New Hepatitis B Sequencing Test Available in Europe

A newly developed molecular diagnostic test identifies genomic sequences of Hepatitis B virus (HBV).

Capable of identifying the DNA sequence of the HBV polymerase gene including all clinically relevant HBV drug resistant mutations, the test will help physicians monitor HBV infections, guide treatment decisions, and predict or reveal drug resistance.

Abbott Molecular (Wiesbaden, Germany) received CE marking to market the HBV Sequencing test in the European Union. It is the first DNA sequencing assay developed and introduced by Abbott Molecular. The assay was developed for use on the Life Technologies (Carlsbad, CA, USA) ABI 3130 DNA sequencing system.

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, patients with HBV genotypes A and B seem to respond better to interferon therapy than those with genotypes C and D.

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.

Abbott Molecular analyzes DNA, RNA, and proteins at the molecular level. Some of Abbott Molecular's tests are designed to detect subtle but key changes in human genes and chromosomes. The results of these tests may aid in the earlier detection or diagnosis of disease, may influence the selection of appropriate therapies, and may improve monitoring of disease progression.

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