Nanosphere Inc. (NSPH) announced the U.S. Food and Drug Administration or FDA granted 510(k) clearance permitting marketing of its C.difficile test on the automated sample-to-result Verigene System.
The C. difficile test expands Nanosphere's infectious disease test capabilities. C. difficile infection is a cause of diarrhea that can lead to colitis, other serious intestinal conditions and death. In less than two hours, the C. difficile test 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 and used for infection control. Early and accurate diagnosis of C. difficile infections is critical in both the proper treatment of infected patients and subsequent implementation of isolation and containment procedures to prevent further spread of the infection.
The sample-to-result test automates the steps of bacterial DNA extraction, amplification, hybridization and target detection on the Verigene System. The ease-of-use and rapid turnaround time of the test allow hospitals of any size to benefit from the speed and accuracy of automated molecular testing.
Nanosphere plans to commercialize the enteric pathogens and gram-negative tests in 2013 following receipt of the necessary regulatory approvals.
by RTT Staff Writer
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