FDA Panel Greenlights Over-the-Counter HIV Test
Experts believe the inexpensive test could detect as many as 45,000 new HIV infections a year.
| Posted Wednesday, May 16, 2012, at 4:01 PM
Photo by David McNew/Getty Images.
Inexpensive home HIV tests may soon hit drug-store shelves after an FDA advisory panel voted unanimously to make the tests available over the counter.
The Washington Post explains that the mouth-swab test would take about 20 minutes to work and accurately detects the presence of HIV in 93 percent of infected people. (It is 99 percent effective for people not infected with HIV.) Some experts on the panel had raised concerns about the test’s accuracy and what might happen when people learn of their HIV status outside a clinical setting, but the board decided the potential to boost general awareness outweighed any drawbacks.
The FDA still has to formally approve the tests, but the agency generally follows its committees’ advice.
An estimated 1.2 million Americans are infected with HIV, according to the CDC, but the Post notes that a recent poll found that 44 percent of Americans said they had never been tested for the virus. An FDA researcher estimated that the privacy of the home test could help diagnose 45,000 cases of HIV a year and in turn prevent about 4,000 new infections. (The CDC estimates one in five HIV-positive people don't know they're infected.)
The test would also be affordable: it would be identical to the $17.95 swab test now used in most clinics, with a possible price adjustment to cover more elaborate packaging, according to its manufacturer.
The FDA panel’s recommendation follows a potential watershed in HIV prevention last week when another FDA panel voted to approve Truvada, a drug that could significantly reduce the risk of HIV.
