Thursday, September 4, 2008

Roche Gets FDA Clearance for Hepatitis B PCR Test

September 4, 2008
NEW YORK – 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.

Source: -GenomeWeb News

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