Roche announced that it has received approval from 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.

The real-time polymerase chain reaction (PCR)-based HCV test is designed for use on Roche’s fully automated COBAS AmpliPrep/COBAS TaqMan System, an established platform for viral load monitoring of multiple infectious diseases that improves workflow in testing laboratories. The system can be combined with the cobas p 630 instrument, which provides an integrated pre-analytical primary tube handling solution.

Citation: FDA approves expanded use of Roche hepatitis C virus RNA test as aid in diagnosis. [news release]. Indianapolis, IN: Roche; March 21, 2016. https://usdiagnostics.roche.com/en/document/cobas_HCV_Test_Confirmatory_Claim_Media_Release_PP-US-06723.pdf. Accessed March 21, 2016.