FDA Approves At-Home HIV Test
BY Michelle Garcia
July 03 2012 2:10 PM ET
The U.S. Food and Drug Administration has approved OraQuick, the first over-the-counter, at-home HIV test to be offered in the nation. The test is an oral swab that produces results in about 20 minutes.
An independent panel recommended that the FDA approve the drug in May.
"This approval marks a major milestone in HIV testing," executives at OraSure, the developers of the test, said in a statement Tuesday. "The OraQuick® In-Home HIV Test will fill an unmet need by providing a testing option for individuals at risk for HIV who may otherwise not test in a professional setting. For the first time ever, individuals will have access to an in-home oral test that will empower them to learn their HIV status and receive the care and support that they need. The oral swab will provide a confidential in-home testing option with results in as little as 20 minutes.
OraQuick should be available at major retailers in the coming months.