FDA expands approval of COBAS AmpliPrep/COBAS TaqMan HCV Test for Hepatitis C- Roche

Roche has received approval from the FDA for its hepatitis C virus (HCV) quantitative RNA test to be used as an aid in the diagnosis of HCV infection for certain patient populations. Results from the COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 can now be used to confirm an active hepatitis infection, in addition to providing an accurate measurement of how much virus is in a patient's blood, to help a physician determine the best course of treatment. This expanded use for the test saves a physician time in making a treatment decision and helps improve patient care.

The Roche test is the first quantitative HCV RNA test to be approved for use as an aid in diagnosis for active HCV infection. This expanded indication is in addition to its approved use as a viral load test to help physicians assess a patient's response to antiviral therapy. Roche HCV viral load tests have also been used to establish the treatment efficacy of direct-acting antiviral treatment regimens recently approved by the FDA.