Orasure seeks approval for expanded use

By Advocate.com Editors

Originally published on Advocate.com October 01 2003 11:00 PM ET

Bethlehem, Pa.-based OraSure Technologies on Monday announced that it is seeking premarket FDA
approval for its OraQuick rapid HIV test for use in detecting HIV in saliva or plasma particles, the Philadelphia Inquirer reports. The new test would eliminate the need for needles or finger pricks and potentially dangerous blood samples, making rapid tests safer and easier to perform. 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. According OraSure, the FDA has 180 days to respond to the application in accordance with agency regulations. 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," said OraSure CEO Mike Gausling.