Colorectal cancer test is FDA moment of sorts

Exact Sciences hit a two-fer with Monday's approval of its colorectal cancer test: Cologuard was the first approved fecal-based screening test for the disease, and it was also the first product the FDA and the Centers for Medicare and Medicaid Services approved on the very same day through the Parallel Review program.

Regulatory Focus explains that the idea for the Parallel Review program started in 2011 and that it has had some setbacks, such as in January, when the two government agencies were set to approve Medtronic's Symplicity Renal Denervation Device, but it failed to hit its Phase-III clinical trial goals and could not be greenlighted.


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