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PrimeraDx Gets CE Mark for Multiplex MDx System, C. diff Assay


PrimeraDx said this week that its ICEPlex quantitative multiplex PCR system and accompanying Clostridium difficile detection assay have received CE marking.

PrimeraDx's assay technology, called scalable target amplification routine, or STAR, integrates standard endpoint PCR with capillary electrophoresis to simultaneously and quantitatively measure multiple target nucleic acids from one well.

The company's ICEPlex instrument is used to develop and run STAR-based assays. Mansfield, Mass.-based PrimeraDx is developing ICEPlex assays in multiple clinical areas including infectious disease, oncology, and companion diagnostics.

The company had originally planned to submit its ICEPlex C. difficile test to the US Food and Drug Administration this year. However, in June, a company executive noted that PrimeraDx was delaying that submission while it rejiggered its FDA submission to better reflect the quantitative nature of its test and to put more resources into using ICEPlex to develop companion diagnostics with pharmaceutical partners (PCR Insider, 5/24/2012).

To that end, in June the company announced a multi-year relationship with Eli Lilly to develop multiplex companion diagnostic assays in support of multiple therapeutic development programs, building on a relationship between the companies that dated back to at least 2011 (PCR insider, 6/28/2012).

"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 … and demonstrates to current and future customers, and strategic partners, our ability to develop and support high-quality diagnostic products" CEO Matt McManus said in a statement.

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