BETHLEHEM, Pa.--(BUSINESS WIRE)--Jan. 28, 2009--OraSure Technologies, Inc. (NASDAQ:OSUR) announced today that the United
States Food and Drug Administration (FDA) has approved its request for
12-month shelf life from the date of manufacture for its OraQuick ADVANCE(R)
Rapid HIV-1/2 Antibody Test.
The FDA approval is based on enhancements made by OraSure to the
manufacturing process and product packaging of its OraQuick ADVANCE(R)
test, and represents a six-month increase in shelf life versus
current product available on the market. The Company anticipates having
the enhanced product available for delivery starting in March 2009.
"The quality and accuracy of our products is our highest priority and
these enhancements to our OraQuick ADVANCE(R) product
represents years of work to make what we believe is the best product
available on the market even better," said Douglas A. Michels, President
and Chief Executive Officer of OraSure Technologies. "These enhancements
will ensure that OraQuick ADVANCE(R) continues to
deliver highly accurate results, consistently and in accordance with our
FDA approved package insert claims."
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 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 testing
solutions for drugs of abuse and for the detection of antibodies to HIV.
For more information on the Company, please go to www.orasure.com.
CONTACT: OraSure Technologies, Inc.
Investor Contact:
Ronald H. Spair
Chief Financial Officer
610-882-1820
investorinfo@orasure.com
or
Media Contact:
Jennifer Moritz
Zer0 to 5ive for OraSure Technologies
917-748-4006
jmoritz@0to5.com
Source: OraSure Technologies, Inc.
