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Indications and Important Risk Information

Cologuard is intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA) and should be followed by colonoscopy. Cologuard is indicated to screen adults of either sex, 45 years or older, who are at typical average risk for CRC. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

Cologuard is not for high-risk individuals, including patients with a personal history of colorectal cancer and adenomas; have had a positive result from another colorectal cancer screening method within the last 6 months; have been diagnosed with a condition associated with high risk for colorectal cancer such as IBD, chronic ulcerative colitis, Crohn’s disease; or have a family history of colorectal cancer, or certain hereditary syndromes.

Positive Cologuard results should be referred to colonoscopy. A negative Cologuard test result does not guarantee absence of cancer or advanced adenoma. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient.

False positives and false negatives do occur. In a clinical study, 13% of patients without colorectal cancer or advanced adenomas received a positive result (false positive) and 8% of patients with cancer received a negative result (false negative). The clinical validation study was conducted in patients 50 years of age and older. Cologuard performance in patients ages 45 to 49 years was estimated by sub-group analysis of near-age groups.

Cologuard performance when used for repeat testing has not been evaluated or established. Rx only.

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  • CRC on the Rise
  • Early Detection
  • Patient Barriers
  • Shared Decision-Making
  • Noninvasive Impact
  • Sensitivity and Specificity
  • Cologuard vs FIT
  • Ease of Use
  • Appropriate Patients
  • National Guidelines
  • Cologuard Adherence
  • Cologuard Rescreening
  • Follow-up Colonoscopy Adherence
  • Life-Years Gained
  • Coverage
  • Comprehensive Support
  • How to Order
  • HCP Resources
  • HCP Media Library
  • Events
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EXACT SCIENCES CORPORATION | 5505 Endeavor Lane, Madison, WI 53719

Cologuard is a registered trademark of Exact Sciences Corporation in the U.S. and other countries. EpicCare® and EpicCare® Link™ are trademarks of Epic Systems Corporation.

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