NEW YORK (GenomeWeb News) – Roche has received US Food and Drug Administration clearance for its Cobas TaqMan HBV Test, the firm said today.
The test uses real-time PCR to quantify the amount of hepatitis B virus DNA in a patient’s blood. It may be used by physicians to determine a baseline level of infection and thereafter as an aid in assessing a patient’s response to therapy.
According to Roche, it is the first hepatitis B viral load test approved for marketing by the FDA.
Roche’s real-time HIV test was cleared by the FDA in May 2007, and the firm has filed for clearance of its quantitative HCV test.