Reuters: Regulatory News: UPDATE 1-Orasure at-home HIV test gets OK from US FDA

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UPDATE 1-Orasure at-home HIV test gets OK from US FDA Jul 3rd 2012, 16:55 Tue Jul 3, 2012 12:55pm EDT July 3 (Reuters) - U.S. health regulators on Tuesday said they approved OraSure Technologies Inc's in-home test for HIV, making it the first available over-the-counter, self-administered test for the virus that causes AIDS. The Food and Drug Administration gave its green light to the OraQuick In-Home HIV Test, which can provide results of an oral fluid sample taken by swabbing the upper and lower gums inside the mouth within 20 to 40 minutes. Shares of the company, which were halted pending the FDA announcement, shot up 5.4 percent in early afternoon trading to $12.12. The company said the test -- which is already approved for use by trained technicians -- will be available starting in October at more than 30,000 retailers and online. The FDA cautioned that a positive result does not mean an individual is definitely infected with HIV, but rather that additional testing should be done in a medical setting to confirm the test. About 1.2 million people in the United States are living with HIV infection, but one in five are not aware of it, according to estimates from the Centers for Disease Control and Prevention. 50,000 new people are infected with HIV each year, often from people who may not know they have the virus, the FDA said. Link this Share this Digg this Email Reprints

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