Dr Nicholas T. Potter Executive Vice President of Clinical Affairs at Molecular Pathology Laboratory Network Inc (MPLN), in a recent letter to the editor of Journal of the American Medical Association (JAMA) Oct 25 2016, clarified the performance characteristics of Epi proColon®, Epigenomics’ recently FDA approved molecular screening test for colorectal cancer.
Earlier this year the US Preventative Services Task Force (USPSTF) published recommendations for colorectal cancer screening, but failed to take into account the latest data for Epigenomics Epi proColon colorectal cancer screening test; the first and only FDA-approved blood test for colorectal cancer screening. The statement listed a number of screening tests, including serologic testing for methylated SEPT9 DNA (Epi proColon). However, the data cited for SEPT9 DNA was based on an earlier version of the assay and does not reflect the test that was granted Premarket Approval (PMA) by the U.S. Food and Drug Administration.
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