Colorectal cancer test is FDA moment of sorts

Share this article:

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.

Share this article:
You must be a registered member of MMM to post a comment.

Next Article in Channel

This compelling e-book shares a wealth of insights designed to help members of sales forces connect with elusive HCPs. An expanded version has also been created that includes video interviews and other multimedia content. Click here for access.