Roche wins FDA approval for hepatitis C viral load test

The test uses Roche’s real-time polymerase chain reaction technology to quantify the amount of hepatitis C RNA in a patient’s blood.

The new test offers a broad dynamic range from high levels of virus in a patients blood to the ‘undetectable’ low levels of viremia – the goal of therapy. To ensure accurate quantification, the test has been calibrated to World Health Organization traceable standards and can detect down to 18IU/ml with 100% certainty, the company said.

In a 1,281 patient clinical trial, the Cobas AmpliPrep/Cobas TaqMan hepatitis C virus (HCV) test confirmed the importance of viral load testing to personalize hepatitis C patient care by accurately predicting treatment response, from onset of therapy through end of treatment.

Daniel O’Day, president and CEO of Roche Molecular Diagnostics, said: “This new Roche test enables laboratories to deliver reliable healthcare information with ease and allows physicians to more efficiently monitor their patients and improve treatment outcomes. We are pleased to offer this new solution for laboratories and physicians to optimize their turnaround time, workflow and patient care with simultaneous processing of HIV and HCV patient samples.”