FDA Panel To Review Proposal To Make OraSure Technologies’ Rapid HIV Test Available for At-Home Use
An advisory panel of FDA on Nov. 3 is scheduled to review a proposal to make OraSure Technologies' rapid HIV test available for use in the home, the New York Times reports. After the panel makes a recommendation, OraSure said it likely will formally apply to sell the test over-the-counter. The test, called OraQuick Advance Rapid HIV 1/2 Antibody Test, has been proven safe, effective and easy to use, and currently is only sold to doctors and clinics. The test requires users to swab their gums and then place the swab in a holder. After 20 minutes, one line appears on the strip if the HIV result is negative, two appear if the result is positive. At-home HIV testing has been debated for the past 18 years, as AIDS advocates and public health officials have feared that making such tests available might cause "widespread suicides, panic and a rush to public health clinics," the Times reports. A 1987 application for an at-home HIV test stalled because of such concerns. However, Freya Spielberg, a researcher at the Center for AIDS Research at the University of Washington, said the availability of a rapid, at-home HIV test "is the most powerful strategy we have to bring down HIV infections." She said that about one-quarter of the nearly one million HIV-positive people in the U.S. do not know they are infected, and between 40% to 45% of people who test HIV-positive do so less than one year before developing AIDS (Harris, New York Times, 10/13). Also, about 8,000 people who test positive for HIV annually at health clinics never return to pick up their results, according to the Allentown Morning Call (Blumenau, Allentown Morning Call, 10/13). Doug Michels, OraSure's president and CEO, said he plans to include in the test's label advice about counseling, adding that OraSure would include anything FDA says is necessary (New York Times, 10/13).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.