BETHLEHEM, Pa., Aug 9, 2011 (GlobeNewswire via COMTEX)- OraSure Technologies, Inc. the market leader in oral fluid diagnostics, announced today that it has closed enrollment for its multi-site clinical study of the Company's OraQuick(R) Rapid HIV-1/2 test for sale in the U.S. consumer or over-the-counter (OTC) market.
As previously announced, OraSure initiated the final phase of clinical testing for an in-home HIV self-test kit in December 2010.
This phase consists of a multi-visit, blinded, unobserved user study in which individuals conduct unsupervised oral fluid self-testing using
the investigational OTC version of the OraQuick ADVANCE(R) Rapid HIV-1/2 test. Once all subject visits are completed and study results are
un-blinded, the performance of the OraQuick ADVANCE(R) Rapid HIV-1/2 Antibody test in an OTC setting will be compared with FDA-approved
blood-based assay performance. One of the study objectives specified by the FDA was to identify at least 100 HIV infected, but
undiagnosed individuals. In order to meet this requirement, the Company enrolled approximately 5,700 participants in the study across 20 clinical sites nationwide.
In planning for its FDA submission, the Company has decided to split its filing into three separate parts or modules, the timing of which will
be spaced to allow the FDA sufficient review time between modules. This is an accepted technique used to start the formal review process
as early as possible. The first of the three modules is expected to be submitted to FDA in the third quarter; the last of the modules,
containing the results of the final clinical study, is expected to be submitted around the end of the year.
"We are extremely pleased to have reached this very significant milestone in our clinical study. The ease of use and non-invasive
nature of the collection process makes our oral fluid rapid HIV Test an ideal candidate device for in-home use by consumers," said Douglas A.
Michels, President and Chief Executive Officer of OraSure Technologies. "We anticipate the completion of the remainder of ongoing clinical
study activities to occur sometime late in the third quarter, followed by data analyses in the fourth quarter. We look forward to
continuing our work with the FDA and the healthcare community to make a home-use rapid HIV test available in the United States."
The Company also recently announced that the FDA and the Company's notified body in Europe have both granted an extension of
shelf life to 30 months for the OraQuick HIV test. This is significant, not just for the professional market, but also for the
over-the-counter market where the retail market typically requires a shelf life of 24 months or more.
OraQuick ADVANCE(R) 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(R) is used extensively throughout the country in public health settings, hospitals, community-based
organizations, and physician offices where HIV testing is conducted.
About OraSure Technologies
OraSure Technologies is a leader in the development, manufacture and distribution of oral fluid diagnostic devices and other technologies
designed to diagnose critical medical conditions and diseases. Its innovative products include rapid tests for the detection of
antibodies to HIV and HCV at the point of care and testing solutions for detecting various drugs of abuse. These products
enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve
and protect their health. OraSure's products are sold globally to various clinical laboratories, hospitals,
clinics, community-based organizations and other public health organizations, distributors, government
agencies, physicians' offices, and commercial and industrial entities. For more information on the
Company, please go to www.orasure.com.
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SOURCE: OraSure Technologies, Inc.
OraSure Technologies, Inc.
Ronald H. Spair, Chief Financial Officer
Zer0 to 5ive for OraSure Technologies
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OraSure Technologies, Inc