OraSure Seeks FDA Approval of Rapid HIV Test for Expanded Use With Saliva, Plasma
Bethlehem, Pa.-based OraSure Technologies on Monday announced that it is seeking pre-market FDA approval for its OraQuick rapid HIV test for use in detecting HIV in saliva or plasma particles, the Philadelphia Inquirer reports (Philadelphia Inquirer, 9/30). The new test would eliminate the need for needles or finger pricks and potentially dangerous blood samples, making the test safer and easier to perform, according to the Allentown Morning Call (Kennedy, Allentown Morning Call, 9/30). Last month, the agency approved the OraQuick HIV test for expanded use in hospitals using blood drawn intravenously and stored in a tube. The test previously could be used only with blood obtained from a finger prick. In February, President Bush announced a plan to expand the availability of the rapid test, which offers results that are 99.6% accurate within 20 minutes, to more than 100,000 doctors' offices and public health clinics nationwide (Kaiser Daily HIV/AIDS Report, 9/11). The FDA has 180 days to respond to the application in accordance with agency regulations, according to an OraSure release. OraSure CEO Mike Gausling said that if the test is approved for testing saliva and plasma, it could "provide advantages over competing blood or urine HIV tests that should broaden the appeal of OraQuick, particularly in the public health market where HIV testing often occurs in the field or other nontraditional settings" (OraSure release, 9/29).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.