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Abbott receives FDA Approval for hepatitis B assay
DES PLAINES, Ill.—The U.S. Food and Drug Administration (FDA) has given Abbott a big nod with its approval to the company to market its Abbott RealTime HBV assay for measuring viral load or the amount of hepatitis B virus (HBV) in a patient's blood.
"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," says 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."
Shares of Abbott rose 99 cents to $50.33 in morning trading the day of the announcement, Sept. 1.
The assay, which is based on real-time 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 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 antiviral 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.
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.
Abbott Molecular was established by Abbott to develop into a leader in molecular diagnostics—the analysis of 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, or may improve monitoring of disease recurrence
According to the World Health Organization, hepatitis B is a serious global public health problem, but preventable with safe and effective vaccines that have been available since 1982. Of the two billion people who have been infected with the hepatitis B virus, more than 350 million have chronic (lifelong) infections. These chronically infected persons are at high risk of death from cirrhosis of the liver and liver cancer, diseases that kill about one million people each year. Although the vaccine will not cure chronic hepatitis, it is 95 percent effective in preventing chronic infections from developing.
About Abbott Molecular
Abbott Molecular, abbottmolecular.com, is an emerging leader in molecular diagnostics - the analysis of 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, or may improve monitoring of disease recurrence
Abbott (NYSE: ABT) 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. The company employs approximately 83,000 people and markets its products in more than 130 countries.