FDA Panel Reviews Proposal To Make OraSure Technologies’ Rapid HIV Test Available for At-Home Use

An FDA advisory panel on Thursday in Gaithersburg, Md., reviewed a proposal to make OraSure Technologies' rapid HIV test available for home use, the Philadelphia Inquirer reports (Loyd, Philadelphia Inquirer, 11/4). Nearly a dozen advocates and researchers said a home test would lead more people to get tested, meaning more HIV-positive people might be diagnosed and treated earlier. They said people could discover their HIV status in the privacy of their homes without fear of being stigmatized (Heavey, Reuters, 11/3). Some health care professionals expressed concern about how people would cope with a positive result without immediate access to counseling and support (Westley, Salt Lake Tribune, 11/4). The test, called OraQuick Advance Rapid HIV 1/2 Antibody Test, has been proven safe, effective and easy to use and currently is sold only 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 (Kaiser Daily HIV/AIDS Report, 10/13). If approved, OraQuick would be the first home test available over the counter for any infectious disease. The committee advised FDA about criteria required for the test to be approved, but it did not formally vote on whether to recommend that the agency approve the proposal. FDA queried the 15-member panel about such issues as the need to conduct studies to confirm the accuracy of the test, the necessity of additional testing to confirm results, and how to handle psychological and social issues (Philadelphia Inquirer, 11/4). The panel told FDA that it should require home HIV tests to work almost as well as professional tests and seemed to be in favor of providing the test over the counter, Reuters reports (Reuters, 11/4). OraSure said it will wait until after the panel meeting to decide whether to formally apply for FDA approval for over-the-counter status for the test (Philadelphia Inquirer, 11/4).