OraSure Technologies, Inc.
OraSure Technologies, Inc. transforms health through actionable insight and powers the shift that connects people to healthcare wherever they are. The company improves access, quality, and value of healthcare with innovation in effortless tests and sample collection solutions. It develops, manufactures, and distributes rapid diagnostic tests and sample collection devices globally, serving clinical laboratories, hospitals, physician’s offices, clinics, public health organizations, research institutions, government agencies, pharmaceutical companies, and consumers. The company also collaborates with subsidiaries like DNA Genotek and Sherlock Biosciences to expand its diagnostic solutions. OraSure is committed to ethical practices, environmental sustainability, and community engagement, operating in over 40 countries.
Industries
Nr. of Employees
large (251-1000)
OraSure Technologies, Inc.
220 East First Street, Bethlehem, PA 18015, USA
Patents
Reagents, methods, and systems for detecting therapeutic agents to monitor adherence to nucleoside reverse transcriptase inhibitor metabolites
US-12099056-B2
View DetailsProducts and methods for monitoring adherence to nucleoside reverse transcriptase inhibitor therapy
US-11795239-B2
View Details
Reagents, methods, and systems for detecting therapeutic agents to monitor adherence to nucleoside reverse transcriptase inhibitor metabolites
US-12099056-B2
View DetailsProducts and methods for monitoring adherence to nucleoside reverse transcriptase inhibitor therapy
US-11795239-B2
View DetailsProducts
Rapid HIV antibody point-of-care test (fingerstick, ~20-minute)
A lateral-flow rapid antibody test for HIV intended for point-of-care use; supports parallel testing workflows from a single fingerstick sample to enable same-visit results.
Rapid HCV antibody point-of-care test (fingerstick, ~20-minute)
A lateral-flow rapid antibody test for hepatitis C intended for point-of-care use; designed to be used in parallel workflows with other rapid assays from a single fingerstick.
Rapid treponemal syphilis lateral-flow test (~10-minute, CLIA-waived)
A lateral-flow treponemal antibody rapid test designed for fingerstick whole-blood testing in CLIA-waived settings, with short time-to-result to support same-visit diagnosis and treatment decisions.
Over-the-counter HIV self-test kit
A consumer-facing rapid HIV self-test kit intended for at-home use and distribution through outreach programs to expand testing reach.
Sample collection kits with ambient nucleic acid stabilization
Self-collection kits and reagents that stabilize DNA and RNA at ambient temperature for long-term transport and storage across multiple sample types (saliva, oral, fecal, vaginal, skin).
Rapid HIV antibody point-of-care test (fingerstick, ~20-minute)
A lateral-flow rapid antibody test for HIV intended for point-of-care use; supports parallel testing workflows from a single fingerstick sample to enable same-visit results.
Rapid HCV antibody point-of-care test (fingerstick, ~20-minute)
A lateral-flow rapid antibody test for hepatitis C intended for point-of-care use; designed to be used in parallel workflows with other rapid assays from a single fingerstick.
Rapid treponemal syphilis lateral-flow test (~10-minute, CLIA-waived)
A lateral-flow treponemal antibody rapid test designed for fingerstick whole-blood testing in CLIA-waived settings, with short time-to-result to support same-visit diagnosis and treatment decisions.
Over-the-counter HIV self-test kit
A consumer-facing rapid HIV self-test kit intended for at-home use and distribution through outreach programs to expand testing reach.
Sample collection kits with ambient nucleic acid stabilization
Self-collection kits and reagents that stabilize DNA and RNA at ambient temperature for long-term transport and storage across multiple sample types (saliva, oral, fecal, vaginal, skin).
Services
Production of rapid diagnostic tests and sample collection devices at a primary manufacturing facility.
Selection and management of distributor partners, licensed third-party distribution and international commercialization support.
Training resources, implementation guidance and on-site support for rapid point-of-care testing, batch workflows and community programs.
Management of corporate compliance systems, privacy and consent processes, and support for regulatory submissions and audits.
Web-based intake and management of product inquiries, sample requests and customer feedback, including multilingual survey collection.
Production of rapid diagnostic tests and sample collection devices at a primary manufacturing facility.
Selection and management of distributor partners, licensed third-party distribution and international commercialization support.
Training resources, implementation guidance and on-site support for rapid point-of-care testing, batch workflows and community programs.
Management of corporate compliance systems, privacy and consent processes, and support for regulatory submissions and audits.
Web-based intake and management of product inquiries, sample requests and customer feedback, including multilingual survey collection.
Expertise Areas
- Point-of-care diagnostic development
- Sample collection and ambient nucleic acid stabilization
- Infectious disease rapid testing and syndemic screening
- Self-test kit programs and direct-to-consumer distribution
Key Technologies
- Lateral-flow immunoassays
- Point-of-care testing workflows
- Over-the-counter self-test kits
- Ambient-temperature nucleic acid stabilization chemistries
News & Updates
Webinar: A Syndemic Approach to Syphilis, HIV and HCV Rapid Screening in Clinic & Outreach Settings
A webinar hosted by the NCSD discussing rapid testing for syphilis, HIV, and HCV in clinic and outreach settings.
Interview: Rapid HIV and HCV Testing for Underserved Communities
An interview with Sandra Marrero-Ashford about using rapid testing in underserved communities.
Case Study: Point-of-care testing to increase HIV and HCV batch testing
A case study on outreach project increasing HIV and HCV testing among substance-using communities.
Frannie Peabody Center's HIVST Program Triples Testing Rates in Maine
A case study on how the Frannie Peabody Center expanded HIV testing using self-tests.
A Mobile Approach to Rapid Syndemic Testing at the Point of Need
A case study on mobile rapid testing in Ramsey County, Minnesota.
Beating Back Syphilis – A Point of Care Testing Strategy
An article on syphilis epidemic and point-of-care testing strategies.
Webinar: A Syndemic Approach to Syphilis, HIV and HCV Rapid Screening in Clinic & Outreach Settings
A webinar hosted by the NCSD discussing rapid testing for syphilis, HIV, and HCV in clinic and outreach settings.
Interview: Rapid HIV and HCV Testing for Underserved Communities
An interview with Sandra Marrero-Ashford about using rapid testing in underserved communities.
Case Study: Point-of-care testing to increase HIV and HCV batch testing
A case study on outreach project increasing HIV and HCV testing among substance-using communities.
Frannie Peabody Center's HIVST Program Triples Testing Rates in Maine
A case study on how the Frannie Peabody Center expanded HIV testing using self-tests.
A Mobile Approach to Rapid Syndemic Testing at the Point of Need
A case study on mobile rapid testing in Ramsey County, Minnesota.
Beating Back Syphilis – A Point of Care Testing Strategy
An article on syphilis epidemic and point-of-care testing strategies.