PrimeraDx’s ICEPlex system and C. difficile detection assay receive CE mark

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

Source:

PrimeraDx

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
From Discovery Biology to ELRIG Chair: A Conversation with Melanie Leveridge