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FDA Approves Roche's HCV Test

NEW YORK (GenomeWeb News) – The US Food and Drug Administration approved Roche's next-generation viral load test for managing patients with chronic hepatitis C virus infection, the company announced today.

The Cobas AmpliPrep/Cobas TaqMan HCV Test, v2.0 is a "novel dual-probe approach" Roche said, which provides extra protection in detecting and quantifying the virus. The in vitro nucleic acid amplification test quantifies hepatitis C virus RNA genotypes 1 to 6 in human ethylenediaminetetraacetic acid plasma or serum and is designed to evaluate how patients respond to antiviral therapy.

The test is intended for managing patients with the virus in conjunction with clinical and laboratory markers of infection and can be used to predict whether a patient will have sustained virologic response early in the course of antiviral therapy.

The PCR-based test runs on Roche's automated Cobas AmpliPrep /Cobas TaqMan System. Roche said it expects to begin shipping the test kit in the US shortly.

"The rapidly changing hepatitis C treatment landscape requires tests with an additional layer of protection in detecting and accurately quantifying hepatitis C RNA across genotypes," Roland Diggelmann, COO of Roche's Diagnostics Division, said in a statement. "This test can play a valuable role in response-guided therapy, helping physicians and patients better manage the disease and optimize treatment choices and duration."

Citing statistics from the World Health Organization, Roche said that about 200 million people worldwide have HCV, with about 170 million chronic carriers, most of whom do not know they carry the disease.