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BAYER HEALTHCARE DIAGNOSTICS RECEIVES FDA APPROVAL FOR HEPATITIS A AND HEPATITIS BC TOTAL; FIVE AUTOMATED ASSAYS FOR HEPATITIS NOW AVAILABLE ON THE ADVIA CENTAUR® IMMUNOASSAY SYSTEM
The fully automated tests, which are used to aid in the diagnosis of acute or chronic hepatitis A and B infections, are available on the ADVIA Centaur® Immunoassay System. The approval of Bayer’s assays for HAV IgM and HBc Total occurred in tandem with the FDA’s approval of the company’s assay for HCV1 (see announcement dated January 17, 2005), bringing to five the total number of FDA-approved, fully-automated hepatitis assays. Bayer Diagnostics offers a comprehensive panel of tests for the hepatitis viruses including assays for the hepatitis A virus (HAV IgM), hepatitis B virus (HBc IgM, anti-HBs and HBc Total) as well as an assay for the detection of the hepatitis C virus, (anti-HCV). “One of our key objectives at Bayer is to offer our global laboratory customers innovative technologies coupled with practical assays that help them advance diagnostic testing and improve care delivery,” stated John Nosenzo, Senior Vice President North America Region for Bayer HealthCare’s Diagnostics Division. “The ADVIA Centaur System, which consistently receives high marks for its unmatched ability to enhance lab productivity, combined with our extensive test panel for infectious diseases, is just one example of how we exceed our commitments and deliver on our promises to our customers.” Bayer Diagnostics’ HAV IgM and HBc Total automated assays on the ADVIA Centaur System are in vitro diagnostic immunoassays for the qualitative determination of IgM antibody to hepatitis A and IgG, and IgM antibodies the hepatitis B core antigen,. Both assays use human serum or plasma (EDTA or heparinized). The addition of these assays to the platform allow laboratorians to enhance their level of automation and optimize their efficiency in performing these assays with such features as: software that provides automatic algorithm processing, cascade reflex testing, user-defined panels, automatic repeats of critical samples, and sample and reagent integrity checks. Hepatitis A Virus (HAV) Hepatitis A, which infects up to 200,000 Americans each year, and at least 1.4 million people worldwide with an estimated cost of $1.5 – 3.0 billion (USD), is a highly contagious virus that attacks the liver. In the United States, the annual cost associated with hepatitis A is estimated at more than $200 million. Patients with hepatitis A are typically contagious for at least two weeks before symptoms appear, and may spread the virus to others unknowingly. While most patients begin to recover from acute illness within two months, in up to 15 per cent of patients, relapses may occur and symptoms may persist for up to six months. Up to 22 per cent of adult patients with the hepatitis A virus require hospitalization and approximately 100 people in the United States die every year from the disease. Hepatitis B Virus According to the World Health Organizations, hepatitis B is one of the major diseases of mankind and is a serious global public health problem. It is 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 persons each year. Although the vaccine will not cure chronic hepatitis, it is 95 per cent effective in preventing chronic infections from developing, and is the first vaccine against a major human cancer. ADVIA Centaur Immunoassay System The ADVIA Centaur system was rated one of the most productive and efficient immunochemistry platforms in the marketplace today by an independent U.S. customer survey.5 In addition to testing for infectious diseases, the system provides testing for a broad range of conditions, including cancer, cardiovascular diseases, fertility, anemia, thyroid diseases, allergy, metabolic diseases and therapeutic drug monitoring. http://www.bayermaterialscience.com
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