of the companies selected to 
appear in the section and is listed alphabetically. 
 

 
 
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Epic Sciences 
San Diego, CA 
www.epicsciences.com 
Epic Sciences is a privately held biotechnology company based in San Diego, California, 
founded in 2008 to commercialize rare cell detection and characterization technology 
originally licensed from Scripps Research. The company has developed a proprietary 
platform centered on its “no cell left behind” approach, enabling the detection and analysis 
of circulating tumor cells (CTCs) using high-definition imaging, multi-parameter analysis, 
and advanced software algorithms. 
Epic Sciences’ technology focuses on its high-definition circulating tumor cell platform, 
which performs detailed characterization of tumor cells through a combination of 
immunofluorescent staining, digital microscopy, and image analysis. This approach 
evaluates a wide range of cellular and morphological parameters, allowing for highly 
sensitive detection of rare tumor cells, including clusters and cells present in early-stage 
disease. The platform supports downstream molecular analysis directly on identified cells, 
including genomic and fluorescence-based techniques, enabling comprehensive tumor 
profiling from a blood sample. 
 Epic Sciences has developed a portfolio of liquid biopsy assays for precision oncology. Its 
AR-V7 assay remains a clinically relevant test for metastatic prostate cancer, identifying 
nuclear localization of androgen receptor splice variants to guide treatment selection. The 
company’s flagship offering, DefineMBC, represents a multi-omic liquid biopsy solution for 
metastatic breast cancer that integrates circulating tumor cell analysis, circulating tumor 
DNA genomic profiling, and protein biomarker assessment to provide a comprehensive view 
of tumor biology. This platform offers therapy selection, treatment response monitoring, and 
identification of resistance mechanisms. 
Epic Sciences expanded its molecular profiling capabilities by broadening genomic panels 
and enhancing single-cell analysis, combining cell-based and cell-free approaches in a 
unified workflow. These developments are accomplished by increasing clinical adoption and 
payer coverage for select genomic assays in oncology. Additionally, the company maintains 
active collaborations with pharmaceutical partners to develop companion diagnostics and 

 
 
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support clinical trials across multiple cancer types, including prostate, breast, lung, 
pancreatic, and bladder cancers. 
Epic Sciences is advancing a multi-omic, data-driven approach to liquid biopsy, integrating 
high-definition CTC analysis with genomic and proteomic insights to support precision 
oncology, treatment decision-making, and disease monitoring. 

 
 
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Foundation Medicine, Inc. 
Cambridge, MA 
www.foundationmedicine.com 
Foundation Medicine, Inc. develops and commercializes molecular diagnostics based on 
comprehensive genomic profiling using next-generation sequencing. The company has built 
a proprietary platform that integrates optimized sample preparation, high-throughput 
sequencing, and advanced bioinformatics to analyze cancer-related genes across their full 
coding regions, enabling detection of multiple classes of genomic alterations that inform 
treatment selection in oncology. 
Foundation Medicine’s portfolio includes tissue- and blood-based genomic profiling assays. 
Its flagship tissue test, FoundationOne CDx, provides broad genomic profiling of solid 
tumors and continues to expand its role through additional companion diagnostic indications 
and broader biomarker coverage. The company also offers FoundationOne Liquid CDx, a 
blood-based assay that enables genomic profiling when tissue samples are unavailable and is 
increasingly used as a primary testing option in certain clinical scenarios. Additional 
offerings include FoundationOne Heme for hematologic malignancies and sarcomas, 
supporting precision oncology decision-making across a wide range of cancers. 
The company has significantly expanded its portfolio with molecular and monitoring 
solutions that support longitudinal cancer care. FoundationOne Tracker is a personalized, 
tissue-informed circulating tumor DNA assay designed for ongoing monitoring of disease 
burden, treatment response, and recurrence, while FoundationOne Monitor provides a tissue-
naïve approach to ctDNA-based disease tracking. FoundationOne RNA further extends the 
platform by enabling the detection of gene fusions and transcriptomic alterations across 
hundreds of genes, complementing DNA-based profiling and improving the identification of 
actionable biomarkers. 
Foundation Medicine has also broadened its offering into a multimodal biomarker platform 
that integrates genomic, transcriptomic, and proteomic analyses. The company has expanded 
its immunohistochemistry menu to include assays such as MET, HER2, PD-L1, CLDN18, 
and FOLR1, enabling protein biomarker assessment alongside genomic testing. In addition, 
the company has entered the hereditary cancer testing space with next-generation sequencing 

 
 
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panels that assess multiple genes associated with inherited cancer risk, extending its reach 
into earlier-stage disease assessment and prevention. 
Collaborations with pharmaceutical partners continue to drive the expansion of companion 
diagnostics tied to targeted therapies across multiple cancer types, including lung, breast, 
colorectal, and hematologic cancers. Through continued development of tissue profiling, 
liquid biopsy, RNA analysis, immunohistochemistry, germline testing, and longitudinal 
monitoring solutions, Foundation Medicine has evolved into a comprehensive provider of 
precision oncology diagnostics, supporting therapy selection, disease monitoring, and 
personalized treatment strategies across the continuum of cancer care. 

 
 
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NeoGenomics 
Fort Myers, FL 
www.neogenomics.com 
NeoGenomics is a CLIA-certified clinical laboratory and pharmaceutical services company 
specializing in cancer genetics and precision oncology testing. The company offers a 
comprehensive menu of diagnostic services spanning cytogenetics, fluorescence in situ 
hybridization (FISH), flow cytometry, immunohistochemistry (IHC), anatomic pathology, 
and molecular genetics. In addition to clinical testing, NeoGenomics provides biomarker and 
laboratory services to pharmaceutical companies supporting oncology clinical trials and 
companion diagnostic development. 
Headquartered in Fort Myers, Florida, NeoGenomics operates a network of laboratories 
across the United States, including facilities in California, Texas, Florida, and Tennessee, as 
well as international operations in Switzerland and Asia to support global clinical trials. The 
company continues to expand its laboratory infrastructure and service capabilities to improve 
turnaround time and support growing demand in oncology testing. 
NeoGenomics offers a broad portfolio of molecular and genomic assays, including its 
NeoTYPE and Neo Comprehensive platforms, which provide next-generation sequencing–
based profiling for solid tumors, hematologic malignancies, and myeloid disorders. The 
company has expanded these offerings with additional panels such as Neo Comprehensive 
Heme Cancers and early-stage cancer profiling assays, as well as rapid testing solutions like 
AML Express, designed to deliver fast genomic insights for acute myeloid leukemia to 
support time-sensitive treatment decisions. 
The company’s liquid biopsy capabilities are anchored by its RaDaR assay, a personalized 
circulating tumor DNA test that tracks tumor-specific variants to detect molecular residual 
disease, recurrence, and treatment response across multiple cancer types. RaDaR has 
emerged as a flagship product with expanding clinical adoption and payer coverage, 
reflecting increasing demand for longitudinal cancer monitoring. 
NeoGenomics continues to expand its companion diagnostic and biomarker portfolio, 
including assays such as PD-L1, c-MET CDx for non-small cell lung cancer, Pan-TRK, and 

 
 
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FOLR1 testing, to support targeted therapy selection. Additional specialized programs, such 
as ovarian cancer biomarker testing initiatives, further extend its clinical utility. The company 
is also advancing into multi-omic approaches through proteomics partnerships, enhancing its 
ability to support biomarker discovery and translational research. 

 
 
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Chapter 19: Company Profiles: Specialists 
Scope 
This section presents a selection of companies that have specialized in diabetes testing and 
monitoring. They have brought and continue to bring innovation to the segment. This is not 
a comprehensive review or history of the companies selected to appear in this section and is 
listed alphabetically. 

 
 
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Ascensia Diabetes Care Holdings AG 
Basel, Switzerland 
www.ascensia.com  
Ascensia Diabetes Care Holdings develops and markets blood glucose monitoring systems 
and related digital health solutions, primarily under the CONTOUR brand, for the 
management of diabetes. The company operates as part of PHC Holdings Corporation, 
formerly known as Panasonic Healthcare Holdings, and has a global presence in both self-
monitoring blood glucose (SMBG) and continuous glucose monitoring markets. 
Ascensia’s SMBG portfolio includes a range of CONTOUR-branded glucose meters such as 
CONTOUR NEXT ONE, CONTOUR NEXT, CONTOUR NEXT LINK, CONTOUR 
NEXT EZ, CONTOUR PLUS, CONTOUR PLUS ONE, and CONTOUR TS, which are 
widely used in home and clinical settings. These systems emphasize accuracy, ease of use, 
and connectivity through integrated digital platforms such as the CONTOUR DIABETES 
app and cloud-based data management tools, enabling patients and healthcare providers to 
track and manage glucose levels more effectively. 
In continuous glucose monitoring, Ascensia partners with Senseonics to commercialize the 
Eversense implantable CGM systems, representing a differentiated approach to long-term 
glucose monitoring. The Eversense E3 system, introduced in recent years, offers up to six 
months of continuous monitoring and is supported by mobile applications including the 
EversenseNOW remote monitoring platform, which enables caregivers and healthcare 
professionals to access patient data in real time. The system has expanded its reimbursement 
access, including broader Medicare coverage, and regulatory advancements such as 
integrated CGM designation, supporting its use within connected diabetes management 
systems. 
The company has continued to advance this platform with the introduction of the Eversense 
365 CGM system, which extends continuous monitoring to up to one year from a single 
implanted sensor, representing a significant advancement in long-duration CGM technology. 
This system reinforces Ascensia’s focus on reducing the frequency of sensor replacements 
while improving patient convenience and long-term adherence. 
 

 
 
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In addition to hardware, Ascensia has expanded its digital health capabilities through 
platforms such as GlucoContro.Online, which integrates data from glucose meters and 
connected applications to support analytics, remote monitoring, and clinical decision-
making. Ascensia continues to evolve its diabetes care portfolio by combining traditional 
SMBG systems, long-duration implantable CGM technologies, and integrated digital health 
solutions to improve outcomes and patient engagement. 
 

 
 
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Insulet Corporation 
Billerica, MA 
www.insulet.com 
Insulet Corporation is a medical device company focused on the development, manufacture, 
and commercialization of the Omnipod Insulin Management System, a tubeless, wearable 
insulin delivery platform for people with insulin-dependent diabetes. The system consists of 
a lightweight, disposable Pod worn on the body for up to three days and a separate controller 
or mobile app that manages insulin delivery. The tubeless design differentiates Omnipod 
from traditional insulin pumps and supports ease of use and patient convenience. 
The company’s flagship platform, Omnipod 5, is a fully automated insulin-delivery system 
that integrates with continuous glucose monitoring to adjust insulin dosing in real time via 
an embedded algorithm. Initially cleared in 2022, the Omnipod 5 builds on the Omnipod 
DASH platform and has since been expanded to offer broader compatibility and 
functionality. The system now integrates with multiple CGM sensors, including Dexcom G7 
and Abbott FreeStyle Libre 2 Plus, and offers control via smartphone applications, including 
iPhone-based operation. Recent enhancements include updates to the automated insulin 
delivery algorithm, which improve flexibility in glycemic control and overall system 
performance, as well as continued expansion of interoperability across connected diabetes 
devices. 
Insulet has also expanded its product portfolio with Omnipod Go, a basal-only insulin 
delivery option designed for individuals with type 2 diabetes who require consistent basal 
insulin without the complexity of full pump therapy. This system provides fixed-rate insulin 
delivery over a multi-day wear period and represents an entry point for patients transitioning 
from injections to wearable insulin delivery. 
In addition to hardware, Insulet has expanded its digital system with platforms such as 
Omnipod Discover, which provides data analytics, retrospective insights, and reporting tools 
for both patients and healthcare providers, providing improved diabetes management and 
clinical decision-making. The company is also advancing next-generation automated insulin 
delivery technologies, including development of fully closed-loop systems, and exploring 
broader applications of its Pod platform beyond insulin delivery. 

 
 
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Medtronic plc 
Dublin, Ireland 
www.medtronic.com  
Medtronic plc is a leading medical technology company that develops and markets therapies 
for chronic diseases across multiple business segments, including Cardiovascular, 
Neuroscience, Medical Surgical, and Diabetes. The Diabetes segment focuses on advanced, 
integrated diabetes management solutions, including insulin pump systems, continuous 
glucose monitoring technologies, and digital therapy management tools. 
Medtronic’s diabetes portfolio has evolved significantly from earlier systems such as the 
MiniMed 530G, 630G, 670G, and 770G to its current flagship MiniMed 780G platform. The 
MiniMed 780G system incorporates automated insulin delivery with SmartGuard 
technology, enabling real-time insulin adjustments and automated correction dosing every 
few minutes. The system is paired with advanced CGM technologies, including the Guardian 
4 sensor and newer sensor options such as Simplera Sync, a disposable, all-in-one CGM 
designed to simplify the user experience. The company continues to enhance its system 
through software and digital tools that provide personalized insights, trend analysis, and 
remote monitoring capabilities, supporting more proactive diabetes management. The 
MiniMed 780G system has also expanded indications, including use in individuals with type 
2 diabetes, and has gained broader reimbursement access. 
Medtronic has been advancing next-generation insulin delivery systems, including smaller, 
more connected pump platforms and additional CGM innovations, reflecting a shift toward 
simplified, smartphone-controlled, and fully integrated diabetes management solutions. A 
major strategic transition is underway following the company’s 2025 announcement to spin 
off its Diabetes business as a standalone entity, MiniMed. As of 2026, this separation is in 
progress through an IPO that was completed in March 2026 and a staged spin-off, with the 
diabetes portfolio, including insulin pumps, CGM systems, automated insulin delivery 
technologies, and digital platforms, being transferred to the new company. 
During the transition period, Medtronic continues to support and report its diabetes 
operations; however, once the separation is complete, MiniMed will operate as an 

 
 
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independent, pure-play diabetes technology company, while Medtronic will exit the diabetes 
market and focus on its remaining core medical technology segments.  
In March 2026, Minimed started trading on the Nasdaq under the ticker “MMED”.  

 
 
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Verily Life Sciences LLC 
Mountain View, CA 
www.verily.com  
Verily Life Sciences, a subsidiary of Alphabet Inc., is an active health technology company 
focused on data-driven healthcare, precision medicine, and digital health platforms. The 
company develops tools and infrastructure to collect, analyze, and apply health data to 
improve clinical decision-making, disease management, and population health outcomes. Its 
areas of focus include chronic disease management, clinical research, bioinformatics, and 
advanced analytics, reflecting a strategic shift away from hardware development toward 
integrated software and data solutions. 
Verily has contributed to the development of next-generation continuous glucose monitoring 
technologies through its collaboration with Dexcom, Inc., emphasizing miniaturization, 
connectivity, and usability. While these efforts supported innovation in CGM design, 
commercialization has largely been driven through Dexcom’s product portfolio, with Verily 
focusing on enabling technologies rather than launching standalone devices. 
The company’s product portfolio offers digital health and analytics platforms. Its flagship 
offering, Lightpath, is an AI-powered chronic care solution designed to support management 
of metabolic conditions such as diabetes, hypertension, obesity, and hyperlipidemia. 
Lightpath integrates clinical care, data from connected devices, and advanced analytics to 
provide personalized insights and treatment support. This platform is complemented by 
patient-facing applications that enable engagement, coaching, and remote care coordination. 
Verily also offers a suite of platforms supporting clinical research and population health. 
These include Workbench, a scalable environment for multi-omic data analysis and large-
scale research programs, and Viewpoint, a platform for clinical trial management and real-
world evidence generation. In public health, Verily has developed solutions for disease 
surveillance and population monitoring, including tools for tracking infectious diseases 
through environmental and data-driven approaches. 
 

 
 
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The company is expanding its capabilities in artificial intelligence and data science, 
integrating predictive analytics and machine learning across its platforms to enhance disease 
detection, monitoring, and treatment optimization 

 
 
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Chapter 20: Company Profiles: Hematology 
(Cell Analysis) and Coagulation Specialists 
Scope 
This section presents a selection of companies that specialize in cell analysis. The profiles 
are not a comprehensive review or history of the companies selected to appear in the section 
and are listed alphabetically. 
 
 
 

 
 
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CellaVision AB 
Lund, Sweden 
www.cellavision.com 
CellaVision AB develops and markets systems for digital cell morphology and automated 
analysis of blood and other body fluids in clinical laboratories. The company’s technology 
combines advanced imaging, automated microscopy, and artificial intelligence to provide the 
identification, classification, and review of blood cells, improving workflow efficiency and 
diagnostic consistency in hematology. 
CellaVision’s portfolio includes digital morphology analyzers such as the DM-series, 
including systems designed for mid- to high-volume laboratories that automate the manual 
differential count of white blood cells and assessment of red blood cell morphology. These 
systems capture high-resolution images of blood smears, pre-classify cells using AI-based 
algorithms, and present results for verification by laboratory professionals. By digitizing 
traditionally manual microscopy workflows, the systems enhance standardization, enable 
remote review, and improve productivity. The portfolio has expanded to include compact 
systems such as the DC-1, which brings digital cell morphology capabilities to smaller 
laboratories and decentralized settings. 
The company has also developed integrated workflow solutions that extend beyond analysis 
to include sample preparation. Through the integration of RAL Diagnostics products, 
CellaVision offers solutions for automated smearing and staining, improving pre-analytical 
quality and consistency. Systems such as the DIFF-Line combine smear preparation, staining, 
and digital analysis into a streamlined workflow tailored for smaller laboratories, enabling 
end-to-end automation of peripheral blood smear processing. 
CellaVision has advanced its software capabilities, including tools for education, proficiency 
testing, and quality assurance, as well as enhanced connectivity that allows digital images 
and results to be shared across laboratory networks. Strategic collaborations, including its 
long-standing and expanded partnership with Sysmex Corporation, support integration of 
digital morphology with hematology analyzers and broader laboratory automation systems. 
This partnership was further strengthened by a renewed strategic alliance agreement that 

 
 
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extends collaboration through 2038, enabling deeper co-development, system integration, 
and workflow optimization across hematology platforms. 
CellaVision is focused on expanding the adoption of digital morphology through scalable 
platforms, AI-driven image analysis, and integrated workflow solutions, supporting 
laboratories of varying sizes in transitioning from manual microscopy to standardized, 
automated hematology diagnostics. 

 
 
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Masimo Corporation 
Irvine, CA  
www.masimo.com 
Masimo Corporation offers advanced noninvasive patient monitoring technologies centered 
on its Signal Extraction Technology (SET) platform. This technology enables accurate 
monitoring of physiological parameters under challenging clinical conditions and forms the 
basis of Masimo’s rainbow pulse CO-oximetry, which allows continuous, noninvasive 
measurement of multiple blood constituents, including total hemoglobin, along with other 
key parameters. 
Masimo’s product portfolio includes the Radical-7 Pulse CO-Oximeter, a flagship monitor 
that tracks multiple parameters, including oxygen saturation, pulse rate, perfusion index, and 
total hemoglobin. The system is used across a wide range of care settings, including operating 
rooms, intensive care units, emergency departments, and neonatal care, to support 
continuous, noninvasive patient assessment. 
The company has continued to expand its monitoring platform with portable and modular 
systems. Devices such as the Rad-G with Temperature provide handheld monitoring of pulse 
oximetry, respiration rate derived from the pleth waveform, and temperature, extending 
Masimo’s capabilities into point-of-care and ambulatory environments. The Radium 
platform further advances this strategy as a modular, scalable patient monitoring system 
integrating multiple parameters, including pulse oximetry, blood pressure, ECG, 
temperature, and respiration, enabling flexible deployment across hospital settings. 
Masimo has also expanded into new categories of monitoring and patient safety. The Opioid 
Halo system represents a wearable solution designed to detect and alert caregivers to opioid-
induced respiratory depression, marking an entry into overdose prevention and remote 
monitoring. In addition, the company has broadened its portfolio into wearable and home-
based monitoring with products such as the Masimo W1 medical watch, which enables 
continuous tracking of oxygen saturation and other physiological parameters in ambulatory 
and home settings. The company has also expanded its consumer and home-use offerings, 
including fingertip pulse oximeters and connected monitoring solutions that support remote 
patient monitoring and telehealth integration. 

 
 
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Nova Biomedical Corporation (Nova) 
Waltham, MA 
www.novabio.us.  
Nova Biomedical is a developer, manufacturer, and marketer of advanced blood-testing 
analyzers and point-of-care testing systems for clinical and research applications. The 
company is one of the largest privately held in vitro diagnostics firms in the United States 
and maintains global operations, with manufacturing in the U.S., Taiwan, and Brazil, and 
subsidiaries across North America, Europe, and Asia. 
Nova’s analyzers use a broad range of measurement technologies, including potentiometric, 
amperometric, conductivity, immunochemical, spectrophotometric, photometric, and 
biosensor-based methods, that support testing in whole blood, plasma, and cell culture media. 
The company is particularly known for its STAT testing platforms, which provide rapid, 
multi-parameter results in critical care settings such as emergency departments, intensive 
care units, and operating rooms. Its product portfolio includes both central laboratory and 
point-of-care systems, as well as handheld meter-and-strip platforms for glucose, ketone, 
lactate, and creatinine testing. 
Nova’s StatStrip platform remains a cornerstone of its point-of-care offering, designed to 
improve glucose measurement accuracy by correcting for hematocrit and minimizing 
interferences that can impact critically ill patients. The company has expanded this platform 
with next-generation hospital glucose meter systems that enhance connectivity, 
interoperability with laboratory and hospital information systems, and usability in high-
acuity environments. In addition, the Nova Max Pro system provides rapid creatinine and 
estimated glomerular filtration rate testing, with increasing adoption in decentralized care 
settings and screening programs for early detection of kidney disease. 
In critical care diagnostics, Nova has expanded its analyzer portfolio with the Prime and 
Prime Plus systems, positioned as next-generation critical care analyzers that deliver 
comprehensive panels of blood gas, electrolyte, metabolite, and hematology parameters from 
small sample volumes with rapid turnaround times. These systems are designed to compete 
with leading critical care platforms by offering expanded menus, workflow efficiency, and 
ease of use. The company has also introduced the Nova Primary glucose reference analyzer, 

 
 
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which is gaining adoption as a replacement for legacy laboratory glucose analyzers and 
provides high-accuracy reference measurements in central laboratories. 
Nova has expanded through industry consolidation. The acquisition of Nova Biomedical by 
Advanced Instruments was completed in 2025, resulting in a merged organization operating 
under the Nova Biomedical name. This combination brings together complementary 
strengths in clinical diagnostics and bioprocessing, further strengthening the company’s 
position across healthcare and life sciences markets. 
 
 

 
 
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Chapter 21: Company Profiles: 
Histopathology Specialists 
Scope 
This section presents a selection of companies that specialize in tissue analysis using 
histopathology techniques for molecular analysis. They have brought and continue to bring 
innovation to the segment. This is not a comprehensive review or history of the companies 
selected to appear in the section and is listed alphabetically. 

 
 
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Amoy Diagnostics Co. Ltd. 
Xiamen, China 
www.amoydx.com 
Amoy Diagnostics Co., Ltd. develops and commercializes molecular diagnostic assays for 
oncology, serving healthcare providers, academic institutions, and pharmaceutical partners. 
The company specializes in detecting gene mutations and measuring gene expression in 
formalin-fixed, paraffin-embedded tumor tissue, with technologies spanning real-time PCR 
and next-generation sequencing. Its proprietary ADx-ARMS PCR platform enables rapid, 
sensitive mutation detection and is widely used in clinical laboratories due to its ease of use 
and compatibility with standard PCR instrumentation. 
AmoyDx has established a broad portfolio of oncology assays targeting key driver mutations, 
including EGFR, KRAS, NRAS, BRAF, PIK3CA, ALK, ROS1, RET, KIT, JAK2, BCR-
ABL, and TP53, along with gene expression assays such as ERCC1, TYMP, STMN1, and 
RRM1 that support chemotherapy decision-making. The company’s assays are widely used 
across solid tumors and hematologic malignancies and have achieved regulatory approvals 
across China, Europe, and Asia, reflecting strong global adoption of its PCR-based 
companion diagnostics. 
AmoyDx’s portfolio includes the Pan Lung Cancer PCR Panel, which enables simultaneous 
detection of multiple actionable driver mutations in non-small cell lung cancer. This panel 
continues to expand its clinical utility through additional companion diagnostic approvals for 
targeted therapies, including RET, MET, and ROS1 inhibitors, reinforcing its role as a rapid, 
front-line, multi-biomarker testing solution in lung cancer. 
AmoyDx has also expanded into immuno-oncology and next-generation sequencing. The 
company has developed PD-L1 expression assays to guide immunotherapy selection and 
introduced broader genomic profiling solutions such as its Essential NGS Panel, which offers 
multi-gene mutation detection and is increasingly positioned as a primary companion 
diagnostic platform for targeted therapies, including detection of EGFR exon 20 insertion 
mutations. This reflects a strategic shift toward combining rapid PCR-based testing with 
more comprehensive NGS-based profiling. 

 
 
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The company’s portfolio has further expanded through companion diagnostic development 
beyond lung cancer, including assays targeting BRCA and homologous recombination repair 
mutations for prostate and breast cancer, HER2 mutation testing associated with targeted 
therapies, and IDH1/2 mutation assays developed through pharmaceutical collaborations. 
These additions broaden AmoyDx’s reach across multiple oncology indications. 
AmoyDx maintains extensive and ongoing collaborations with global pharmaceutical 
partners, supporting companion diagnostic development, biomarker identification, and 
targeted therapy selection across multiple cancer types 

 
 
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Applied Spectral Imaging Inc. (ASI) 
Carlsbad, CA 
www.spectral-imaging.com 
Applied Spectral Imaging (ASI) is a provider of automated microscopy imaging and digital 
analysis solutions for cytogenetics and pathology laboratories. Founded in 1993, the 
company has established a global presence with thousands of systems installed worldwide 
and a broad distributor network across North America, Europe, and Asia. ASI focuses on 
improving laboratory efficiency and diagnostic accuracy through automation, digital 
imaging, and advanced software for analysis of immunohistochemistry and fluorescence in 
situ hybridization assays. 
ASI’s portfolio is focused on its GenASIs platform, a modular software and imaging 
environment that supports a wide range of cytogenetic and pathology applications. Core 
solutions include BandView for karyotyping, FISHView for fluorescence in situ 
hybridization analysis, and SpotScan applications supporting assays such as CEP XY, 
UroVysion, ALK, and HER2. The company has expanded this platform with additional 
modules such as HiFISH, HiBand, and CytoPower, enabling comprehensive chromosome 
analysis and FISH workflows. In digital pathology, ASI offers solutions such as HiPath and 
HiPath Pro, which provide scanner-agnostic image analysis and quantitative interpretation 
for immunohistochemistry. 
The GenASIs platform has evolved into an integrated, all-in-one workflow solution that 
combines cytogenetics, FISH, and digital pathology within a unified system. Enhancements 
in recent software releases, including versions 8.4 and 8.4.1, introduce improved AI-assisted 
chromosome classification, advanced karyotyping tools, mitotic index calculation, and 
enhanced automation capabilities. The platform also supports remote and distributed 
workflows through solutions such as GenASIs AnyWhere, enabling telepathology, remote 
case review, and collaboration across laboratory networks. 
ASI continues to strengthen its system through strategic partnerships and integration 
initiatives. Collaborations with companies such as CytoCell, a division of Oxford Gene 
Technology within Sysmex Corporation, expand access to complementary probe 
technologies and global distribution channels. Partnerships with digital imaging providers, 

 
 
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including Barco and Motic, support integrated digital pathology solutions that combine 
imaging hardware, displays, and analysis software. In addition, ASI has expanded its 
capabilities through integration within the ZYTOMICS group, supporting the development 
of more comprehensive end-to-end diagnostic solutions that combine reagents, imaging, and 
analytics. 

 
 
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Visiopharm 
Hørsholm, Denmark 
www.visiopharm.com 
Visiopharm provides quantitative digital pathology software solutions that enable 
pathologists and researchers to analyze tissue samples with high accuracy, reproducibility, 
and efficiency. Headquartered in Denmark with a North American presence in Colorado, the 
company focuses on image analysis, artificial intelligence, and workflow optimization for 
clinical diagnostics, life sciences research, and biopharmaceutical applications. 
Visiopharm’s platform focuses on modular software suites such as Oncotopix and Biotopix, 
which deliver advanced image analysis algorithms for tissue-based diagnostics and research. 
These platforms automate histological assessment and are used across cancer diagnostics, 
translational research, and drug development. Central components of the platform include 
the Engine module for processing digitized tissue sections and executing analysis 
applications, and the Viewer/Viewer+ modules, which support a wide range of whole-slide 
imaging formats and modalities, including brightfield, fluorescence, and multispectral 
imaging. The Author module enables users to develop and customize analysis applications 
without requiring programming expertise, supporting flexible deployment across 
laboratories. 
The platform is further enhanced with specialized tools such as Tissuealign for alignment 
and analysis of serial sections, Tissuearray for high-throughput tissue microarray analysis, 
and Stereotopix for unbiased quantification of tissue morphology using stereological 
methods. These capabilities allow for detailed analysis of tumor microenvironments, 
biomarker expression, and tissue architecture. The company also offers integration with high-
resolution slide scanners, including systems developed by Hamamatsu Photonics, enabling 
efficient digitization, storage, and sharing of pathology images across networks. 
Visiopharm continues to expand its capabilities through artificial intelligence and multiplex 
imaging. Solutions such as Phenoplex provide integrated workflows for multiplex tissue 
analysis, enabling simultaneous evaluation of multiple biomarkers within a single tissue 
sample. The company also offers the advanced diagnostic algorithms, including Ki67 
proliferation analysis tools, supporting clinical decision-making in oncology, and continued 

 
 
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enhancement of its platform through ongoing software updates that improve AI performance, 
workflow automation, and diagnostic application development. 
Strategic collaborations remain a key component of Visiopharm’s growth. The company has 
partnered with organizations such as Proscia, Deep Bio, Minerva Imaging, Grundium, 
Agilent, and PathAI to expand interoperability and integrate AI-driven pathology solutions. 
More recent collaborations include integration with Indica Labs’ image management 
platform to enable seamless workflow connectivity, partnerships in spatial biology with Cell 
Signaling Technology, and collaborations with research organizations such as Glint Lab to 
enhance biomarker discovery and tissue analysis workflows. 
 

 
 
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Chapter 22: Company Profiles: Immunoassay Specialists 
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Chapter 22: Company Profiles: Immunoassay 
Specialists 
Scope 
This section presents a selection of companies that specialize in immunoassays and have 
brought and continue to bring innovation to this segment in 2025. It is not a comprehensive 
review or history of the companies selected to appear in the section and is listed 
alphabetically. 

 
 
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Biohit Healthcare 
Helsinki, Finland 
www.biohithealthcare.com  
Biohit Oyj, founded in 1988, develops and markets diagnostic tests and laboratory solutions 
focused on gastrointestinal diseases and associated conditions. The company operates 
internationally with subsidiaries in Europe and Asia and is listed on the Nasdaq Helsinki 
exchange. Biohit’s strategy centers on noninvasive diagnostic testing, particularly for 
conditions related to digestive health and nutrient absorption. 
Biohit’s  product portfolio includes the GastroPanel test, a blood-based diagnostic panel used 
to assess Helicobacter pylori infection and atrophic gastritis. The test measures key 
biomarkers, including pepsinogen I, pepsinogen II, gastrin-17, and H. pylori antibodies, 
providing a noninvasive method to evaluate gastric mucosal status. GastroPanel is also used 
to identify patients at increased risk of gastric cancer, peptic ulcer disease, gastroesophageal 
reflux disease, and deficiencies in vitamin B12, calcium, and iron, and continues to be 
positioned as a key tool for risk stratification, early detection, and population-level screening 
of gastric diseases. 
Additionally, Biohit offers a range of rapid and laboratory-based tests targeting 
gastrointestinal and metabolic conditions. These include assays for active vitamin B12 
(holotranscobalamin), celiac disease testing based on transglutaminase antibodies, and rapid 
tests for Helicobacter pylori and lactose intolerance. The company’s Celiac Quick Test 
enables point-of-care detection from a fingerstick blood sample, supporting faster diagnosis 
in decentralized settings. 
Biohit also provides stool-based diagnostics, including calprotectin testing to differentiate 
inflammatory bowel disease from irritable bowel syndrome, as well as fecal 
immunochemical tests such as ColonView for colorectal cancer screening. ColonView 
continues to gain adoption as a noninvasive screening tool with improved sensitivity 
compared to traditional methods, supporting broader use in colorectal cancer screening 
programs. 

 
 
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Recent product developments include the introduction of the FAEX Sample System, 
designed to improve stool sample collection, handling, and workflow efficiency in fecal 
testing applications. This addition complements Biohit’s existing gastrointestinal testing 
portfolio by addressing pre-analytical challenges and supporting more reliable diagnostic 
results. Biohit continues to enhance its gastrointestinal diagnostic portfolio through 
incremental improvements to its core assays and sample-handling solutions, with an ongoing 
focus on noninvasive screening and early disease detection. 
 

 
 
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Biomerica Inc. 
Irvine, CA 
www.biomerica.com  
Biomerica, Inc. develops, manufactures, and markets diagnostic products for use in the home, 
physician offices, and clinical laboratories, with a focus on early detection and monitoring of 
disease. The company’s portfolio spans gastrointestinal health, diabetes, women’s health, 
allergy and food sensitivity, and selected infectious disease applications, with a strong 
emphasis on point-of-care and over-the-counter testing. 
Biomerica’s consumer product line includes widely distributed over-the-counter tests such 
as EZ Detect for fecal occult blood, Fortel pregnancy tests, and the Aware Breast Self-
Examination Pad. EZ Detect remains a flagship product, offering a noninvasive approach to 
colorectal screening that does not require direct stool handling or dietary restrictions, 
supporting ease of use in home settings. The company also offers Fortel Microalbumin 
Screening tests for early detection of kidney dysfunction, particularly in diabetic patients, 
and continues to expand its portfolio of rapid and home-use diagnostics. 
In 
laboratory 
diagnostics, 
Biomerica 
provides 
ELISA-based 
assays 
including 
Transglutaminase IgA and Antigliadin IgA/IgG tests for celiac disease, as well as food 
sensitivity panels such as the Food Intolerance 14G test. The company has also expanded its 
gastrointestinal testing portfolio with products targeting Helicobacter pylori infection, 
including hp+detect and Fortel Ulcer tests, supporting both clinical and point-of-care 
applications. 
Biomerica markets diagnostic offerings such as the InFoods IBS test, a laboratory-developed 
test designed to identify patient-specific food triggers associated with irritable bowel 
syndrome, enabling more targeted dietary management. The company has expanded this 
platform with the introduction of an AI-enabled dietary management tool that provides 
personalized guidance, meal planning, and food substitution recommendations to improve 
patient adherence and outcomes. Clinical validation studies and real-world data continue to 
support the effectiveness of the InFoods approach, and recent reimbursement developments 
are expected to support broader clinical adoption. The company continues to advance this 

 
 
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platform with additional InFoods-based applications focused on personalized nutrition and 
gastrointestinal health. 
Geographically, Biomerica has expanded its distribution footprint through international 
partnerships. Agreements in regions such as China and the Middle East support broader 
access to its colorectal cancer screening and breast self-examination products, while recent 
commercialization collaborations, including partnerships to expand physician adoption in the 
United States, are expected to further drive uptake of its diagnostic solutions. 

 
 
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Bio-Techne Corporation 
Minneapolis, MN 
www.bio-techne.com  
Bio-Techne is a developer and manufacturer of bioactive tools and diagnostic solutions for 
research, clinical, and biopharmaceutical applications. With more than four decades of 
experience, the company is a leading supplier of proteins, including cytokines and growth 
factors, antibodies, immunoassays, and small molecules used by biomedical researchers and 
clinical laboratories worldwide. 
Bio-Techne has expanded its capabilities in cell and gene therapy by offering a 
comprehensive portfolio that includes GMP-grade cytokines, growth factors, media, and 
small molecules, as well as antibodies for cell characterization. The company has also 
provided enabling technologies such as Cloudz cell activation kits and automated 
immunoassay platforms like Ella, designed to streamline workflows, improve 
reproducibility, and support quality control in advanced therapy manufacturing. Recent 
additions include innovations in cell culture systems such as synthetic extracellular matrices 
designed to improve consistency and scalability in organoid and stem cell workflows, as well 
as GMP-ready cytokine packaging formats that support closed-system manufacturing 
environments. 
The ProteinSimple-branded portfolio offered by Bio-Techne includes platforms such as 
Maurice and MauriceFlex, which support protein characterization through charge variant 
analysis and electrophoretic separation. Enhancements such as the CE-SDS PLUS system 
improve data consistency and analysis of complex biologics, while newer systems expand 
automation and increase throughput for protein analysis. The Ella platform continues to 
evolve with customizable cartridge options, enabling flexible, high-throughput 
immunoassays for research and bioprocessing applications. 
Bio-Techne has also strengthened its position in molecular and spatial biology through its 
Advanced Cell Diagnostics RNAscope technology, which enables highly sensitive in situ 
hybridization for RNA detection. New assay formats and expanded probe menus support 
applications in oncology, gene therapy, and translational research. The company further 
expanded its spatial biology capabilities through the acquisition of Lunaphore, adding 

 
 
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automated multiplex tissue analysis and microfluidics-based imaging platforms and enabling 
integrated RNA and protein analysis workflows. 
Strategic partnerships and collaborations play a key role in Bio-Techne’s growth. The 
company has established relationships with organizations such as Thermo Fisher Scientific, 
Akoya Biosciences, and Spear Bio to expand distribution, enhance spatial biology 
workflows, and advance ultrasensitive immunoassay technologies. More recent 
collaborations include partnerships in AI-enabled protein engineering, expanded agreements 
in genetic sequencing technologies, and collaborations supporting biopharmaceutical 
standards and advanced therapeutic development. 
Recent developments also include biomarker assay initiatives designed for point-of-care 
applications on existing immunoassay platforms, as well as the continued expansion of 
distribution agreements to broaden global reach. The company has also streamlined its 
portfolio through selective divestitures while retaining access to underlying technologies for 
future development. 

 
 
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Eurobio Scientific 
Paris, France 
www.eurobio-scientific.com  
Eurobio Scientific is a Paris-based diagnostics group formed through the combination of 
Exonhit, InGen BioSciences, and Eurobio, creating a diversified provider of proprietary and 
distributed in vitro diagnostic products. The company operates across Europe, with an 
additional international presence, and has expanded through a series of acquisitions to build 
a broad portfolio spanning transplantation, infectious diseases, oncology, and specialty 
diagnostics. 
Eurobio Scientific markets a mix of proprietary assays and distributed products. Its 
proprietary portfolio includes tests such as Tetanus Quick Stick for assessing tetanus 
immunity and BJI Inoplex for diagnosing bone and joint prosthetic infections. The company 
has also commercialized molecular diagnostics such as AlloMap in Europe under license for 
heart transplant monitoring, along with internally developed assays including thyroid cancer 
diagnostics designed to support clinical decision-making when cytology results are 
inconclusive. 
The company has significantly expanded its molecular diagnostics capabilities, including 
mobile and decentralized testing solutions through agreements such as the commercialization 
of compact PCR-based systems designed for point-of-care and emergency use. Eurobio has 
also developed multiplex PCR assays under its Eurobioplex brand, including tests for 
respiratory viruses and emerging infectious diseases, supporting routine screening and 
variant detection. Additional developments include specialized assays such as fertility-
related PCR tests targeting genetic markers associated with male infertility, as well as newer 
IVDR-compliant molecular assays that strengthen its regulatory and product positioning in 
Europe. 
Eurobio Scientific has pursued an active acquisition strategy to strengthen its product 
portfolio and geographic reach. Key acquisitions include GenDx, which enhanced its HLA 
typing capabilities for transplantation compatibility, and multiple European distributors that 
expanded its commercial footprint across regions such as Benelux and Southern Europe. 

 
 
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More recent acquisitions, including companies and assets focused on molecular biology and 
oncology diagnostics, continue to broaden its capabilities and distribution network. 
The company has also expanded its oncology diagnostics portfolio through agreements to 
distribute advanced biomarker tests, including genomic assays such as EndoPredict and 
Prolaris, as well as blood-based biomarkers for monitoring treatment response in cancer 
patients. These additions complement its growing presence in precision medicine and 
companion diagnostics. Eurobio Scientific has further strengthened this strategy by 
advancing companion diagnostic development through collaborations in immuno-oncology 
and precision medicine, including initiatives leveraging HLA-based technologies. 
 

 
 
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EUROIMMUN AG (Revvity) 
Lübeck, Germany 
www.euroimmun.com  
A Revvity company, EUROIMMUN, founded in 1987, is a global developer and 
manufacturer of diagnostic reagents and systems, with subsidiaries across Europe, North 
America, Asia, and other regions. The company continues to operate under its established 
brand while benefiting from integration within Revvity’s broader life sciences and 
diagnostics portfolio. 
EUROIMMUN focuses on laboratory diagnostics for autoimmune diseases, infectious 
diseases, and allergy testing. Its technologies include indirect immunofluorescence, ELISA, 
chemiluminescence immunoassays, blot-based assays such as EUROLINE and 
EUROASSAY, and molecular diagnostic methods including PCR-based testing. The 
company is particularly known for its BIOCHIP technology, which enables miniaturized, 
standardized multiplex immunofluorescence testing by combining multiple substrates on a 
single slide. BIOCHIP mosaics enable the simultaneous detection of multiple antibodies, 
supporting efficient and comprehensive diagnostics for autoimmune and infectious diseases. 
EUROIMMUN offers a broad menu of ELISA and immunoassay tests, as well as advanced 
blot systems that improve specificity and differentiation of antibodies that may be difficult 
to interpret using traditional immunofluorescence. Its platforms support both manual and 
automated workflows, including integration with digital microscopy systems such as 
EUROPattern for automated image acquisition and interpretation. 
The company has continued to expand its product portfolio with molecular and specialty 
diagnostics. These include multiplex PCR assays such as EUROArray panels for infectious 
disease detection, as well as applications in oncology and women’s health, including tests 
used alongside HPV screening to assess cancer risk. EUROIMMUN has also expanded into 
therapeutic drug monitoring with both ELISA- and chemiluminescence-based assays, and 
into genetic testing, including APOE genotyping. 
EUROIMMUN has strengthened its automation strategy with the introduction of the IDS i20, 
a fully automated random-access immunoassay platform designed to support high-

 
 
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throughput chemiluminescence testing across multiple diagnostic areas, including 
autoimmune, infectious disease, allergy, and endocrinology. In addition, the company 
continues to expand assay menus on platforms such as UNIQO, enabling broader 
autoimmune and specialty testing panels. 
Recent developments also include continued additions to infectious disease testing, such as 
measles antibody detection assays, and expansion of molecular diagnostics through 
partnerships that increase access to PCR-based test kits across European markets. 
EUROIMMUN remains an active and growing diagnostics provider within Revvity, 
continuing to develop and commercialize its own branded products while expanding its 
capabilities across immunology, molecular diagnostics, and automation-driven laboratory 
workflows. 
 
 

 
 
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INOVA Diagnostics, Inc. 
San Diego, CA  
www.inovadiagnostics.com 
INOVA Diagnostics, part of Werfen, is a long-established provider of autoimmune 
diagnostic reagents and systems with nearly three decades of experience supporting clinical 
laboratories. The company focuses on assays for autoimmune diseases including anti-
phospholipid syndrome, celiac disease, connective tissue disorders, gastrointestinal and liver 
diseases, rheumatoid arthritis, thyroid disorders, and vasculitis, and remains a key player in 
the global autoimmunity diagnostics market. Its portfolio includes QUANTA Lite ELISA 
assays, NOVA Lite IFA kits, NOVAGel systems, QUANTA Chek reference panels, and 
QUANTA Plex multiplexing reagents, which are run on BIO-FLASH chemiluminescent 
analyzers, NOVA View automated fluorescence microscopes, and QUANTA-Lyser 
processing systems. These platforms are integrated through QUANTA Link software, 
enabling automated workflow management across IFA, ELISA, and chemiluminescence 
testing and supporting improved standardization and laboratory efficiency. 
The company expanded its chemiluminescent QUANTA Flash menu on BIO-FLASH, 
particularly in rheumatoid arthritis and connective tissue disease testing, including assays for 
CCP antibodies and rheumatoid factor isotypes, as well as additional markers supporting 
earlier and more comprehensive autoimmune disease detection. Its NOVA Lite DAPI ANA 
and dsDNA Crithidia luciliae assays are used for systemic lupus erythematosus testing, with 
ongoing emphasis on automation and digital image interpretation through NOVA View.  
INOVA has been focusing on consolidation of autoimmune testing onto fewer platforms, 
broader adoption of random-access chemiluminescence, and improved connectivity across 
laboratory networks. As part of Werfen, the business is also benefiting from greater global 
reach and alignment with Werfen’s broader specialty diagnostics strategy, with continued 
investment in menu expansion, workflow automation, and integrated data management 
solutions. 

 
 
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VolitionRx Limited 
Namur, Belgium 
www.volitionrx.com  
VolitionRx Limited, founded in 2010 and operating as Volition, is a diagnostics company 
focused on developing blood-based tests for cancer and other diseases using epigenetic 
biomarkers. The company’s research and development activities are centered in Belgium, 
with additional international operations supporting its global commercialization strategy. 
Volition’s core technology platform, Nu.Q, is based on nucleosomics, which enables the 
detection and characterization of circulating nucleosomes in blood. These nucleosomes carry 
disease-specific signatures, including patterns of histone modifications, DNA methylation, 
and other structural changes, enabling differentiation between cancerous and non-cancerous 
conditions, as well as between different cancer types. The company’s goal is to develop 
simple, noninvasive blood tests that can be used routinely for early detection, prognosis, and 
disease monitoring. 
The Nu.Q platform has expanded into a range of applications, including oncology, 
inflammatory diseases, and veterinary diagnostics. In cancer diagnostics, Volition has 
advanced its Nu.Q cancer assays toward commercialization, with initial clinical adoption and 
use in specialized laboratories to support prognosis and treatment decision-making. The 
company continues to generate clinical data across multiple cancer types, including lung, 
colorectal, and ovarian cancers. 
Volition has broadened the application of its Nu.Q NETs assays, which are designed to detect 
neutrophil extracellular trap formation associated with inflammation and immune response. 
These assays are being evaluated and implemented in additional clinical settings, including 
sepsis and chronic inflammatory conditions, reflecting expansion into non-oncology 
indications. 
Strategic collaborations remain central to Volition’s growth, including partnerships to 
support market entry in Asia, expansion of veterinary diagnostics, and use of Nu.Q assays in 
pharmaceutical clinical trials. The company is also participating in large-scale clinical and 

 
 
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real-world evaluation programs to demonstrate the clinical utility of its biomarkers for early 
disease detection. 
Volition is transitioning from a development-stage company to early commercialization, 
expanding its nucleosomics platform across oncology, inflammation, and veterinary 
diagnostics while building partnerships to support global adoption and clinical integration. 
 
. 
 
 
 
 
 
 
 

 
 
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Chapter 23: Company Profiles: Microbiology 
Specialists 
Scope 
This section presents a selection of companies that have specialized in molecular and 
immunoassay-based pathogen detection (microbiology) tests and technologies. They have 
brought and continue to bring innovation to the segment. The profiles include events that 
have occurred in the past several years; they are not a comprehensive review or history of the 
companies selected to appear in the section and are listed alphabetically. 

 
 
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Advanced Biological Laboratories, S.A. (ABL) 
Luxembourg 
www.ablsa.com  
Advanced Biological Laboratories (ABL) is a biotechnology company founded in 2000 as a 
spin-off from CRP-Santé in Luxembourg. The company was further shaped through the 
merger with TherapyEdge, a clinical decision-support software company originally spun out 
of Triangle Pharmaceuticals, creating a combined organization focused on molecular 
diagnostics and bioinformatics-driven healthcare solutions. 
ABL specializes in infectious disease diagnostics and clinical decision support, particularly 
in virology. The company integrates molecular testing with advanced data analysis tools to 
support personalized treatment decisions for chronic viral infections such as HIV and 
hepatitis. Its solutions combine sequencing technologies, proprietary databases, and 
interpretation software to deliver clinically actionable insights. 
A main component of ABL’s portfolio is the ViroScore Suite, part of the TherapyEdge 
platform, which provides genotype interpretation, sequence analysis, and reporting tools for 
viruses including HIV. The platform leverages curated genetic databases and advanced 
algorithms to support viral subtyping, resistance interpretation, and treatment guidance. 
ABL has expanded its capabilities with the DeepChek platform, a next-generation 
sequencing-based solution designed to manage, analyze, and interpret high-throughput 
sequencing data. DeepChek supports multiple viral applications, including HIV, HBV, HCV, 
CMV, HSV, and tuberculosis, enabling laboratories to generate clinically relevant 
genotyping and drug-resistance reports for personalized patient management. The platform 
continues to evolve, with expanded workflows and integration of advanced library 
preparation technologies to improve scalability and reduce turnaround time. 
In addition to its sequencing-based solutions, ABL has introduced syndromic molecular 
diagnostics through its UltraGene portfolio of multiplex qPCR panels. These panels support 
the detection of a wide range of infectious diseases, including respiratory, neurological, 
gastrointestinal, and urogenital infections, enabling rapid and comprehensive pathogen 
identification in clinical settings. 

 
 
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ABL continues to expand globally through strategic collaborations and distribution 
agreements, including partnerships to support the commercialization of its molecular 
diagnostics platforms in Asia and the integration of new sequencing and bioinformatics 
technologies. The company has also extended its capabilities into oncology and viral 
genomics through licensing and research collaborations, further broadening its application 
areas. 

 
 
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altona Diagnostics 
Hamburg, Germany 
www.altona-diagnostics.com 
altona Diagnostics GmbH is a Hamburg-based molecular diagnostics company founded in 
2007 (originally as astra Diagnostics) and rebranded as altona Diagnostics in 2011. The 
company specializes in the development and commercialization of real-time PCR–based 
assays for the detection of infectious diseases, with a strong focus on emerging pathogens 
and rapid response to outbreak situations. 
altona Diagnostics offers a broad portfolio of CE-marked real-time PCR assays under its 
RealStar, AltoStar, and FlexStar product lines. These assays cover a wide spectrum of 
infectious diseases, including respiratory pathogens, gastrointestinal infections, blood-borne 
viruses, tropical diseases, and opportunistic infections such as herpesviruses and 
polyomaviruses. The company is also known for its Fever, Tropical, and Emerging (FTE) 
panel, which includes assays for pathogens such as dengue, chikungunya, and Zika virus, 
supporting testing in regions affected by endemic and emerging infectious diseases. 
The RealStar product line is a cornerstone of the portfolio, offering highly specific PCR kits 
for individual pathogens, including malaria, yellow fever, orthopoxviruses, and a wide range 
of viral and bacterial targets. The company has demonstrated agility in responding to 
emerging threats, developing assays for pathogens such as SARS-CoV-2, monkeypox virus, 
and other outbreak-related organisms. 
altona has expanded its offerings with the FlexStar platform, which provides multiplex PCR 
detection mixes for simultaneous identification and differentiation of multiple pathogens, 
including respiratory viruses, gastrointestinal infections, and co-infections such as SARS-
CoV-2 and influenza. The AltoStar platform offers automated, high-throughput molecular 
diagnostics workflows that integrate nucleic acid extraction and PCR testing for routine 
laboratory use, reflecting the company’s strategic focus on laboratory automation. 
In addition to assay development, altona provides workflow solutions, including nucleic acid 
extraction kits such as the ExtraStar Purification Kit, designed for automated systems and 

 
 
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optimized compatibility with its PCR assays. The company continues to expand its 
automation capabilities to support higher throughput and standardized laboratory workflows. 
Recent product developments include expanded assay menus across the AltoStar and 
FlexStar platforms, including new IVDR-compliant assays targeting parvovirus B19, 
hepatitis D virus, and Treponema pallidum, as well as multiplex panels for gastrointestinal 
pathogens and tropical diseases, including triplex detection of chikungunya, dengue, and 
Zika viruses. These developments reflect an ongoing transition toward IVDR-compliant 
products, expansion of multiplex testing capabilities, and continued emphasis on automated 
molecular diagnostic workflows. 

 
 
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ArcDia International Oy Ltd. 
Turku, Finland 
www.arcdia.com  
ArcDia International Ltd is a Finland-based diagnostics company focused on developing and 
commercializing rapid, multianalyte point-of-care testing solutions for infectious diseases. 
The company remains active and operating as of 2026, continuing to expand its mariPOC 
platform and proprietary ArcDia TPX detection technology. 
ArcDia’s core product is the mariPOC system, a fully automated point-of-care immunoassay 
platform designed for the rapid detection of respiratory and other infectious diseases. The 
system delivers results in approximately 20 minutes and is intended for near-patient settings 
such as clinics and emergency departments, enabling faster clinical decision-making and 
reducing the need for follow-up visits. The mariPOC test menu includes a broad panel of 
viral and bacterial pathogens associated with acute respiratory infections, as well as selected 
applications in gastrointestinal infections and tonsillitis. 
The mariPOC platform is based on ArcDia’s proprietary two-photon excitation fluorescence 
detection technology, which enables separation-free immunoassay analysis from small 
sample volumes. The system utilizes microparticle-based immunocomplex formation and 
optical detection to differentiate bound and unbound components, supporting high sensitivity 
and specificity without the need for traditional washing steps. This approach enables 
automated, walk-away testing with multiplexing capabilities. 
ArcDia has expanded the mariPOC system beyond the core analyzer to include integrated 
solutions such as syndromic respiratory panels, real-time epidemiological data platforms, and 
research-use tools for antimicrobial susceptibility testing. These additions offer broader 
clinical utility, including surveillance and infection management, and reflect a shift toward 
integrated diagnostic ecosystems. 
Since its initial launch, the mariPOC platform has expanded its geographic reach across 
Europe, the Middle East, and Asia through a network of distributors and partnerships. The 
company continues to strengthen its commercial footprint through healthcare collaborations, 
including recent agreements supporting the deployment of mariPOC systems in clinical 

 
 
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networks. ArcDia has also pursued international expansion strategies, including licensing 
and localization agreements to support production and commercialization in key markets 
such as China. 
Recent developments include continued enhancement of the mariPOC test menu and 
performance, particularly in respiratory diagnostics, as well as improvements in rapid 
antigen-based testing to better identify active infectious phases of disease. The company has 
also introduced advanced combination testing approaches for respiratory pathogens, 
including SARS-CoV-2, to support real-time clinical decision-making. 
 

 
 
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COPAN ITALIA S.p.A. and COPAN Diagnostics, Inc. 
Brescia, Italy and Murrieta, CA 
www.copangroup.com and www.copanusa.com 
COPAN Italia S.p.A., founded in 1979, is a global leader in microbiology sample collection, 
transport, and laboratory automation. Originally established as a distributor of laboratory 
products, the company quickly transitioned into manufacturing and became a pioneer in pre-
analytical solutions. COPAN operates worldwide through subsidiaries, including COPAN 
Diagnostics, Inc., which supports commercialization across the Americas. 
COPAN is widely recognized for its innovations in specimen collection and transport, 
including the development of FLOQSwabs, ESwab liquid-based microbiology collection 
systems, and Universal Transport Medium. These products are designed to improve sample 
quality, recovery, and compatibility with both culture-based and molecular diagnostic 
methods. FLOQSwabs, based on patented flocking technology, enhance sample uptake and 
release, enabling improved detection sensitivity for infectious disease testing. 
The company has expanded its portfolio beyond collection systems into laboratory 
automation, particularly in microbiology workflows. Key platforms include the WASP 
(Walk-Away Specimen Processor) and WASPLab, which automate specimen inoculation, 
incubation, imaging, and analysis. These systems are designed to streamline laboratory 
operations, improve standardization, and reduce manual workload. COPAN also offers a 
broad range of consumables, including microbial sampling devices, inoculation loops, and 
pipettes. 
COPAN continues to innovate in pre-analytics and automation, with products such as 
FecalSwab, a Cary-Blair–based stool collection and preservation system optimized for 
molecular and culture-based testing. The company has also advanced automation capabilities 
with systems such as Colibri, an automated pre-analytic processor that prepares samples for 
identification and antimicrobial susceptibility testing workflows, including integration with 
MALDI-TOF mass spectrometry systems. Software solutions such as PhenoMATRIX 
further enhance automation by enabling intelligent colony selection and workflow 
optimization. 

 
 
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Recent developments include expanded automation solutions across the laboratory 
workflow. These include systems for automated handling and tracking of positive blood 
cultures, platforms for automated urine specimen processing, and AI-driven digital 
microbiology tools that support image analysis and colony classification. The company has 
also extended its automation capabilities into pharmaceutical microbiology applications and 
continues to invest in manufacturing expansion to support growing global demand. 

 
 
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Genetic Analysis AS 
Oslo, Norway 
www.genetic-analysis.com  
Genetic Analysis AS is a privately held molecular diagnostics company focused on analyzing 
microbial imbalances in the gastrointestinal tract. The company develops DNA-based 
diagnostic solutions using its proprietary GA-map platform, which profiles gut microbiota 
composition and supports the identification of dysbiosis associated with gastrointestinal 
disorders, including irritable bowel syndrome and inflammatory bowel disease. 
The GA-map Dysbiosis Test is the company’s flagship product, offering CE-marked 
microbiome analysis for clinical use. The test is based on targeted DNA detection and 
provides a standardized profile of bacterial composition in stool samples, enabling clinicians 
to assess microbial imbalance and support diagnosis and treatment decisions. The platform 
is compatible with multiplex systems such as the Luminex MAGPIX instrument, allowing 
simultaneous detection of multiple bacterial targets in a single assay. 
Genetic Analysis is  expanding the clinical and commercial reach of its microbiome 
diagnostics through international regulatory approvals and distribution partnerships. The 
GA-map Dysbiosis Test has gained regulatory clearance in additional markets, including 
Asia, and is being commercialized through regional partnerships in areas such as Southeast 
Asia, India, and parts of Europe. These agreements support broader adoption of microbiome 
testing in both clinical and research settings. 
The company has also pursued strategic collaborations to extend its technology into new 
applications. Partnerships with industry and research organizations are focused on 
developing microbiome-based diagnostics and potential therapeutic solutions, as well as 
integrating microbiome testing into digital health platforms. These initiatives reflect a 
growing emphasis on combining diagnostic data with digital tools to support personalized 
healthcare. 
Recent product developments include expanding the GA-map platform with new solutions, 
such as AI-assisted interpretation tools that translate microbiome data into clinically 
actionable insights, and additional microbiome assays that provide standardized health 

 
 
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indices for gut microbiota assessment. The company is also advancing next-generation 
diagnostics for inflammatory bowel disease, designed to support prediction of disease 
progression and enable more personalized treatment strategies. 
More recent developments include expansion into direct-to-consumer testing markets, with 
adapted versions of the GA-map Dysbiosis Test introduced through regional partners to 
increase accessibility of microbiome analysis. These offerings are tailored to local markets 
while maintaining the underlying GA-map technology platform. 

 
 
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Q-linea AB 
Uppsala, Sweden 
https://qlinea.com 
Q-linea AB is a Sweden-based diagnostics company founded in 2008 that develops rapid 
antimicrobial susceptibility testing (AST) solutions to improve the management of infectious 
diseases, particularly sepsis. The company focuses on accelerating the identification of 
effective antibiotic treatments by providing phenotypic AST results faster than conventional 
laboratory methods. 
Q-linea’s primary platform is the ASTar system, a fully automated instrument that performs 
antibiotic susceptibility testing directly from positive blood cultures. The system delivers 
minimum inhibitory concentration (MIC) results within approximately six hours, 
significantly reducing the time required compared to traditional culture-based workflows. 
ASTar supports random access loading and utilizes comprehensive antibiotic panels covering 
a broad range of clinically relevant pathogens, including expanded panels for gram-negative 
bacteria with a large number of antibiotic-pathogen combinations. Following regulatory 
clearance, the company has begun commercialization of ASTar in key markets, including the 
United States, with early clinical adoption in hospital laboratories. 
The company is also developing the ASTrID platform, which is designed to combine rapid 
pathogen identification and susceptibility testing directly from whole blood samples. ASTrID 
utilizes padlock probe technology and circle-to-circle amplification to enable highly 
multiplexed detection of pathogens and resistance markers. While ASTrID remains in 
development, the company has shifted its strategic focus toward commercialization of the 
ASTar platform, with ASTrID positioned as a longer-term innovation. 
Q-linea has streamlined its operations to facilitate this commercial transition, focusing 
resources on expanding ASTar adoption, enhancing test menus, and improving operational 
efficiency. The company continues to update and expand its antibiotic panels to increase 
clinical utility, including broader pathogen coverage and resistance profiling. 
 

 
 
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The company has expanded its international footprint through distribution agreements in 
Europe and partnerships supporting market entry in regions such as the Middle East, while 
continuing to build its presence in the U.S. diagnostics market. 

 
 
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Chapter 24: Company Profiles: Molecular 
Test Specialists 
Scope 
In this section, Kalorama has selected a group of companies that have demonstrated 
longevity, market penetration, and/or contributed important innovation in molecular IVD. 
The profiles include events that have occurred in the past several years; they are not a 
comprehensive review or history of the companies selected to appear in the section and are 
listed alphabetically. 

 
 
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Pacific Biosciences of California, Inc. (PacBio) 
Menlo Park, CA 
www.pacb.com  
Pacific Biosciences of California, Inc. (PacBio) is a leading developer of advanced DNA 
sequencing technologies, with a focus on long-read sequencing. The company’s core 
platform is based on Single Molecule, Real-Time (SMRT) sequencing, which enables highly 
accurate, long-read analysis of complex genomes, structural variants, and epigenetic 
modifications. PacBio’s technology is widely used in applications such as de novo genome 
assembly, rare disease research, oncology, and population genomics. 
PacBio’s product portfolio has evolved significantly beyond earlier systems such as the RS 
II. The company now focuses its offerings on high-throughput, high-accuracy sequencing 
platforms, including the Sequel II and Sequel IIe systems, which utilize SMRT Cell 8M 
technology to deliver substantially higher data output and improved cost efficiency. These 
systems offer HiFi sequencing, which combines long read lengths with high accuracy, 
enabling more comprehensive genomic analysis. 
The company has expanded its platform lineup with the introduction of the Revio system, a 
high-throughput long-read sequencing platform designed for large-scale genomic studies, 
and the Vega system, a benchtop long-read sequencer that extends SMRT sequencing to 
smaller laboratories and decentralized settings. These platforms have been further enhanced 
with advanced sequencing chemistries that significantly reduce the cost of whole genome 
sequencing while improving throughput and performance. 
PacBio has also advanced its technology with new sequencing chemistries and workflows 
that enable integrated multiomic analysis, allowing simultaneous assessment of genomic 
variation and epigenetic features such as DNA modifications and chromatin structure. These 
developments strengthen the utility of SMRT sequencing in both research and emerging 
clinical applications. 
The company has increasingly focused its strategy on long-read sequencing, streamlining its 
portfolio to prioritize HiFi sequencing technologies while continuing to expand its 
applications in clinical genomics, rare disease research, and population-scale sequencing 

 
 
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projects. Enhancements to platforms such as Revio and Vega have improved scalability, 
speed, and cost efficiency, supporting broader adoption across research and clinical 
environments. 
PacBio continues to expand its global presence through strategic collaborations and 
partnerships, including initiatives that support rare disease research, large-scale genomic data 
generation, and AI-driven metagenomics, as well as collaborations aimed at enhancing 
sequencing workflows and enabling advanced multi-omic analysis. These partnerships 
strengthen its role in both research and clinical genomics systems. 

 
 
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Standard BioTools 
S. San Francisco, CA 
www.standardbio.com  
Standard BioTools Inc. develops, manufactures, and markets analytical and preparatory 
systems for applications in single-cell biology, genomics, and proteomics. The company’s 
platforms are based on proprietary microfluidics and mass cytometry technologies, designed 
to simplify workflows, increase throughput, and deliver high-quality, high-dimensional 
biological data. 
Standard BioTools’ technology includes integrated fluidic circuits (IFCs), which precisely 
control nanoliter-scale fluid movement and enable highly multiplexed reactions. A 
foundational product is the BioMark real-time PCR system, which supports high-throughput 
genetic analysis using dynamic array technology, enabling thousands of reactions to be 
performed simultaneously with reduced reagent consumption and improved efficiency. The 
system is widely used for gene expression analysis, genotyping, and the detection of rare 
mutations. 
The company’s portfolio also includes advanced solutions for single-cell and multiomic 
analysis. Platforms such as the C1 system support detailed cellular characterization, 
including applications that combine RNA and protein analysis within individual cells. 
Additional technologies enable highly multiplexed targeted sequencing and genomic 
profiling for research applications, including oncology. 
Standard BioTools is a leader in mass cytometry through its CyTOF and Imaging Mass 
Cytometry platforms, which allow high-dimensional analysis of proteins at the single-cell 
level. Systems such as Hyperion enable visualization and quantification of dozens of 
biomarkers simultaneously, supporting research in immunology, oncology, and drug 
development. The company has expanded these capabilities with next-generation imaging 
systems that improve speed, throughput, and reproducibility for large-scale and multi-site 
studies. The company offers next-generation mass cytometry systems with enhanced 
throughput and automation, further strengthening its position in high-dimensional single-cell 
and spatial biology research. 

 
 
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The company continues to enhance its product portfolio with high-throughput PCR systems, 
including advanced instruments capable of performing thousands of nanoliter-scale reactions 
per run, as well as expanded software and reagent solutions to support data analysis and 
workflow integration. It also offers comprehensive immune profiling solutions that enable 
standardized, reproducible analysis of immune cell populations across different sample types. 
Increasingly, the company is incorporating advanced data analytics and artificial intelligence 
approaches to support biomarker discovery and interpretation of complex multiomic datasets. 
Recent strategic developments include a shift in business focus, with the company divesting 
its SomaLogic proteomics business, including the SomaScan platform, to Illumina, Inc. in 
2025. This move reflects a strategic decision to concentrate on its core strengths in genomics, 
single-cell analysis, and mass cytometry, while streamlining operations and improving focus 
on high-growth research markets. 

 
 
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Chapter 25: Company Profiles: Point of Care 
Test Specialists 
Scope 
This section presents a selection of companies that specialize in point-of-care (POC) testing. 
This is not a comprehensive review or history of the companies selected to appear in the 
section and is listed alphabetically. 
 
 

 
 
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Abingdon Health Ltd. 
York, England, UK 
www.abingdonhealth.com 
Abingdon Health plc is a medical diagnostics company focused on the development, 
manufacture, and commercialization of point-of-care lateral flow immunoassays. The 
company specializes in rapid diagnostic technologies for a range of applications, including 
infectious diseases, women’s health, and other conditions requiring decentralized testing. 
While earlier efforts included work in areas such as hematology and oncology, the company’s 
primary focus has evolved toward infectious disease, consumer diagnostics, and contract 
development and manufacturing services. 
Abingdon Health offers proprietary lateral flow technologies, including nucleic acid lateral 
flow immunoassays such as PCRD and PCRD FLEX. These products provide a rapid and 
user-friendly alternative to traditional molecular detection methods, enabling visualization of 
amplified DNA products without the need for gel electrophoresis. The company’s platforms 
are designed for ease of use in both laboratory and near-patient settings. 
The company has established multiple collaborations to expand its test development and 
manufacturing capabilities. Partnerships with organizations such as Vatic Health and other 
developers have supported the creation of rapid tests for infectious diseases, including 
influenza and other viral pathogens. Abingdon has also positioned itself as a contract 
development and manufacturing organization providing lateral flow assay development, 
manufacturing, and regulatory support services to third-party partners. 
Abingdon Health has expanded its commercial activities in consumer diagnostics through 
distribution agreements, including the launch of saliva-based pregnancy testing products in 
European markets. These products reflect the company’s growing presence in over-the-
counter and home-testing segments. 
Recent developments include the expansion of manufacturing capacity with a new facility in 
the United States, strengthening its ability to serve international customers and scale 
production. The company has also entered into agreements to support regulatory submissions 

 
 
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for multiple self-tests targeting infectious diseases such as HIV, hepatitis B, hepatitis C, and 
syphilis, reflecting a continued push into regulated consumer and clinical markets. 
In addition, Abingdon Health has expanded its capabilities with digital tools for test 
interpretation, including smartphone-based reader applications, and has initiated 
development of more sustainable lateral flow devices using alternative materials. The 
company is also advancing a broader pipeline of multiplex and duplex lateral flow assays 
across infectious disease, pharmaceutical, and veterinary applications. These developments, 
combined with strong growth in CDMO contracts and expanding U.S. operations, highlight 
a strategic shift toward integrated diagnostic services and scalable manufacturing. 

 
 
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binx Health 
Trowbridge, UK 
www.mybinxhealth.com 
binx health, formerly Atlas Genetics, is a molecular diagnostics company focused on 
expanding access to rapid, point-of-care testing for sexually transmitted infections, 
particularly chlamydia and gonorrhea. The company’s main platform, the binx io, is an FDA-
cleared and CLIA-waived molecular system designed to deliver laboratory-quality PCR 
results in approximately 30 minutes, enabling true “test-and-treat” care in a single patient 
visit. The system offers both male urine and female vaginal swab samples and is positioned 
for use across decentralized healthcare settings including urgent care centers, public health 
clinics, and retail-based care environments. 
The binx io platform utilizes a proprietary electrochemical detection method and a cartridge-
based design capable of multiplex testing, supporting future menu expansion to include 
additional infectious disease targets such as HSV, HPV, Group A and Group B 
Streptococcus, and other high-impact conditions. While these expanded assays remain in 
development, the platform’s architecture supports broader applications, including infectious 
disease panels and potential companion diagnostics aligned with personalized medicine 
strategies. 
Recent developments highlight the company’s continued commercial and clinical 
momentum. binx Health has expanded national distribution through partnerships such as 
Cardinal Health and additional regional distributors, supporting wider adoption of its CLIA-
waived platform across the United States. The company also secured significant growth 
financing to accelerate commercialization and instrument placement. Clinical data released 
in 2025 demonstrated that the use of binx io significantly improves antibiotic stewardship, 
reducing inappropriate treatment rates by more than half and reinforcing its value in 
addressing antimicrobial resistance and improving patient outcomes. 
Strategically, binx health has streamlined its operations to focus on its core diagnostics 
platform following the divestiture of its consumer testing business. The company continues 
to advance decentralized care models through programs that combine on-site rapid testing 
with at-home sample-collection initiatives, improving access to screening and treatment for 

 
 
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underserved populations. As of 2026, binx health remains focused on expanding its installed 
base, advancing its test menu pipeline, and strengthening its position in the growing market 
for rapid molecular point-of-care diagnostics in sexual health and beyond. 
. 

 
 
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Chembio Diagnostic Systems, Inc. 
Medford, NY 
www.chembio.com 
Chembio Diagnostics, now part of Biosynex, develops and commercializes rapid diagnostic 
tests for infectious diseases, with a strong emphasis on point-of-care and decentralized testing 
markets. The company has established a strong presence in global HIV screening, with its 
rapid tests incorporated into national testing programs across Africa, Asia, and Latin 
America, supporting large-scale public health initiatives focused on early detection and 
treatment. These efforts remain aligned with ongoing international programs addressing 
HIV/AIDS and other infectious diseases in resource-limited settings. 
Chembio’s proprietary Dual Path Platform (DPP) technology continues to lead its product 
portfolio, offering a dual-membrane design that separates sample and reagent flow to 
improve assay performance, sensitivity, and specificity compared to traditional lateral flow 
tests. The platform also offers multiplexing capabilities, enabling the detection of multiple 
analytes from a single sample and supporting a development pipeline spanning HIV, syphilis, 
hepatitis C, and a range of tropical and neglected diseases affecting both human and animal 
health. 
Since its acquisition by Biosynex in 2023, Chembio has been integrated into a broader global 
diagnostics network, enabling expanded commercialization and distribution, particularly in 
Europe and emerging markets. The company’s strategy has shifted toward scaling its existing 
product portfolio while leveraging Biosynex’s manufacturing and market access capabilities 
to increase penetration in decentralized and public health testing environments. 
Recent developments highlight a growing emphasis on self-testing and consumer-access 
diagnostics. The SureCheck HIV Self-Test, a rapid immunochromatographic assay designed 
to detect antibodies to HIV-1 and HIV-2, has received Breakthrough Device designation and 
is being positioned for expanded use in at-home and community-based screening programs. 
This reflects a broader industry trend toward empowering patients through accessible 
diagnostic solutions and supporting earlier detection outside of traditional clinical settings. 
 

 
 
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As of 2026, Chembio’s direction focuses on expanding access to rapid infectious disease 
diagnostics through decentralized care models, advancing its multiplex DPP pipeline, and 
strengthening its role in global health initiatives, with particular emphasis on HIV and 
sexually transmitted infection testing in underserved populations. 
 
 

 
 
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Co-Diagnostics, Inc. 
Salt Lake City, UT 
www.codiagnostics.com 
Co-Diagnostics is a Utah-based molecular diagnostics company focused on the development, 
manufacture, and commercialization of PCR-based reagents and testing systems for 
decentralized, point-of-care, and at-home use. Following the sharp decline in COVID-19 
testing demand, the company has shifted its strategy toward expanding its broader infectious 
disease menu and advancing its Co-Dx PCR platform. The Co-Dx PCR Pro instrument, along 
with a companion at-home system, remains under regulatory review and is not yet 
commercially available as of 2026. The company has made progress toward regulatory 
clearance by initiating clinical evaluations of a multiplex respiratory assay capable of 
detecting influenza A and B, COVID-19, and RSV from a single test, positioning the platform 
within the growing syndromic testing segment. 
Beyond respiratory testing, Co-Diagnostics continues to expand its pipeline with assays 
targeting tuberculosis, HPV, and other infectious diseases, with development and validation 
efforts supported in part through its CoSara joint venture in India. CoSara plays an important 
role in advancing TB and HPV programs, reflecting India’s high burden of infectious 
diseases and increasing emphasis on accessible molecular diagnostics. In addition, Co-
Diagnostics is investing in workflow improvements, including the development of a 
proprietary sample preparation system designed to simplify point-of-care PCR testing. The 
company has also begun integrating artificial intelligence into its assay design and platform 
functionality to improve performance and reduce operator variability. 
Internationally, Co-Diagnostics is expanding its footprint through partnerships and joint 
ventures, including efforts to localize manufacturing and distribution in regions such as the 
Middle East, while continuing to strengthen its intellectual property position with new 
patents covering its PCR platform.  

 
 
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Genedrive plc (formerly Epistem Holdings) 
Manchester, UK 
www.Genedrive.com 
Founded in 2000 as Epistem Holdings, genedrive plc has evolved into a focused molecular 
diagnostics company centered on rapid, point-of-care genetic testing. While the company 
initially operated across contract research, pharmacogenomics services, and therapeutic 
development, its strategy has shifted toward commercialization of its proprietary Genedrive 
platform and a targeted menu of clinically actionable assays. 
The Genedrive system is a portable, rapid molecular diagnostic platform designed to deliver 
PCR-based genetic results in decentralized and near-patient settings. The device is 
engineered for ease of use, low cost, and fast turnaround times, typically providing results in 
under an hour. It offers high-sensitivity DNA analysis for applications including infectious 
disease detection, antimicrobial resistance, and pharmacogenomics, with a particular 
emphasis on enabling immediate clinical decision-making in acute care environments. 
A focus for the company is the MT-RNR1 ID Kit, a rapid point-of-care genetic test designed 
to identify neonates carrying a mitochondrial variant associated with aminoglycoside-
induced hearing loss. This test enables clinicians to avoid administering certain antibiotics to 
at-risk infants, preventing irreversible hearing damage. The assay has gained significant 
regulatory and clinical momentum, including positive recommendations from UK health 
authorities and Breakthrough Device designation in the United States. More recently, the 
MT-RNR1 test has transitioned into real-world clinical use, with increasing adoption across 
UK hospitals and expansion into broader neonatal screening programs, reflecting a shift from 
early innovation to routine clinical implementation. 
In addition, genedrive has expanded its presence in pharmacogenomics with the CYP2C19 
ID Kit, which detects key genetic variants that influence patient response to clopidogrel. This 
test supports personalized treatment strategies in cardiovascular care and has received 
regulatory approval under the European IVDR. The company is actively supporting national 
rollout efforts, particularly within the UK healthcare system, while generating real-world 
evidence to demonstrate clinical utility and economic value. At the same time, genedrive 

 
 
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continues to pursue U.S. regulatory clearance for its MT-RNR1 test through the FDA De 
Novo pathway. 

 
 
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 MedMira, Inc. 
Halifax, Nova Scotia, Canada 
www.medmira.com 
Established in 1993, MedMira is a biotechnology company based in Nova Scotia, Canada, 
focused on developing and commercializing rapid diagnostic tests for infectious diseases. 
The company specializes in point-of-care and decentralized testing solutions using its 
proprietary Rapid Vertical Flow (RVF) technology platform, which delivers results in 
approximately three minutes and provides a fast, portable alternative to conventional 
laboratory-based diagnostics. 
MedMira’s product portfolio features rapid HIV and sexually transmitted infection testing, 
anchored by its Reveal family of assays, including the Reveal G4 Rapid HIV-1/2 Antibody 
Test, which has expanded regulatory clearances and supports use in decentralized clinical 
settings. The company has continued to strengthen its STI offering by adding rapid syphilis 
diagnostics, including the Reveal TP test, as well as multiplex assays under the Multiplo 
brand. The Multiplo TP/HIV test, which detects both HIV-1/2 and syphilis antibodies from 
a single sample, has been commercialized in Canada and other markets, reflecting growing 
demand for combined STI screening solutions. MedMira is also advancing next-generation 
multiplex assays, including tests designed to differentiate active from past syphilis infection, 
further enhancing clinical utility. 
The company previously expanded its U.S. commercial presence through distribution 
relationships with major partners such as Cardinal Health and VWR; however, these 
arrangements have since been discontinued. MedMira has since shifted toward new 
distribution and market access strategies, including partnerships that expand reach across 
large healthcare provider networks and government channels, strengthening its presence in 
North America. 
MedMira continues to advance its  HIV testing franchise, with the Reveal G4 assay receiving 
additional regulatory recognition, including expanded claims and approval for point-of-care 
use in Canada. MedMira has regulatory clearance for its rapid HIV testing products in the 
United States; however, adoption remains limited due to the current classification of its 
assays as moderate-complexity tests. The company is pursuing CLIA-waived status, which 

 
 
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is expected to significantly expand access across decentralized care settings such as clinics, 
pharmacies, and community screening programs. 
In addition to its current product line, MedMira is developing a next-generation quantitative 
rapid testing platform, MiRO Q, which is designed to extend the capabilities of RVF 
technology beyond qualitative results to include quantitative measurement and advanced data 
analysis. This platform is expected to support future applications in areas such as oncology 
and disease monitoring, incorporating digital and AI-enabled features to enhance clinical 
decision-making. 
 
 
 
 
 
 
 
 

 
 
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Chapter 26: Company Profiles: Prenatal Test 
Service Providers 
Scope 
In this section, Kalorama has selected a group of companies that provide prenatal tests. These 
companies represent a variety of molecular technologies and products used in prenatal and 
neonatal (newborn) testing. This is not a comprehensive review or history of the companies 
selected to appear in the section and is listed alphabetically. 

 
 
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Berry Genomics Co. ltd. 
Beijing, China 
www.berrygenomics 
Founded in 2010, Berry Genomics is a China-based molecular diagnostics company focused 
on applying advanced sequencing technologies to clinical genetic testing and reproductive 
health. The company provides both clinical testing services and sequencing solutions and has 
established a broad network of hospital partnerships across China, supporting large-scale 
adoption of genomic testing in prenatal and clinical settings. 
Berry Genomics is a leading provider of non-invasive prenatal testing (NIPT) in China, with 
its Bambni test serving as a core offering. The test analyzes circulating fetal DNA from 
maternal plasma to detect common chromosomal abnormalities, including trisomy 21, 
trisomy 18, and trisomy 13, and has been expanded to include additional chromosomal 
aneuploidies and microdeletions. The company also offers complementary reproductive 
health diagnostics, including Xromate for detecting chromosomal abnormalities, ChroSure 
for preimplantation genetic testing, and extended carrier screening panels tailored to 
population-specific genetic risks. 
Berry Genomics has expanded into broader clinical genomics through the development of 
proprietary sequencing platforms and advanced diagnostic assays. The company has 
introduced sequencing systems, such as the NextSeq CN500, to support high-throughput 
clinical genetic testing and reduce reliance on imported technologies, enabling applications 
in prenatal screening and genetic disease diagnostics. 
Berry Genomics has advanced into third-generation sequencing technologies by introducing 
long-read sequencing systems clinically, marking a significant expansion beyond traditional 
short-read NGS. This platform enables more comprehensive detection of complex genetic 
variations, including structural variants, repeat expansions, and copy number variations, and 
supports new clinical applications in rare and inherited diseases. Initial assay offerings 
include thalassemia testing, with planned expansion into additional conditions such as Fragile 
X syndrome, spinal muscular atrophy, Duchenne muscular dystrophy, and other single-gene 
disorders. 

 
 
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The company continues to strengthen its clinical portfolio with regulatory approvals for 
advanced genomic assays, including CNV-seq detection kits for identifying chromosomal 
abnormalities in high-risk pregnancies. At the same time, Berry Genomics is integrating 
bioinformatics and AI-driven analysis tools to support the interpretation of large-scale 
genomic data and improve clinical reporting workflows. 
As of 2026, Berry Genomics is transitioning from a primarily NIPT-focused provider to a 
broader clinical genomics company, with expanding capabilities across reproductive health, 
rare disease diagnostics, oncology, and precision medicine. 

 
 
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INEX Innovate 
Singapore 
www.inex.sg 
Innovations Exchange Pte Ltd (INEX), a spinoff from the National University of Singapore 
established in 2006, has evolved into a women’s health-focused diagnostics company 
operating under INEX Innovate. The company is engaged in the research, development, 
commercialization, and licensing of technologies targeting maternal and fetal health, with a 
growing portfolio spanning reproductive health, oncology, and prenatal diagnostics. 
INEX’s prenatal offering is the iGene platform, a non-invasive prenatal testing solution that 
analyzes circulating fetal DNA using next-generation sequencing and proprietary 
bioinformatics. Initially developed to detect common chromosomal abnormalities, including 
trisomy 21, trisomy 18, and trisomy 13, the test has been expanded to include sex 
chromosome aneuploidies such as Turner syndrome, Klinefelter syndrome, Triple X, and 
XYY. The platform is supported by centralized laboratory testing infrastructure in Singapore 
and serves multiple markets across Asia Pacific, with continued efforts to improve workflow 
efficiency and broaden clinical adoption. 
The company also offers FlashFISH, a rapid cytogenetic diagnostic solution based on 
modified fluorescence in situ hybridization technology that delivers results within hours 
following amniocentesis. FlashFISH enables the detection of major chromosomal 
abnormalities and provides a faster alternative to conventional karyotyping in high-risk 
pregnancies. The technology, originally developed at the National University of Singapore, 
is exclusively licensed to INEX and remains a differentiated offering in rapid prenatal 
diagnostics. 
INEX has expanded its portfolio through licensing and technology partnerships, including 
collaborations focused on next-generation prenatal testing approaches such as circulating 
fetal cell analysis and semi-automated systems. The company’s evolution accelerated 
following its merger with Nova Satra, which formed INEX Innovate and established a 
FemTech platform with a broad intellectual property base and a commercial presence across 
Asia Pacific markets. 

 
 
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Recent product development has significantly broadened the company’s scope beyond 
prenatal screening into women’s health and oncology diagnostics. The OvaCis Rapid Test is 
a point-of-care assay designed to differentiate between benign and malignant ovarian cysts, 
delivering rapid results to support intraoperative and clinical decision-making. Adoption of 
OvaCis has expanded across surgical and gynecologic workflows, with increasing use as a 
rapid triage tool for ovarian masses in Asia Pacific markets. INEX has also introduced 
epiHera for early detection of endometrial cancer, reflecting its growing focus on 
gynecologic oncology and early disease detection. 
The company has further advanced its genomic testing capabilities with the introduction of 
FetalExome, a whole-exome sequencing solution for high-risk pregnancies that enables more 
comprehensive analysis of genetic abnormalities beyond standard NIPT. Utilization of 
advanced genomic testing is increasing in specialist maternal-fetal medicine settings, 
providing more detailed diagnostic insights in complex pregnancies. In addition, INEX has 
expanded into pregnancy-related conditions by developing a preeclampsia test, further 
broadening its women’s health portfolio. 
As of 2026, the company is positioned as an integrated FemTech diagnostics provider, 
combining prenatal screening, rapid cytogenetics, oncology diagnostics, and advanced 
genomic testing, with continued geographic expansion and increasing emphasis on clinically 
actionable, decentralized diagnostic solutions. 

 
 
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Oxford Gene Technology 
Oxfordshire, UK 
www.ogt.com 
Oxford Gene Technology (OGT), founded in 1995, is a molecular genetics company focused 
on providing genomic research and clinical diagnostic solutions to academic, clinical, and 
research institutions. Now operating as part of Sysmex Corporation following its acquisition 
in 2017, OGT plays a key role in expanding Sysmex’s capabilities in cytogenetics, molecular 
diagnostics, and genomic analysis. 
OGT offers a broad portfolio spanning next-generation sequencing panels, microarray-based 
cytogenetics solutions, fluorescence in situ hybridization probes, and genomic services. Its 
CytoSure array platform supports detection of copy number variations across a wide range 
of genetic disorders and is available in genome-wide, targeted, and custom configurations, 
along with associated software and reagents. The company also provides specialized arrays 
for applications such as preimplantation genetic testing, enabling screening of embryos for 
chromosomal abnormalities. 
In cytogenetics, OGT’s CytoCell FISH probes are widely used for hematology and oncology 
applications, supporting identification of chromosomal abnormalities in cancer and genetic 
disease. The company has received regulatory recognition for a range of FISH probes in 
hematologic testing and continues to expand its cytogenetics offering through integration 
with imaging and analysis solutions, enabling more automated and digitally enabled 
laboratory workflows. 
OGT has continued to expand its NGS portfolio through the SureSeq product line, with a 
strong focus on oncology and hematologic malignancies. Recent developments include 
enhanced panels for myeloid disorders and measurable residual disease (MRD) detection in 
acute myeloid leukemia, as well as updated panels for chronic lymphocytic leukemia with 
expanded gene content, improved probe density, and greater sensitivity for copy number 
variation detection. These assays are increasingly positioned to support longitudinal disease 
monitoring and treatment response assessment, aligning with the growing clinical importance 
of MRD testing in precision oncology. 

 
 
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As part of Sysmex, OGT is increasingly integrated into a broader diagnostics system that 
combines cytogenetics, molecular testing, and hematology platforms to support more 
comprehensive, end-to-end diagnostic solutions. This integration enables improved 
workflow efficiency and supports the adoption of advanced genomic tools in routine clinical 
practice. 
OGT’s growth is driven by continued enhancements to its existing platforms rather than by 
new standalone technologies, with an emphasis on expanding its oncology test menu, 
advancing MRD applications, and supporting automated, high-throughput cytogenetics and 
sequencing workflows in clinical and research settings. 

 
 
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Yourgene Health 
Manchester, UK 
www.yourgene-health.com 
Yourgene Health is a molecular diagnostics company focused on non-invasive prenatal 
testing, reproductive health, and broader genomic applications including oncology and early 
disease detection. In 2023, the company was acquired by Novacyt, strengthening Novacyt’s 
capabilities in molecular diagnostics and expanding its presence in reproductive health and 
sequencing-based testing. 
Yourgene Health originated from the merger of Premaitha Health and Yourgene Bioscience, 
combining NGS-based prenatal testing expertise with advanced bioinformatics capabilities, 
including a strong footprint in Asia through operations in Taiwan. This integration enabled 
the company to expand access to high-growth NIPT markets while supporting global 
commercialization and cross-selling opportunities. 
The company’s flagship product is the IONA NIPT workflow, which uses next-generation 
sequencing and proprietary bioinformatics to analyze circulating fetal DNA for the detection 
of chromosomal abnormalities, including trisomy 21, trisomy 18, and trisomy 13. The 
platform has been expanded with additional capabilities such as microdeletion screening 
through modular software enhancements, allowing laboratories to broaden their clinical 
menu. Building on this foundation, Yourgene has introduced IONA Care+, a service-based 
prenatal screening offering that combines laboratory testing, reporting, and support services, 
and is being expanded across the UK and selected international markets as part of a shift 
toward integrated genomic service delivery. 
Yourgene has continued to strengthen its technology portfolio with flexible bioinformatics 
solutions, including the Yourgene Flex analysis platform, which enables customizable NGS 
data processing and reporting for reproductive health, oncology, and other clinical 
applications. The company has also expanded its laboratory workflow solutions with 
automated sample-preparation technologies, such as the MagBench DNA extraction system, 
positioning itself as a provider of end-to-end genomic workflows spanning sample 
preparation, sequencing, and data analysis. 

 
 
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The company’s product portfolio also includes rapid aneuploidy testing solutions such as the 
QST*R assay, which is gaining adoption as a complementary tool to NIPT by providing 
faster diagnostic results in prenatal settings. This reflects a broader strategy to support both 
screening and diagnostic workflows within reproductive health. 
Yourgene is increasingly integrated into Novacyt’s global diagnostics platform, leveraging 
expanded distribution channels and cross-selling opportunities to accelerate international 
growth. The company continues to expand its presence in emerging markets across Latin 
America, the Middle East, and Africa, while also exploring direct-to-consumer and retail-
based testing channels to broaden access. 
 
 
 

 
 
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Chapter 27: Company Profiles: Quality 
Control & Sample Pretreatment Specialists 
Scope 
In this section, Kalorama presents a selection of companies that have been simplifying the 
process of molecular sample preparation. In recent years, molecular assays across all 
diagnostic test segments, along with liquid biopsy testing, have increasingly moved from 
research to routine diagnostics. As a result, advanced sample treatment is required to ensure 
testing quality, while quality control materials help assure test validity. The profiles include 
events that have occurred in the past several years; they are not a comprehensive review or 
history of the companies selected to appear in the section and are listed alphabetically. 
 
 

 
 
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Agena Bioscience, Inc. 
San Diego, CA 
www.agenabio.com  
Agena Bioscience is a molecular diagnostics company focused on targeted genetic analysis 
using mass spectrometry-based technologies and operates as part of Mesa Laboratories. Its 
core platform, the MassARRAY system, enables rapid, highly multiplexed detection of 
genetic variants and is widely used in research, translational, and increasingly clinical 
laboratory settings. 
The MassARRAY platform uses mass spectrometry to deliver precise, scalable genotyping, 
allowing simultaneous interrogation of tens to hundreds of genetic targets. It is particularly 
suited for targeted mutation analysis, orthogonal validation of next-generation sequencing 
results, and applications requiring cost-effective, medium-throughput workflows. The 
system offers flexible assay design, though robust performance requires appropriate 
analytical validation and optimization. 
Agena Bioscience provides a comprehensive portfolio of instruments, reagents, and pre-
designed panels, along with custom assay development services. Its product range spans 
oncology, pharmacogenomics, infectious disease research, identity testing, and sample 
quality control. UltraSEEK chemistry supports highly sensitive detection of low-frequency 
variants, particularly in liquid biopsy applications, while iPLEX chemistries enable multiplex 
genotyping in both somatic and germline testing. Oncology panels target key mutations in 
cancers such as colorectal and lung, while broader panels support profiling of multiple 
oncogenic mutations and gene fusions. 
The introduction of MassARRAY Dx PLUS assays has expanded the company’s presence in 
regulated diagnostic testing, enabling laboratories to adopt validated assays for targeted 
mutation analysis. In pharmacogenomics, updated panels, such as newer versions of the 
VeriDose portfolio, provide expanded coverage of clinically relevant variants and support 
guideline-aligned drug-response testing. These advancements strengthen Agena’s position in 
precision medicine and clinical research. 

 
 
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The company has also expanded its role in liquid biopsy through collaborations that integrate 
upstream sample-preparation technologies with MassARRAY detection, thereby improving 
sensitivity for low-frequency circulating tumor DNA variants. In addition, emerging data 
highlight the platform’s ability to complement next-generation sequencing, particularly in 
detecting actionable mutations in challenging samples such as degraded or low-input 
specimens. 

 
 
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Biotype Diagnostic GmbH 
Dresden, Germany 
http://www.biotype.de/en.html  
Biotype Diagnostic GmbH develops and commercializes specialized molecular diagnostic 
solutions for clinical research and routine diagnostics, with a primary focus on 
hematology/oncology and dermatology. The company also offers integrated sample 
preparation technologies designed to support molecular workflows. Its diagnostic portfolio 
is marketed under the Mentype and MycoType product families, with an expanding presence 
in oncology-focused molecular profiling. 
Biotype’s Mentype product line includes a range of multiplex PCR- and qPCR-based assays 
for hematology and transplant monitoring. The Mentype AMLplex QS assay enables detailed 
subtype classification of acute myeloid leukemia through detection of multiple gene fusions 
and transcript variants. For post-transplant monitoring, the Mentype Chimera assay supports 
chimerism analysis using polymorphic STR markers, while the Mentype DIPscreen and 
DIPquant assays provide qualitative and quantitative chimerism assessment based on 
insertion/deletion polymorphisms, offering high sensitivity for detecting minimal residual 
disease and engraftment status. The company continues to refine its chimerism portfolio, 
including updates to improve analytical sensitivity and workflow efficiency. 
In dermatological and infectious disease diagnostics, Biotype offers multiplex PCR assays 
such as Mentype MycoDermQS, designed to identify a broad range of dermatomycosis 
pathogens, alongside lateral flow-based detection formats and the MycoType Skin and 
MycoType Skin Med assays for fungal pathogen identification. These products provid rapid, 
targeted diagnosis in clinical microbiology and dermatology settings. 
Biotype’s Sampletype i-sep system provides a streamlined solution for DNA extraction and 
sample preparation across clinical and forensic applications. The i-sep SQ tubes enable 
combined lysis and DNA extraction in a single closed system, reducing handling steps and 
contamination risk, while the i-sep DL tubes incorporate a reversible membrane for 
differential extraction workflows. This design is particularly useful for complex sample 
types, including mixed forensic samples and FFPE tissues, enabling sequential processing 
and efficient separation of cellular components. 

 
 
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The company has expanded its oncology portfolio through its Modaplex platform, a benchtop 
molecular system designed for rapid, multiplex biomarker analysis. Available assays include 
mutation analysis kits for KRAS, NRAS, BRAF, POLE, and FGFR alterations, offering 
precision oncology applications, particularly in colorectal and urothelial cancers. Continued 
enhancements to the Modaplex platform have improved multi-gene testing capabilities, 
turnaround time, and workflow flexibility, positioning the system for decentralized molecular 
testing environments. 
Biotype has also broadened its strategic collaborations to advance precision medicine. 
Partnerships focused on liquid biopsy development support early cancer detection and 
disease monitoring from blood-based samples, while collaborations in digital PCR 
technologies have expanded capabilities for highly sensitive mutation detection. Additional 
partnerships in molecular pathology aim to improve diagnostics and treatment stratification 
for cancers such as bladder cancer. 
Product developments include updates to leukemia testing panels and chimerism assays, 
including enhancements to the Mentype DIPscreen and AMLplex QS assays to improve 
sensitivity and clinical utility. The company has further expanded its molecular profiling 
portfolio under the MODAPLEX brand, including assays targeting FGFR mutations and 
fusions, as well as expanded NRAS mutation panels designed to guide therapy selection in 
oncology. 
Biotype Diagnostic has also accelerated its international expansion strategy, targeting growth 
in emerging and high-demand markets for precision diagnostics. The company is 
strengthening its distribution network through new regional partnerships and increasing its 
presence in Asia, where adoption of molecular oncology and transplant monitoring solutions 
is rising. At the same time, Biotype is aligning its product portfolio with evolving European 
regulatory requirements, including IVDR compliance, to support broader clinical adoption 
and global market access. The company is also increasing participation in collaborative life 
sciences networks to advance biomarker research and validation. 

 
 
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IncellDx 
San Carlos, CA 
www.incelldx.com 
IncellDx, Inc. is a molecular diagnostics company focused on the detection and monitoring 
of complex diseases, including cervical cancer, infectious diseases such as HIV and hepatitis, 
and immune-related conditions, including transplant rejection and chronic inflammatory 
disorders. The company’s core technology platform is based on proprietary methods for 
simultaneous, multiplex detection of protein, mRNA, and DNA biomarkers at the single-cell 
level using advanced flow cytometry and cell-based analysis. This approach enables detailed 
characterization of cellular function and disease progression with high specificity. 
IncellDx’s oncology portfolio provides its HPV OncoTect assay, which is designed to assess 
oncogenic activity associated with persistent human papillomavirus (HPV) infection. Unlike 
conventional HPV DNA testing, which detects viral DNA, HPV OncoTect assesses the 
expression of the E6/E7 mRNA oncogenes in individual cells. By quantifying both oncogene 
expression levels and the proportion of affected cells, the assay provides a more precise 
indication of whether an infection is progressing toward malignant transformation. This 
enables improved differentiation between transient infections and clinically significant 
disease, supporting more informed clinical decision-making and reducing unnecessary 
invasive procedures. The test can be performed directly from standard liquid-based cytology 
samples and delivers results within a few hours, making it suitable for integration into routine 
screening workflows. 
IncellDx has also developed technologies for circulating tumor cell (CTC) analysis, including 
the bioINK PD-L1 CTC Core Kit, which enables sensitive detection and quantification of 
protein and mRNA biomarkers at single-cell resolution. The platform incorporates 
proprietary fixation and processing methods designed to preserve cellular integrity while 
minimizing background interference, supporting applications in immuno-oncology and 
biomarker research. 
The company has expanded its capabilities in multi-omic analysis through collaborations 
aimed at integrating immunophenotyping with next-generation sequencing workflows. Its 
IncellMax-Seq technology enables in situ library preparation, allowing simultaneous analysis 

 
 
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of cellular phenotype and genomic information from the same sample. This approach offers 
advanced research applications and the development of more comprehensive cancer 
diagnostics. 
IncellDx has broadened its product and technology portfolio with additional reagent kits and 
tools designed to support single-cell and multi-omic analysis workflows across both clinical 
and research environments 
The company has focused on immune profiling, particularly in the analysis of cytokines and 
inflammatory markers associated with immune dysregulation. These capabilities are being 
applied to a growing range of clinical areas, including post-viral syndromes, chronic 
inflammatory diseases, and immune-mediated conditions, reflecting a broader shift toward 
immune-based diagnostics in precision medicine. 
IncellDx has strengthened its strategic collaborations and global presence. Partnerships with 
international organizations have supported the expansion of its diagnostic technologies into 
new markets and clinical applications, including initiatives focused on long COVID and 
immune system monitoring. The company’s collaboration efforts also extend to advanced 
molecular and sequencing technologies, further enhancing its role in precision oncology and 
biomarker discovery. 

 
 
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LGC SeraCare Life Sciences, Inc. 
Milford, MA 
www.seracare.com  
In November 2018, SeraCare Life Sciences was acquired by LGC Group and now operates 
within LGC’s Clinical Diagnostics division. For more than three decades, SeraCare has 
developed a comprehensive portfolio of quality control materials, reference standards, and 
biological products that support assay development, validation, and routine clinical testing 
across molecular diagnostics, immunoassays, and next-generation sequencing applications. 
SeraCare’s product portfolio includes ACCURUN quality controls, research panels, KPL 
antibodies and immunoassay reagents, SeraCon processed biological materials, specialty 
human blood products, and characterized disease-state specimens. These offerings are widely 
used by clinical laboratories, assay developers, and diagnostic manufacturers to ensure 
accuracy, reproducibility, and regulatory compliance. 
The ACCURUN line remains a cornerstone of the company’s quality control portfolio, 
providing third-party controls for infectious disease, molecular, and serology testing. 
Products such as ACCURUN controls for Chlamydia trachomatis and Neisseria gonorrhoeae 
are designed for use with nucleic acid amplification tests, while ACCURUN 611 supports 
the detection of key coagulation-related genetic variants, including Factor V Leiden, Factor 
II, and MTHFR mutations. These materials are derived from well-characterized human 
samples and validated across multiple assay platforms to ensure consistent and reliable 
performance. 
SeraCare’s Seraseq portfolio includes biosynthetic and cell line–derived reference materials 
designed to support next-generation sequencing and precision oncology applications. 
Products such as the Seraseq Solid Tumor Mutation Mix provide defined allele frequencies 
for evaluating assay sensitivity and performance. The company has expanded this portfolio 
with additional reference materials targeting clinically relevant genes, including BRCA1/2 
large genomic rearrangements and DPYD mutations, supporting oncology and 
pharmacogenomics workflows. Newer additions also include carrier screening and inherited 
disease testing, reflecting the increasing demand for comprehensive multi-gene panels. 

 
 
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The company also offers AccuSpan viral molecular panels designed to assess assay linearity, 
sensitivity, and dynamic range for a variety of viral targets, including adenovirus, 
herpesviruses, and polyomaviruses. These panels are provided in standardized, ready-to-use 
formats with consistent concentrations across lots, enabling reliable benchmarking of 
molecular assays. 

 
 
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PreAnalytiX GmbH 
Hombrechtikon, Switzerland 
www.preanalytix.com 
PreAnalytiX, established in 1999 as a joint venture between Becton, Dickinson and Company 
and QIAGEN N.V., continues to operate as of 2026 as a specialist provider of pre-analytical 
sample handling technologies. The company focuses on the collection, stabilization, and 
purification of nucleic acids from blood, bone marrow, tissue, and emerging sample types. 
Its products are primarily marketed and distributed through QIAGEN and are widely used in 
research, biobanking, and molecular testing workflows. 
PreAnalytiX develops integrated systems designed to preserve the integrity of RNA, 
microRNA, and DNA from the point of collection through downstream processing. Its 
solutions serve healthcare institutions, academic researchers, clinical laboratories, and 
pharmaceutical companies, supporting applications in translational research, biomarker 
discovery, and molecular analysis. 
The company’s portfolio offers the PAXgene product family, which includes systems for 
blood and tissue collection and stabilization. Key products include the PAXgene Blood RNA 
system, PAXgene Blood DNA system, PAXgene Blood miRNA system, and the PAXgene 
Tissue platform. These systems standardize pre-analytical variables by stabilizing nucleic 
acids immediately upon collection, improving reproducibility and downstream assay 
performance. The PAXgene Blood DNA Tube enables collection of whole blood in a closed, 
evacuated system with stabilizing additives, allowing for high-quality genomic DNA 
isolation using silica membrane, magnetic bead, or precipitation-based extraction methods. 
PreAnalytiX products are widely adopted in research and biobanking environments, where 
sample integrity and consistency are critical. While much of the portfolio is designated for 
research use, the systems are frequently integrated into regulated laboratory workflows when 
used in combination with automation platforms such as QIAsymphony and QIAcube 
systems. 
PreAnalytiX has expanded its portfolio beyond traditional blood and tissue applications to 
support emerging liquid biopsy workflows. This includes the development of systems for 

 
 
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stabilization of cell-free DNA in urine and continued advancements in blood-based cfDNA 
collection technologies. The company has also introduced saliva-based collection solutions, 
enabling decentralized and population-scale genomic testing. These additions reflect a 
broader strategic shift toward supporting non-invasive sampling and expanding access to 
molecular diagnostics. 
PreAnalytiX continues to refine its preanalytical workflows to improve nucleic acid yield, 
stability, and purity, including enhancements to automated extraction protocols that reduce 
genomic DNA contamination and improve RNA integrity. These improvements support 
high-performance downstream applications such as PCR, digital PCR, and next-generation 
sequencing. 

 
 
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Precipio, Inc.  
New Haven, CT 
www.precipiodx.com 
In June 2017, Transgenomic, Inc. merged with Precipio, Inc. and the combined entity adopted 
the Precipio name. The legacy Transgenomic business contributed advanced molecular 
technologies, including ICE COLD-PCR, a highly sensitive method for enrichment and 
detection of low-frequency mutations, supporting applications such as liquid biopsy and early 
cancer detection. 
Precipio, Inc. is a specialty diagnostics company focused on improving diagnostic accuracy 
in oncology, particularly in hematologic malignancies. The company offers a combination of 
diagnostic services and proprietary products designed to reduce diagnostic errors by 
integrating advanced molecular testing with expert pathology review. Its model incorporates 
collaborations with leading academic institutions, including the Yale School of Medicine, to 
provide enhanced diagnostic insight and second-opinion services. 
HemeScreen platform, a suite of molecular assays designed for rapid detection of clinically 
relevant mutations associated with hematologic cancers is Precipio’s flagship. The 
HemeScreen panels include assays for myeloproliferative neoplasms (MPN), acute myeloid 
leukemia (AML), chronic lymphocytic leukemia (CLL), and anemia/myelodysplastic 
syndromes (MDS). These assays are designed to deliver results within a few hours, 
supporting timely clinical decision-making. The platform has evolved with the introduction 
of streamlined, one-step assay formats that eliminate confirmatory testing steps required in 
earlier versions, enabling both positive and negative results to be obtained in a single run and 
improving laboratory efficiency. 
Precipio has also expanded the analytical capabilities of its assays. Updates to its MPN panel 
enable differentiation between clinically significant mutation subtypes, such as CALR type 
1 and type 2 variants, which are important for disease classification and prognosis. In addition 
to HemeScreen, the company markets IV-Cell, a proprietary reagent designed to improve 
sample preparation and reduce interference in molecular testing workflows. 

 
 
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The company has broadened its molecular diagnostics portfolio by introducing and 
expanding its Bloodhound assay platform, including assays designed for the sensitive 
detection and monitoring of leukemia-associated mutations, such as BCR::ABL1. These 
assays extend Precipio’s capabilities beyond initial screening into disease monitoring and 
quantitative analysis, supporting treatment management and longitudinal patient assessment. 
 

 
 
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Quanterix Corporation 
Lexington, MA 
www.quanterix.com 
Quanterix Corporation, established in 2007, is a life sciences company focused on ultra-
sensitive protein detection using its proprietary Single Molecule Array (Simoa) technology. 
The Simoa platform enables single-molecule digital immunoassay measurements, allowing 
detection of proteins at concentrations significantly lower than those achievable with 
conventional ELISA methods. The technology is based on arrays of femtoliter-sized reaction 
wells, each capable of isolating and detecting individual target molecules, enabling highly 
sensitive and quantitative biomarker analysis. 
Simoa assays utilize a sandwich immunoassay format adapted for digital detection, enabling 
both singleplex and multiplex protein measurements with high sensitivity and precision. The 
platform has been widely adopted in research and clinical settings for applications in 
neurology, oncology, immunology, and inflammatory disease, where detection of low-
abundance biomarkers is critical.  
Quanterix has developed a portfolio of instruments and assay kits based on the Simoa 
platform, including the Simoa HD-X and SR-X analyzers and the SP-X imaging and 
detection system for multiplex and planar assay applications. These platforms support a broad 
menu of assays and customizable workflows.  Multiplexing capabilities enable simultaneous 
measurement of multiple biomarkers without compromising sensitivity. 
The company has expanded its presence in neurology through the development of blood-
based biomarker assays for neurodegenerative diseases. Its Simoa neurofilament light chain 
(NfL) assays are used to quantitatively measure neuronal damage and have received 
regulatory recognition for their potential clinical utility. Quanterix has also developed 
plasma-based assays for phosphorylated tau proteins, including pTau-181 and pTau-217. 
These assays are available as laboratory-developed tests and research-use kits and are being 
incorporated into clinical research and diagnostic evaluation workflows. The LucentAD test 
portfolio further evaluates Alzheimer’s disease by offering blood-based biomarker testing to 
aid in assessing patients with cognitive impairment. 

 
 
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Quanterix has strengthened its position in precision diagnostics through strategic 
collaborations and licensing agreements, including partnerships to advance biomarker 
development in neurodegenerative diseases. The company continues to build clinical 
validation for its assays through collaborations with pharmaceutical companies and academic 
research institutions. 
Recent strategic acquisitions have expanded Quanterix’s capabilities beyond blood-based 
biomarker detection. The acquisition of Emission enhanced the company’s technology base 
in ultrasensitive detection, while the acquisition of Akoya Biosciences in 2025 extended its 
capabilities into tissue-based and spatial biology analysis. This combination enables 
integrated analysis of biomarkers across blood and tissue, supporting a more comprehensive 
understanding of disease biology. 
Quanterix has also continued to expand its technology platform by developing next-
generation instrumentation to broaden access to ultra-sensitive biomarker detection, 
including systems designed to simplify workflows and support wider adoption in clinical and 
translational environments. The company has also advanced its assay portfolio with highly 
sensitive neurology biomarkers, including BD-Tau and other next-generation assays, 
reinforcing its leadership in neurodegenerative disease research. 
Through the integration of its Simoa platform with newly acquired spatial biology 
capabilities, Quanterix is positioned to expand its offerings across both circulating and tissue-
based biomarker analysis. This combined approach enables correlation of blood-based 
biomarkers with tissue-level expression, enhancing applications in neurology, oncology, and 
immunology, as well as in drug development and precision medicine. 

 
 
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Streck Inc. 
La Viste, NE 
www.streck.com 
Streck, Inc. is a developer, manufacturer and marketer of products for clinical and research 
laboratories in cell stabilization technologies. The company’s product portfolio offers 
applications in hematology, immunology, molecular diagnostics, and flow cytometry, with a 
strong emphasis on quality control materials, sample collection, and pre-analytical 
stabilization. 
Streck’s  technology in cell stabilization dates back to the early development of automated 
hematology testing, where stabilized blood components enabled more accurate and 
reproducible cell counting. Since then, the company has expanded its product offerings, 
supplying reagents and controls for many leading diagnostic platforms from major 
instrument manufacturers. Its technologies are widely adopted in clinical laboratories to 
improve sample integrity, standardization, and assay performance. 
The company offers a broad range of quality control products, including flow cytometry 
controls such as CD-Chex TdT Plus and CD-Chex CD103 Plus, which provide multi-
parameter controls for evaluating intracellular and surface markers relevant to hematologic 
malignancies. These controls are designed to support assay validation and performance 
monitoring across major flow cytometry platforms. 
In hematology and clinical chemistry, Streck provides stabilized whole-blood controls, such 
as A1c-Cellular, a glycated hemoglobin control with intact red blood cells that is compatible 
with a wide range of automated analyzers. These controls are used to ensure accuracy and 
consistency in HbA1c testing across multiple instrument platforms. 
Streck has also expanded its presence in molecular diagnostics and sample stabilization. Its 
Cell-Free DNA Blood Collection Tube is widely used to stabilize circulating nucleic acids in 
liquid biopsy workflows, helping minimize pre-analytical variability and preserve sample 
integrity during transport and storage. The company has extended its stabilization 
technologies to additional sample types, including urine-based preservation systems for cell-

 
 
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free DNA and RNA stabilization solutions for downstream sequencing and transcriptomic 
applications. 
In infectious disease and molecular quality control, Streck has introduced products such as 
MDx-Chex controls designed to verify the performance of multiplex molecular assays, 
including blood culture identification panels used in sepsis diagnostics. The MDx-Chex 
portfolio has continued to expand to include controls for sexually transmitted infection panels 
and multiplex vaginal testing, extending the company’s reach into women’s health and 
syndromic molecular diagnostics. These controls are designed to function as patient-like 
materials, enabling evaluation of the entire testing workflow from extraction through 
detection. 
Streck offers its sample collection and stabilization portfolio with products such as Protein 
Plus BCT, designed to maintain native plasma protein concentrations at the time of blood 
draw, supporting applications in proteomics and biomarker research. 
In addition, the company has developed molecular assay kits targeting antimicrobial 
resistance, including ARM-D kits designed to detect clinically relevant resistance genes. 
Recent enhancements to these assays have expanded coverage to include additional gene 
families and variants, reflecting the growing importance of rapid resistance detection in 
clinical microbiology. 
Streck has expanded into emerging areas such as cell and gene therapy through collaborations 
that integrate its flow cytometry controls with automated platforms, supporting quality 
control in advanced therapeutic workflows. At the same time, the company is reinforcing its 
leadership in liquid biopsy by advancing stabilization technologies for cell-free DNA and 
RNA, which are increasingly critical for next-generation sequencing and precision medicine 
applications. 
 
 
 

 
 
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Chapter 28: Test Service Providers 
Scope 
In this section, Kalorama has selected a group of companies that provide laboratory testing 
services. The chapter presents both established companies and new entrants that operate 
company-sponsored laboratories. The profiles include events that have occurred in the past 
several years; they are not a comprehensive review or history of the companies selected to 
appear in the section and are listed alphabetically. 
 
 
 
 
 

 
 
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Agendia BV 
Huntington Beach, CA, and Amsterdam, The Netherlands 
www.agendia.com 
Agendia is a molecular diagnostics company specializing in genomic assays that offer 
personalized treatment decisions in oncology, particularly in breast cancer. The company 
develops and markets gene expression–based diagnostic tests primarily using FFPE tissue 
samples, enabling clinicians to assess tumor biology and guide therapy selection. 
Agendia’s core offering is its Symphony suite for breast cancer, which includes 
MammaPrint, BluePrint, and TargetPrint. MammaPrint is a widely adopted gene expression 
assay that stratifies early-stage breast cancer patients based on risk of recurrence, helping to 
determine whether patients are likely to benefit from adjuvant chemotherapy. BluePrint 
provides molecular subtyping of tumors into functional subgroups, offering additional insight 
into tumor biology beyond traditional pathology. TargetPrint complements these assays by 
quantitatively assessing ER, PR, and HER2 gene expression, supporting treatment selection 
decisions. Together, these tests provide a comprehensive genomic profile to guide 
personalized therapy strategies and reduce overtreatment. 
Agendia also offers ColoPrint, a gene expression assay designed to assess recurrence risk in 
stage II colon cancer patients. The company continues to expand its oncology pipeline and 
has played a significant role in major clinical studies. 
Agendia has advanced its technology platform with the introduction of Digital MammaPrint, 
an AI-enabled version of its flagship assay developed in collaboration with Paige. This digital 
approach is designed to integrate artificial intelligence with genomic testing workflows, 
enabling faster turnaround times and supporting decentralized testing models. The company 
has also expanded its collaboration with Illumina to support next-generation sequencing–
based deployment of its assays, facilitating broader access to its tests in distributed laboratory 
settings. 

 
 
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Ambry Genetics 
Aliso Viejo, CA 
www.ambrygen.com 
Ambry Genetics, founded in 1999, is a CAP-accredited and CLIA-certified clinical 
laboratory specializing in genetic testing and genomic services. The company is recognized 
as a leader in hereditary disease testing, with a strong focus on oncology, reproductive health, 
cardiology, and rare diseases. Ambry has played a pioneering role in the adoption of next-
generation sequencing in clinical diagnostics and continues to expand its portfolio of 
comprehensive genetic testing solutions. 
In 2017, Ambry Genetics was acquired by Konica Minolta as part of a strategy to build a 
global precision medicine platform. More recently, Ambry has been integrated into Tempus 
AI, reflecting a strategic shift toward combining genomic testing with advanced data 
analytics and artificial intelligence to support data-driven healthcare and personalized 
medicine. 
Ambry’s test portfolio includes a broad range of hereditary cancer panels, exome sequencing 
services, and reproductive carrier screening assays. The company was among the first to 
introduce clinical NGS-based diagnostic testing and early adopters of clinical exome 
sequencing, helping to establish these technologies as standards in medical genetics. Its 
CancerNext-Expanded panel analyzes a wide range of genes associated with hereditary 
cancer risk, supporting comprehensive risk assessment and clinical management. The 
company has also expanded its hereditary cancer offerings by introducing more flexible, 
customizable panel configurations to address increasingly complex clinical needs. 
Ambry has advanced genomic testing by integrating RNA analysis with DNA sequencing. 
Its +RNAinsight platform enables simultaneous evaluation of DNA variants and RNA 
expression, improving variant interpretation and increasing diagnostic yield, particularly in 
genes such as BRCA1 and BRCA2. This approach has evolved into a core component of 
Ambry’s testing strategy and is now broadly integrated across hereditary cancer and exome 
testing. 

 
 
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With this multiomic approach, Ambry has enhanced its exome sequencing services through 
RNA-enabled testing, enabling more comprehensive detection of clinically relevant variants 
in rare and inherited diseases. These advancements improve diagnostic accuracy, reduce 
variants of uncertain significance, and increase overall diagnostic yield. The company has 
also achieved large-scale adoption of its combined DNA and RNA testing approach, with 
more than one million such tests performed, adding to its growing clinical impact. 
Ambry continues to expand its role in longitudinal genomic diagnostics through programs 
that enable ongoing reanalysis of patient data as new genetic insights emerge, improving 
diagnostic outcomes over time and supporting more equitable access to updated clinical 
information. 
The company also offers a range of sequencing and molecular services supporting both 
clinical diagnostics and research applications, including targeted gene panels, whole exome 
sequencing, and specialized testing for inherited and somatic conditions. Ambry continues to 
support precision oncology initiatives through collaborations with biopharmaceutical 
companies, helping to identify patients for targeted therapies and clinical trials. 
In addition to its laboratory services, Ambry has expanded into digital health and clinical 
workflow solutions. Its CARE program is designed to identify patients who may benefit from 
genetic testing and to streamline test ordering and integration into clinical practice, 
supporting broader adoption of genomic medicine. 
Ambry has established strategic partnerships to expand access to its testing services globally, 
including collaborations with international laboratory networks and diagnostic providers 
supporting clinical trials and healthcare systems outside the United States. 

 
 
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ARUP Laboratories 
Salt Lake City, UT 
www.aruplab.com 
ARUP Laboratories, founded in 1984, is a national reference laboratory and a nonprofit 
enterprise of the University of Utah and its Department of Pathology. ARUP offers an 
extensive test menu of more than 3,000 assays and test combinations, ranging from routine 
clinical tests to highly specialized molecular, genetic, and esoteric diagnostics. The 
laboratory serves a broad client base across the United States, including academic medical 
centers, children’s hospitals, multihospital systems, commercial laboratories, government 
agencies, and large healthcare networks. 
The laboratory has expanded its test menu in response to emerging clinical needs. In 
toxicology and newborn testing, ARUP introduced assays for detecting substances such as 
kratom in umbilical cord tissue. In coagulation and cardiovascular testing, the laboratory 
offers assays to measure levels of direct factor Xa inhibitors, including apixaban, edoxaban, 
and rivaroxaban, supporting therapeutic monitoring and patient management. 
In infectious disease diagnostics, ARUP has expanded its molecular testing capabilities with 
assays, including a PCR-based test for Candida auris, enabling rapid and specific 
identification of this emerging pathogen. The laboratory has also introduced advanced 
influenza A assays, including subtyping for strains such as H5, as well as molecular testing 
for measles that can distinguish vaccine-related from infection-derived strains. 
ARUP has also developed and supported companion diagnostic testing, including assays such 
as AAV5 DetectCDx for use in guiding gene therapy in hemophilia, reflecting its growing 
role in precision medicine and advanced therapeutics. 
The organization is increasingly integrating digital pathology and artificial intelligence into 
its workflows. Collaborations with technology partners have supported the development of 
AI-enabled tools for hematopathology, including analysis of bone marrow biopsies, as well 
as the expansion of AI-augmented screening for gastrointestinal parasites across the full 
testing workflow. These initiatives will likely improve diagnostic accuracy, efficiency, and 
scalability. 

 
 
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ARUP is also advancing access to testing through partnerships that support at-home blood 
collection and decentralized testing. Additionally, the laboratory is expanding its capabilities 
in genomic medicine, including rapid whole-genome sequencing for critically ill patients, 
particularly in neonatal and acute-care settings. 
In addition, ARUP has expanded its neurology and biomarker testing portfolio with assays 
such as plasma pTau 217, supporting the evaluation of Alzheimer’s disease and other 
neurodegenerative conditions. 
 

 
 
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Aspira Women’s Health  
Austin, TX 
www.aspirawh.com 
Aspira Women’s Health, formerly known as Vermillion, Inc., rebranded in 2020 to reflect an 
expanded focus on women’s health and gynecologic disease diagnostics. The company is 
dedicated to the discovery, development, and commercialization of diagnostic tests designed 
to improve the detection and clinical management of gynecologic cancers and related 
conditions, with a particular emphasis on ovarian cancer risk assessment. 
Aspira’s product portfolio includes OVA1, a blood-based test used in the clinical assessment 
of women with adnexal masses to help determine the likelihood of malignancy prior to 
surgical intervention. OVERA serves as a second-generation multivariate index assay 
designed to maintain high sensitivity while improving specificity. The company also offers 
OVA1+, a reflex testing strategy that utilizes OVA1 as the primary test with OVERA as a 
confirmatory tool to enhance diagnostic accuracy and clinical decision-making. 
In addition to protein biomarker–based testing, Aspira has expanded into genetic and 
multiomic diagnostics through its Aspira GenetiX platform, which provides genetic risk 
assessment for gynecologic and related cancers, including ovarian, breast, endometrial, and 
other reproductive system malignancies. The company is also developing its Aspira Synergy 
platform, a decentralized and cloud-based technology infrastructure designed to integrate 
diagnostic data, algorithms, and clinical decision support tools. 
Aspira has continued to expand its ovarian cancer testing portfolio with the introduction of 
OvaWatch, a blood-based test designed to assess the risk of ovarian cancer in women with 
adnexal masses initially classified as indeterminate or likely benign. OvaWatch is intended 
for use in monitoring patients over time and supporting clinical decisions regarding 
surveillance versus surgical intervention. Recent enhancements to the OvaWatch platform 
incorporate longitudinal monitoring capabilities and advanced algorithmic analysis, 
including artificial intelligence–driven risk assessment models that evaluate changes in 
biomarker levels over time. 
 

 
 
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The company has strengthened commercialization of its OvaSuite portfolio through strategic 
partnerships that expand access to its tests across key U.S. markets and support broader 
clinical adoption. Regulatory milestones, including expanded state-level approvals, have 
further supported the uptake of OvaWatch and related assays. 
Aspira is also advancing a pipeline of next-generation diagnostics, including a multiomic 
ovarian cancer test that integrates microRNA and protein biomarkers with clinical data to 
improve diagnostic accuracy and risk stratification. In addition, the company is developing a 
non-invasive blood test for endometriosis, targeting a significant unmet need in women’s 
health and expanding its reach beyond oncology into broader gynecologic conditions. 
The company has expanded its research and development efforts through collaborations with 
leading academic institutions, including partnerships aimed at developing microRNA-based 
diagnostic approaches for ovarian cancer detection. These initiatives reflect Aspira’s broader 
strategy to integrate multiple biomarker modalities and data-driven analytics into its 
diagnostic offerings. 

 
 
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Blueprint Genetics Oy 
Helsinki, Finland 
http://blueprintgenetics.com 
Blueprint Genetics, founded in 2012 and headquartered in Helsinki, Finland, is a global 
provider of genetic testing for inherited diseases. The company serves customers in more 
than 70 countries and offers a comprehensive portfolio of next-generation sequencing–based 
tests, including hundreds of gene panels spanning multiple medical specialties such as 
neurology, cardiology, oncology, ophthalmology, and metabolic disorders. 
Blueprint Genetics specializes in high-quality variant interpretation and clinical reporting, 
combining advanced sequencing technologies with curated databases and bioinformatics 
tools to provide accurate diagnosis of rare and inherited conditions. Its test menu includes 
more than 200 targeted panels, as well as exome-based testing solutions, enabling both 
focused and broad genomic analysis. 
The company  expanded its reproductive and proactive genetic screening offerings through 
its Family Screening Tests portfolio, designed to offer family planning and early risk 
assessment. The reproductive screening category provides carrier testing for couples 
planning a pregnancy, identifying whether individuals carry genetic variants that could 
increase the risk of inherited disorders in their offspring. The proactive screening category 
offers individuals insight into their predisposition to hereditary conditions, including cancer, 
cardiovascular, and metabolic diseases. 
Blueprint Genetics has further enhanced its carrier screening portfolio with DUO testing 
options, which assess the combined genetic risk of couples for autosomal recessive and X-
linked conditions. These tests are designed to provide more comprehensive risk evaluation 
and support informed reproductive decision-making. 
The company continues to expand its NGS-based testing capabilities with the addition of 
panels that incorporate repeat expansion analysis, including tests for conditions associated 
with FMR1 gene expansions. These include panels for X-linked intellectual disability, 
premature ovarian failure, and hereditary ataxias, reflecting the growing importance of 
detecting repeat expansion disorders alongside sequence variants. 

 
 
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In reproductive genetics, Blueprint Genetics markets expanded carrier screening options with 
multiple configurations, including comprehensive, core, and population-specific panels, as 
well as corresponding DUO formats. These tests include analysis of FMR1 repeat expansions 
and are designed to address diverse patient populations and clinical needs, including targeted 
screening for specific ethnic groups. 
Blueprint Genetics has also significantly expanded its diagnostic capabilities through growth 
in its gene content and panel customization options, enabling access to tens of thousands of 
genes for tailored testing. The company is increasingly emphasizing broader genomic 
approaches, including whole exome sequencing, and enhanced detection of complex variant 
types such as repeat expansions and mitochondrial variants. 
As part of Quest Diagnostics, Blueprint Genetics continues to strengthen its global reach and 
integration into large-scale genomics operations, supporting expanded access to advanced 
genetic testing services. At the same time, the company maintains a strong focus on 
preventive and proactive genomics through its growing screening portfolio. 

 
 
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Boston Heart Diagnostics 
Framingham, MA 
https://bostonheartdiagnostics.com/  
Boston Heart Diagnostics, a subsidiary of Eurofins Scientific, focuses cardiovascular care 
through personalized diagnostic testing and integrated clinical insights. The company 
combines advanced biomarker analysis, genetic testing, and risk assessment tools to support 
more individualized prevention and management of cardiovascular and metabolic disease. 
Boston Heart Diagnostics offers a broad portfolio of cardiovascular and metabolic tests 
designed to provide deeper insight into lipid metabolism, inflammation, and cardiometabolic 
risk. Its Cholesterol Balance test evaluates markers of cholesterol synthesis and absorption, 
including lathosterol and desmosterol, to guide more targeted lipid-lowering strategies. The 
Fatty Acid Balance test measures key fatty acids to support cardiovascular risk 
characterization and dietary intervention planning, while the Prediabetes Assessment 
provides insight into early metabolic dysfunction and diabetes risk. 
The company has also developed pharmacogenomic testing capabilities, including its 
StatinSmart test, which analyzes variants in the SLCO1B1 gene associated with an increased 
risk of statin-induced myopathy. This test provides personalized statin therapy by identifying 
patients who may be more susceptible to adverse effects, thereby improving treatment 
adherence and outcomes. 
Boston Heart has expanded its genomic testing portfolio with LipidSeq, a next-generation 
sequencing based test designed to identify genetic causes of lipid and lipoprotein disorders. 
The company has also introduced polygenic risk assessment tools, including its Polygenic 
Risk Map, which evaluates genetic risk across multiple variants to provide a more 
comprehensive assessment of susceptibility to complex cardiovascular and metabolic 
diseases. 
Boston Heart has introduced at-home testing options using dried blood spot collection, 
enabling patients to collect samples remotely and send them to the laboratory for analysis. 
The company has significantly expanded this capability, offering a wide range of dried blood 
spot–based assays across cardiometabolic and wellness testing categories. 

 
 
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Boston Heart has advanced its platform with integrated risk assessment tools such as CVMap, 
which combines multiple advanced biomarkers to provide a more comprehensive and 
longitudinal evaluation of cardiovascular risk. These tools are designed to support 
personalized intervention strategies and ongoing monitoring of patient health. 
The company has expanded its precision medicine approach by integrating genetic, 
biochemical, and lifestyle-related data into its diagnostic offerings. This includes increased 
use of polygenic risk scoring, expanded genomic panels, and enhanced reporting tools 
designed to support clinical decision-making and patient-provider communication. 
Boston Heart has also expanded access to its services through integration with digital health 
and clinical workflow platforms, enabling more efficient test ordering, reporting, and 
interpretation within healthcare systems. 

 
 
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CareDx, Inc. 
South San Francisco, CA 
www.caredxinc.com 
CareDx, Inc., originally founded in 2000 as XDx Inc., is a molecular diagnostics company 
focused on improving outcomes for transplant patients through non-invasive monitoring and 
data-driven clinical solutions. The company specializes in transplant diagnostics across heart, 
kidney, lung, and other organ transplants, combining genomic testing, digital health tools, 
and clinical services. 
CareDx’s flagship product, AlloMap, is a gene expression profiling test designed to assess 
immune activity in heart transplant recipients. The test helps identify patients with stable 
graft function who have a low risk of moderate-to-severe acute cellular rejection, enabling 
clinicians to reduce reliance on invasive biopsy procedures. 
The company has expanded its transplant monitoring portfolio with AlloSure, a donor-
derived cell-free DNA  test used to detect early signs of organ rejection. AlloSure is used 
across multiple transplant types, including kidney, heart, and lung, with expanded clinical 
indications supporting broader patient populations, including pediatric heart transplant 
recipients and patients undergoing simultaneous pancreas-kidney transplantation. 
CareDx offers next-generation innovations such as AlloSure Plus, an artificial intelligence–
driven extension of its core platform that integrates biomarker data with clinical variables to 
provide personalized risk assessment for transplant rejection and improved clinical decision-
making. 
CareDx has also expanded into tissue-based diagnostics with the introduction of HistoMap 
Kidney, a gene expression profiling test designed to enhance biopsy interpretation and 
improve classification of rejection types, bridging molecular diagnostics with traditional 
histopathology. 
The company has further broadened its portfolio into new clinical areas with the development 
of AlloHeme, a novel assay designed to detect relapse in hematologic cancers, representing 
an expansion beyond transplant diagnostics into oncology applications. 

 
 
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CareDx has also developed a suite of next-generation sequencing–based products under the 
AlloSeq brand, supporting both pre- and post-transplant testing. These include HLA typing 
solutions for donor-recipient matching, chimerism testing for hematopoietic cell 
transplantation, and cfDNA-based monitoring. Products include high-throughput HLA 
typing solutions, including updated assays with expanded genetic coverage, designed for 
large-volume laboratory environments. 
In addition to diagnostics, CareDx has expanded into digital transplant management and 
clinical decision support. The acquisition of transplant management software platforms, 
including OTTR and XynManagement, has enabled the company to provide integrated 
solutions for patient tracking, outcomes management, and workflow integration with 
electronic medical records systems. 
CareDx has incorporated artificial intelligence and predictive analytics into its offerings 
through partnerships and proprietary tools, combining biomarker data with clinical variables 
to predict rejection risk and long-term graft survival, supporting more personalized transplant 
care. 
The company continues to strengthen its transplant system through strategic collaborations, 
including partnerships to advance HLA genotyping technologies and improve donor-
recipient matching. It has also expanded reimbursement coverage for key assays, including 
broader payer support for AlloSure in lung transplantation. 
Recent product and clinical updates include expanded indications for AlloSure across 
additional transplant populations, continued rollout of AlloSeq products in international 
markets, and ongoing development of integrated diagnostic and digital solutions for 
transplant care. 

 
 
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Predictive Oncology 
Pittsburgh, PA 
www.predicitve-oncology.com 
Predictive Oncology offers its Comprehensive Tumor Profile, which includes: ChemoFx, 
BioSpeciFx and GeneFx Colon. This approach to precision medicine combines genomic 
expression and molecular information specific and clinically relevant to a patient’s cancer, 
answering a broad range of clinical questions that physicians encounter every day while 
managing their patients’ care. 
Predictive Oncology is committed to individualizing cancer therapy through a proprietary 
platform. The company develops novel markers to help guide treatment decisions based on 
the biological processes of each individual's cancer. 
Predictive Oncology’s state-of-the-art bioinformatics, combined with the analysis of the 
functional molecular, genomic, and proteomic activity of each patient's cancer, offers an 
innovative foundation for further development and commercialization of novel predictive 
markers for cancer therapy. 
Comprehensive Tumor Profiling combines three core platforms of personalized medicine to 
capture the total sum of genomic, proteomic and functional information for each patient's 
cancer through a portfolio of multi-platform tests for cancer treatment in multiple tumor 
types. 
ChemoFx Chemoresponse Marker (ChemoFx), the company's flagship product, is a 
proprietary chemoresponse marker that helps improve patient outcomes by supporting 
physicians in the selection of effective treatments for their gynecologic cancer patients. The 
test measures an individual's malignant tumor response to a range of standard 
chemotherapies. The test offers a method of identifying cancer cell response and sensitivity 
to various chemotherapeutic and biologic agents at the biopsy stage -- long before a patient 
actually begins chemotherapy -- providing a custom blueprint of a patient's probable tumor 
response. 
The diagnostic test works by taking a sample of a patient's tumor, which is removed during 
biopsy or surgery, and sending that sample to the Helomics laboratory for sensitivity and 

 
 
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resistance testing. In a controlled environment that closely parallels what happens within the 
human body, those cells are incubated and treated by a fully automated system using a 
number of chemotherapy and biologic agents selected by that patient's physician. Helomics 
then sends the physician a report that details how the cancerous cells responded to each drug 
or chemotherapy combination. Integrating the results with clinical judgment, the physician 
can then use the report to support his decision on a treatment regimen for the patient, with 
the tandem objective of eradicating the disease and optimizing quality of life during 
chemotherapy treatment. 
The BioSpeciFx is a panel of 23 markers that identify molecular targets within a patient's cell 
(extracted from FFPE tissue) using microarray technology. By using the information 
generated by BioSpeciFx in combination with ChemoFx, physicians may gain a 
complementary sum of information, which will enable physicians to look at both the relevant 
molecular targets as well as the synergistic activity of drug combinations on the entire cell. 
BioSpeciFx provides proteomic and genomic information, while ChemoFx considers all of 
the functional characteristics of a tumor including those not captured by biomarker testing, 
providing both sensitivity and resistance information. 
Predictive Oncology’s GeneFx Colon signature complements its Comprehensive Tumor 
Profiling for stage II colon cancer. The test uses microarray analysis of FFPE tissue to 
establish gene signature information. GeneFx Colon is an addition to the to the BioSpeciFx 
portfolio. The test is designed to help physicians assess which patients are at higher risk of 
recurrence and may therefore be candidates for adjuvant chemotherapy treatment. 
D-CHIP (Dynamic Clinical Health Insight Platform), Helomics’ bioinformatics platform 
aimed at pharmaceutical and diagnostic companies, was launched in April 2017. D-CHIP is 
searchable and can be used to mine proprietary multi-omic and clinical data from cancer 
patients for biomarker discovery and development, virtual clinical trials, and patient 
recruitment and selection. The cloud-based platform is said to be secure and compliant with 
regulations and offers rich, de-identified patient demographic data with state-of-the-art 
analytics. 
GeneFx Lung is a proprietary gene expression-based test to improve staging and identify 
patients with early-stage non-small-cell lung cancer (NSCLC) who, following surgical 
removal of their tumor, are at higher or lower risk of mortality. GeneFx Lung is expected to 
provide better-informed, personalized treatment decisions to assist in selecting patients for 
adjuvant chemotherapy. Patients classified by GeneFx Lung as high risk benefited from 

 
 
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adjuvant chemotherapy, and those classified as low risk did not benefit and may have 
experienced a detrimental effect from adjuvant chemotherapy. 

 
 
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Labcorp, Laboratory Corporation of America 
Burlington, NC 
www.Labcorp.com 
Labcorp is one of the largest global providers of clinical laboratory services, offering a broad 
range of routine and specialized diagnostic testing. The company employs tens of thousands 
of people worldwide and performs hundreds of millions of tests annually for patients, 
healthcare providers, biopharmaceutical companies, and health systems. Labcorp operates an 
extensive network of patient service centers, hospital-based laboratories, and regional 
facilities, supporting both centralized and decentralized testing models. 
Labcorp’s business is organized into two primary segments: Diagnostic Laboratories, which 
includes routine and specialty clinical testing, and Biopharma Laboratory Services, which 
supports drug development through central laboratory and clinical trial services.  
Labcorp has expanded its diagnostics footprint through acquisitions and strategic 
partnerships. The company has acquired multiple regional and outreach laboratory 
businesses, including assets from BioReference Health, Baystate Health, Providence health 
system laboratories, North Mississippi Health Services, and Incyte Diagnostics. These 
acquisitions have strengthened Labcorp’s regional presence, expanded access to testing 
services, and enhanced its capabilities in oncology and anatomic pathology. 
In addition, Labcorp completed the acquisition of Invitae, significantly expanding its 
capabilities in genetic testing, including oncology and rare disease diagnostics. The company 
has also entered into partnerships with healthcare systems to manage hospital laboratory 
operations, further integrating its services into clinical care delivery. 
Labcorp continues to augment its test portfolio with a focus on molecular diagnostics, 
genomics, and precision medicine. The company markets a range of new assays, including 
liquid biopsy tests such as PGDx elio plasma focus Dx, a next-generation sequencing–based 
assay designed to detect multiple genomic alterations across solid tumors. It has also 
introduced Plasma Detect, a test designed to assess risk of disease recurrence in colorectal 
cancer patients and has expanded this platform to support minimal residual disease detection 
across multiple cancer types. 

 
 
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In neurology, Labcorp has expanded its biomarker testing with the introduction of advanced 
blood-based assays, including pTau-based testing for Alzheimer’s disease.  In infectious 
disease, the company has developed molecular assays for emerging pathogens, including 
tests for avian influenza. In women’s health and reproductive testing portfolio,  Lab Corp 
offers first-trimester preeclampsia screening and self-collection options for HPV and 
sexually transmitted infection testing, improving access and patient convenience. 
Labcorp continues to build its oncology testing capabilities with expanded next-generation 
sequencing panels for solid tumors and hematologic malignancies, including myeloid, 
lymphoid, and pan-hematologic panels. These offerings support precision oncology by 
enabling comprehensive genomic profiling and therapy selection. 
Additionally, Labcorp is advancing companion diagnostics and gene therapy support, 
including assays designed to identify patients eligible for targeted therapies. The company 
has received regulatory authorization for assays supporting gene therapy applications, 
reflecting its growing role in advanced therapeutics. 
Labcorp is expanding into artificial intelligence–enabled diagnostics, including the 
deployment of digital pathology platforms to enhance diagnostic workflows and accuracy. 
These initiatives complement the company’s broader efforts to integrate advanced analytics 
and data-driven insights into laboratory medicine. 
Labcorp offers the first FDA-cleared rapid fentanyl test, Fentanyl Urine Visual Test. The test 
assesses fentanyl exposure by detecting norfentanyl in urine up to 48 hours after initial 
exposure. The test is CLIA certified and provides rapid screening with results obtained in 10 
minutes. This provides fast, actionable answers for healthcare providers when treating 
suspected fentanyl exposure in emergency departments, hospitals and clinics. 
 

 
 
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 Mayo Clinic Laboratories 
Rochester, MN 
www.mayoreferenceservices.org 
Mayo Clinic Laboratories is the reference laboratory of the Mayo Clinic and is widely 
recognized as a leader in esoteric and advanced diagnostic testing. The laboratory provides 
an extensive test menu of more than 3,000 assays spanning all major areas of medicine, 
including molecular diagnostics, genetics, infectious disease, oncology, neurology, and 
endocrinology. It serves as a primary reference laboratory for healthcare providers across the 
United States and internationally, including hospitals, health systems, and laboratories with 
specialized testing and clinical expertise. 
Mayo Clinic Laboratories is particularly known for its leadership in gene-based and precision 
diagnostics, with a continuously expanding genetic and molecular testing portfolio. The 
organization routinely introduces new assays across multiple clinical domains, reflecting its 
strong emphasis on innovation and translational research. Its services also include direct 
access to Mayo Clinic physicians and scientists for consultation on complex cases, 
supporting interpretation of results and clinical decision-making. 
The laboratory has expanded its test offerings in both routine and esoteric areas, with ongoing 
additions in oncology, infectious disease, neurology, and rare genetic conditions. 
Developments include expanded next-generation sequencing panels for hereditary diseases, 
such as hereditary pancreatitis and connective tissue disorders, as well as continued growth 
in immunohistochemistry and biomarker-based oncology testing. 
Mayo Clinic Laboratories has strengthened its position in precision oncology by integrating 
liquid biopsy technologies that detect circulating tumor DNA and RNA, enabling 
comprehensive cancer profiling. Partnerships with technology providers have expanded 
access to advanced multiomic cancer testing and broadened the laboratory’s global reach. 
In neurology, the laboratory has introduced advanced assays for neurodegenerative diseases, 
including seed amplification–based testing and cerebrospinal fluid assays that can distinguish 
prion disease from other causes of rapidly progressive dementia. These offerings reflect 

 
 
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increasing demand for highly sensitive and specific diagnostics in neurodegenerative 
disorders. 
In women’s health, the laboratory launched a preeclampsia-specific risk assessment test 
designed to stratify patients earlier in pregnancy, supporting improved maternal and fetal 
outcomes. Additional expansion in reproductive and genetic testing continues to support 
early detection and risk assessment across a range of conditions. 
The company is also advancing infectious disease diagnostics by developing rapid antibody-
based tests for conditions such as Valley fever, designed to deliver results within minutes and 
improve early diagnosis in endemic regions. Expanded molecular testing for emerging 
pathogens further supports public health and outbreak response. 
Mayo Clinic Laboratories continues to invest in innovative diagnostic technologies, 
including advanced molecular assays, multiomic profiling, and AI-informed interpretation 
approaches. These efforts are complemented by the ongoing expansion of its test menu, with 
dozens of new assays introduced annually. 

 
 
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MDxHealth SA 
Liege, Belgium 
www.mdxhealth.com 
MDxHealth is a molecular diagnostics company focused on developing and commercializing 
genomic and epigenetic tests for cancer assessment, with a primary emphasis on urologic 
oncology. The company applies proprietary DNA methylation and genomic technologies to 
support cancer detection, risk stratification, prognosis, and treatment decision-making. 
MDxHealth’s strategy combines the development of laboratory-developed tests and 
companion diagnostics with pharmaceutical partners, alongside commercialization of 
clinical diagnostic assays through its CLIA-certified laboratory and dedicated sales 
infrastructure in the United States. The company has increasingly focused its portfolio on 
prostate cancer diagnostics, positioning itself as a key player in precision urology. 
The company’s earlier epigenetic platform featured ConfirmMDx for Prostate Cancer, a 
tissue-based test designed to help reduce unnecessary repeat biopsies by detecting DNA 
methylation changes associated with cancer in histologically negative biopsy samples. The 
test evaluates methylation biomarkers such as GSTP1, APC, and RASSF1, providing 
clinicians with additional insight into cancer risk and helping guide clinical management 
decisions. 
MDxHealth has since expanded beyond epigenetic-only testing to incorporate genomic 
profiling technologies. A major milestone was the acquisition of the Genomic Prostate Score  
test, now marketed as Oncotype DX GPS, which analyzes gene expression to assess the 
aggressiveness of prostate cancer and support treatment decisions, including active 
surveillance versus intervention. This acquisition significantly strengthened the company’s 
position in the prostate cancer diagnostics market. The company also markets ResolveMDx 
for urinary tract infections.  
The company has expanded and repositioned its portfolio through the acquisition of Exosome 
Diagnostics, adding the ExoDx Prostate test, a non-invasive urine-based liquid biopsy assay 
designed to assess the risk of high-grade prostate cancer.  
 

 
 
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OPKO Diagnostics/Opko Health 
Miami, FL 
www.opko.com 
OPKO Health, Inc. is a diversified healthcare and medical technology company with 
operations spanning pharmaceuticals, biologics, laboratory medicine, medical devices, and 
in vitro diagnostics. The company’s diagnostics activities are primarily conducted through 
its subsidiary BioReference Health, which provides a range of clinical testing services, 
including specialty and oncology diagnostics. 
BioReference Health is known for its proprietary 4Kscore test, a blood-based assay used to 
assess the risk of aggressive prostate cancer. The test combines multiple biomarkers with 
clinical information to support biopsy decision-making and reduce unnecessary procedures. 
Recent enhancements to the 4Kscore test have improved its clinical usability and expanded 
its application in routine screening workflows, reinforcing its role as the company’s primary 
diagnostic offering. 
OPKO has also developed point-of-care diagnostic technologies through its Claros 
Diagnostics platform, a microfluidics-based system designed for rapid testing of multiple 
analytes in near-patient settings. The Claros 1 Analyzer, paired with the Sangia PSA Test, 
enables quantitative measurement of prostate-specific antigen from a fingerstick blood 
sample, supporting decentralized prostate cancer screening and monitoring. 
OPKO has streamlined its diagnostics operations through the divestiture of selected 
BioReference Health assets, including clinical diagnostics, oncology, and women’s health 
testing services. This restructuring has allowed the company to focus on higher-value 
specialty diagnostics and core laboratory services while improving operational efficiency. 
As part of this strategic shift, OPKO is increasingly concentrating on its 4Kscore franchise 
and select specialty testing services, aligning its diagnostics business with a more focused, 
higher-margin model. At the same time, the company continues to support regional 
laboratory operations and maintain its presence in clinical testing.  

 
 
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Quest Diagnostics 
Madison, NJ 
www.questdiagnostics.com 
Quest Diagnostics is a leading provider of diagnostic information services, offering a broad 
range of laboratory testing, information, and services to patients, physicians, hospitals, 
employers, insurers, and biopharmaceutical companies. The company operates an extensive 
network of laboratories and patient service centers across the United States and 
internationally, supported by a large medical and scientific staff that provides consultative 
expertise and interpretation of complex test results. 
Quest Diagnostics offers a comprehensive test menu ranging from routine clinical assays, 
such as lipid panels, cytology testing, and complete blood counts, to advanced molecular, 
genetic, and oncology diagnostics. The company has expanded its capabilities in precision 
medicine, including next-generation sequencing, companion diagnostics, and advanced 
biomarker testing to personalize treatment decisions. 
Through its specialized reference laboratory, Nichols Institute, Quest provides advanced 
esoteric testing services to hospitals and laboratories worldwide, supporting complex 
diagnostic needs across the Americas, Europe, and Asia. The company maintains an 
international presence with laboratory operations and partnerships in multiple countries, 
supporting global clinical trials and diagnostic services. 
Quest Diagnostics also offers a broad range of population health and employer-focused 
solutions, including workplace drug testing, wellness screening programs, and risk 
assessment services for the insurance industry. Its Blueprint for Wellness program provides 
employers with health insights to improve workforce health and productivity. 
The company is recognized for its large-scale data analytics capabilities, leveraging one of 
the largest clinical laboratory databases in the United States. Through initiatives such as its 
Health Trends reports and Drug Testing Index, Quest provides insights into disease 
prevalence, public health patterns, and workforce drug use trends, supporting clinical 
research, policy development, and public health decision-making. 
 

 
 
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Quest Diagnostics has continued to invest in advanced diagnostics, digital health integration, 
and data-driven healthcare solutions. The company is expanding its offerings in areas such 
as oncology, infectious disease, and genetic testing, while also enhancing access through 
patient-centric services, including convenient testing locations and digital engagement tools. 
Key Acquisitions, Alliances, and Partnerships 
Quest Diagnostics continues to  enter into targeted acquisitions and strategic collaborations 
designed to expand its geographic footprint, enhance service capabilities, and strengthen its 
position in advanced diagnostics. The company regularly evaluates both domestic and 
international opportunities to broaden access to laboratory services and add differentiated 
capabilities in areas such as oncology, digital pathology, and precision medicine. 
Quest has completed a series of acquisitions focused on expanding its outreach laboratory 
services and strengthening regional market presence. These include acquisitions of hospital-
based outreach laboratory businesses, such as those from University Hospitals in Ohio and 
OhioHealth, which extend Quest’s access to hospital networks and patient populations in key 
U.S. regions. The company has also expanded into specialty diagnostics through the 
acquisition of kidney disease and dialysis-related laboratory assets, strengthening its 
capabilities in chronic disease testing. 
Quest has complemented acquisitions with strategic collaborations and joint ventures to 
expand access to diagnostic services. These include multi-year partnerships with healthcare 
systems and payers to broaden laboratory access across multiple regions, as well as large-
scale joint ventures with health systems to manage laboratory operations and develop 
regional testing infrastructure. 
In advanced diagnostics, Quest has strengthened its capabilities through innovation-focused 
collaborations. With PathAI, the company has integrated digital and artificial intelligence–
enabled pathology into clinical workflows, improving diagnostic efficiency and accuracy. In 
oncology, the acquisition of Haystack Oncology has expanded Quest’s capabilities in 
minimal residual disease testing and liquid biopsy, reinforcing its position in precision 
oncology. 
 

 
 
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Quest strengthened its specialty genetics portfolio through the acquisition of Blueprint 
Genetics, enhancing its capabilities in rare disease and inherited condition testing. The 
company continues to integrate prior acquisitions to drive growth in new geographies and 
expand advanced diagnostic offerings. 
Products and Services 
Quest Diagnostics offers a comprehensive range of diagnostic testing services in the United 
States through a national network of approximately 2,000–2,200 patient service centers and 
an extensive team of physicians and scientific experts. The company provides services to a 
significant portion of the U.S. population, including a large share of hospitals and healthcare 
providers, and remains primarily focused on the domestic market while maintaining selective 
international operations. 
Quest’s test menu spans a broad spectrum of clinical areas, including anatomic pathology, 
genetic and hereditary disease testing, oncology, dermatology, hematology, cardiovascular 
disease, endocrinology, infectious disease, toxicology, and neurology. The company 
continues to emphasize the development of less invasive diagnostic approaches, including 
blood-based and molecular tests that support earlier detection and improved patient 
compliance. 
Through the QuestDirect offering, the company has expanded its direct-to-consumer and 
patient-initiated testing capabilities. The program allows retail partners to provide access to 
a wide range of health tests across categories such as general wellness, women’s health, 
allergy, digestive health, and infectious disease.  
In infectious disease diagnostics, Quest offerings include molecular PCR-based assays for 
emerging pathogens. Its dual-target PCR test for orthopoxviruses enabled differentiation of 
specific viral strains and supported public health response efforts. 
Quest continues to expand its portfolio with new diagnostic offerings across multiple 
specialties. In oncology, the company markets MelaNodal Predict, a gene expression 
profiling test designed to help guide treatment decisions in melanoma. The company has also 
expanded its oncology capabilities with advanced minimal residual disease testing, including 
both ctDNA-based assays for solid tumors and a novel blood-based test for multiple myeloma 
that enables ultrasensitive detection of residual disease using non-invasive samples. 

 
 
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In neurology, Quest has advanced its Alzheimer’s disease testing portfolio with blood-based 
biomarker assays, including the AD-Detect platform, which combines amyloid and tau 
biomarkers to support assessment of amyloid pathology. The company has also expanded 
into advanced genomics through collaborations aimed at evaluating whole genome 
sequencing as a first-line diagnostic approach for developmental disorders, reflecting a 
broader shift toward comprehensive genomic testing in clinical practice. 
In women’s health, Quest has introduced HPV self-collection solutions to support cervical 
cancer screening, improving access and convenience for patients. Additionally, the company 
continues to enhance its patient engagement offerings, including personalized health 
coaching programs. 

 
 
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Sonic Healthcare 
Sydney, Australia 
www.sonichealthcare.com 
Sonic Healthcare is a leading international provider of medical diagnostics services, with 
operations spanning laboratory medicine, radiology, and primary care. The company serves 
well over 100 million patients annually through a global network of laboratories, imaging 
centers, and clinics. Sonic operates a significant primary care network in Australia, 
comprising more than 150 clinics and thousands of affiliated physicians, alongside a large 
workforce that includes pathologists, medical scientists, and technical staff. 
Sonic Healthcare offers an extensive test menu of more than 3,000 diagnostic assays, ranging 
from routine clinical testing to highly specialized esoteric and molecular diagnostics. The 
company is widely recognized for its expertise in complex testing, including genomics, 
infectious disease diagnostics, and advanced pathology services. Its client base includes 
physicians, hospitals, community health providers, and patients across multiple regions. 
Geographically, Sonic Healthcare maintains a strong presence in Australia, Europe, the 
United States, and New Zealand, with Europe representing its largest market, followed by 
Australia and North America.  
Sonic has made acquisitions and strategic investments. Recent acquisitions include regional 
laboratory groups in Germany, strengthening its European footprint, as well as U.S.-based 
diagnostic companies that expand capabilities in specialty and oncology testing. These 
investments allow Sonic’s transition toward advanced diagnostic technologies and more 
integrated testing services. 
The company has further strengthened its position in oncology diagnostics through the 
acquisition of  Cairo Diagnostics, a hematology and oncology diagnostics provider in the 
United States. This acquisition enables more comprehensive cancer diagnostic workflows 
and faster turnaround times for complex cases. 
Sonic is also advancing its capabilities in digital pathology, integrating imaging, automation, 
and artificial intelligence–enabled tools to improve diagnostic accuracy and efficiency. The 

 
 
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continued integration of digital pathology platforms, including dermatopathology solutions, 
provides the company’s transition toward more scalable and data-driven diagnostic services.