FDA approves automated hepatitis C virus assay on ADVIA Centaur Immunoassay system

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Bayer HealthCare, Diagnostics Division, a member of the Bayer Group announced today that the U.S. Food and Drug Administration (FDA) approved the company’s automated assay for the hepatitis C virus (HCV) on its ADVIA Centaur® Immunoassay System. Other FDA-approved, automated hepatitis assays available from Bayer are Anti-HBs and Anti-HBc-IgM.

The HCV assay is developed, manufactured and sold by Bayer Diagnostics for Ortho-Clinical Diagnostics, Inc. (Ortho), a subsidiary of Johnson & Johnson, under an agreement entered into with Bayer, Ortho and Chiron Corporation in 2001. 

Under the terms of the agreement, Bayer will not represent the product for blood or plasma screening.

“As a principal investigator in the U.S. Clinical Trials for this assay, I have had the opportunity to extensively review data compiled for the FDA submission. I have been extremely impressed by the accuracy of the results when compared to the comparative method, and particularly by the accuracy of positive results when compared to confirmatory methods, such as RIBA and/or NAD methodologies. I anticipate that the availability of this assay on the ‘best of breed,’ high-volume immunoassay analyzer will have a significant impact on our laboratory’s performance by reducing errors, reducing the requirement for confirmatory testing, reducing turnaround times and significantly reducing our labor requirements for this examination,” said Joseph Schappert, M.D., Vice Chair, Pathology and Laboratory Medicine, Beth Israel Medical Center, NYC.

Hepatitis C Virus

Described as a “viral time bomb” by the World Health Organization, hepatitis C is a viral infection of the liver that affects an estimated 200 million people worldwide, approximately three percent of the world’s population.1 Recent statistics from the Center for Disease Control and Prevention (CDC) estimate that nearly 3.9 million Americans are infected with viral hepatitis C (HCV)2, which is spread primarily by direct contact with human blood.

HCV is a challenging health care concern, as many infected individuals never show signs of disease. However, nearly 80 percent of newly infected patients develop chronic liver infection such as Cirrhosis, which develops in about 10 to 20 percent of persons, and one in five percent develops liver cancer. There is currently no vaccine to prevent the transmission of hepatitis C virus between individuals.

“The HCV assay, on the ADVIA Centaur Immunoassay System, automates a test that until now, was considered to be a cumbersome and labor intensive process. Bayer’s automated assay for the detection of antibodies to the hepatitis C virus will make the testing of at-risk individuals a more routine and reliable assay, reducing errors often garnered through manual test methods,” stated John Nosenzo, Senior Vice President North America Region for Bayer HealthCare’s Diagnostics Division.

Efficiency and Reliability with the ADVIA Centaur

Bayer’s HCV automated assay on the ADVIA Centaur is an in vitro diagnostic immunoassay for the qualitative determination of antibodies to hepatitis C virus (HCV) in human serum and plasma. The addition of this assay to the platform allows 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.

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.

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, Diabetes Care, Diagnostics and Pharmaceuticals. More than 34,000 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. 

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