OraSure Technologies, Inc. is a Bethlehem, Pennsylvania–based diagnostic and medical device company specializing in the development, manufacture and commercialization of point-of-care and self-testing products. Founded in 1988, OraSure has built a portfolio of oral fluid and other non-invasive specimen collection technologies that support the detection of infectious diseases, drugs of abuse, and health and wellness biomarkers.
The company’s flagship product, the OraQuick® rapid HIV test, was the first Food and Drug Administration–approved over-the-counter oral fluid test for the detection of HIV-1/2 antibodies. Beyond HIV screening, OraSure offers a suite of products that include the OraQuick® HCV Rapid Antibody Test for hepatitis C, oral fluid and blood-based drug of abuse tests under the Intercept® and OraSure® brands, and collection devices for DNA-based analysis in forensic and bio-sampling applications. More recently, OraSure has leveraged its collection and assay expertise to introduce COVID-19 antigen and antibody tests.
Serving healthcare providers, public health agencies, clinical laboratories and consumers around the world, OraSure maintains regulatory clearances or approvals in key markets across North America, Europe and Asia. The company products are distributed through direct sales teams, strategic partnerships and third-party distributors, with a focus on expanding access to rapid, accurate diagnostics in both professional and at-home settings.
OraSure Technologies is led by Chairman, President and Chief Executive Officer William Caragol, who has guided the company’s growth and diversification since joining in 2006. Under his leadership, OraSure continues to invest in research and development to advance non-invasive testing solutions and strengthen its position in the global diagnostic marketplace.
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