FDA Approves Roche's Hepatitis C Viral Load Test

Ruzanna Harutyunyan's picture
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Roche Molecular Diagnostics today announced that the U.S. Food & Drug Administration (FDA) has approved the COBAS AmpliPrep / COBAS TaqMan HCV Test for use in the United States. The test uses Roche's proprietary real-time PCR technology to quantify the amount of Hepatitis C RNA in a patient's blood. Physicians use Hepatitis C viral load testing results to establish a baseline level of hepatitis C infection and to serially monitor viral load levels and treatment effectiveness in patients on therapy.

"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," said Daniel O'Day, President and CEO of Roche Molecular Diagnostics. "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."

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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 (WHO) traceable standards and can detect down to 18 IU/mL with 100% certainty. In a 1,281 patient clinical trial, the COBAS AmpliPrep / COBAS TaqMan 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.

About the COBAS AmpliPrep/COBAS TaqMan System

The COBAS AmpliPrep / COBAS TaqMan HCV Viral Load Test is designed for use on the first fully automated, FDA approved, real-time PCR platform, providing sample-in/results-out capability. The platform is flexible and customizable to meet the space and workflow needs of any laboratory. In the United States, more than 130 laboratories already utilize this fully automated platform for HIV testing.

The COBAS AmpliPrep / COBAS TaqMan HCV Test is the third Roche COBAS TaqMan real-time PCR test approved by the FDA in the last eighteen months. The COBAS AmpliPrep / COBAS TaqMan System menu includes an FDA approved HIV viral load test, with continuous loading of samples in addition to parallel processing of HIV and HCV tests. In September 2008, Roche received FDA approval of the COBAS TaqMan HBV Test to monitor Hepatitis B viral load in patients on therapy.

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