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Roche Gets FDA OK for New Hepatitis C Test

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Roche today said that it has received US Food and Drug Administration clearance for the second-generation version its real-time PCR Cobas TaqMan HCV Test.

The test quantifies the amount of hepatitis C viral RNA in human plasma or serum of HCV-infected individuals. It incorporates a manual specimen preparation with Roche's Cobas TaqMan 48 Analyzer for automated amplification and detection.

Teresa Wright, chief medical officer of Roche Molecular Diagnostics, said in a statement that the test "is key to measuring the effectiveness of many antivirals that are currently in clinical development for the treatment of hepatitis C."

Last month, the FDA cleared for marketing Roche's second-generation Cobas AmpliPrep/Cobas TaqMan HBV Test for quantitative detection of hepatitis B virus DNA in human plasma or serum for patients on hepatitis B virus antiviral therapy.

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