Exact Sciences’ Cologuard Gets Panel Nod As Colorectal Cancer Screen
This article was originally published in The Pink Sheet Daily
Executive Summary
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.
You may also be interested in...
Research Briefs: Studies From Exact Sciences, EndoChoice; Neuroimaging Overuse
In the lead up to an FDA panel, positive data is published for Exact Science’s Cologuard multi-target stool DNA-based screening test. EndoChoice’s Fuse endoscope sees more colon cancer than traditional endoscopes. Overuse of neuroimaging for headaches documented. Long-term study finds high-frequency oscillatory ventilation is better for premature babies than standard ventilation. Drug-coated balloon trial.
FDA-CMS Parallel Review Saves Time, Clinical Trial Costs, Participant Says
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.
White House To Deliver 25 Million Face Masks To Low-Income Americans
The White House will be spending $86m to provide tens of millions of coronavirus masks to poorer American households.