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

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 Centaurreg; 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