Roche viral load test cleared by FDA

Roche Diagnostic Division, a subsidiary of the Swiss drug major, has gained US Food and Drug Administration approval for its COBAS TaqMan HBV Test, the first nucleic acid test for hepatitis B that measures the amount of viral load 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, says Roche. The 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 therapy to assess an individual's response.