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BD Announces FDA 510(k) Clearance of Novel Molecular Assay to Diagnose Clostridium difficile Infections
Date:1/12/2009

SAN DIEGO, Jan. 12 /PRNewswire-FirstCall/ -- BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), announced today it has received clearance from the U.S. Food and Drug Administration to market the BD GeneOhm(TM) Cdiff molecular assay for the rapid detection of the Toxin B gene found in toxigenic Clostridium difficile, the bacterial pathogen responsible for Clostridium difficile infection (CDI). It is the first CDI molecular diagnostic that offers sensitivity, simplicity and speed in one test procedure.

"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 at the Indiana University School of Medicine, and Pathologist with Wishard Health Services and Clarian Health laboratories. "This test should improve patient care because it gives labs the option of a single assay that will markedly reduce or even eliminate the need for multiple screening and confirmatory tests. This would speed up reporting and help avoid unnecessary antibiotic use."

In the United States, an estimated 500,000 people are infected annually, and more than 28,000 die from CDI. A recent national survey conducted by the Association for Professionals in Infection Control and Epidemiology suggests that 13 out of every 1,000 hospitalized patients are suffering from CDI, and more than 7,000 patients in U.S. hospitals have CDI on any given day. The average length of stay for a CDI patient is nearly three times longer than the typical patient, and CDI is estimated to lead to $1 billion in excess healthcare costs annually in the United States. CDI rates continue to increase, driven by a new epidemic strain known as BI/
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SOURCE BD-Becton Dickinson
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