SOUTH SAN FRANCISCO (dpa-AFX) - Swiss pharmaceutical giant Roche Holding AG (RHHBY, ROG.SW, RO.SW) announced Tuesday that the US Food and Drug Administration or FDA has provided 510(k) clearance for the cobas Cdiff Test to detect Clostridium difficile or C. difficile in stool specimens.
C. difficile is an anaerobic, toxin producing microorganism known to cause severe diarrhea, pseudomembranous colitis or toxic megacolon, in patients where normal bacterial flora of the gut has been altered following antibiotic therapy.
The cobas Cdiff Test targets the toxin B gene found in toxigenic C. difficile strains directly in specimens from symptomatic patients. The company said the test provides accurate information which assists clinicians in making timely treatment decisions and aids in the prevention of further infection in healthcare settings.
In a clinical trial program conducted at sites throughout the United States, the cobas Cdiff Test demonstrated excellent performance compared to direct and enrichment toxigenic culture, the company said.
Paul Brown, head of Roche Molecular Diagnostics, said, 'With the addition of the cobas Cdiff Test to the cobas 4800 System menu, Roche is able to expand the tools available to assist clinicians in the management of healthcare associated infections. The cobas Cdiff Test requires less sample handling and provides laboratories with a simplified workflow, when compared to other molecular methods.'
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