Prodesse Releases CE Marked PCR Assay for Detection of Toxigenic C. difficile
Prodesse, Inc. have released 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.”
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