Roche will make its Cobas HIV-1, hepatitis C virus, and HCV genotyping assays commercially available in countries accepting the CE mark, the firm announced today. The three assays can run simultaneously on the Cobas 4800 PCR system, which performs automated nucleic acid purification, PCR set-up, real-time amplification, and detection. The assays were CE-marked in December of last year, and add to a menu on the Cobas 4800 that also includes nine other in vitro diagnostic tests for infectious diseases and cancer-related mutations.
The dual-target HIV-1 assay amplifies two regions of the genome that are not subject to selective drug pressure, enabling more effective quantification of HIV-1 RNA in patient samples. The HCV detection assay is a dual-probe test to confirm active infection or assess response to antiviral therapy, while the HCV genotyping test identifies genotypes 1 to 6 as well as genotype 1 subtypes a and b in plasma or serum from chronically infected patients.