About Cologuard^®

Exact Sciences is changing the way we think about detecting and treating cancer. By providing earlier answers and life-changing treatment guidance, Exact Sciences is committed to helping patients make informed decisions across the cancer care continuum.

Exact Sciences’ current portfolio of products focuses on colon and breast cancers, with research and development looking at the top 15 deadliest cancers, including multi-cancer testing.

In 2014, Exact Sciences launched Cologuard^®, expanding colon cancer screening options for patients. Cologuard is an FDA-approved, noninvasive stool-based DNA screening test for adults 45 and older who are at average risk for colon cancer. Since launch, millions have used Cologuard to screen for colon cancer at home.¹

Colon cancer affects all races, genders, and ethnicities, and it’s on the rise in people younger than 50.^2,3 Many people with early-stage colon cancer have no symptoms or family history – that’s why screening is critical because it can detect colon cancer in early stages, when it’s more treatable.^4,5,6,* Talk to your healthcare provider about screening for colon cancer with Cologuard.

To learn more, visit Cologuard.com

Indications and Important Risk Information

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. Do not use if you have had adenomas, have inflammatory bowel disease and certain hereditary syndromes, or a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high risk patients. Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard 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 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. False positives and false negative results 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). Rx only.

References

¹ Internal Data on File. Exact Sciences Corporation. Madison, WI.

² Wolf AMD, Fontham ETH, Church TR, et al. Colorectal cancer screening for average‐risk adults: 2018 guidelines update from the American Cancer Society. CA Cancer J Clin. 2018;68(4):250‐281.

³ Henley SJ, Ward EM, Scott S, et al. Annual report to the nation on the status of cancer, part I: national cancer statistics. Cancer.
2020;126(10):2225-2249.

⁴ NCI. Genetics of colorectal cancer (PDQ) - health professional version. Accessed October 7, 2022. https://www.cancer.gov/types/colorectal/hp/colorectal-genetics-pdq#_235_toc

⁵ Colorectal (colon) cancer: what can I do to reduce my risk of colorectal cancer? Centers for Disease Control and Prevention. Accessed October 7, 2022. https://www.cdc.gov/cancer/colorectal/basic_info/prevention.htm

⁶ National Cancer Institute. Cancer stat facts: colorectal cancer. Accessed October 7, 2022. https://seer.cancer.gov/statfacts/html/colorect.html