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Roche Gets FDA OK for HCV Viral Load Test

NEW YORK (GenomeWeb News) - Roche Molecular Diagnostics announced yesterday that it has received US Food and Drug Administration clearance for its hepatitis C viral load test.
The COBAS AmpliPrep/COBAS TaqMan HCV test is fully automated and uses Roche’s proprietary real-time PCR technology to quantify the amount of virus in an individual’s blood.
Now that the test has been given the green light in the US, physicians can use it to monitor viral load at baseline and during treatment to help determine the effectiveness of therapy. The test, which has been calibrated to World Health Organization traceable standards, can detect a broad dynamic viral range — from high levels to low levels once considered undetectable.
That, in turn, helps to predict treatment response from onset to completion. A clinical trial of the test in 1,281 patients reportedly validated the importance of viral load testing for personalized HCV treatment.
“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,” Roche Molecular Diagnostics President and CEO Daniel O’Day said in a statement.
Early last month, Roche received FDA clearance of the COBAS TaqMan hepatitis B viral load test. Its COBAS AmpliPrep/COBAS TaqMan system menu also includes an FDA approved HIV viral load test, which allows continuous loading of samples and parallel processing of HIV and HCV tests. More than 130 American laboratories already utilize the platform for HIV testing, according to Roche.

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