Epigenomics' Epi proColon Blood Test Finally Makes The Grade With FDA
This article was originally published in The Gray Sheet
FDA approved the first blood-based colorectal cancer screening test, developed by Epigenomics, after a challenging regulatory path for the product, including a 2014 not-approvable letter.
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CMS opened a national coverage determination for Exact Sciences Cologuard, the first stool-based colorectal cancer screening test on the same day FDA approved the test. This is the first simultaneous approval/coverage determination under FDA and CMS’ joint parallel review program.
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Germany’s Merck KGaA rapidly expanded its life sciences services business to support the manufacture of COVID-19 vaccines during 2020, and also expects cancer and multiple sclerosis products to fuel its sales growth in coming years.