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.

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.

 

Contraindications1


Cologuard is intended for use with patients, age 45 years and older, at average risk who are typical candidates for CRC screening. Cologuard was not clinically evaluated for the following types of patients:


  • Patients with a history of colorectal cancer, adenomas, or other related cancers
  • Patients who have had a positive result from another colorectal cancer screening method within the last 6 months
  • Patients who have been diagnosed with a condition that is associated with high risk for colorectal cancer. These include but are not limited to:
    • Inflammatory bowel disease (IBD)
    • Chronic ulcerative colitis (CUC)
    • Crohn’s disease
    • Familial adenomatous polyposis (FAP)
    • Family history of colorectal cancer
  • Patients who have been diagnosed with a relevant familial (hereditary) cancer syndrome, such as hereditary nonpolyposis colorectal cancer syndrome (HNPCC) or Lynch syndrome, Peutz-Jeghers syndrome, MYH-associated polyposis (MAP), Gardner’s syndrome, Turcot’s (or Crail’s) syndrome, Cowden’s syndrome, juvenile polyposis, Cronkhite-Canada syndrome, neurofibromatosis, or familial hyperplastic polyposis.
  • 1 Cologuard® Clinician Brochure. Madison, WI: Exact Sciences Corporation.

Warnings, Precautions, and Risks1


  • The performance of Cologuard has been established in a cross-sectional study (ie, single point in time). Programmatic performance of Cologuard (ie, benefits and risks with repeated testing over an established period of time) has not been studied. Performance has not been evaluated in adults who have been previously tested with Cologuard. Noninferiority or superiority of Cologuard programmatic sensitivity as compared to other recommended screening methods for CRC and AA has not been established
  • The clinical validation study was conducted in patients 50 years of age and older. ACS guidelines recommend screening begin at age 45. Cologuard performance in patients aged 45 to 49 years was estimated by subgroup analysis of near-age groups
  • CRC screening guideline recommendations vary for persons over the age of 75. The decision to screen persons over the age of 75 should be made on an individualized basis in consultation with a healthcare provider. Cologuard test results should be interpreted with caution in older patients, as the rate of false positive results increases with age
  • A negative Cologuard test result does not guarantee absence of cancer or advanced adenoma. Patients with a negative Cologuard test result should be advised to continue participating in a colorectal cancer screening program with another recommended screening method. The screening interval for this follow-up has not been established
  • Cologuard may produce false-negative or false-positive results. A false-positive result occurs when Cologuard produces a positive result, even though a colonoscopy will not find cancer or precancerous polyps. A false-negative result occurs when Cologuard does not detect a precancerous polyp or colorectal cancer, even when a colonoscopy identifies the positive result
  • Patients should not provide a sample for Cologuard if they have diarrhea or if they have blood in their urine or stool (eg, from bleeding hemorrhoids, bleeding cuts or wounds on their hands, rectal bleeding, or menstruation)
  • To ensure the integrity of the sample, the laboratory must receive the patient specimens within 96 hours of collection. Patients should send stool samples to the laboratory according to the instructions stated in the Cologuard Patient Guide
  • Patients should be advised of the caution listed in the Cologuard Patient Guide. Patients should NOT drink the preservative liquid
  • The risks related to using the Cologuard collection kit are low, with no serious adverse events reported among people in a clinical trial. Patients should be careful when opening and closing the lids to avoid the risk of hand strain
  • 1Cologuard® Clinician Brochure. Madison, WI: Exact Sciences Corporation.