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FDA Approves VITROS(R) Anti-HCV Assay for Use On VITROS 5600(R) Integrated and VITROS 3600(R) Immunodiagnostic Systems
Date:7/21/2009

RARITAN, N.J., July 21 /PRNewswire/ -- Ortho Clinical Diagnostics today announced the U.S. Food and Drug Administration (FDA) approval of the VITROS((R)) Anti-HCV assay for use on the VITROS 5600((R)) Integrated and 3600((R)) Immunodiagnostic Systems. This approval marks a major milestone in the successful launches of Ortho Clinical Diagnostics' clinical laboratory testing platforms, and enables the consolidation of hepatitis C testing with routine assays on the VITROS((R)) 5600 Integrated System.

"This approval builds upon Ortho Clinical Diagnostics' history as the innovator of automated hepatitis C testing for clinical laboratories," said Michael Samoszuk, M.D., Chief Medical Officer, Ortho Clinical Diagnostics. "Clinicians can now test for hepatitis C as a part of their routine assay testing on the VITROS((R)) Systems, which will help make labs more efficient in delivering quality results."

According to the Centers for Disease Control and Prevention (CDC), a person can only be diagnosed with hepatitis C after a positive result for an anti-HCV screening test has been verified(1). Hepatitis C is often referred to as the "silent disease" because up to 70 percent of people with the disease do not typically experience any symptoms(2).

The VITROS((R)) Anti-HCV assay is an in vitro diagnostic immunoassay for the qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. It can be run with excellent precision, sensitivity, low sample volume requirements and quick, random access results on the VITROS((R) )Systems, with results readily available in 55 minutes.

The approval of the VITROS((R)) Anti-HCV assay will now expand the availability of hepatitis C testing across all of Ortho Clinical Diagnostics' VITROS((R)) immunoassay platforms, including the VITROS((R)) ECi/ECi
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SOURCE Ortho Clinical Diagnostics
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