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FDA Panel Backs First Rapid, Take Home HIV Test
from USA Today
WASHINGTON (Associated Press) - American consumers may soon be able to test themselves for the virus that causes AIDS in the privacy of their own homes, after a panel of experts on Tuesday recommended approval of the first rapid, over-the-counter HIV test.
The 17 members of the federal Food and Drug Administration advisory panel voted unanimously that the benefits of the OraQuick HIV test outweigh its potential risks for consumers. While the test, which uses a mouth swab to return a result in 20 minutes, does not appear to be as accurate as professionally-administered diagnostics, panelists said it could provide an important way to expand HIV testing.
The FDA will make its final decision on whether to approve the product later this year, weighing the opinion of the panel. Government officials estimate one-fifth, or about 240,000 people, of the 1.2 million HIV carriers in the U.S. are not aware they are infected. Testing is one of the chief means of slowing new infections, which have held steady at about 50,000 per year for two decades.
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