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FDA Approves Hepatitis B Viral DNA Test

September 4, 2008

The U.S. Food and Drug Administration has approved the first hepatitis B nucleic acid test that measures the amount of viral DNA in a patient’s blood.

The FDA said 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 federal agency said. 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 Dr. Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health. “The COBAS TaqMan test gives health care providers a new and sensitive tool for this process.”

The newly approved test is manufactured by Roche Diagnostics of Basel, Switzerland.




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