OraSure Receives FDA Approval for Test to Detect HIV-2 Antibodies


BETHLEHEM, Pa. -- OraSure Technologies, Inc. announces that the U.S. Food and Drug Administration (FDA) has approved the company's new OraQuick Rapid HIV-1/2 Antibody Test. This approval will allow the simultaneous detection of antibodies to both the HIV-1 and HIV-2 viruses in finger stick and venipuncture whole blood specimens.

"Receiving FDA approval to test for HIV-2 is another significant milestone," said Mike Gausling, president and CEO of OraSure Technologies. "Our ability to offer a single rapid test for detecting antibodies to both HIV-1 and HIV-2 will allow for broader detection, treatment and prevention of HIV/AIDS. This is particularly important in the higher prevalence urban areas here in the United States where HIV-2 infection is more likely to occur and in many foreign countries where HIV-2 testing is required as part of the normal testing regimen."

The company obtained FDA approval of an HIV-1/2 test in anticipation of receiving a world-wide, nonexclusive license to certain HIV-2 patents held by Bio-Rad Laboratories. The company is cautiously optimistic that a license will be granted in the near future.

There are an estimated 40 million people in the world currently living with the HIV virus. Although the number of reported cases of HIV-2 infection in the United States is currently believed to be relatively low, the documented incidence of HIV-2 infection is much higher globally, as many foreign countries require testing for both HIV-1 and HIV-2.

The company also has submissions pending with the FDA for approval of oral fluid and plasma claims for the OraQuick Rapid HIV-1/2 Antibody Test. With these approvals, the company believes it will have a significant market advantage by providing the most versatile rapid HIV test available in both the United States and around the world.

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 antibodies to HIV-1.

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