Indications / Contraindications

 The multi-target stool DNA (mt-sDNA) is intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool.1 A positive result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA) and should be followed by diagnostic colonoscopy.1 mt-sDNA is indicated to screen adults of either sex, 45 years or older, who are at typical average-risk for CRC.1 mt-sDNA is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high risk individuals.1

mt-sDNA is indicated to screen adults of either sex, 45 years or older, who are at typical average-risk for CRC1
  • mt-sDNA is contraindicated for:1
    • personal history of CRC, adenomas, or other related cancer
    • positive result from another CRC method within the last 6 months
    • diagnosis of a condition associated with high risk of CRC
    • familial (hereditary) cancer syndrome
 

Additional information on Contraindications1

List of Contraindication personal history conditions
List of Contraindication diagnosed conditions
  • Incidence of CRC is reportedly six times higher in patients with IBD than the general population2
  • For both ulcerative colitis and Crohn’s disease, it is difficult to identify dysplasia when inflammation is so severe; due to disease duration and anatomic extent, recommendations for CRC screening should begin at 7 years post diagnosis2
  • ~30% of all CRC cases are an inherited form of the disease4
List of Contraindication hereditary conditions
  • HNPCC or Lynch syndrome is an inherited cancer syndrome associated with a genetic predisposition to different cancer types3
    • Presents a 50-80% lifetime risk of developing colon cancer3
    • Average age at diagnosis is mid-40s3
  • In MYH-Associated polyposis, patients develop multiple adenomatous colon polyps (adenomas, sessile serrated polyps and hyperplastic polyps) and are at increased risk for CRC5
    • Screening recommendation is colonoscopy every 1-2 years beginning at age 25 to 305
  • Serrated polyposis syndrome, formerly known as familial hyperplastic polyposis, is characterized by multiple serrated polyps in the large bowel6
    • Increased CRC risk for individual and first- degree relatives6
    • Patients frequently develop conventional adenomatous polyps, which may comprise up to 50% of the polyp burden6

Indications for Use

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 diagnostic 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.

Contraindications

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 non-polyposis colorectal cancer syndrome (HNPCCC or Lynch Syndrome), PeutzJeghers 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. 

Warnings and Precautions

  • The performance of Cologuard® has been established in a cross-sectional study (i.e., single point in time). Programmatic performance of Cologuard (i.e., 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. Non-inferiority 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 ages 45 to 49 years was estimated by sub-group 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 (e.g., 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 72 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.

    RX Only
Please see complete prescribing information for Cologuard in the Cologuard Physician Brochure.

References

Cologuard Physician Brochure. Exact Sciences Corporation. Madison, WI.

Bae S, Kim YS. Colon cancer screening and surveillance in inflammatory bowel disease. Clin Endosc. 2014;47(6):509-515.

Brosens L, Offerhaus GJ, Giardiello F. Hereditary colorectal cancer: Genetics and screening. Surg Clin North Am. 2015;95(5):1067-1180.

Jasperson KW, Tuohy TM, Neklason D, et al. Hereditary and familial colon cancer. Gastroenterol. 2010;138(6):2044-2058.

Nielsen M, Lynch H, Infante E, Brand R. MUTYH-Associated Polyposis. 2012 [Updated 2021] Gene Reviews [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2021.

Young JP, Price TJ, Parry S. Serrated polyposis: the problem of definition and its relationship to the population at risk for syndrome-related colorectal cancer. Transl Cancer Res. 2017;6(9):1480-1483.

Last updated: 3/1/2022