OraSure Technologies Inc. (OSUR) said Tuesday the U.S. Food and Drug Administration has approved its "OraQuick In-Home" HIV Test for sale directly to consumers in the over-the-counter, or OTC market - making it the first and only rapid OTC HIV test approved in the U.S.
OraSure shares are up currently gaining over 4 percent in afternoon trade on the Nasdaq.
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 as little as 20 minutes.
It is the first rapid diagnostic test for any infectious disease that has been approved by the FDA for sale over the counter.
"Approval of the OraQuick In-Home HIV Test represents a major breakthrough in HIV testing," said Douglas Michels, President and Chief Executive Officer 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..."
The OraQuick In-Home HIV Test is an over-the-counter version of the company's OraQuick ADVANCE HIV 1/2 Antibody Test.
The OraQuick In-Home HIV Test is expected to be available for purchase this October at more than 30,000 retail outlets throughout the country and online.
According to the Centers for Disease Control and Prevention, there are about 1.2 million people in the U.S. that have HIV.
OSUR is trading on the Nasdaq at $12.01, up $0.51 or 4.44%.
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