OraSure Technologies to Present before the FDA Blood Products Advisory Committee on November 3, 2005
12 Ottobre 2005 - 12:00PM
Business Wire
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.
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