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BD Gets CE Mark for C. difficile Molecular Test

NEW YORK (GenomeWeb News) – Becton Dickinson said today that European Union regulatory authorities have granted the CE Mark for its BD GeneOhm Cdiff molecular diagnostic test for patients with Clostridium difficile infection.
The assay detects the toxin B gene, which is found in toxigenic C. difficile strains, directly from stool specimens. BD said that it is the only C. difficile test on the market that offers high sensitivity and a rapid turnaround time of less than two hours.
BD said that it also has submitted the test to the US Food and Drug Administration for marketing clearance.
BD competitor Cepheid said in February that it expects to introduce new tests this year in Europe for the hospital-acquired infections market, including assays for vancomycin-resistant Enterococci and C. difficile. The firm also intends to seek clearance of those assays in the US in 2009.
BD’s Cdiff molecular assay is one of a handful of molecular diagnostic tests for the hospital-acquired infections market developed and sold by BD, since it acquired GeneOhm in early 2006 for $230 million and an extra $25 million in incentives. The other HAI molecular diagnostic tests sold by the firm include assays for methicillin-resistant Staphylococcus aureus, methicilllin-susceptible Staphylococcus aureus, and vancomycin-resistant Enterococci.
Molecular diagnostics, particularly in the fields of HAIs and bacterial infections, has become an increasing area of focus for BD. In addition to the GeneOhm acquisition, the firm recently struck a bacterial diagnostics alliance with Accelr8 Technology.

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