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.
Bethlehem, Pennsylvania, United States, North America
Products
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
In-house manufacturing of diagnostic and collection devices
Production of rapid diagnostic tests and sample collection devices at a primary manufacturing facility.
Global distribution and channel management
Selection and management of distributor partners, licensed third-party distribution and international commercialization support.
Training and implementation support for POC testing programs
Training resources, implementation guidance and on-site support for rapid point-of-care testing, batch workflows and community programs.
Regulatory and compliance program implementation
Management of corporate compliance systems, privacy and consent processes, and support for regulatory submissions and audits.
Online inquiry and sample-request processing
Web-based intake and management of product inquiries, sample requests and customer feedback, including multilingual survey collection.
In-house manufacturing of diagnostic and collection devices
Production of rapid diagnostic tests and sample collection devices at a primary manufacturing facility.
Global distribution and channel management
Selection and management of distributor partners, licensed third-party distribution and international commercialization support.
Training and implementation support for POC testing programs
Training resources, implementation guidance and on-site support for rapid point-of-care testing, batch workflows and community programs.
Regulatory and compliance program implementation
Management of corporate compliance systems, privacy and consent processes, and support for regulatory submissions and audits.
Online inquiry and sample-request processing
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