OraSure commences enrollment in final study for FDA approval of OraQuick Rapid HIV-1/2 OTC test

OraSure Technologies, Inc. (Nasdaq:OSUR), the market leader in oral fluid diagnostics, announced today that it has enrolled the first subject in its final phase of clinical studies for United States Food and Drug Administration ("FDA") approval of the Company's OraQuick^® Rapid HIV-1/2 test for sale in the U.S. consumer or over-the-counter ("OTC") market.

As previously announced in November, the FDA granted an Investigational Device Exemption ("IDE") which allowed OraSure to begin the final phase of clinical testing for the at home HIV test kit. This phase consists of an unobserved user study in which individuals will conduct unsupervised oral fluid self-testing using the investigational OTC version of the OraQuick ADVANCE ^® Rapid HIV-1/2 test.

OraSure also announced today that the FDA recently approved its request to extend product expiration dating to 24-months for its OraQuick ADVANCE ^® Rapid HIV-1/2 test which is currently available in the professional market. The FDA approval is based on prior enhancements made by OraSure to the manufacturing process for this product.

"We are extremely pleased to announce these two important milestones in our quest for FDA approval for an over-the-counter offering of our OraQuick^® HIV test," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "We believe that the OraQuick^® test, with its robust technology, ease of use, and oral fluid testing capability, is the best rapid HIV test available on the market, and is ideally suited for consumer self testing. We look forward to the successful completion of our clinical studies and the formal submission of our clinical data as we continue our work with the FDA to make an at home rapid HIV test kit available in the United States."

OraQuick ADVANCE ^® is the first and only FDA-approved and CLIA-waived rapid point-of-care test that can detect antibodies to both HIV-1 and HIV-2 in 20 minutes, using oral fluid, finger-stick or venipuncture whole blood or plasma specimens. As the market leader, OraQuick ADVANCE ^® is used extensively throughout the country in public health settings, hospitals, community-based organizations, and physician offices where HIV testing is conducted.

According to the Centers for Disease Control and Prevention, approximately 1.1 million individuals in the United States are infected with HIV, yet approximately one-quarter do not know they have the disease.