The ICEPlex c. difficile Assay Kit and the ICEPlex System from PrimeraDx have received FDA 510(k) clearance. The ICEPlex c. difficile Assay Kit is a molecular diagnostic test for the detection of Clostridium difficile in human stool samples.

The ICEPlex System is a quantitative multiplex PCR system with the unique ability to amplify and quantify multiple nucleic acid species of different types in a single reaction, starting from fresh, frozen or formalin-fixed paraffin-embedded samples. This makes it ideal for high-multiplex assays involving panels of such diverse analytes as mRNAs, microRNAs and genomic loci, and thus for the next generation of in vitro molecular diagnostics.