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.

The FDA has estimated that 2.8 million people might test themselves in the first year after over-the-counter test becomes available. FDA projected that the test could pick up 45,000 infections that otherwise would have remained undetected, while missing 3,800 infections, based upon the test’s 93 percent rate of correctly identifying infections in clinical trials. In addition, the agency estimated that by identifying 45,000 HIV-positive people, the test could prevent them from unwittingly transmitting it to another 4,000 people.

“This is a big step forward for HIV prevention. Anything that encourages people to get tested is a good thing,” said Dr. Richard Besser, ABC News chief health and medical editor, and a former acting director of the federal Centers for
Disease Control and Prevention. “Twenty percent of Americans with HIV don’t even know it.  It’s hard to prevent the spread if you don’t even know you’re infected. HIV is now a treatable as well as preventable disease.”

Besser said it’s important that anyone who gets tested, whether at home or in a doctor’s office , “is connected to support services.”



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