PrimeraDx Gets FDA Clearance for System, C. Difficile Assay | GenomeWeb

NEW YORK (GenomeWeb News) – PrimeraDx said that it has received US Food and Drug Administration 510(k) clearance for its ICEPlex System and ICEPlex C. difficile Assay Kit.

The ICEPlex System is a quantitative multiplex PCR system and can run panels of such diverse analytes as mRNAs, microRNAs, and genomic loci. The platform runs an assay technology called scalable target amplification routine, or STAR, which integrates standard endpoint PCR with capillary electrophoresis to simultaneously quantitatively measure multiple target nucleic acids.

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