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PrimeraDx Gets FDA Clearance for System, C. Difficile Assay

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.

The ICEPlex C. difficile Assay Kit detects Clostridium difficile in human stool samples.

PrimeraDx CEO and President Matt McManus said in a statement that the FDA clearances were "clearly a major step forward for the company," and noted that the firm is developing multi-analyte tests for oncology and infectious disease applications.

As reported recently by PCR Insider, Mansfield, Mass.-based PrimeraDx is undergoing a restructuring, which has forced the firm to downsize, and it is attempting to raise additional funding.