OraSure Over-The-Counter HIV Test: Complete PMA Filing Planned By Year End
This article was originally published in The Gray Sheet
Executive Summary
OraSure Technologies expects to complete a PMA filing for its OraQuick Advance rapid HIV-1 and -2 over-the-counter saliva test by the end of the year.
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FDA’s Blood Products Advisory Committee endorses OraSure’s OraQuick in-home HIV test in a unanimous 17-0 vote on May 15. If approved, OraQuick would be the first-ever over-the-counter test for HIV that can be performed entirely in the home by untrained users.
OraSure In-Home HIV Test’s Promise Outweighs Risks, Panel Concludes
FDA’s Blood Products Advisory Committee endorses OraSure’s OraQuick in-home HIV test in a unanimous 17-0 vote on May 15. If approved, OraQuick would be the first-ever over-the-counter test for HIV that can be performed entirely in the home by untrained users.
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