FDA approves new Roche test to evaluate response to hepatitis C therapy

Viral load test uses a novel dual-probe approach designed to manage patients being treated with antiviral therapies. Roche announced today that it has received approval from the US Food and Drug Administration (FDA) for a next-generation viral load test to be used in the management of patients with chronic hepatitis C virus (HCV) infection. The COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 provides a novel dual-probe approach, for an extra layer of protection in detecting and quantifying the virus. The test is designed to accurately determine the amount of hepatitis C virus ribonucleic acid (RNA) in order to assess a patient’s response to antiviral therapy.
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news