OraSure Technologies
OraSure Technologies (NASDAQ: OSUR) develops oral fluid and molecular diagnostic tests plus sample collection devices, serving public health programs, clinical labs, and consumers via the OraQuick HIV Self-Test, Colli-Pee Dx urine collection kits, and DNA Genotek molecular products.
- Company typePublic
- Founded2012
- HeadquartersBethlehem, United States
- Headcount251–500
- GTM typeB2B and B2C
- OfferingHardware or Manufacturing
What OraSure Technologies does
OraSure Technologies, Inc. (NASDAQ: OSUR) is a publicly traded diagnostics company headquartered in Bethlehem, Pennsylvania, that develops, manufactures, and distributes oral fluid diagnostic tests, molecular sample collection devices, and rapid point-of-care testing products. The company operates two reporting segments: Infectious Disease Diagnostics, anchored by the OraQuick HIV Self-Test (the first FDA-approved oral HIV self-test, also Health Canada-licensed) and OraQuick HCV rapid tests, and Sample Management Solutions, led by subsidiary DNA Genotek, which supplies specimen collection kits that stabilize DNA/RNA at ambient temperatures for pharmaceutical, biotech, research, and consumer genomics customers. OraSure sells through direct enterprise sales to clinical laboratories, hospitals, and physicians' offices, through an e-commerce storefront (store.orasure.com), through global distributors, and through exclusive partnerships such as St. Michael's Hospital for Canada.
The company's recent product strategy has pivoted toward at-home and decentralized diagnostics, exemplified by the June 2026 FDA clearance of the Colli-Pee Dx Urine Collection Kit — built on proprietary NucleoPresicion Technology — for at-home STI sample collection integrated with Roche's cobas molecular diagnostic systems to detect Chlamydia, Gonorrhea, Trichomonas, and Mycoplasma genitalium. Complementary capabilities include the Sherlock Biosciences molecular diagnostics platform (acquired December 2024 for CRISPR-based rapid STI testing) and the BioMedomics sickle cell disease testing portfolio (acquired November 2025 for ~$4M, targeting Africa and Latin America). Revenue is generated through hardware sales of tests and consumables, plus professional microbiome services via subsidiary Diversigen.
OraSure is in a multi-year operational transformation. Full-year 2025 revenue declined 38% YoY following the collapse of COVID-19 rapid antigen demand and reduced Sample Management Solutions revenue from a major consumer genomics customer; the company has executed approximately 40% workforce reductions since 2023 and consolidated facilities. With ~$199M in cash and no debt, the company retains financial flexibility to fund new product launches and pursue further M&A. Activist investor Altai Capital Management (~5% stake) reached a cooperation agreement in April 2026 that included board declassification and director refresh, signaling potential strategic alternatives under evaluation.
OraSure Technologies firmographics
Firmographics- Name
- OraSure Technologies
- Legal name
- OraSure Technologies, Inc.
- Website
- https://orasure.com
- Company type
- Public
- Founded year
- 2012
- Operating status
- Operating
- Headcount range
- 251–500 employees
- Short description
- OraSure Technologies (NASDAQ: OSUR) develops oral fluid and molecular diagnostic tests plus sample collection devices, serving public health programs, clinical labs, and consumers via the OraQuick HIV Self-Test, Colli-Pee Dx urine collection kits, and DNA Genotek molecular products.
- Ownership category
- akta.pro rank
OraSure Technologies industry classification
Industry- Product category
- In Vitro Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Testing Laboratories (8734)
- akta.pro primary industry
- Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays) (HLAAALAL)
- akta.pro secondary industries
- Genetic & Genomic Testing (germline, somatic, carrier, pharmacogenomics) (HLAAALAD), Microbiology & Infectious Disease Testing (Trial Support) (HLAGAEAF), Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF), Molecular Diagnostics & Genomics Laboratories (HLAFAMAE)
Keywords
Where OraSure Technologies is headquartered
LocationHeadquarters
- HQ city
- Bethlehem
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
OraSure Technologies business model
Business model- GTM type
- B2B and B2C
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales, Supply Chain
Revenue model
- Oral Fluid HIV Testing Products: Revenue from OraQuick HIV tests and related oral fluid diagnostic products sold to consumers and healthcare providers through OTC and professional channels.
- Molecular Sample Collection Devices: DNA Genotek subsidiary generates revenue from specimen collection kits used for genetic material collection, stabilization, transport and storage for molecular testing. Serves disease risk management, diagnostics, pharmaceutical, biotech, nutrition, companion animal and environmental markets.
- Consumables and Related Products: Ongoing revenue from consumables, reagents, and related products supporting the installed base of testing and collection devices.
- Professional Services: Diversigen provides microbiome laboratory testing and analytical services generating service-based revenue.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | OraQuick HIV Self-Test consumer pricing |
Go-to-market motion3 records
Distribution channels5 records
Marketing channels3 records
OraSure Technologies product offering
Product offeringCore offering
OraSure Technologies develops, manufactures, and distributes oral fluid diagnostic and collection devices focused on infectious disease detection and molecular sample collection. The company sells rapid point-of-care diagnostic tests (including the FDA-approved OraQuick HIV Self-Test and HCV rapid tests) and specimen collection kits manufactured by its DNA Genotek subsidiary, used for collecting, stabilizing, transporting, and storing genetic material for molecular testing across disease risk management, diagnostics, pharmaceutical, biotech, and research markets.
Product overview
OraSure Technologies operates as a diversified diagnostics company organized around two primary segments: Infectious Disease Diagnostics (offering rapid point-of-care tests) and Sample Management Solutions (specializing in biological sample collection devices). The core portfolio includes the OraQuick HIV Self-Test (an oral swab-based rapid test available in OTC and professional versions), HCV Rapid Tests, and Drug of Abuse Tests. The company's Sample Management Solutions are led by subsidiary DNA Genotek's molecular collection kits and complemented by Novosanis urine collection devices and Diversigen microbiome services. Following acquisitions of Sherlock Biosciences (December 2024) and BioMedomics (November 2025), OraSure expanded into rapid molecular self-testing for STIs (Sherlock platform) and sickle cell disease testing. The flagship integration is the FDA-cleared Colli-Pee Dx Urine Collection Kit, which connects DNA Genotek's collection technology with Roche's cobas molecular diagnostic systems for laboratory processing of STI samples.
Differentiator
Problem solved
Functional benefit
Brands
- OraQuick: Rapid HIV testing products including OraQuick HIV Self-Test and OraQuick HCV rapid tests
- Colli-Pee
- DNA Genotek
- Sherlock Biosciences
- BioMedomics
Products and services
- OraQuick HIV Self-Test An oral swab-based rapid HIV test that detects HIV-1 and HIV-2 antibodies with results in approximately 20 minutes. Available as both over-the-counter (OTC) and professional use versions. The first and only oral HIV self-test approved in the US and Canada.
- Colli-Pee Dx Urine Collection Kit An FDA-cleared at-home first-void urine self-collection device for STI testing, manufactured by subsidiary DNA Genotek. Uses NucleoPresicion Technology to stabilize DNA and RNA at ambient temperatures, enabling patients to collect and mail samples for laboratory processing on Roche's cobas molecular diagnostic systems to detect Chlamydia, Gonorrhea, Trichomonas, and Mycoplasma genitalium.
- Sherlock Rapid Molecular Self-Test A rapid molecular self-test for Chlamydia and Gonorrhea (CT/NG) that delivers results in approximately 30 minutes. Part of the Sherlock Biosciences molecular diagnostics platform acquired by OraSure in December 2024 for home STI testing.
- Molecular Sample Collection Devices (DNA Genotek) Specimen collection kits manufactured and sold by subsidiary DNA Genotek for collecting, stabilizing, transporting, and storing genetic material samples for molecular testing. Serves disease risk management, diagnostics, pharmaceutical, biotech, nutrition, companion animal, and environmental markets.
- HCV Rapid Tests Rapid diagnostic tests for Hepatitis C virus detection, sold alongside oral fluid HIV testing products for point-of-care and professional diagnostic use.
- BioMedomics Sickle Cell Disease Tests Sickle cell disease rapid tests acquired through the November 2025 purchase of BioMedomics for approximately $4 million. Focused on high-prevalence markets in Africa and Latin America.
- Drug of Abuse Tests Tests for drugs of abuse that are processed in a laboratory setting, forming part of OraSure's diagnostic portfolio alongside oral fluid and rapid testing products.
- Novosanis First-Void Urine Collection Device A device for the collection of first-void urine samples in humans, sold by subsidiary Novosanis N.V., part of OraSure's sample collection portfolio.
- Microbiome Laboratory Testing and Analytical Services Microbiome laboratory testing and analytical services provided by subsidiary Diversigen, Inc., offering sample analysis and insights for research and clinical applications.
Quantifiable outcome
- FDA clearance for Colli-Pee Dx kit enables at-home STI testing for Chlamydia, Gonorrhea, Trichomonas, and Mycoplasma genitalium
- +1 more outcomes
Companies that use OraSure Technologies
Customer profileNamed customers4 records
Segments3 records
Ideal customer profiles3 records
OraSure Technologies technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration1 record
Feature4 records
OraSure Technologies partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered core.
- Roche DiagnosticscoreStrategic partnership combining OraSure's Colli-Pee Dx Urine Collection Kit with Roche's cobas molecular diagnostic systems (cobas 5800, 6800, and 8800) for STI testing. The kit enables at-home first-void urine self-collection with samples mailed to laboratories for processing on Roche's systems, detecting Chlamydia, Gonorrhea, Trichomonas, and Mycoplasma genitalium.
- St. Michael's Hospital (Unity Health Toronto)coreExclusive distributor partnership for OraQuick HIV Self-Test in Canada. St. Michael's Hospital's MAP Centre for Urban Health Solutions will distribute the first oral HIV self-test available in Canada, beginning distribution to health providers and front-line agencies.
- Sherlock BiosciencescoreAcquired Sherlock Biosciences in December 2024 to integrate Sherlock's molecular diagnostics platform for home testing of sexually transmitted infections. Sherlock develops rapid, accurate, and affordable diagnostic tests using CRISPR-based technology.
Scale indicators6 records
Recent moves6 records
Expansion highlights6 records
OraSure Technologies competitors and assessment
Company assessmentDirect peers
- Abbott Laboratories: Direct competitor in rapid infectious disease diagnostics including HIV rapid tests (Determine HIV), i-STAT handheld diagnostics, and STI testing. Abbott is also a broad incumbent in immunoassay and molecular diagnostics, directly contesting OraSure in core POC categories.
- QuidelOrtho Corporation: Direct peer in rapid diagnostic testing with Sofia platform for infectious disease screening including HIV, HSV, and respiratory pathogens. Competes directly with OraSure's OraQuick franchise in POC and clinical settings.
- Cepheid (Danaher): Direct competitor in rapid molecular diagnostics for infectious disease and STI testing via GeneXpert systems. Competes with OraSure's Sherlock platform on speed-to-result and test menu breadth in near-patient molecular testing.
- Trinity Biotech: Direct peer in infectious disease rapid diagnostics including HIV, with similar product positioning in decentralized and POC testing. Comparable business model and customer base to OraSure's diagnostics segment.
- GenMark Diagnostics (Roche): Direct peer in rapid molecular diagnostics via ePlex system for syndromic infectious disease testing, now part of Roche. Overlaps with OraSure's Sherlock-based strategy for rapid molecular testing at POC.
Broad incumbents
- Hologic: Broad incumbent in molecular diagnostics (Aptima) for STI screening including Chlamydia and Gonorrhea, the same pathogens OraSure targets through Colli-Pee Dx and Sherlock. Hologic's Panther system is the entrenched lab-based standard that OraSure's decentralized workflow must displace.
- Becton Dickinson (BD): Broad incumbent in microbiology diagnostics and sample collection devices (BD Max, BD Veritor, BD ProbeTec). Overlaps with OraSure's HIV/STI diagnostics and Diversigen microbiome services across lab and POC workflows.
- bioMérieux: Broad incumbent in microbiology diagnostics (VITEK, BioFire FilmArray) and now molecular STI through BioFire. Comparable to OraSure's infectious disease focus and Diversigen microbiome testing services.
- Danaher Corporation: Parent of Cepheid and Beckman Coulter, with a broad diagnostics and life sciences portfolio spanning molecular, immunoassay, and sample prep. Comparable in scale and platform breadth, and a potential acquirer given OraSure's depressed valuation.
Others
- Roche Diagnostics: Strategic partner via cobas integration for Colli-Pee Dx and a broad incumbent in molecular diagnostics. While not a direct competitor in POC, Roche's cobas installed base is the critical distribution channel for OraSure's at-home STI collection strategy.
Market position
Strengths5 records
Weaknesses4 records
Competitive moat4 records
Key risks5 records
Key highlights6 records
Customer concentration
OraSure Technologies social profiles
Digital presenceOraSure Technologies compliance and trust
Trust signalCompliance3 records
OraSure Technologies financial estimates
Financial estimateRevenue estimate
Valuation estimate
OraSure Technologies leadership team
Management profileNumber of profiles
Profiles9 records
OraSure Technologies subsidiaries and ownership
Company hierarchySubsidiaries5 records
OraSure Technologies funding detail
Funding detailFunding overview
Funding rounds3 records
Investors3 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
OraSure Technologies M&A and investment
M&A and investmentM&A7 records
Investments1 record
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about OraSure Technologies
What does OraSure Technologies do?
OraSure Technologies develops, manufactures, and distributes oral fluid diagnostic and collection devices focused on infectious disease detection and molecular sample collection. The company sells rapid point-of-care diagnostic tests (including the FDA-approved OraQuick HIV Self-Test and HCV rapid tests) and specimen collection kits manufactured by its DNA Genotek subsidiary, used for collecting, stabilizing, transporting, and storing genetic material for molecular testing across disease risk management, diagnostics, pharmaceutical, biotech, and research markets.
Is OraSure Technologies a public or private company?
OraSure Technologies is a public company. It is classified as public and is currently operating.
When was OraSure Technologies founded?
OraSure Technologies was founded in 2012. It employs 251 to 500 people.
Where is OraSure Technologies based?
OraSure Technologies is headquartered in Bethlehem, United States, in the North America region.
How does OraSure Technologies make money?
Four revenue lines are on record. Oral Fluid HIV Testing Products are the primary driver. The others are molecular Sample Collection Devices, consumables and Related Products and professional Services.
Who are OraSure Technologies's main competitors?
Direct peers on record are Abbott Laboratories, QuidelOrtho Corporation, Cepheid (Danaher), Trinity Biotech and GenMark Diagnostics (Roche). Broad incumbents are Hologic, Becton Dickinson (BD), bioMérieux and Danaher Corporation. Roche Diagnostics is listed as an others.
Does OraSure Technologies have an API?
No public API is recorded for OraSure Technologies.
What industry is OraSure Technologies in?
OraSure Technologies's product category is In Vitro Diagnostics. Its primary akta.pro industry code is HLAAALAL, Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays), with a secondary code of HLAAALAD, Genetic & Genomic Testing (germline, somatic, carrier, pharmacogenomics). Its NAICS code is 325413 and its SIC code is 2835.