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FDA Approves Roche's Second-generation Hepatitis C Viral Load Test

SUMMARY: Roche announced this week that the U.S. Food and Drug Administration (FDA) has approved a new version of its next-generation hepatitis C virus (HCV) viral load test. The company said the latest COBAS TaqMan assay, based on technology that has been used extensively in hepatitis C research and dug development, will help clinicians monitor treatment outcomes for their patients with hepatitis C.

Below is an edited excerpt from a recent press release from Roche Diagnostics announcing the approval.

Roche Receives FDA Approval for a
Second-Generation Hepatitis C Viral Load Test

Another Roche FDA approval in the COBAS TaqMan viral load portfolio

Pleasanton, Calif. -- October 25, 2010 -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and 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, MD, 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 System

Designed 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 Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80,000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information:


Roche Diagnostics. Roche Receives FDA Approval for a Second-Generation Hepatitis C Viral Load Test. Press release. October 25, 2010.






















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