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Medical Device Regulation Regulation

Epigenomics' Epi proColon Blood Test Finally Makes The Grade With FDA

This article was originally published in The Gray Sheet

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Executive Summary

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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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