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Exact Sciences’ Cologuard Gets Panel Nod As Colorectal Cancer Screen

This article was originally published in The Gray Sheet

Executive Summary

Exact Sciences Corp.’s Cologuard stool test for colorectal cancer screening gained full support from the FDA Molecular and Clinical Genetics Advisory Panel March 27, putting it in a good position to gain approval and, potentially, a Medicare national coverage determination.

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Parallel Review Progress: FDA Approves, CMS Assesses Cologuard Cancer Test

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.

Parallel Review Progress: FDA Approves, CMS Assesses Cologuard Cancer Test

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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