FDA approves Cobas HBV and Cobas HCV viral load tests for hepatitis B and hepatitis C- Roche

Roche has received FDA approval for the Cobas HBV and Cobas HCV viral load tests, the first assays approved by the FDA for use on the Cobas 6800 and Cobas 8800 Systems. The new tests are used to manage the treatment of patients chronically infected with hepatitis B or hepatitis C virus. The two new assays for viral load monitoring can run simultaneously on the cobas 6800/8800 systems, streamlining workflow while increasing flexibility for patient sample management. Cobas HBV is a real-time PCR test designed to offer an expanded linear range coupled with broad coverage of all known HBV genotypes (A-H), including pre-core mutations with improved sensitivity.