Health Canada has licensed the new BD GeneOhm™ Cdiff molecular assay for the rapid detection of the toxin B gene found in toxigenic Clostridium difficile. It is the first CDI molecular diagnostic that offers sensitivity, simplicity and speed in one test procedure.

“Clostridium difficile poses a significant challenge for healthcare facilities across Canada,” said Jay Glasscock, Vice President and General Manager, BD in Canada. “We applaud Health Canada for fast-tracking the licensing of this important new test, which will help provide more definitive and more rapid diagnoses of CDI patients. The BD GeneOhm Cdiff assay was developed by BD research scientists in Québec and will be produced in our new manufacturing facility in Parc Tecnologuique du Québec Metropolitain.

” In Canada, the number of cases and deaths attributed to toxigenic Clostridium difficile increased by 50 percent over the last 30 months, according to data collected by the Public Healthy Agency of Canada. In that time period, at least 460 patients with CDIs died in Ontario hospitals. The healthcare-associated CDI outbreak in Québec that lasted from 2003 to 2004 led to the death of 1,270 patients. Given the emerging risk to public health, the Ontario Ministry of Health mandated public reporting of CDIs in Ontario hospitals as of September 30, 2008.

“The BD GeneOhm Cdiff assay is a sensitive and specific test that provides a rapid turnaround time,” said Vivian Loo, M.D., Chief of Microbiology, McGill University Health Centre. “This assay should improve patient care and allow Canadian hospitals to use resources effectively for patient isolation, ultimately preventing transmission of Clostridium difficile.

”The test, performed directly from stool specimens, targets the toxin B gene found in toxigenic Clostridium difficile strains, including the BI/NAP1/027 epidemic strain associated with the major 2003 CDI outbreak.It is the only CDI molecular assay that combines high sensitivity, specificity and can lead to a definitive diagnosis 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 Clostridium difficile 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.

The BD GeneOhm Cdiff assay adds to BD´s expanding menu of rapid molecular tests to help prevent healthcare-associated infections, including tests for Staphylococcus aureus and methicillin-resistant Staphylococcus aureus.Additionally, BD recently submitted a test to detect the resistant genes associated with vancomycin-resistant Enterococci to Health Canada for licensure.