Prodesse, Inc. has received 510(k) clearance from the FDA to market its ProGastro™ Cd Assay as an in vitro diagnostic product in the United States.

The clearance came in less than 90 days from submission. ProGastro Cd uses real-time PCR technology; it 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.

Clinical 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.