In Development
OraSure Technologies' product pipeline underlies the Company's commitment to delivering accurate, versatile and easy-to-use tools used in the fields of infectious disease, drugs of abuse detection and cryosurgery technology. We have several potential new products in the pipeline including:
Rapid HIV Antibody test for Over-the-Counter ("OTC") Use
OraSure is pursuing clinical development in order to obtain FDA approval for sale "over-the-counter" (OTC) of a self-test application of a rapid test for HIV antibodies.
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Fully Automated Oral Fluid Drugs of Abuse Assays
OraSure Technologies and Roche Diagnostics are currently collaborating on the development and commercialization of homogeneous fully-automated oral fluid drugs of abuse assays that can run on random access chemistry analyzers. The oral fluid assays are for use with OraSure's Intercept® Oral Specimen Collection Device and Roche's KIMS (kinetic interaction of microparticles in solution) technology. To date, the FDA has issued 510(k) clearances for five assays, including PCP, cocaine, opiates, methamphetamine and amphetamine. An assay for THC (marijuana) is currently in development.
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