FDA Approves an in vitro Diagnostic Automated Immunoassay for Hepatitis A
Apr 3, 2005 - 9:30:00 AM
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The addition of this assay to the platform allows laboratorians to enhance their level of automation 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.
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By Bayer HealthCare,
[RxPG] Bayer HealthCare, Diagnostics Division, a member of the Bayer Group (NYSE:BAY) announced today the sixth FDA approved, automated assay for hepatitis on its market leading ADVIA Centaur® Immunoassay System.
The US Food and Drug Administration approved Bayer HealthCare Diagnostics' assay for Hepatitis A (HAV) Total, an in vitro diagnostic immunoassay for the qualitative determination of total antibodies to the hepatitis A virus in human serum or plasma. The assay can be used by laboratories to aid in the diagnosis of previous or ongoing hepatitis A viral infection or in the identification of HAV-susceptible individuals for vaccination.
With this most recent approval, Bayer HealthCare Diagnostics offers one of the most comprehensive test panels for hepatitis testing in United States including two assays for the hepatitis A virus (HAV IgM and Total), three assays for the 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).(1)
Bayer HealthCare Diagnostics offers the HAV Total assay on the ADVIA Centaur immunoassay system, making the hepatitis panel ideal for medium and large volume laboratories.
The addition of this assay to the platform allows laboratorians to enhance their level of automation 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.
The approval of the assay for HAV Total brings Bayer HealthCare Diagnostics one step closer to offering the industry's most extensive panel for hepatitis testing. At the same time, this meets our customers' demands for practical assays that enhance the efficiency and value of their laboratories, commented John Nosenzo, Senior Vice President and General Manager of the North America Region for Bayer HealthCare's Diagnostics Division.
Hepatitis A Virus (HAV)
Hepatitis A, which infects up to 200,000 Americans each year, is a highly contagious virus that attacks the liver. It is spread by the fecal-oral route through close person-to-person contact, or by ingesting contaminated food or water. Infected individuals can unknowingly infect others two weeks prior to feeling ill themselves. Up to 22 percent of adult hepatitis A patients require hospitalization and approximately 100 people in this country die every year from the disease. In the United States, the annual cost associated with hepatitis A is estimated at more than $ 450 million.(2)
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.(3) 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.
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U.S. Food and Drug Administration (FDA)
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Additional information about the news article
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Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the health care and medical products industry. In 2004, the Bayer HealthCare subgroup generated sales amounting to some 8.5 billion Euro.
The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Bayer HealthCare employed 35,300 people worldwide in 2004.
Bayer HealthCare's aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.
Forward-looking statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
1 The ADVIA Centaur HCV assay is developed, manufactured and sold by Bayer HealthCare LLC for Ortho-Clinical Diagnostics, Inc.
2 The Hepatitis Information Network, Hepatitis A - Fact Sheet, www.hepnet.com
3 2003 EAC Data
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