FDA approves Abbott's automated test to monitor hepatitis B therapy
This article was originally published in Clinica
The FDA has granted premarket approval (PMA) for Abbott's RealTime HBV assay, which measures viral load in patients with the hepatitis B virus (HBV). The PCR-based test is intended to monitor patients with chronic HBV who are undergoing antiviral therapy, to assess their response to treatment. It is not intended as a screening or diagnostic test for the virus. The assay runs on Abbott's m2000 automated molecular diagnostic platform. The Abbott Park, Illinois company CE marked the RealTime HBV test for sale in Europe in 2007 (www.clinica.co.uk, 29 June 2007).