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Roche Receives FDA Approval for a Second-Generation Hepatitis C Viral Load Test
Date:10/25/2010

PLEASANTON, Calif., Oct. 25 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food & Drug Administration (FDA) has approved the real-time PCR COBAS® TaqMan® HCV Test, v2.0. Clinical research organizations have depended on COBAS® TaqMan® technology to support hepatitis C pharmaceutical trials and development. This new test will help clinicians to more confidently and effectively monitor their patients, and to improve treatment outcomes.

"This HCV quantitative test is key to measuring the effectiveness of many antivirals that are currently in clinical development for the treatment of hepatitis C," said Teresa Wright, M.D., Chief Medical Officer of Roche Molecular Diagnostics. "Roche is committed to providing complete diagnostic and treatment solutions for this important global disease."

About COBAS® TaqMan® HCV Test, v2.0 For Use With High Pure SystemDesigned for use with the High Pure System Viral Nucleic Acid Kit, the COBAS® TaqMan® HCV Test, v2.0 is intended to quantify the amount of hepatitis C viral RNA in human plasma or serum of HCV infected individuals. The test incorporates a manual specimen preparation and the COBAS® TaqMan® 48 Analyzer for automated amplification and detection. Roche now offers HCV viral load test for both automated and manual specimen preparation methods; further demonstrating Roche's commitment in providing workflow options and flexibilities for the diverse needs of laboratories. The test system benefits from the proven contamination controls designed into all COBAS® TaqMan® assays, including built-in Roche-proprietary AmpErase enzyme.

About Hepatitis CAccording to the Centers for Disease Control, Hepatitis C virus (HCV) infection is the most common chronic blood borne infection in the United States; approximately 3.2 million persons are chronically infected.

Each year in the U.S. approximately 8,000 &
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