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Bayer Healthcare, Diagnostics (Tarrytown, NY) Receives FDA Approval For First Fully-Automated Human Immunodeficiency Virus (HIV) Antibody Test


6/21/2006 10:25:57 AM

TARRYTOWN, N.Y., June 21 /PRNewswire-FirstCall/ -- Bayer HealthCare Diagnostics Division, a member of the Bayer Group (NYSE: BAY - News), today announced that the first fully-automated test for antibodies for human immunodeficiency virus, called EHIV (Human Immunodeficiency Virus, Enhanced), has received U.S. Food and Drug Administration (FDA) approval for use on the ADVIA Centaur® Immunoassay System. Bayer's ADVIA Centaur EHIV test is an in vitro diagnostic immunoassay for the qualitative determination of antibodies to HIV 1, HIV 2 and HIV 1 -- sub-type O in human serum and plasma. ADVIA Centaur EHIV is the only fully-automated FDA-approved test that contains a range of recombinant proteins and sub-type O peptide for the detection of antibodies to HIV-1, HIV- 2, and sub-type O peptide. This meets the worldwide healthcare standards for detecting all known types of HIV infection.

With its availability on Bayer's ADVIA Centaur, the EHIV fully-automated testing process eliminates manual labor and provides advanced features such as: automatic algorithm processing, cascade reflex testing, user-defined panels, and automatic repeats of critical samples. Combined with security and verification features, such as use of sample tips and assay verification processes, ADVIA Centaur EHIV allows laboratorians to increase their HIV testing productivity with enhanced confidence in their HIV results.

"With the addition of the EHIV test, Bayer offers the most comprehensive fully automated infectious disease portfolio in the United States, thus enabling laboratorians to enhance their level of testing and aid physicians in making treatment decisions," said Tony Bihl, President, Bayer Diagnostics. The Bayer automated infectious diseases testing portfolio also includes testing for hepatitis A, B and C: HBsAg, HBsAg Confirmatory, HBsAb, HBc-T, HBc-IgM, HCV, HAV-T and HAV-IgM.

The EHIV test is developed, manufactured and sold by Bayer Diagnostics for Ortho Clinical (Ortho) Diagnostics, a subsidiary of Johnson & Johnson (NYSE: JNJ - News), under an agreement entered into with Bayer, Ortho and Chiron Corporation (Nasdaq: CHIR - News) in 2001. Under the terms of the agreement, Bayer will not represent the product for blood or plasma screening.

About ADVIA Centaur Immunoassay System

In addition to testing for infectious diseases, the ADVIA Centaur® Immunoassay System provides testing for a broad range of conditions, including cancer, cardiovascular diseases, fertility, anemia, thyroid diseases, allergy, metabolic diseases and therapeutic drug monitoring. The ADVIA Centaur System provides productivity, ease of use, automation and expanded capabilities for cost-effective workstation consolidation.

About Bayer HealthCare Diagnostics Division

Bayer HealthCare Diagnostics Division, based in Tarrytown, New York, U.S.A, is one of the world's market leaders in diagnostics for critical and intensive care, hematology, DCA (hemoglobin A1C), urinalysis, immunology, clinical chemistry and molecular testing.

With operations in more than 100 countries, Bayer Diagnostics offers an extensive portfolio of diagnostic systems, point of care testing, molecular diagnostics, laboratory automation and productivity solutions and services to hospitals and health care organizations, laboratories and physician's offices across the world.

Bayer Diagnostics' extensive portfolio covers a myriad of disease states, including: allergy, anemia, autoimmune, cardiopulmonary care, cardiovascular/heart, congenital, diabetes, fertility, infectious diseases/AIDS, urinary tract infections, immunosuppressants, kidney, metabolic function, therapeutic drug monitoring, thyroid functions, oncology, and virology.

Bayer HealthCare Diagnostics Division operates as part of Bayer HealthCare LLC, a member of the worldwide Bayer HealthCare group.

About Bayer HealthCare AG

Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. Bayer HealthCare generated sales amounting to some 9.4 billion euros and employed 33.800 people worldwide in 2005.

The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals divisions. The new Pharmaceuticals division was established on January 1, 2006, and comprises the former Biological Products and Pharmaceutical divisions. Pharmaceuticals now has three business units: Hematology/Cardiology, Oncology and Primary Care.

Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating diseases.

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.

Source: Bayer HealthCare


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