Prodesse, Inc. announced that US FDA has granted 510(k) clearance to market its ProGastro Cd Assay for detection of clostridium difficileas in the US. The clearance came in less than 90 days from submission. ProGastro Cd uses real-time PCR (polymerase chain reaction) technology which is simple to use and easily integrates into existing lab workflow. The product has been optimized for the use of automated extraction technology so that its inhibition rate is extremely low. A result can be obtained in as little as 3 hours using the assay. Trials were conducted at three clinical laboratories in the US. They reported that ProGastro Cd was easy-to-use and that it rapidly and accurately detected toxigenic strains of Clostridium difficile. In its clinical trials, ProGastro Cd detected 43% more positives than did the current gold standard, the cell cytotoxin assay. Genetic sequencing confirmed that over 90% of the additional positives detected by ProGastro Cd were accurate. In addition, there were no inhibited samples reported by the three clinical sites.