CE mark approval for C.diff detection assay and PCR system
PrimeraDx receives regulatory approval for ICEPlex and C.diff assays
PrimeraDx has received CE mark approval for its ICEPlex quantitative multiplex PCR system and C.difficile detection assay.
"Obtaining the CE mark on our instrument and assay is an important step in the process of global commercialisation of our molecular diagnostics products in infectious disease and oncology,”said PrimeraDx chief executive and president, Matt McManus.
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 has a unique ability to test for many different target types all in one well.
The C.difficile assay is a molecular diagnostic test for the detection of the infection. Based on a clinical platform which combines PCR with capillary electrophoresis, the test is performed on nucleic acids purified from human stool samples.
