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news.The FDA has approved the OraSure Technologies' OraQuick In-Home HIV Test for sale directly to consumers in the over-the-counter (OTC) market.
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The OraQuick In-Home HIV 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 20 minutes.
According to the company, the product is the first rapid diagnostic test for any infectious disease that was approved by the FDA for sale over the counter.
OraSure Technologies president and chief executive officer Douglas Michels said 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," Michels added.
The OraQuick In-Home HIV Test, which is an OTC version of the company’s OraQuick ADVANCE HIV 1/2 Antibody Test, is expected to be available for purchase in October 2012 at retail outlets and online.