What is Cologuard?
Cologuard is an easy to use, noninvasive colon cancer screening test that you can use in the privacy of your own home. It identifies altered DNA and/or blood in stool, which are associated with the possibility of colon cancer or precancer. Your healthcare provider will talk with you about your results. For more about understanding results, click here.
How do you get DNA out of stool?
DNA is continuously shed from cells in the intestinal lining, where it is passed into the stool. If cancer or precancer is present, abnormal cells will shed into the colon and stool along with normal cells. We use a molecular biology process to capture specific pieces of DNA for further analysis.
Why does Cologuard use stool samples and not blood samples?
DNA is continuously shed from cells in the intestinal lining and passed into the stool. Both precancer and cancer shed DNA, so it can be an early indicator of the presence of colon cancer or precancerous lesions, before altered DNA would be present in the blood stream.
Is Cologuard a genetic test?
No. Cologuard is not a test to confirm or deny a suspected genetic condition, or help determine a person's chance of developing or passing on colon cancer. Cologuard does not provide information about DNA changes that are inherited or can be passed on to your children. Cologuard identifies DNA mutations that are acquired over time in cells lining the colon; these mutations can be associated with the presence of colon cancer or precancerous lesions.
How was Cologuard developed?
Cologuard was developed by Exact Sciences in collaboration with researchers at the Mayo Foundation for Medical Education and Research. It went through extensive research and development, including a clinical study of 10,000 average risk study participants that validated the test's safety and efficacy in screening for colon cancer and precancer.
Is Cologuard FDA approved?
Yes, Cologuard was approved by the FDA in August 2014 after undergoing a rigorous review process known as a Pre-Market Approval (or PMA).
How effective is Cologuard?
In a clinical study of 10,000 participants of average risk for colon cancer, Cologuard found 92% of cancer. Cologuard was negative in 87% of participants without cancer or advanced precancerous lesions.
Should colonoscopy be used in addition to Cologuard?
Cologuard is a screening test. Any positive result should be discussed with your healthcare provider and followed by a diagnostic colonoscopy.
How often should Cologuard be used?
Cologuard is covered by Medicare every 3 years for average risk patients between the age of 50-85. Cologuard is recommended every 3 years by the American Cancer Society.
Colon cancer screening guideline recommendations vary for people over the age of 75. The decision to screen people over the age of 75 should be made in consultation with a healthcare provider. The rate of false positive Cologuard results increases with age. Talk to your healthcare provider about what screening program is appropriate for you.
Is Cologuard included in the United States Preventive Services Task Force (USPSTF) guidelines? What does this mean?
Yes, Cologuard is included in the United States Preventive Services Task Force (USPSTF) guidelines on colon cancer screening as of its June 2016 update. The USPSTF strongly recommends colon cancer screening for people aged 50-75 (‘A’ rating), meaning the committee finds a substantial net benefit in colon cancer screening.
Cologuard is included on equal standing among the other 'A rated' colon cancer screening options, including colonoscopy, CT colonography, flexible sigmoidoscopy, flexible sigmoidoscopy with FIT, gFOBT, and FIT. Read the USPSTF’s guidance on colon cancer screening in full by visiting its website.
Is Cologuard included in the Healthcare Effectiveness Data and Information Set (HEDIS) quality measures? Why does this matter?
Yes, stool DNA (i.e. Cologuard) is one of the methods permitted as part of the National Committee for Quality Assurance’s (NCQA) Healthcare Effectiveness Data and Information Set* (HEDIS®) quality measure for colon cancer screening. HEDIS is a helpful tool used by more than 90% of health plans in America. The quality measures analyze the performance of healthcare services and care. The data and results are used to make improvements in the healthcare provider's quality of care and service.
*Third party guidelines do not specifically endorse commercial products, and inclusion in guidelines does not imply otherwise.