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| |  FDA Approves DNA Test to Measure Hepatitis B Virus Levels ROCKVILLE, Md -- September 4, 2008 -- The US Food and Drug Administration has approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA in a patient's blood. Assessing a patient's viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections. The COBAS TaqMan HBV Test extracts and then amplifies sections of viral DNA from human plasma or serum. The viral DNA sections are measured to establish a baseline level before beginning treatment, and then used again during treatment to assess an individual's response to therapy. "Measuring a patient's HBV viral load is an important aspect of managing chronic hepatitis B infections," said Daniel G. Schultz, MD, FDA's Center for Devices and Radiological Health, Rockville, Maryland. "The COBAS TaqMan test gives health care providers a new and sensitive tool for this process." SOURCE: US Food and Drug Administration
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