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OraSure gets approval for first-ever over-the-counter HIV test

Stacy Wescoe//July 3, 2012

OraSure gets approval for first-ever over-the-counter HIV test

Stacy Wescoe//July 3, 2012//

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The approval, announced this week, makes OraQuick the first and only rapid over-the-counter HIV test approved in the U.S., as well as the first over-the-counter rapid diagnostic test for any infectious disease.

The test can detect antibodies to both HIV-1 and HIV-2 with an oral swab, providing a confidential in-home testing option with results in as little as 20 minutes.

“Approval of the OraQuick In-Home HIV Test represents a major breakthrough in HIV testing,” said Douglas A. Michels, president and CEO of OraSure Technologies. “For the first time ever, individuals will have access to an in-home oral test that will empower them to learn their HIV status in the comfort of their home and obtain referral to care if needed. This new in-home rapid test – the same test doctors have used for years — will help individuals at risk for HIV who otherwise may not test in a professional or clinical setting.”

The test is expected to be available for purchase this October at more than 30,000 retail outlets throughout the country and online.

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