Roche Gets FDA Clearance for Hepatitis B PCR Test | GenomeWeb
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.
 

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