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BD Announces FDA 510(k) Clearance of Novel Molecular Assay to Diagnose Clostridium difficile Infections

Monday, January 12, 2009 General News J E 4
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SAN DIEGO, Jan. 12 BD Diagnostics, a segment ofBD (Becton, Dickinson and Company) (NYSE: BDX), announced today it hasreceived clearance from the U.S. Food and Drug Administration to market the BDGeneOhm(TM) Cdiff molecular assay for the rapid detection of the Toxin B genefound in toxigenic Clostridium difficile, the bacterial pathogen responsiblefor Clostridium difficile infection (CDI). It is the first CDI moleculardiagnostic that offers sensitivity, simplicity and speed in one test procedure.

"The BD GeneOhm Cdiff assay provides a simple and rapid stool test withexcellent sensitivity and specificity that allows same-day identification oftoxigenic 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 asingle assay that will markedly reduce or even eliminate the need for multiplescreening and confirmatory tests. This would speed up reporting and help avoidunnecessary 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 theAssociation for Professionals in Infection Control and Epidemiology suggeststhat 13 out of every 1,000 hospitalized patients are suffering from CDI, andmore than 7,000 patients in U.S. hospitals have CDI on any given day. Theaverage length of stay for a CDI patient is nearly three times longer than thetypical patient, and CDI is estimated to lead to $1 billion in excesshealthcare costs annually in the United States. CDI rates continue toincrease, driven by a new epidemic strain known as BI/NAP1/027, which has nowbeen detected in at least 38 states, Canada and 14 European countries.

"CDI poses a significant challenge for healthcare facilities around theworld," said Jamie Condie, Vice President and General Manager, BD Diagnostics- Molecular Diagnostics. "The introduction of the BD GeneOhm Cdiff assaydemonstrates BD's ongoing commitment to develop a broad range of products tohelp prevent HAIs. BD provides molecular tests for key pathogens associatedwith HAIs, including Staphylococcus aureus, methicillin-resistantStaphylococcus aureus, vancomycin-resistant enterococci, and now Clostridiumdifficile."

Cleared for the identification of toxigenic Clostridium difficile directlyfrom stool specimens, the BD GeneOhm Cdiff assay targets the Toxin B gene,found in virtually all toxigenic Clostridium difficile strains, including theemerging BI/NAP1/027 epidemic strain. It is the only CDI molecular assay thatcombines high sensitivity and specificity and provides definitive test resultsin less than two hours. This new test may facilitate earlier and moreappropriate antibiotic treatment of CDI patients. It may also lead to earlierimplementation of infection control interventions that help prevent thetransmission of the pathogen to other patients. Until now, diagnosing CDIrapidly has proven difficult. Traditional methods, including immunoassays,lack sufficient sensitivity, while tissue culture cytotoxicity methods aredifficult to perform and require several days to yield results.

About BD

BD is a leading global medical technology company that develops,manufactures and sells medical devices, instrument systems and reagents. TheCompany is dedicated to improving people's health throughout the world. BD isfocused on improving drug delivery, enhancing the quality and speed ofdiagnosing infectious diseases and cancers, and advancing research, discoveryand production of new drugs and vaccines. BD's capabilities are instrumentalin combating many of the world's most pressing diseases. Founded in 1897 andheadquartered in Franklin Lakes, New Jersey, BD employs approximately 28,000people in approximately 50 countries throughout the world. The Company serveshealthcare institutions, life science researchers, clinical laboratories, thepharmaceutical industry and the general public. For more information, pleasevisit http://www.bd.com.

SOURCE BD-Becton Dickinson
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