MILWAUKEE, WI (May 15, 2008) – Prodesse, Inc. announced today the commercial release of its CE Marked ProGastro™ Cd Assay for European and other customers outside the US. It is also now available in the US as a Research Use Only product for non-clinical use. ProGastro Cd rapidly and accurately detects toxigenic strains of the Clostridium difficile bacterium. Current methods of detecting this hospital-acquired infection suffer from a variety of shortcomings. The most commonly used tests lack sensitivity with reported values as low as 60%. The gold standard cell cytotoxin assay is difficult to perform, requires special capabilities and takes 48 hours or more. The real-time PCR technology used in ProGastro Cd makes the detection process far easier than the gold standard cytotoxin assay, yielding answers in as little as 3 hours.
Prodesse Chief Marketing Officer Andy Shrago commented, “We have been very pleased with the performance of our ProGastro Cd Assay. There is a clear and pressing need for a better test for C. difficile. In the UK, the incidence of C. diff is several times that of MRSA, and the death rate from C. diff is double that of MRSA. In the US, the annual incremental cost burden due to C. difficile associated diarrhea is $1.1 billion. US clinical trials are continuing, and we look forward to submitting our application for FDA 510(k) clearance in the upcoming months.”
Clostridium difficile is an important cause of antibiotic associated diarrhea (known as CDAD – C. difficile associated diarrhea); C. difficile is also responsible for almost all cases of pseudomembranous colitis. It can also cause toxic megacolon and sepsis. C. difficile has traditionally been a concern only for hospitalized or institutionalized (i.e., nursing home) patients. However, there is considerable evidence that it is now occurring in the community. In addition, there is a new, highly toxigenic strain (NAP1/027 or Toxinotype III). This strain was originally discovered in Québec, Canada, but has since been found in the United States and several European countries. The incidence of C. difficile is increasing rapidly. This pathogen is a potent nosocomial and can spread through hospital wards rapidly.
About Prodesse
Prodesse is a biotechnology company focused on developing molecular diagnostic reagents for a variety of infectious disease applications. The company’s products are designed based on a combination of Prodesse’s patented technologies and other licensed technologies. Prodesse sells FDA 510(k) cleared products worldwide, CE Marked in vitro diagnostic kits outside the US and research use only kits worldwide. The company’s products can be used on multiple nucleic acid extraction and real-time PCR platforms. Prodesse also operates a CLIA certified laboratory for testing services in the Midwest area. For more information about Prodesse and its products, call 888-589-6974 or go to www.prodesse.com.
Press Contact:
Andy Shrago, Chief Marketing Officer
Prodesse, Inc.
Phone: (262) 446-0700
Email: ashrago@prodesse.com
