FDA Advisory Panel Approves Home HIV Test Kit
Americans are a step closer to being able to quickly determine in the privacy of their own homes whether they’re infected with HIV, the virus that causes AIDS.
An advisory panel to the U.S. Food and Drug Administration Tuesday voted 17-0 in favor of approving the OraQuick In-Home HIV Test, which produces results within 20 minutes of a quick swab along the gum line. A positive test result still must be confirmed with a traditional blood test performed in a laboratory.
The FDA, which isn’t bound by the recommendations of its advisory panels, is expected to make a final decision about the home test this year. A thumbs-up for the over-the-counter test kit from OraSure Technologies Inc., of Bethlehem, Pa., has the potential to reduce the number of people who unknowingly spread the virus because they’re unaware they’re infected. An estimated quarter million Americans are HIV-positive, but haven’t been tested. Each year, about 50,000 Americans become infected.