May 16, 2012
Expert Health Panel Urges FDA To Approve In-Home HIV Test
The US Food and Drug Administration (FDA) will be tasked with deciding the fate of a new over-the-counter HIV testing kit that would allow people to test for the virus in the privacy of their own home.
The call was made by a panel of experts for the Blood Products Advisory Committee, who urged the federal regulatory agency to approve the new OraQuick In-Home HIV Test, saying it was safe and effective and that the benefits outweighed any risks.OraSure, the manufacturer of the device, presented data to the panel showing that 5,700 people have taken the in-home test. The data showed that 114 of those people received positive results, and 106 were confirmed, through blood testing, to be true positives, giving the test a 93 percent accuracy rate for positive tests.
The test, which takes 20 minutes and requires a swab around the outer gum area and uses oral fluid to test for HIV, also has a 99.8 percent accuracy rate for negative results, according to the data.
The expert panel voted 17-0 in favor of the new testing kit, saying it would help people who are HIV-positive get access to healthcare and social services. The testing kit was approved by the FDA in 2004 for use by medical professionals. So it seems likely that the FDA will approve it for in-home use as well, especially with the unanimous support of the Blood Products Advisory Committee.
While it showed support, the panel did urge that OraSure include highly visible warnings about false negative results on the package. It also urged that the packaging should carry a toll-free number offering counseling to those who test positive.
“We are always looking for game changers, and we believe this is one of them,” Carl Schmid, deputy director of the AIDS Institute, told the Associated Press (AP) in response to the panel´s approval of the test.
“Not only will it help reduce the number of infections but it will bring more people into care and treatment,” Schmid told AP reporter Matthew Perrone.
Although the FDA does not have to follow the advice of the expert panel, it usually does.
The OraQuick test could sell for less than $60 if approved, OraSure said in a statement.
The FDA also recently approved a drug called Truvada, which could become the first drug in tablet form to protect healthy people from contracting the HIV virus.