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Abbott Receives FDA Approval for First Automated Molecular Test for Assessing Hepatitis B Treatment
Date:9/1/2010

automating the most labor intensive steps of HBV testing."

Abbott's molecular HBV assay detects and measures all known HBV genotypes (A-H) by targeting an essential, highly conserved segment of the HBV genome.  The capability for detecting HBV genotypes is important for both monitoring the disease and guiding treatment decisions.  For example, genotype C is prevalent in Asia and is associated with more severe liver disease and development of hepatocellular carcinoma.  In contrast, genotype B (also prevalent in Asia) has a better prognosis, is rarely associated with progression to liver cancer, and patients seem to respond better to certain antiviral therapies. Immigration and international travel have increased the incidence of HBV strains predominantly found outside the United States.

In addition, the Abbott RealTime HBV assay offers a broad dynamic range, capable of quantitating both very low levels of the virus (10 IU/mL) and very high levels of the virus (1 billion IU/mL) in a patient's blood.  This broad dynamic range is an important factor in helping physicians accurately assess a patient's response to therapy.

The Abbott RealTime HBV assay, initially introduced in Europe and other markets in 2007, was developed for use on the Abbott m2000 system, an automated instrument for DNA and RNA testing.  The m2000 is designed to efficiently detect viruses and bacteria in patient samples in less than six hours.  The Abbott m2000 instrument is available in most major markets throughout the world. Outside the United States, an extensive menu for infectious disease testing is available that includes HIV-1 viral load, HBV viral load, chlamydia, chlamydia/gonorrhea (CT/NG) combination, hepatitis C (HCV) viral load, HCV genotyping, cytomegalovirus (CMV), Epstein Barr virus (EBV) and human papillomavirus (HPV).  In December 2009, Abbott Molecular introduced the first oncology assay o
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