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Abbott's RealTime Hepatitis B Viral Load Test Receives CE Marking in Europe

makes it a very reliable test for detecting and measuring all known HBV genotypes," said John Robinson, Ph.D., senior director, research and development, Abbott Molecular. "It gives physicians one of the most precise tests available to guide treatment decisions and builds upon Abbott's 30-year legacy in hepatitis testing." HBV genomes have been classified into eight genotypes (A-H). Detecting HBV genotypes is important in terms of both monitoring the disease and guiding treatment decisions. For example, genotype C, which is prevalent in Asia, is considered to be associated with more severe liver disease and development of hepatocellular carcinoma. In contrast, genotype B (also prevalent in the Asia region) has a better prognosis, is rarely associated with hepatocellular carcinoma and seems to have a better response to certain antiviral therapies compared with genotype C.

The Abbott RealTime HBV assay has been developed for use on the Abbott m2000 system, an automated instrument for DNA and RNA testing in molecular laboratories. The m2000 system is based on real-time polymerase chain reaction (PCR) technology and is designed to efficiently detect and measure life-threatening viruses and bacteria in patient serum or plasma samples in less than five hours, compared to other testing methods that may take up to two days. The RealTime HBV test is not intended as a screening test for HBV or as a diagnostic test for confirming the presence of HBV infection.

Abbott currently markets the m2000 system and a menu of tests in countries throughout the world as part of a strategic alliance with Celera.

In Europe, the instrument's menu includes assays for HIV-1 viral load, HCV viral load, chlamydia, and a combination test for chlamydia and gonorrhea.

"We're very pleased that the menu for the m2000 system is expanding in Europe with the registration of the RealTime assay for monitoring hepatitis
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