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

May 9, 2013

Roche has received approval from the U.S. 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 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. Roche expects to begin shipping the new HCV viral load test kit in the U.S. shortly.

Roland Diggelmann, Chief Operating Officer of Roche’s Diagnostics Division, says, “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.”

The COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 is intended for use in the management of patients with chronic HCV, in conjunction with clinical and laboratory markers of infection. It is an in vitro nucleic acid amplification test for the quantitation of hepatitis C virus RNA genotypes 1 to 6 in human EDTA plasma or serum. The test can be used to predict the probability of sustained virologic response early during a course of antiviral therapy and to assess viral response to antiviral treatment (response-guided therapy), as measured by changes of HCV RNA levels. Learn more about this new test.