U.S. FDA Approves Oraquick Advance(R) 12-Month Shelf Life Dating

Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 29 Jan 2009 - 4:00 PDT

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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® 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® 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® 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® continues to deliver highly accurate results, consistently and in accordance with our FDA approved package insert claims."

OraQuick ADVANCE® 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® 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.

OraSure Technologies