OraSure Technologies Inc. yesterday announced that FDA's Blood Products Advisory Committee (BPAC) provided a unanimous positive recommendation for the company's OraQuick In-Home HIV Test. The BPAC provides advice to the FDA on issues related to the safety and effectiveness of biological products and medical devices seeking FDA approval.

The BPAC voted on two questions posed by FDA:

• Do the projected benefits of the test outweigh the potential risks of false positive and false negative test results? The committee voted 17-0 in the affirmative to that question.
• Do the available data provide reasonable assurance that the test is safe and effective for its intended use? The committee voted 17-0 in the affirmative to that question.

In addition to reviewing the company's clinical data and performance, the BPAC considered data presented by FDA and testimonies shared during the public comment session.The committee also discussed risk mitigation strategies that should be considered in addition to the current proposed labeling.

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 is the first and only FDA-approved and CLIA-waived rapid point-of-care test that can detect antibodies to both HIV-1 and HIV-2 in oral fluid in 20 minutes, according to OraSure Technologies.