Abbott (NYSE: ABT) announced today it has received approval from the U.S. Food and Drug Administration (FDA) to market the Abbott RealTime HBV assay for measuring viral load or the amount of hepatitis B virus (HBV) in a patient's blood. It is the first and only approved test capable of automating HBV viral load testing from sample extraction to final results.
The Abbott RealTime HBV assay, based on real-time PCR (polymerase chain reaction) technology, is now available for laboratories that use the Abbott m2000 automated instrument system for molecular diagnostic testing. The test offers sensitive measurement (quantitation) of HBV in human plasma or serum from individuals chronically infected with HBV.
The assay is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. Assay results must be interpreted within the context of all relevant clinical and lab findings. Use of the assay to determine the clinical stage of HBV infection has not been established. Clinical performance characteristics have been established for individuals treated with adefovir dipivoxil. The assay is not intended as a screening test for HBV or as a diagnostic test for confirming the presence of HBV infection.
"The Abbott RealTime HBV assay, which is the first and only automated HBV viral load test approved by the FDA, is an important tool for helping physicians make and adjust treatment decisions for newly diagnosed patients and those taking anti-viral medications," said Stafford O'Kelly, head of Abbott's molecular diagnostics business. "The test will also help improve laboratory productivity by 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 on its m2000 system outside the United States — the Abbott RealTime mS9 Colorectal Cancer — that detects the methylated form of Septin 9, a gene linked to colorectal cancer, in blood specimens. In the United States, the following tests are currently available on the m2000 platform: RealTime HIV-1, CT/NG, and now HBV.
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