Parallel Review Progress: FDA Approves, CMS Assesses Cologuard Cancer Test
This article was originally published in The Pink Sheet Daily
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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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.
The firm’s SYMPLICITY HTN-3 trial failed to meet its primary efficacy endpoint, scuttling Medtronic’s plans to earn a PMA for renal denervation this year. The primary investigator for the trial acknowledges in an interview that the finding raises serious questions for the future of renal denervation in hypertension.
Exact Sciences, one of the first companies to volunteer for a pilot program launched in 2011 testing FDA-CMS parallel review, says its experience with the process so far is very positive. Agency officials are planning to review experiences with the program to make improvements.