FDA considers approval of OraQuick In-Home HIV test!

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FDA panel backs at-home HIV test that analyzes mouth swab in 20 minutes

Great News in the fight against HIV/AIDS. An at-home HIV test that claims to diagnose the disease in 20 minutes from saliva on a mouth swab is a step closer to hitting store shelves, now that an advisory panel of experts recommended the test kit's approval to the Food and Drug Administration.

Truvada for HIV prevention backed by advisory panel, FDA may decide by June

The 17 members of the panel voted unanimously that the benefits of the OraQuick HIV test outweigh its potential risks for consumers. The test does not appear to be as accurate as professionally-administered diagnostics, but 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. The agency does not have to follow the panel's advice though it typically does.
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.
Based in Bethlehem, Pa., Orasure has marketed a version of OraQuick to doctors, nurses and other health care practitioners since 2004. The FDA has already approved other at-home HIV test kits, although they require taking a blood sample that must be sent to a laboratory for analysis. Orasure executives argue that a test that can be done at home will appeal to a much broader group of people. The company sells its professional version of the test for $17.50, though company executives declined to price the consumer version.

When used by professionals, the new test is shown to accurately identify both carriers and non-carriers 99 percent of the time.
But a trial conducted by the company showed the home test only correctly detected HIV in those carrying the virus 93 percent of the time. The FDA estimated the test would miss about 3,800 HIV-positive people per year, while correctly identifying 45,000, if approved for U.S. consumers. The test could prevent 4,000 new transmissions of the virus annually, though the figure could vary based on the kit's sales. While it's not clear why the test was less accurate in consumer trials, company researchers said they expected the test's sensitivity to drop when used by consumers versus professionals.
Panelists stressed that the test's labeling should state that a negative reading does not automatically mean the person does not have HIV, and highlight the importance of a toll-free number to put those who test positive in touch with counseling and medical care.
Despite concerns about less-than-perfect use by the public, the panel overwhelmingly sided with more than two dozen HIV advocates and doctors, who said the test represents a step forward in combating the virus.

"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 product to slow the spread of HIV. Last Thursday a similar panel of drug experts endorsed the HIV daily pill Truvada for preventive use, CBS News reported. 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.

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.

Dr. Arthur Caplan, a professor of medical ethics at the University of Pennsylvania, says the at-home kit raises ethical concerns because there is no mandatory counseling that comes with the test.

"Having a home test kit for HIV is a bit like relying on a bathroom scale in the battle against obesity," he wrote in a blog on MSNBC, saying both can tell you potentially life-saving information. But without counseling, "there is a pretty good chance you will either say 'Thank goodness I did not test positive' and keep doing whatever it is you are doing even if it is bad for you - or test positive and say 'I have a problem and I am so ashamed or frightened I won't do anything at all about it.'"

HIV kills a body's CD4 cells that help the body ward off disease and infection. It can be transmitted through sex with an infected person, sharing drug needles, a transfusion with infected blood, or passed from a pregnant mother to a child. With regard to youth, HIV disproportionately affects young gay and bisexual men and young African Americans, according to the CDC.