Roche hepatitis C viral load test gets FDA approval

Roche has got US Food & Drug Administration (FDA) approval for the real-time PCR COBAS TaqMan HCV test, v2.0.

Designed for use with the High Pure System Viral Nucleic Acid Kit, the COBAS TaqMan HCV test, v2.0 is intended to quantify the amount of hepatitis C viral RNA in human plasma or serum of HCV infected individuals.

Roche claims that the new test will help clinicians to more confidently and effectively monitor their patients, and to improve treatment outcomes.

Roche Molecular Diagnostics chief medical officer Teresa Wright said that this HCV quantitative test is key to measuring the effectiveness of many antivirals that are currently in clinical development for the treatment of hepatitis C.