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Ortho Clinical Diagnostics Receives FDA Approval for First Anti-HIV 1+2 Test for Use on Random Access, Integrated Laboratory Testing System
Date:10/14/2009

RARITAN, N.J., Oct. 14 /PRNewswire/ -- Ortho Clinical Diagnostics today announced U.S. Food and Drug Administration (FDA) approval of a diagnostic assay for the detection of antibodies to human immunodeficiency virus (HIV) types 1+2 (Anti-HIV 1+2) for use on the VITROS® 5600 Integrated and VITROS® 3600 Immunodiagnostic Systems. This is the first HIV diagnostic assay approved for an integrated system in the United States, allowing laboratories to run HIV and other routine tests on a single testing platform and eliminating the need for expensive batch testing of multiple patient samples.

"By providing a fast, cost-effective and reliable method for testing HIV, the VITROS® Anti-HIV 1+2 Assay will help enhance the clinical laboratory's ability to adhere to the Centers for Disease Control and Prevention (CDC) HIV screening guidelines, while at the same time increasing the lab's productivity and efficiency," said Mike Samoszuk, M.D., Chief Medical Officer, Ortho Clinical Diagnostics. "This approval underscores Ortho Clinical Diagnostics' continuing commitment to providing clinical laboratories with tests that help detect diseases earlier for better patient outcomes."

The CDC recommends routine screening for people between the ages of 13 and 64 during annual check-ups, pregnant women either before or during pregnancy, and newborns. Currently, more than 230,000 people living with HIV in the U.S. are unaware they have the disease, increasing the need for routine screening.(1) HIV screening plays an invaluable role in early disease detection, prevention and treatment.

The VITROS® Anti-HIV 1+2 Assay is an in vitro diagnostic immunoassay for the qualitative detection of HIV 1+2 in human serum and plasma. It provides physicians with a reliable and quick test for HIV, a virus that causes acquired immunodeficiency syndrome (AIDS) and can lead to death. It may also be used to screen for HIV in pregnant women
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SOURCE Ortho-Clinical Diagnostics, Inc.
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