Exact Launches Real-World Trial Of Cologuard Colon Cancer Screening
Executive Summary
Exact Sciences Corp. and the Mayo Clinic are launching a 150,000-patient clinical trial examining the real-world effects of colorectal cancer screening with the Cologuard colon cancer test.
You may also be interested in...
USPSTF Recommendations For Colon Cancer Screening At Age 45 Could Give Cologuard A Boost
If the USPSTF recommendations are finalized, most insurers would need to reimburse Exact Sciences’ US FDA-approved at-home stool DNA test for colorectal cancer and encourage doctors to prescribe more at-home testing.
Despite Only Two Parallel Review Success Stories, CMS Touts Better Coordination
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.
US FDA Waits Until December To Enforce Unique Device Identifier Database For Low-Risk Devices
Agency won’t require manufacturers to submit class I devices to the database for an extra 75 days, and doesn't plan to enforce GUDID regulations against consumer health products.