About Cologuard

Did you know?

• Colon cancer is the 2^nd leading cause of cancer-related deaths^1†
• When caught early, it's treatable in 90% of people²

Cologuard® is an easy, noninvasive colon cancer screening test you can use at home. It’s the only FDA-approved test based on stool DNA science and finds 92%* of colon cancers³. Plus, it’s covered by Medicare and most major insurers.  

If you’ve been putting off screening, and you’re 45 years of age or older at average risk for colon cancer, ask your healthcare provider today if this noninvasive option is right for you.

To learn more, visit Cologuard.com

*Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older.

ABOUT COLOGUARD

The Cologuard test was approved by the FDA in August 2014, and results from Exact Sciences' prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. The Cologuard test is included in the American Cancer Society's (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2021) and National Comprehensive Cancer Network (2016). The Cologuard test is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high-risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. The Cologuard test performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. Medicare and most major insurers cover the Cologuard test. For more information about the Cologuard test, visit www.cologuard.com. Rx only.

INDICATIONS FOR USE

Cologuard® is intended to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Cologuard is not a replacement for surveillance colonoscopy in high risk individuals for diagnostic colonoscopy.

IMPORTANT RISK INFORMATION

Cologuard should not be used if you:

• have a history of colorectal cancer, adenomas or other related cancers
• had a positive result from another colorectal cancer screening test within the last 6 months
• have a condition that places you at high risk for colorectal cancer, including Inflammatory Bowel Disease (IBD) or certain hereditary syndromes or a family history of colorectal cancer
• Talk to your healthcare provider if any of these situations apply to you.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy.

A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their healthcare provider when they need to be tested again.

False positives and false negatives can occur. In a clinical study, 13% of people without cancer received a positive result (false positive) and 8% of people with cancer received a negative result (false negative). It is important to talk to your doctor about your test results.

Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. 

Do not provide a sample for Cologuard if you have diarrhea or have blood in your urine or stool.

The risks related to using the Cologuard Collection Kit are low, with no serious adverse events reported among people in a clinical trial. You should be careful when opening and closing the lids to avoid the risk of hand strain.

Please read the Instructions for Use and talk to your healthcare provider to see if Cologuard is right for you. This product is available by prescription only. 

Cologuard® colorectal cancer screening test is a registered trademark of Exact Sciences Corporation.

For complete information on Cologuard, please click here.

^†Statistic is applicable to colorectal cancer

References:

1. American Cancer Society. Key statistics for colorectal cancer. https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html. Last revised January 2019. Accessed October 23, 2019.
2. National Cancer Institute. SEER Cancer stat facts: colorectal cancer. https://seer.cancer.gov/statfacts/html/colorect.html. Accessed October 23, 2019.
3. Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297.