Product News: PrimeraDx Receives CE Marks for the ICEPlex System and C. difficile Detection Assay

13 Sep 2012

PrimeraDx, a molecular diagnostics company, announced today that the ICEPlex system, a quantitative multiplex PCR system, and their C. difficile detection assay have both received the CE mark.

"Obtaining the CE mark on our instrument and assay is an important step in the process of global commercialization of our extensive pipeline of molecular diagnostics products in infectious disease and oncology," said CEO and President Matt McManus. Dr. McManus continued, "The CE mark demonstrates to current and future customers, and strategic partners, our ability to develop and support high quality diagnostic products."

The ICEPlex system consists of a platform on which PrimeraDx develops high multiplex, quantitative, molecular diagnostic products. These products span multiple clinical areas including infectious disease, oncology and companion diagnostics. The system's unique ability to test for many different target types "all in one well" is critical to satisfying the next generation of clinical diagnostic needs.

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 is a molecular diagnostic test for the detection of the Clostridium difficile. Based on a novel, game-changing clinical platform which combines PCR with capillary electrophoresis, the ICEPlex C. difficile Assay is performed on nucleic acids purified from human stool samples.

"The two CE Marks, and our previously announced ISO 13485:2003 certification demonstrate our commitment and ability to develop regulated molecular diagnostic products," added Fayyaz Memon, Vice President of Regulatory Affairs and Quality Assurance.