Abbott and OraSure Technologies Enter Agreement for OraQuick ADVANCE Rapid HIV-1/2 Test

ABBOTT PARK, Ill., and BETHLEHEM, Pa. -- Abbott and OraSure Technologies today announced an agreement for the distribution of OraSure Technologies' OraQuick ADVANCE rapid antibody test for the detection of antibodies to the Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2). Under the terms of the distribution agreement, Abbott was appointed as exclusive distributor of the OraQuick ADVANCE HIV-1/2 test for hospitals and as a non-exclusive distributor to physician offices in the United States.


"We believe this agreement will enable us to capitalize on the growing demand for our new OraQuick ADVANCE test and help achieve our goal of making rapid HIV testing available to all who need it," said Douglas A. Michels, president and CEO of OraSure Technologies. "With the sales and marketing teams from OraSure and Abbott working together, we will expand the reach of this product in the United States."


Providing results in as little as 20 minutes, OraQuick ADVANCE is the only rapid, point-of-care test for the detection of antibodies to both HIV-1 and HIV-2 approved by the U.S. Food and Drug Administration (FDA) for use on oral fluid, finger stick or venipuncture whole blood, and plasma specimens. The test is also CLIA (Clinical Laboratory Improvements Amendments Act of 1988) waived for all specimen types except plasma. OraSure commercially launched the OraQuick ADVANCE test in October 2004.

"This agreement allows us to provide an important test to assist in the rapid detection of HIV," said Michael J. Collins, vice president, U.S. Diagnostic Commercial Operations, Abbott. "The test's flexibility with sample type, including oral fluid, and its ability to screen for both HIV-1 and HIV-2 make it an ideal fit for hospitals, providing them with a simple, yet comprehensive, rapid HIV test."


Under the agreement, OraSure Technologies will sell the OraQuick ADVANCE to physician offices on a non-exclusive basis and exclusively to the Centers for Disease Control and Prevention (CDC), the Substance Abuse and Mental Health Administration, community-based organizations, state and county public health departments, correctional and criminal justice facilities, clinics and other public health customers. Other terms of the agreement were not disclosed.


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.


A leader in HIV/AIDS research since the early years of the epidemic, Abbott has continually improved the diagnostic effectiveness of its tests, targeting sensitivity to detect HIV infections earlier and developing advanced technology to automate HIV testing for patient diagnosis, managing therapy and screening donated blood. Abbott also has developed two protease inhibitors for the treatment of HIV/AIDS. Abbott is a global, broad-based healthcare company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 60,000 people and markets its products in more than 130 countries.