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OraSure Makes Final FDA Submission for Approval of Over-the-Counter Rapid HIV Test


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The third module contains the findings from the final phase of clinical testing, which involved the use of the OraQuick(R) Rapid HIV-1/2 test with subjects in an unobserved setting. Approximately 5,800 subjects were enrolled and tested in this phase across 20 sites nationwide, resulting in the identification of more than 100 previously undiagnosed individuals with HIV.

According to the Centers for Disease Control and Prevention (CDC), there are approximately 1.2 million people in the U.S. that have HIV and approximately 240,000 of them are unaware of their status, despite current HIV testing options. Not only is their own health at risk, they are also unknowingly responsible for up to 70 percent of the approximately 50,000 new HIV infections occurring each year in the U.S. The CDC recommends routine HIV screening for all people ages 13 to 64, with more frequent testing for people at higher risk.

"The latest CDC figures demonstrate the status quo for testing is inadequate and additional options to capture undiagnosed individuals infected with HIV must be brought to the market. We've been working closely with the community and FDA on the development of a powerful new HIV testing option for individuals. This submission was a major undertaking for OraSure and the culmination of years of hard work and financial commitment. An easy-to-use, private, and accurate in-home HIV test will enable more people to learn their presumptive HIV status so that they can receive necessary care and support," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "The completion of our submission to the FDA is a critical milestone in our efforts to secure approval and expand the tools available to combat the spread of HIV."

The final phase of clinical testing consisted of a multi-visit, blinded, unobserved user study in which individuals conducted unsupervised oral fluid self-testing using an investigational OTC version of the OraQuick ADVANCE(R) Rapid HIV-1/2 test. Once all subject tests were complete and study results unblinded, the performance of the OraQuick HIV test in the unobserved OTC setting was compared with FDA-approved laboratory HIV test results.

The Company intends to provide the necessary resources to ensure optimal support for individuals who, pending approval, would then be able to use the OraQuick HIV test in an OTC setting. In addition to a highly informative website, OraSure will offer "live" support and comprehensive referral services 24 hours a day, seven days a week, every day of the year, through a highly trained specialized toll-free call center, which was functional as part of the clinical trials. Detailed, easy-to-understand information on HIV and HIV testing was part of the clinical studies as well and will also be included in every test kit.

The first module for FDA review was submitted to the agency in the third quarter of 2011 and contained data from all studies performed prior to the final phase of testing. The second module was submitted to the FDA several weeks ago and included information about manufacturing and the customer care call center.

In the professional market, OraSure manufactures and sells the OraQuick ADVANCE(R) Rapid HIV 1/2 Test which 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 leading rapid HIV test with over 20 million tests sold, OraQuick ADVANCE(R) is used extensively throughout the country in public health settings, hospitals, community-based organizations, and physician offices where HIV testing is conducted.

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