FDA advisory committee recommends OTC availability of HIV test
BETHLEHEM, Pa. — OraSure Technologies on Tuesday announced that the Food and Drug Administration's Blood Products Advisory Committee recommended that the OraQuick In-Home HIV test be made available without a prescription.
“There was broad support expressed by the HIV community at [the] meeting, and we look forward to continuing our work with them in the fight against HIV," stated OraSure president and CEO Douglas Michels. "We believe the OraQuick In-Home HIV Test will make a valuable contribution in this fight.”
The OraQuick In-Home HIV Test is an over-the-counter version of the OraQuick Advance Rapid HIV-1/2 Test, which is currently sold into the professional market. The OraQuick Advance test can detect antibodies to both HIV-1 and HIV-2 in oral fluid within 20 minutes, the company stated.