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

This article was originally published in The Pink Sheet Daily

Executive Summary

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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