WIESBADEN, Germany, March 31, 2011 /PRNewswire/ -- Abbott Molecular announced today that it has received CE Marking (Conformite Europeene) to market the Abbott HBV Sequencing test in the European Union. This molecular diagnostic test, developed to identify genomic sequences of the hepatitis B virus (HBV) and help physicians monitor HBV infections, guide treatment decisions, and predict or discover drug resistance, is the first DNA sequencing assay developed and introduced by Abbott Molecular.

The CE-Marked Abbott HBV Sequencing test identifies the DNA sequence of the HBV polymerase gene including all clinically relevant HBV drug resistant mutations. The test is not intended for screening blood donors, plasma or tissue donors for HBV, or to be used as a diagnostic test to confirm the presence of HBV infection.

HBV is classified into eight separate genotypes (labeled A-H). HBV genotype is a prognostic indicator because it correlates with disease severity and response to interferon therapy. For example, genotype C is prevalent in Asia and associated with more severe liver disease and development of liver cancer. In contrast, genotype B (also prevalent in Asia) has a better prognosis and is rarely associated with progression to liver cancer. Also, patients with HBV genotypes A and B seem to respond better to interferon therapy than those with genotypes C and D.

Significant progress has occurred in recent years in developing antiviral therapies for HBV. Several anti-polymerase drugs are available worldwide. The new HBV Sequencing assay can be used in tandem with Abbott's RealTime HBV viral load assay to monitor the efficacy of HBV treatments.

"The addition of the Abbott HBV Sequencing assay offers laboratories a highly precise method for managing HBV patients. After assessing patient viral loads, physicians can order the HBV Sequencing test to select or change antiviral therapies based on known drug resistance of specific viral genotypes," said Kristina Rodnikova, divisional vice president and general manager of Abbott's molecular diagnostics business in Europe.

"The Abbott RealTime HBV viral load and HBV Sequencing assays are examples of how molecular diagnostic technologies are helping clinicians worldwide manage serious infectious diseases more precisely and effectively through optimal utilization of antiviral drugs."

The Abbott HBV Sequencing assay was developed for use on the Life Technologies ABI 3130 DNA sequencing system.