OraSure Technologies

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.

Name

OraSure Technologies

Legal name

OraSure Technologies, Inc.

Website

https://orasure.com

Company type

Public

Founded year

2012

Operating status

Operating

Headcount range

501–1,000 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

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 industry

PRIMARYHLAAALAL

Multiplex & High-Throughput Diagnostics Platforms (microarrays, digital PCR, lab automation-enabled assays)

Healthcare & Life Sciences/Biotechnology & Biologics/Diagnostics (Biotech-related)

SECONDARYHLAAALAD

Genetic & Genomic Testing (germline, somatic, carrier, pharmacogenomics)

Healthcare & Life Sciences/Biotechnology & Biologics/Diagnostics (Biotech-related)

SECONDARYHLAGAEAF

Microbiology & Infectious Disease Testing (Trial Support)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Central Labs & Clinical Diagnostics Services (Trial Support)

SECONDARYHLAGADAF

Molecular & Genetic Testing (PCR/NGS/qPCR)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Laboratory Testing & Analytical Services

SECONDARYHLAFAMAE

Molecular Diagnostics & Genomics Laboratories

Healthcare & Life Sciences/Healthcare Providers & Systems/Clinical Laboratories

Keywords

• Diagnostic test kits
• Oral fluid diagnostics
• Molecular sample collection
• Infectious disease testing
• Rapid HIV testing

Headquarters

HQ city

Bethlehem

HQ country

United States

HQ region

North America

Offices2 records

Markets served

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

1. 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.
2. 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.
3. Consumables and Related Products: Ongoing revenue from consumables, reagents, and related products supporting the installed base of testing and collection devices.
4. Professional Services: Diversigen provides microbiome laboratory testing and analytical services generating service-based revenue.

Pricing tiers

Go-to-market motion3 records

Distribution channels5 records

Marketing channels3 records

Core 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

Named customers4 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature4 records

Partnerships

Three partnerships are on record, tiered core.

• Roche DiagnosticscoreTechnology or Integration · 11 June 2026Strategic 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)coreChannel Partner/ Reseller/ Distributor · 10 February 2026Exclusive 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 BiosciencescoreTechnology or Integration · 1 December 2024Acquired 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

Direct 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

• Xx.com/orasure
• Facebookfacebook.com/orasure
• LinkedInlinkedin.com/company/orasure-technologies

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries5 records

Funding overview

Funding rounds3 records

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A7 records

Investments1 record

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about OraSure Technologies