Nanosphere Gets FDA OK for C. Difficile Test | GenomeWeb

NEW YORK (GenomeWeb News) – Nanosphere today said that the US Food and Drug Administration has granted 510(k) clearance for the firm's Clostridium difficile molecular test.

The test, which runs on Nanosphere's Verigene system, detects the toxin A and B gene sequences of C. difficile and identifies the PCR ribotype 027 strain, which is associated with increased severity of disease. The test automates the steps of bacterial DNA extraction, amplification, hybridization, and target detection on the Verigene system.

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