A recent article by Anne Paxton in CAP Today (November 2016) discusses the FDA approval of the Epigenomics Epi proColon® assay for colon cancer screening. MPLN's Dr. Nicholas Potter explains the series of events and the study data from the initial application through to the FDA's requirement for a post market real-world study, the ADMIT (Adherence to Minimally Invasive Testing) trial. How Epi proColon compares with already existing screening methods, most notably FIT, was a key question in the FDA’s review and in the absence of any true effectiveness data, whether compliance or adherence could be increased by offering a blood test.
Dr. Potter also discusses the opportunity that this test offers to smaller CLIA high-complexity laboratories who would like to participate in colon cancer screening initiatives utilizing a new and novel molecular diagnostic test.
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