Cobas CV Genotyping (GT) assay for the hepatitis C virus receives CE mark approval in the EU- Roche

Roche has announced the commercial availability of the cobas HCV Genotyping (GT) assay for the hepatitis C virus in countries accepting the CE mark. The new molecular diagnostic assay increases the available menu on the cobas 4800 System.

The cobas HCV Genotyping Test is a highly accurate and sensitive real-time PCR-based test for the qualitative identification of HCV genotypes 1 to 6 and genotype 1 subtypes a and b in human plasma or serum from individuals with chronic HCV infection. Identification of the infecting genotype is required before a patient is prescribed antiviral therapy as response to treatment correlates to the HCV genotype. Virology assays can run simultaneously on the cobas 4800 System with two different sample processing volumes for HIV-1 and HCV (200 µL and 400 µL) and only 400 µL for HCV GT, streamlining workflow while increasing flexibility for patient sample management.