Abbott Molecular announced that it has received CE Marking (Conformité Européene) 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 (labelled 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.

A serious global public health problem, hepatitis B is an inflammatory liver disease caused by the Hepatitis B Virus that results in liver cell damage. The damage can lead to scarring of the liver (cirrhosis) and increased risk of liver cancer.

Hepatitis B is preventable with safe and effective vaccines that has been available since 1982, according to the World Health Organization (WHO). But today some two billion people has been infected with the hepatitis B virus, and more than 350 million are chronic carriers.

In countries with a high prevalence of chronic HBV infection, the most common route of infection is from mother to child at birth or from young children infecting each other. In areas of low prevalence, HBV usually is transmitted during adulthood from intravenous drug use or high-risk sexual activity.

Abbott Molecular, is an emerging leader in molecular diagnostics — the analysis of DNA, RNA, and proteins at the molecular level. Some of its tests are designed to detect subtle but key changes in human genes and chromosomes.

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.