OraSure granted FDA approval for final phase studies of OraQuick Rapid HIV-1/2 Antibody Test

OraSure Technologies, Inc. (Nasdaq:OSUR), the market leader in oral fluid diagnostics, today announced that the U.S. Food and Drug Administration ("FDA") has granted an investigational device exemption (IDE) for the Company to conduct the final phase of clinical testing for FDA approval of its OraQuick^® Rapid HIV-1/2 Antibody Test for sale in the consumer or over-the-counter ("OTC") market.

Receipt of the IDE allows the Company to proceed with the final phase of clinical testing which consists of a study in which individuals will conduct unsupervised self-testing using the investigational OTC version of the OraQuick^® HIV test with an oral fluid collection.

As previously announced, OraSure has already initiated site selection, training and preparation and Institutional Review Board (IRB) review for this final phase and expects enrollment to begin before the end of the year.

"We are extremely pleased to have approval to begin the final phase of studies to support our efforts to obtain 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 look forward to continuing our work with the FDA and other members of the community to make a home use rapid HIV test available in the United States."