Roche Receives FDA Approval for Viral Load Test Designed to Evaluate Hepatitis C Therapy

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, which affects 200 million people globally. 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.

“The rapidly changing hepatitis C treatment landscape requires tests with an additional layer of protection in detecting and accurately quantifying hepatitis C RNA across genotypes,” stated Roland Diggelmann, Chief Operating Officer of Roche’s Diagnostics Division. “This test can play a valuable role in response-guided therapy, helping physicians and patients better manage the disease and optimize treatment choices and duration.”

Furthermore, Roche tests have been used in the development of recently FDA-approved direct-acting antiviral treatment regimens. With this launch Roche Molecular Diagnostics continues its long heritage of providing innovative viral load testing solutions for establishing treatment efficacy for new therapeutic regimens.
The new HCV viral load test is part of Roche’s complete portfolio of diagnostic tests to diagnose, confirm and manage hepatitis C infection. Roche expects to begin shipping the new HCV viral load test kit in the US shortly.