Parallel Review Progress: FDA Approves, CMS Assesses Cologuard Cancer Test
This article was originally published in The Gray Sheet
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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While only two devices have received approval and a national coverage determination through US FDA/CMS' parallel review program, a top CMS official says industry needs to look beyond just the numbers. Instead, she says the parallel review program is part of a sea-change that has allowed for better communication between CMS, FDA and sponsors.
The program, which allows select manufacturers to have their products reviewed simultaneously for FDA approval and Medicare coverage, has been in the pilot stage since 2011. Now it is formally in full implementation mode and the agencies are looking for more manufacturers to participate.
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.