BETHLEHEM, Pa., July 3 (UPI) -- The U.S. Food and Drug Administration has approved OraQuick's In-Home HIV Test for sale directly to consumers over-the-counter, officials said.
Douglas A. Michels, president and chief executive officer of OraSure Technologies, said his company's product is the first rapid diagnostic test for any infectious disease that has been approved by the FDA for sale over-the-counter.
He said it can detect antibodies to both HIV-1 and HIV-2 with an oral swab in an in-home testing option in 20 minutes.
"Approval of the OraQuick In-Home HIV Test represents a major breakthrough in HIV testing," Michels said in a statement. "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 OraQuick In-Home HIV Test is expected to be available for purchase in October at more than 30,000 U.S. retail outlets and online.
The Centers for Disease Control and Prevention said approximately 1.2 million people in the United States have HIV and approximately 240,000 of them do not know it.