FDA Panel Calls on Orasure To Devise Trials to Test Accuracy, Safety of OraQuick Oral HIV Test
The FDA Blood Products Advisory Committee in a public hearing on Friday told Bethlehem, Pa.-based OraSure Technologies that it must devise a clinical study to test the accuracy and safety of its oral OraQuick Advance Rapid HIV 1/2 Antibody Test before moving forward with the federal approval process, the Newark Star-Ledger reports (MacPherson, Newark Star-Ledger, 3/11). The oral 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, and two appear if the result is positive (Kaiser Daily HIV/AIDS Report, 12/22/05). The committee recommended a multiple-phase experiment of home HIV tests, which would explore whether people could perform the test correctly and what psychological risks exist for those who test HIV-positive. According to the Allentown Morning Call, the hearing was a "critical step" in the process that could lead to the approval of OraQuick for use as an at-home test (Kennedy, Allentown Morning Call, 3/11). "If the data show that home testing is feasible, I think it is certainly possible that home testing can play a role," Jennifer Ruth, a CDC spokesperson said (Newark Star-Ledger, 3/11). OraSure CEO Douglas Michels at a news conference on Friday said, "We're very pleased at what we feel is unequivocal support," adding, "By and large, this is what we anticipated." Michels said he expects to establish concrete plans for the trial by the end of this month and to launch it this summer. He said he does not yet know when the trial would conclude. FDA will determine the next steps in the approval process for at-home HIV testing after the study is completed (Allentown Morning Call, 3/11).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.