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Diagnostics In Brief

This article was originally published in The Gray Sheet

Executive Summary

Ortho Clinical Diagnostics assays: J&J subsidiary announces FDA approval of two new infectious disease assays to run on its recently launched Vitros 5600 and 3600 immunodiagnostic systems July 21 at the American Association for Clinical Chemistry annual meeting in Chicago. The new Vitros Anti-HCV immunoassay is used to confirm hepatitis C diagnosis by qualitatively detecting immunoglobulin G antibodies to hepatitis C in human serum and plasma. The second assay, Vitros Anti-HBc IgM, detects hepatitis B. The assays are the first of six infectious disease assays the firm plans to launch on the 5600 and 3600 systems beginning in 2010, Ortho Clinical Diagnostics VP-Worldwide Marketing Betsy Hanna says. Three tests are pending FDA approval, and the final test, a hepatitis B surface antibody assay, will be submitted for FDA approval at the end of the summer, Hanna said
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