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news.Medical technology company BD Diagnostics, a segment of Becton, Dickinson and Company, has received clearance from the FDA to market the BD GeneOhm 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 or CDI.
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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, the company said.
According to the company, 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.
Jamie Condie, vice president and general manager at BD Diagnostics for molecular diagnostics, said: “The introduction of the BD GeneOhm Cdiff assay demonstrates BD’s ongoing commitment to develop a broad range of products to help prevent healthcare-associated infections (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.”