OraSure Launches OraQuick ADVANCE Rapid HIV-1/2 Antibody Test

OraQuick® ADVANCE Rapid HIV-1/2 Antibody Test, is the first and only FDA approved and CLIA waived rapid point-of-care test that provides accurate results for both HIV-1 and HIV-2 in 20 minutes, using oral fluid, finger-stick or venipuncture whole blood or plasma specimens.

Shipments of the new test are expected to begin in early November 2004. The new product is being unveiled on October 21, 2004 at the United States Conference on AIDS (USCA) in Philadelphia, Pennsylvania.

Earlier in 2004, OraSure announced that its OraQuick® Rapid HIV-1/2 Antibody Test had received approval from the FDA for use in detecting antibodies to both HIV-1 and HIV-2 in oral fluid, finger stick and venous whole blood, and plasma samples. Also in June 2004, OraSure announced that the OraQuick® HIV-1/2 test had received a CLIA waiver, which will allow the test to be used by more than 180,000 sites in the United States, including outreach clinics, community-based organizations, and physicians' offices.

The launch follows the successful completion of a previously announced assessment conducted by the Company regarding a subset of data from an isolated clinical trial of the new oral fluid test. As part of the assessment, the Company executed a study that mirrored the use of the test in the field, in which over 12,000 test readings were reviewed. The results from that study, in addition to data analyzed from several independent studies involving over 7,000 oral fluid samples, clearly indicate that the test is operating within its specifications. OraSure Technologies will unveil the new OraQuick® ADVANCE test