Test for Clostridium Difficile Is Rapid and Efficient

A result can be obtained in as little as 3 hours using the assay. Clinical trials were conducted at three clinical laboratories in the United States. They reported that ProGastro Cd was easy-to-use and that it rapidly and accurately detected toxigenic strains of C. difficile.

ProGastro Cd, a product of Prodesse Inc. (Waukesha, WI, USA), detected 43% more positives than 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.

Prodesse Inc has received approval from the U.S. Food and Drug Administration (FDA; Rockville, MD, USA) to sell ProGastro Cd, the user-friendly molecular assay for detection of toxic strains of the bacterial infection C. difficile. The clearance came in less than 90 days from submission.

C. difficile is a major cause of healthcare-associated infections, notably antibiotic-associated diarrhea, pseudomembranous colitis, and toxic megacolon. Annually, there are over 500,000 U.S. infections (and over 28,000 deaths) and over 800,000 infections in the European Union. A recent study estimated the economic impact in the United States at US$3.2 billion.

Related Links:
Prodesse Inc.
U.S. Food and Drug Administration