OraSure's over-the-counter HIV test
This article was originally published in The Gray Sheet
OraSure Technologies says it will continue to pursue FDA approval of its OraQuick HIV OTC over-the-counter HIV test, based on feedback from a closed-door FDA advisory panel session. During the Nov. 17 discussion by FDA's Blood Products Advisory Committee on over-the-counter, home-use HIV test kits, the panel met privately with OraSure to review the results of ongoing clinical studies and discuss what additional data would be needed for approval
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