Roche said this week that it has received approval from the US Food and Drug Administration for its Cobas AmpliPrep/Cobas TaqMan HCV Test, v2.0.
Roche's assay is designed to help manage patients with chronic hepatitis C virus infection, in conjunction with clinical and laboratory markers of infection. The test quantifies hepatitis C virus RNA genotypes 1 to 6 in human EDTA plasma or serum, and 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, as measured by changes of HCV RNA levels.
The real-time PCR-based assay is designed for use on Roche's fully automated Cobas AmpliPrep/Cobas TaqMan System, a platform for viral load monitoring of multiple infectious diseases. The system can be combined with the Cobas p 630 instrument, which provides an integrated pre-analytical primary tube handling solution.