Cases of Clostridium difficile infection have in recent years become more prevalent, more severe, and more difficult to treat. C. difficile is the most commonly acquired hospital infection, generating a need for rapid and accurate detection. PrimeraDx has developed an assay to test for infection of C. difficile that offers the accuracy of real-time PCR with the time and cost savings of multiplex technology. The C. difficile assay is currently under investigational use only and PrimeraDx is running a clinical trial towards 510(k) clearance of the assay.
In addition to the ICEPlex C. difficile Assay, PrimeraDx has a pipeline of additional panels that we will seek regulatory clearance on.