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news.Roche has announced that the FDA has approved its Cobas TaqMan HBV test, the first assay for quantitating hepatitis B virus DNA approved in the US.
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The test uses Roche’s real-time polymerase chain reaction technology to quantify the amount of hepatitis B virus DNA in a patient’s blood. Doctors may use viral load testing results to establish a baseline level of infection and during treatment as an aid in assessing individual responses to therapy.
The test was designed to quantify all major hepatitis B genotypes, including pre-core mutants that can lead to more severe liver disease and reduced response to antiviral therapy.
Teresa Wright, chief medical officer of Roche Molecular Diagnostics, said: “Viral load testing with an FDA approved test has long been the standard for managing patients with HIV and hepatitis C. Availability of this new Roche test enables doctors and laboratories to bring that same level of standardized viral load measurement to hepatitis B treatment.”