OraSure Technologies to Present Before the FDA Blood Products Advisory Committee on November 3, 2005
Posted on: Wednesday, 12 October 2005, 06:02 CDT
OraSure Technologies, Inc. (NASDAQ:OSUR), the market leader in oral fluid diagnostics, announced today that it will present at a meeting of the Blood Products Advisory Committee ("BPAC") of the U.S. Food and Drug Administration ("FDA") in Gaithersburg, Maryland on November 3, 2005. The public meeting will include an OraSure proposal for an Over-the-Counter Home-Use Rapid HIV Test Kit.
The full BPAC meeting agenda for the November 3rd session can be viewed at: http://www.fda.gov/oc/advisory/accalendar/2005/ cber19516dd11030405.html (Due to its length, this URL may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.)
The BPAC advises the Commissioner of Food and Drugs in discharging his responsibilities as they relate to helping to ensure safe and effective biological products and related medical devices, and, as required, any other product for which the FDA has regulatory responsibility. The Committee reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood products derived from blood and serum or biotechnology which are intended for use in the diagnosis, prevention, or treatment of human diseases, and, as required, any other product for which the FDA has regulatory responsibility, and advises the Commissioner of Food and Drugs of its findings regarding the safety, effectiveness, and labeling of the products, on clinical and laboratory studies involving such products, on the affirmation or revocation of biological product licenses, and on the quality and relevance of FDA's research program which provides the scientific support for regulating these agents.
OraSure Technologies is the manufacturer of the OraQuick(R) ADVANCE(TM) Rapid HIV-1/2 Antibody Test, the first and only FDA approved, CLIA waived, rapid point-of-care test that provides results for both HIV-1 and HIV-2 with greater than 99 percent accuracy in as little as 20 minutes, using an oral fluid, finger-stick or venipuncture whole blood or plasma sample.
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities.
OraSure Technologies is the leading supplier of oral-fluid collection devices and assays to the life insurance industry and public health markets for the detection of HIV. In addition, the Company supplies oral-fluid testing solutions for drugs of abuse testing. For more information on the Company, please go to http://www.orasure.com.
Source: Business Wire
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