PrimeraDx gets FDA clearance for ICEPlex C. difficile Assay Kit and ICEPlex System

PrimeraDx, a molecular diagnostics company, announced today that the ICEPlex C. difficile Assay Kit and the ICEPlex System have received 510(k) clearance from the United States Food and Drug Administration.

"Obtaining clearance from the FDA for our multiplex PCR system and the ICEPlex C. difficile Assay Kit is clearly a major step forward for the company," said CEO and President Matt McManus, "as we apply our next-generation PCR platform to develop multi-analyte in vitro diagnostics—including companion diagnostics— in oncology and infectious diseases."

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.

C. difficile is one of the common and deadly hospital-acquired infections and is linked to about 14,000 US deaths annually, according to the Centers of Diseases and Prevention Controls. The ICEPlex C. difficile Assay Kit is a molecular diagnostic test for the detection of Clostridium difficile in human stool samples.

"The clearance of ICEPlex C. difficile kit and the ICEPlex System by the FDA reflects the dedication of the entire team at PrimeraDx to developing molecular diagnostic products that meet all clinical and regulatory requirements," commented Fayyaz Memon, Vice President of Regulatory Affairs and Quality Assurance. "We are delighted to add these 510(k) clearances to the CE Marks we secured last year."