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Roche's Novel Tests for the Management of Hepatitis C Virus Infection Receive CE Mark

Roche announced that its novel, state of the art Hepatitis C virus (HCV) qualitative and quantitative tests received CE mark. The tests detect HCV RNA, which is a crucial marker in the management of hepatitis C infection. In the new era of antiviral HCV therapies, sensitive detection and measurement of HCV RNA play an important role in determining treatment duration and predicting treatment response.

"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," said 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."

COBAS AmpliPrep/COBAS TaqMan HCV Qualitative Test, v2.0(1) is intended for the confirmation of HCV antibody positive specimens and 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 standardized with the World Health Organization (WHO) International Standard and have a limit of detection and lower limit of quantitation of 15 IU/mL. These characteristics make them medically relevant diagnostic tools in the management of hepatitis C infection.

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