17 Apr Prodesse gets OK on C. diff tool
MILWAUKEE — Prodesse Inc. has received approval from the U.S. Food and Drug Administration to sell ProGastro Cd, a diagnostic tool used to detect toxic strains of the bacterial infection colostridium difficile, or c. difficile.
This tool can produce a result in about three hours. It uses real-time polymerase chain reaction technology, is simple to use and easily integrates into existing lab workflow, according to the company, and has been optimized for the use of automated extraction technology.
“Even though we expected this was going to be a large market when we made the decision to develop a C. diff assay, we’ve been surprised by the intensity of interest from laboratories that want to perform evaluations. With this clearance, we expect to increase our customer base very substantially,” stated Prodesse CEO Tom Shannon.
In trials at three clinics, ProGastro Cd detected 43 percent more positives than did the current gold standard. Genetic sequencing confirmed that more than 90 percent of the additional positives detected by ProGastro Cd were accurate. In addition, there were no inhibited samples reported by the three clinical sites.
Clostridium 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 in Infection Control and Hospital Epidemiology estimated the economic impact in the US at $3.2 billion.
Prodesse is a biotechnology company focused on developing molecular diagnostic reagents for a variety of infectious disease applications.