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CE Mark Granted to Roche's New Hep C Tests

The Editors at Hepatitis Central
January 9, 2012

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Indicative of its compliance with Europe’s standards, Roche’s tests to confirm Hepatitis C infection and predict treatment response have been acknowledged by the EU.

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

By: PR Newswire

Jan. 5, 2012

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today 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.”

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