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GEN News Highlights : Jan 5, 2012

Roche Gets CE Clearance for Two HCV Molecular Diagnostics

One confirms HCV antibody positive specimens; the other monitors viral load.

Roche’s HCV qualitative and quantitative tests have received CE mark. The tests, based on the firm’s Cobas platform, detect HCV RNA, which is a crucial marker in the management of hepatitis C infection.

Cobas AmpliPrep/Cobas TaqMan HCV Qualitative Test v2.0 is intended for the confirmation of HCV antibody positive specimens. Cobas AmpliPrep/Cobas TaqMan HCV Quantitative Test v2.0 is intended for viral load monitoring and the prediction of virological response to antiviral therapy. Both tests are reportedly standardized with the World Health Organization (WHO) international standard and have a limit of detection and lower limit of quantitation of 15 IU/mL.

"The two tests provide a holistic solution for the management of hepatitis C infection, from the confirmation of a hepatitis C infection to the prediction and assessment of treatment response," says Paul Brown, Ph.D., head of Roche Molecular Diagnostics. "Considering the rapidly changing hepatitis C treatment environment, we are pleased to provide two medically relevant tests on one fully automated platform. This offers clinicians the tools to manage their patients effectively and laboratories the automation and flexibility to maximize their workflow efficiency."

Roche also offers the Cobas TaqMan HIV-1 v2.0, HBV v2.0, and CMV tests on the same fully automated Cobas AmpliPrep/COBAS TaqMan System.