An advisory panel to the Food and Drug Administration has recommended the agency approve what would be the first over-the-counter at-home HIV test.
The test is produced by Bethlehem, Pa.- based OraSure Technologies.
Company president Doug Michels said the firm is “extremely pleased” with the panel’s 17-0 unanimous decision.
“There are approximately 1.2 million people in the United States that have HIV and approximately 20 percent of them, or 240,000, are unaware of their HIV status,” Michels said in a conference call to reporters. “So this is a momentous day for the company and, we believe, for public health.”
The test is an oral swab that takes about 20 minutes to produce a result.
The panel voted that the benefits of the test outweigh the potential risks, but they did express concern about false negatives for people who had been infected too recently for the test detect the virus.
Dr. Marla Gold, dean of Drexel University’s School of Public Health, said at a doctor’s office, patients may be more likely to talk about recent possible exposure and set up a follow-up test.
“At home, some people might think they’re infected, get a negative test, and stop right there,” Gold said. “But, overall, we are talking about a small number of people and that’s no reason not to make the test accessible for the masses.”
The company says it will work with the FDA on its package labeling in the upcoming months to address the issue of false positives and negatives.
The FDA typically follows recommendations from advisory panels, but is not required to do so.
OraSure has not determined a price for the test or — if the FDA approves it — how soon after approval it would be available.