Exact Sciences Celebrates 2 Years since Cologuard®’s FDA Approval
Two years ago this month, the Food and Drug Administration approved Exact Sciences’ Cologuard.
The news on August 11, 2014 made Cologuard the first and only FDA-approved stool DNA screening test for colorectal cancer. It was also the first time in history that the FDA approved a technology and the Centers for Medicare & Medicaid Services (CMS) proposed a national coverage determination on the same day. Cologuard was the first product reviewed through the FDA-CMS parallel review program, a process aimed at reducing the time between FDA’s approval of a device and Medicare coverage.
This approval gave patients an innovative, noninvasive option for colon cancer screening. Once prescribed by a doctor, a Cologuard collection kit is shipped directly to the patient so they can collect their sample in the privacy of their own home. They then ship their sample to the lab for testing.
Since receiving FDA approval, Exact Sciences has completed 202,000 Cologuard tests through the second quarter of 2016. Also since launch, Cologuard has achieved a number of pivotal milestones, including:
- The American Cancer Society included Cologuard in its national guidelines for colorectal cancer screening in the fall of 2014;
- In June of 2016, the United States Preventive Services Task Force included Cologuard in its colorectal cancer recommendations;
- In July of 2016, the National Committee for Quality Assurance proposed to broaden the 2017 Healthcare Effectiveness Data and Information Set (HEDIS) quality measures for colorectal cancer screening to include Cologuard;
- Including Medicare and a growing number of commercial plans, Cologuard is now covered for 62 percent of its total target population.
The Exact Sciences team is proud of the impact Cologuard has made in the fight against colon cancer, and to have helped so many people get screened for colon cancer. Want to help spread the word about Cologuard and the importance of colon cancer screening? Learn more about our Cologuard Champion program here.
Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. For more information about Cologuard, visit www.CologuardTest.com. Rx Only.
