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Clearance gained for cobas Cdiff Test
July 2015
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PLEASANTON, Calif.—The U.S. Food and Drug Administration has granted 510(k) clearance for Roche's cobas Cdiff Test to detect Clostridium difficile (C. difficile) in stool samples. The test targets the toxin B gene found in toxigenic C. difficile strains directly in specimens from symptomatic patients, and demonstrated excellent performance in a clinical trial program, offering high assay sensitivity and rapid turnaround time.
 
“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," said Paul Brown, head of Roche Molecular Diagnostics. “The cobas Cdiff Test requires less sample handling and provides laboratories with a simplified workflow when compared to other molecular methods. It also delivers a lower inhibition rate, which means fewer repeat samples and chances for error, enabling better patient care.”
 
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