The FDA Approves DNA Test to Measure Hepatitis B Virus Levels

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The US Food and Drug Administration (FDA) in September approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA in a patient's blood. 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. The test is used with other clinical findings, such as results from biochemical and serologic testing.

“Measuring a patient's HBV viral load is an important aspect of managing chronic hepatitis B infections,” said Daniel G. Schultz, MD, director of FDA's Center for Devices and Radiological Health. “The COBAS TaqMan test gives health care providers a new and sensitive tool for this process.” HBV is the most serious type of viral hepatitis, infecting about 2 billion people worldwide each year, according to the World Health Organization. A vaccine for HBV has been available in the United States since 1982. However, according to the Centers for Disease Control and Prevention, about 1.25 million people in the United States have chronic hepatitis B. Another 60,000 become infected each year and some 5000 die from hepatitis B-related complications.

HBV is spread through sexual exposure, use of infected needles, and transmitted from infected mother to child during birth. Symptoms occur in about 70% of patients, and include abdominal pain, jaundice, fatigue, loss of appetite, nausea, and vomiting.

The COBAS TaqMan HBV Test is manufactured by Roche Diagnostic Division, Basel, Switzerland.