BD Announces CE Marking of a New Molecular Test to Diagnose Patients with Clostridium difficile Infections

BD GeneOhm™ Cdiff Assay Submitted for FDA Clearance

BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), announced today the CE marking of the BD GeneOhm™ 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 eliminates the need for multiple screening and confirmatory assays, speeds up reporting and helps avoid unnecessary antibiotic use.”

“CDI poses a significant challenge for healthcare facilities around the world,” said Jamie Condie, Vice President and General Manager, BD Diagnostics - GeneOhm. “The introduction of the BD GeneOhm Cdiff assay demonstrates BD’s ongoing commitment to develop a broad range of products that can help prevent healthcare-associated infections (HAIs). BD provides molecular tests for key pathogens associated with HAIs, including methicillin-resistant Staphylococcus aureus (MRSA), methicillin-susceptible Staphylococcus aureus, vancomycin-resistant Enterococci, and now Clostridium difficile.”

In the United Kingdom, Clostridium difficile infections have risen 40 percent in the last three years, infecting eight times as many patients as MRSA and killing twice as many. In the United States annually, an estimated 500,000 people are hospitalized and more than 28,000 die from CDI. The average length of stay for a CDI patient is nearly three times longer than the average patient and excess healthcare costs exceed $1 billion. U.S. rates of CDI continue to increase, driven by a hypervirulent strain known as BI/NAP1/027. This dangerous strain has now been isolated in at least 38 states, Canada and 14 European countries.