Pivotal clinical study
In a clinical study published in 2014 that included more than 90 sites throughout the US and Canada, Cologuard’s stool DNA technology was evaluated in 10,000 participants:
- Evaluated Cologuard for detecting colorectal cancer and precancer
- One of the largest colorectal cancer studies ever conducted
Compared Cologuard to a leading fecal immunochemical test (FIT)*
- Prospective cross-sectional study
*OC FIT-CHEK, Polymedco, Inc.
Visit the New England Journal of Medicine website and search "stool DNA" to view the clinical study.
Exact Sciences and Cologuard are not affiliated with the New England Journal of Medicine.
Clinically proven sensitivity in a noninvasive colorectal cancer screening test1
- 92% sensitivity in detecting cancer stages I-IV (compared to ~74% for FIT)
- 94% sensitive in detecting early-stage colorectal cancer (stage I-II)
- 87% specificity compared to 95% for a leading fecal immunochemical test (FIT)*
*OC FIT-CHEK, Polymedco, Inc.
Innovative multiple-marker stool DNA technology and how it works
Cologuard is the only screening test that uses multiple-marker, stool DNA (sDNA) technology to detect colorectal cancer and precancer.
- Eleven distinct biomarkers
- DNA methylation and mutation biomarkers are incorporated that are associated with cancer and precancer
- Cellular exfoliation of DNA into stool occurs continuously
Cologuard is intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. Cologuard is for use with the Cologuard collection kit and the following instruments: BioTek ELx808 Absorbance Microplate Reader; Applied Biosystems® 7500 Fast Dx Real-Time PCR; Hamilton Microlab® STARlet; and the Exact Sciences System Software with Cologuard Test Definition.
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, 50 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 intended for use with patients, age 50 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 relevant familial (hereditary) cancer syndrome, such as Hereditary non-polyposis colorectal cancer syndrome (HNPCCC 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, Familial Hyperplastic Polyposis.
- 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
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.
- 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 Kits 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.