FDA Reviews First Rapid, Take-Home Test for HIV

The Food and Drug Administration is considering approval of the first over-the-counter HIV test that would allow consumers to quickly test themselves for the virus at home, without medical supervision.

FDA reviewers said Friday the OraQuick In-Home HIV test could play a significant role in slowing the spread of HIV, according to briefing documents posted online. But they also raised concerns about the accuracy of the test, a mouth swab that returns results in about 20 minutes.

The review comes one day after an FDA advisory panel endorsed the HIV pill Truvada for preventive use. If FDA follows the group's advice, the daily medication would become the first drug approved to prevent healthy people from becoming infected with the virus that causes AIDS.

Public health experts 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.

In a trial conducted by the company OraSure Technologies Inc., the test correctly detected HIV in those carrying the virus 93 percent of the time. That rate is below the FDA-recommended 95 percent threshold for accuracy.

The FDA estimates the test would miss about 3,800 HIV-positive people per year, if approved for U.S. consumers.

The test was more accurate at correctly clearing patients who do not have the disease. In company studies, OraQuick correctly identified HIV-negative users 99 percent of the time.

In their briefing documents, FDA scientists noted both the benefits and risks of expanding HIV testing with the take-home diagnostic kit.

"There is considerable personal and public health value in informing infected, but otherwise untested, persons of their true positive HIV status," the reviewers state. "However, this benefit is offset in some measure by HIV-positive individuals who receive an incorrect message that they are not infected."

The lukewarm endorsement apparently spooked investors. OraSure's stock tumbled $1.32, or 11.8 percent, to close at $9.85 in trading Friday.

On Tuesday, the FDA will ask a panel of outside experts whether the test should be approved for over-the-counter sales in U.S. The agency is not required to follow the group's advice, though it usually does.

Based in Bethlehem, Pa., OraSure has marketed a version of OraQuick to doctors, nurses and other health care practitioners since 2004. The test sells for $17.50, though OraSure declined to discuss how it would price the consumer version. When used by professionals, the test is shown to accurately identify both carriers and non-carriers 99 percent of the time.

While it's not clear why the test was less accurate in consumer trials, CEO Doug Michels said company researchers anticipated that its "performance in the hands of a consumer would be different from that observed in hands of a professional."

OraSure tried the new version of the test in a study of 5,800 people of various sexual orientation, race and income levels. The trial identified about 100 HIV carriers who were previously undiagnosed.

The FDA has already approved HIV test kits that people take home. However, those kits, which require a blood sample, must be sent to a laboratory for development. But OraSure argues that a test that can be done at home will appeal to a much broader group of people.

According to the company's study, 41 percent of people who discovered they were HIV-positive using OraQuick had never been tested previously. In its own briefing documents, the company estimates that 9,000 new HIV carriers would be identified for every 1 million people who use the test.