BD Announces FDA 510(k) Clearance Of Novel Molecular Assay To Diagnose Clostridium Difficile Infections

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 13 Jan 2009 - 1:00 PST

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BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), announced 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/NAP1/027, which has now been detected in at least 38 states, Canada and 14 European countries.

"CDI poses a significant challenge for healthcare facilities around the world," said Jamie Condie, Vice President and General Manager, BD Diagnostics - Molecular Diagnostics. "The introduction of the BD GeneOhm Cdiff assay demonstrates BD's ongoing commitment to develop a broad range of products to help prevent HAIs. BD provides molecular tests for key pathogens associated with HAIs, including Staphylococcus aureus, methicillin-resistant Staphylococcus aureus, vancomycin-resistant enterococci, and now Clostridium difficile."

Cleared for the identification of toxigenic Clostridium difficile directly from stool specimens, the BD GeneOhm Cdiff assay targets the Toxin B gene, found in virtually all toxigenic Clostridium difficile strains, including the emerging BI/NAP1/027 epidemic strain. It is the only CDI molecular assay that combines high sensitivity and specificity and provides definitive test results in less than two hours. This new test may facilitate earlier and more appropriate antibiotic treatment of CDI patients. It may also lead to earlier implementation of infection control interventions that help prevent the transmission of the pathogen to other patients. Until now, diagnosing CDI rapidly has proven difficult. Traditional methods, including immunoassays, lack sufficient sensitivity, while tissue culture cytotoxicity methods are difficult 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. The Company is dedicated to improving people's health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 28,000 people in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. For more information, please visit http://www.bd.com.

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