Bayer Diagnostics Receives FDA Approval for Second Hepatitis B Assay


TARRYTOWN, N.Y. -- The Diagnostics Professional Testing Systems Division of Bayer HealthCare LLC, a member of the Bayer Group announced today that it has received U.S. Food and Drug Administration (FDA) approval for its second hepatitis B assay on the ADVIA Centaur(R) Immunoassay System in eleven weeks. The Anti-HBc-IgM assay, a fully automated test on its leading automated immunoassay platform -- the ADVIA Centaur Immunoassay System -- is used to aid in the diagnosis of hepatitis B virus (HBV) infections.

"The availability of the Anti-HBc-IgM assay is another step for Bayer in offering customers a total solution for their infectious disease testing panel, which will ultimately include the complete HBV panel, HAV, HCV(1) and HIV(1) assays," said John Nosenzo, senior vice president North America Region for Bayer Diagnostics' Professional Testing Systems. "The highly automated ADVIA Centaur System makes it much easier for the laboratory to run these assays in real time instead of in batches, shortening the turnaround time for physicians."

Due to the complex nature of the hepatitis B virus (HBV) lifecycle, a variety of tests including the Anti-HBc-IgM assay are used to detect infection, replication and immunity:

Anti-HBc-IgM is utilized with other HBV markers to help healthcare professionals define the clinical status of HBV infected patients. The Anti HBc-IgM assay, along with HBs Ag and HBc Total assays, may also be useful in the differentiation of acute and chronic HBV infections. Anti-HBs is used to detect a previous HBV infection, determine the presence of protective immunity from vaccination or evaluate the recovery of a patient from a HBV infection.

A worldwide health concern, HBV is the most common form of hepatitis with 350 million carriers globally. HBV is 100 times more infectious than HIV(2). More than 95 percent of adults infected with HBV recover within six months and develop immunity. The remaining 5 percent 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.

(1) Manufactured for Ortho-Clinical Diagnostics, Inc. by Bayer HealthCare LLC


(2) Hepatitis Foundation International. 30 Sunrise Terrace, Cedar Grove, NJ 07009-1423

Source: Bayer HealthCare LLC

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