PrimeraDx snags CE marks for assays

Molecular diagnostics company PrimeraDx got CE marks for its ICEPlex platform and a companion C. difficile-detection assay, a development the company says is huge step forward in its global commercialization efforts.

ICEPlex combines two diagnostic technologies--polymerase chain reaction (PCR) and capillary electrophoresis--into one benchtop unit, allowing for the quick development of multimodal assays in the clinic, the company says. The all-in-one unit can support infectious disease, oncology and companion diagnostics, among other applications, PrimeraDx says.

The company's C. difficile test uses the ICEPlex platform, performed on nucleic acids purified from human stool samples. C. difficile is a common and often deadly hospital-borne infection tied to about 14,000 deaths in the U.S. each year, according to Centers of Diseases and Prevention Controls. PrimeraDx says its test combines multiple DNA and RNA biomarkers into a single multiplex assay.

"The two CE marks and our previously announced ISO 13485:2003 certification demonstrate our commitment and ability to develop regulated molecular diagnostic products," said Fayyaz Memon, PrimeraDx's vice president of regulatory affairs, in a statement.

PrimeraDx's platform has attracted some Big Pharma attention, too. In June, the company teamed up with Eli Lilly ($LLY), agreeing to provide its ICEPlex technology for the development of companion diagnostics for Lilly's pipeline cancer drugs. The multi-year deal is focused on oncology in the short term, but the two companies said PrimeraDx's technology will come in handy for other therapies in the future.

- read PrimeraDx's announcement

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