OTC Test for HIV Endorsed By FDA Panel

A Food and Drug Administration panel has endorsed an HIV test that would be available over the counter and can give a diagnosis in only 20 minutes. The test could receive FDA approval before the end of 2012.

The OraQuick HIV Test is already available for usage at doctor’s offices. It is not a cure, but could mark a big victory in the battle against HIV. An advisory panel consisting of 17 members endorsed the test that allows consumers to give themselves the HIV test in the privacy of their home.

The test is not 100% accurate, but the panel has deemed the benefits of regular testing in the home outweigh the potential for risks and recommended that the FDA approve it for OTC sales.

The test, which is manufactured by Orasure a Bethlehem, Pennsylvania based company, and uses an oral swab to give the diagnosis for HIV in minutes. In clinical settings, the test is already being used. While not as accurate as lab diagnostics, it could be helpful in curbing the spread of the virus allowing people to perform more regular discrete testing. The disease is spread most often via sexual content between two partners who may not be aware one or the other is infected with the virus.

The panel believes its impact could be substantial as there are over 240,000 people thought to be infected in the U.S. who do not know they even are carriers. The test, in clinical trials has shown an accuracy rate of identifying the virus of approximately 93%.