CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Epigenomics has submitted to the FDA the fourth and final module of its premarket approval for its blood-based Epi proColon test for the detection of colorectal cancer.
The fourth module of the PMA contains the clinical data generated with the test, including the results of a head-to-head comparative study of Epi proColon with fecal immunochemical testing; previously announced data from a clinical validation study in a cohort of prospectively collected samples; and other clinical study results generated during the development of Epi proColon.
Epigenomics, 206-883-2900