Bayer HealthCare Diagnostics Division, a member of the Bayer Group (NYSE:BAY) announced today it received approval from
the US Food and Drug Administration (FDA) for its automated HBsAg (hepatitis B surface antigen) and HBsAg Confirmatory
assays. The fully automated tests, which are used to aid in the diagnosis and confirmation of acute or chronic hepatitis B
infections, are available on the ADVIA Centaur® Immunoassay System.
With this approval, Bayer HealthCare offers the industry's only complete, FDA-approved automated panel for acute hepatitis
testing including assays for HBsAg, anti-HCVi, anti-HBc IgM and anti-HAV IgM. In addition to the panel for acute hepatitis,
Bayer HealthCare offers assays for HBsAg Confirmatory, anti-HBs, anti-HBc Total and anti-HAV Total. This brings to eight the
total number of hepatitis assays available on the ADVIA Centaur - the most comprehensive, automated hepatitis (A, B and C)
testing portfolio available in the United States.
"As part of a United States pre-marketing trial, our lab reviewed the performance of Bayer HealthCare's ADVIA Centaur HBsAg
test in a large dialysis population," commented Arthur F. Rosenthal, Ph.D., Director ESRD / Nationwide Laboratories in Fort
Lauderdale, Fl. "Results were compared with the currently used semi-automated method on several thousand such specimens. The
Bayer methodology gave very accurate results, including its performance in confirming positive results. The Bayer
methodology, however, is far superior in terms of reduced turnaround time and labor requirements."
The ADVIA Centaur HBsAg Assay is an in vitro diagnostic immunoassay for the qualitative detection of hepatitis B surface
antigen (HBsAg) in human serum and plasma using the ADVIA Centaur system. The ADVIA Centaur HBsAg Confirmatory Assay is an in
vitro diagnostic immunoassay for the qualitative confirmation of the presence of hepatitis B surface antigen (HBsAg) in human
serum and plasma using the ADVIA Centaur system. The addition of these assays to the platform allows laboratorians to enhance
their level of automation and optimize their efficiency in performing these assays with such features as a fully-automated
"smart algorithm" that identifies samples which require repeat or confirmatory tests. The HBsAg assay also provides a "hot
zone" feature that determines, based on the value of the sample results, whether the specimen requires any follow-up tests,
effectively reducing the number of tests to be conducted and saving valuable time and labor resources for the lab.
"The Center for Disease Control and Prevention estimates that 1.25 million Americans are chronically infected with HBVii.
With such a staggering number of individuals affected, the demand on lab testing resources can be extreme. Bayer Diagnostics'
automated panel for acute hepatitis can benefit laboratories by enabling them to achieve testing efficiencies, while at the
same time improving lab services to physicians by delivering accurate results in a rapid timeframe," stated John Nosenzo,
Senior Vice President North America Region for Bayer HealthCare's Diagnostics Division.
Hepatitis B is the most common, serious liver infection in the world. It is caused by the hepatitis B virus (HBV) that
attacks liver cells and can lead to liver failure, cirrhosis or cancer of the liver. An estimated two billion people
worldwide (one out of three) have been infected with HBV, and one million people will die each year from the virus and its
complicationsiii.
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 surveyiv. 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.
About Bayer HealthCare AG
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.
i The ADVIA Centaur HCV assay is developed, manufactured and sold by Bayer HealthCare LLC for Ortho-Clinical Diagnostics,
Inc.
ii cdc
iii hepb
iv 2003 EAC Data
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