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"We are always looking for game changers, and we believe this is one of them," said Carl Schmid, deputy director of the AIDS Institute. "Not only will it help reduce the number of infections but it will bring more people into care and treatment." Tuesday's meeting was the second time in less than a week that FDA advisers recommended approval of a novel medical product to slow the spread of HIV. Last Thursday a similar panel of drug experts endorsed the HIV daily pill Truvada for preventive use. If FDA follows the group's advice, the daily medication will become the first drug approved to prevent healthy people from becoming infected with the virus. The FDA has already approved other HIV test kits designed to be used at home, although those kits
-- which require a blood sample -- must be sent to a laboratory for development. Orasure executives argue that a test that can be done at home will appeal to a much broader group of people. FDA officials said it is impossible to predict how widely the test would be used, but it would be most effective in the hands of people at high risk of acquiring the virus, including men who have sex with men. A recent survey of gay and bisexual men cited by public health officials found that 84 percent would test themselves more frequently if they could buy an over-the-counter HIV test.
Orasure sells its professional version of the test for $17.50, though company executives declined to discuss how they would price the consumer version.
[Associated
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