Bayer Anti-HBs Assay Now Available on the ADVIA Centaur(reg) Immunoassay System

Main Category: Liver Disease / Hepatitis
Article Date: 25 May 2004 - 0:00 PDT

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The Diagnostics Division of Bayer HealthCare LLC, a member of the Bayer Group (NYSE:BAY) announced today that it has received U.S. Food and Drug Administration (FDA) approval for its Anti-HBs assay, a fully automated test on its leading automated immunoassay platform - the ADVIA Centaur(reg) Immunoassay System. The Anti-HBs assay is used to aid in the diagnosis of hepatitis B virus (HBV) infections.

The Anti-HBs assay detects the presence of antibodies to hepatitis B surface antigen (Anti-HBs) in blood. These antibodies, which have been formed during a previous HBV infection or because of the HBV vaccine, help protect against future HBV infections. In knowing a patient's Anti-HBs levels following a therapy regimen, physicians can determine if a protective immunity has been achieved.

"The availability of the Anti-HBs assay is the first step for Bayer in being able to offer customers a total solution for their infectious disease testing needs," said Gerald Rosenberg, senior vice president, Bayer Diagnostics. "Bayer is committed to providing a comprehensive and fully automated infectious disease testing panel which will include the complete HBV panel, HAV, HCVi, and HIV1ii assays."

Due to the complex nature of the HBV lifecycle, a variety of tests including the Anti-HBs assay are used to detect infection, replication, and immunity:

- HBsAg and HBc Total are used to diagnosis acute and chronic infections.

- Anti-HBc IgM is used to aid in the diagnosis of acute hepatitis B and may also be useful in the differentiation of acute and chronic HBV infections.

Bayer offers the Anti-HBs assay on the ADVIA Centaur immunoassay system, making it ideal for medium and large volume laboratories. The addition of this assay to the system allows laboratorians to be concern free about any sample carryover due to individual sample tips; 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.

A worldwide health concern, HBV is the most common form of hepatitis with 350 million carriers globally. HBV is 100 times more infectious than HIViii, with 30-40% of people with HBV infection showing no symptoms and unknowingly can pass the virus to others. More than 90% of adults infected with HBV recover within six months and develop immunity.

The remaining 10% develop chronic hepatitis or become carriers of the virus, leading to disease complications occurring in both acute and chronic cases. An estimated 1.25 million Americans are chronically infected with HBV, with 20 to 30 percent acquiring their infections in childhood, according to the U.S. Centers for Disease Control and Prevention.

The Hepatitis A, Hepatitis B, Hepatitis C, and HIV 1/O/2 assays are currently available in European, Latin American and Asia Pacific countries outside of the United States. Bayer has submitted the ADVIA Centaur HBc-IgM, HBsAg, HBc Total, HCV, HAV Total and HAV IgM assays to the US FDA where they are pending approval.

ADVIA Centaur(reg) 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. It provides testing for a broad range of conditions, including cancer, cardiovascular diseases, fertility, anemia, thyroid diseases, allergy, metabolic diseases, therapeutic drug monitoring and infectious diseases.

About Bayer HealthCare Diagnostics

With approximately 7,000 employees worldwide and 2003 sales of $2.1 billion, Bayer HealthCare Diagnostics (www.bayerdiag.com), based in Tarrytown, New York, U.S.A., is one of the largest diagnostic businesses in the world. The organization supports customers in 100 countries through an extensive portfolio of central, self-testing, nucleic acid and near patient care diagnostics meters and services for use in the assessment and management of health, including the areas of cardiovascular and kidney disease, oncology, virology, women's health and diabetes. Bayer HealthCare Diagnostics' global headquarters in the United States operates as part of Bayer HealthCare LLC, a member of the worldwide Bayer HealthCare group.

About Bayer HealthCare AG

Bayer HealthCare AG, a subgroup of Bayer AG with sales of approximately 8.9 billion Euro in 2003, is one of the world's leading, innovative companies in the health care and medical products industry.

The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceuticals. 34,600 people are employed by Bayer HealthCare worldwide.

Our aim is to discover and manufacture innovative products that will improve human and animal health worldwide. Our 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 Manufactured for Ortho-Clinical Diagnostics, Inc. by Bayer HealthCare LLC

ii Manufactured for Ortho-Clinical Diagnostics, Inc. by Bayer HealthCare LLC

iii Hepatitis Foundation International. 30 Sunrise Terrace, Cedar Grove, NJ 07009-1423 http://www.hepfi.org/stats.htm

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