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BD Announces CE Marking of a New Molecular Test to Diagnose Patients with Clostridium difficile Infections
Date:7/6/2008

BD GeneOhm(TM) Cdiff Assay Submitted for FDA Clearance

SAN DIEGO, July 7 /PRNewswire-FirstCall/ -- BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), announced today the CE marking of the BD GeneOhm(TM) Cdiff molecular assay for the rapid diagnosis of patients with Clostridium difficile infection (CDI). It is the first CDI diagnostic test that offers sensitivity, simplicity and speed in one test procedure. BD has also submitted this assay to the U.S. Food and Drug Administration for clearance.

CE marked under the European In Vitro Diagnostics Directive for the identification of toxigenic Clostridium difficile directly from stool specimens, the BD GeneOhm Cdiff assay targets the toxin B gene, found in toxigenic Clostriduim difficile strains. It is the only CDI diagnostic test that combines high assay sensitivity with a rapid turnaround time of less than two hours, facilitating earlier appropriate treatment of patients suffering from CDI and earlier implementation of infection control interventions to prevent transmission of Clostridium difficile to other patients. Until now, rapid diagnosis of CDI has been difficult since traditional methods consist of immunoassays, which lack sufficient sensitivity, and traditional "gold standard" tissue culture cytotoxicity methods, which are difficult to perform and require several days to yield results.

"The BD GeneOhm Cdiff assay provides a simple and rapid stool test with excellent sensitivity and specificity that allows same-day identification of toxigenic Clostridium difficile," said Thomas Davis, M.D., Ph.D., Professor, Pathology and Laboratory Medicine, Clarian Pathology Laboratory. "This test should improve patient care because it effectively
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SOURCE BD-Becton Dickinson
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