FDA questions accuracy of OraSure's at-home HIV test ahead of panel meeting
This article was originally published in Clinica
Executive Summary
OraSure Technologies' OraQuick In-Home HIV test is set for a tough FDA panel review, after the agency found that some users get the wrong result. The Blood Products Advisory Committee is due to meet on 15 May to discuss whether the benefits of the diagnostic outweigh its risks; the agency usually follows the recommendations of its panels when deciding whether to approve products, but is not bound by them.