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FDA panel recommends at-home HIV Test Kit

Submitted by FDA

An HIV test may soon be available for use in the privacy of your home.

On May 15, 2012 a 17 member federal advisory committee unanimously voted to recommend that the FDA approve OraSure Technologies Inc.’s OraQuick In-Home HIV Test citing that the accessibility factor of the test outweighs the risks of false results.

If approved the oral swab screening device will be the first infectious-disease test approved for home use. A version of OraQuick has been sold to doctors and other health care professionals since 2004.

The panel’s decision came after considering two questions posed by the FDA:
* Do the projected benefits of the test outweigh the potential risks of false positive and false negative test results?
* Do the available data provide reasonable assurance that the test is safe and effective for its intended use?
An affirmative response was given to both questions.

The panel heard from HIV advocates, Black community representatives and doctors who expressed overwhelming favor-able support of OraQuick. They testified that this is a step forward in combating the virus, especially for African American men and women.

“We believe we are at a deciding moment in the trajectory of the AIDS epidemic. The key to that begins with getting them tested,” Phill Wilson, president and CEO of the Black AIDS Institute, told the panel.

Of the 1.2 million people living with HIV, about 20 percent are not aware they are infected, according to (PDF) the Kaiser Family Foundation. OraSure found that 41 percent of the people who used the test in the clinical trial had never been tested before. OraQuick has the potential to uncover approximately 4,000 infections a year, reports USA Today.

The opinion of the panel will be a factor in the FDA’s decision to approve the product. A decision is expected later this year.

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