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.
Nanosphere CEO Bill Moffitt noted in a statement that the firm has had four new products cleared by the FDA in the last 12 months. The other tests are for gram positive bloodstream infections, respiratory viruses, hypercoagulation, and warfarin metabolism.
Nearly 500,000 Americans are infected with C. difficile annually and is linked to more than 30,000 deaths per year in the US, said Nanosphere.