BD Diagnostics, Franklin Lakes, NJ, a part of BD (Becton, Dickinson and Co) reports the CE marking of the GeneOhm (TM: 92.24, -0.93, -0.99%) Cdiff molecular assay for the rapid diagnosis of patients with Clostridium difficile infection (CDI: 23.27, +0.12, +0.51%), and the company is seeking FDA clearance for the test.
The diagnostic offers sensitivity, simplicity, and speed in one test procedure.
CE marked under the European In Vitro Diagnostics Directive for the identification of toxigenic Clostridium difficile directly from stool specimens, the assay targets the toxin B gene, found in toxigenic Clostriduim difficile strains. It combines high-assay sensitivity with a turnaround time of less than 2 hours, facilitating earlier treatment of patients suffering from CDI and earlier implementation of infection-control interventions to help prevent transmission of Clostridium difficile to other patients.
"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," said Thomas Davis, MD, PhD, professor, pathology and lab medicine, Clarian Pathology Laboratory, Indianapolis.
"CDI poses a significant challenge for health care facilities around the world," said Jamie Condie, VP, general manager, BD Diagnostics. "The introduction of the BD GeneOhm Cdiff assay demonstrates BD’s ongoing commitment to develop a broad range of products that can help prevent health care-associated infections.”
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 health care costs exceed $1 billion. US 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.
BD is a global medical-technology company that develops, manufactures, and sells medical devices, instrument systems, and reagents. The company focuses on improving drug delivery, enhancing methods of diagnosing infectious diseases and cancers, and advancing research, discovery, and production of new drugs and vaccines.