Cologuard Plus™ result report references

Important Information about Cologuard Plus

Intended Use and Indications for Use

The Cologuard Plus™ test is a qualitative in vitro diagnostic test intended for the detection of colorectal neoplasia-associated DNA markers and for the presence of occult hemoglobin in human stool. The Cologuard Plus test is performed on samples collected using the Cologuard Plus Collection Kit. A positive result may indicate the presence of colorectal cancer (CRC) or advanced precancerous lesions (APL) and should be followed by colonoscopy. The Cologuard Plus test is indicated to screen adults 45 years or older, who are at average risk for CRC. The Cologuard Plus test is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.

The Cologuard Plus test is performed at Exact Sciences, Madison, WI.

Contraindications

The Cologuard Plus test is not indicated for use in patients who have the following:

• A personal history of CRC or APLs.
• A positive result from another CRC screening method within the last 6 months, or:
• 12 months for a fecal occult blood test (FOBT) or a fecal immunochemical test (FIT)
• 36 months for a FIT-DNA test
• A family history of CRC, defined as having a first degree relative (parent, sibling, or child) with a CRC diagnosis at any age.
• Personal history of any of the following high-risk conditions for CRC:
• A diagnosis of Inflammatory Bowel Disease (Chronic Ulcerative Colitis, Crohn’s Disease).
• A diagnosis of a relevant familial (hereditary) cancer syndrome or other polyposis syndrome, including but not limited to: Familial adenomatous polyposis (FAP or Gardner’s), Hereditary non-polyposis colorectal cancer syndrome (HNPCC or Lynch), Peutz-Jeghers, MYH-Associated Polyposis (MAP), Turcot’s (or Crail’s), Cowden’s, Juvenile Polyposis, Cronkhite-Canada, Neurofibromatosis, or Serrated Polyposis.

Warnings and Precautions

• Patients should not provide a sample if they are experiencing diarrhea or have known blood in their urine or stool (e.g., from bleeding hemorrhoids, bleeding cuts or wounds on their hands, rectal bleeding, or menstrual bleeding). Unexpected bleeding should be discussed with your healthcare provider.
• Reference national guidelines for the recommended screening ages for colorectal cancer.4 The decision to screen persons over the age of 75 should be made on an individualized basis in consultation with your healthcare provider. Cologuard Plus test results should be interpreted with caution in older patients as the rate of false positive results increases with age.
• The Cologuard Plus test may produce false negative or false positive results. A false positive result occurs when the Cologuard Plus test produces a positive result, even though a colonoscopy will not find CRC or APL. A false negative result occurs when the Cologuard Plus test does not detect an APL or CRC even when a colonoscopy identifies either of these findings.
• Out of every 100 patients testing positive, approximately 3 patients will have CRC, 34 patients will have APL, 33 will have a nonadvanced adenoma, and 30 will have no neoplastic findings.
• Out of every 10,000 patients testing negative, approximately 2 will be falsely assured that they do not have CRC. Out of every 100 patients testing negative, approximately 7 patients will be falsely assured that they do not have APL.
• A negative Cologuard Plus test result does not guarantee the absence of CRC or APL. Patients with a negative Cologuard Plus test result should continue participating in colorectal cancer screening programs, at the appropriate guideline recommended intervals.
• The performance of the Cologuard Plus test has been established in a cross-sectional study (i.e., single point in time). Programmatic performance of the Cologuard Plus test (i.e., benefits and risks with repeated testing over an established period of time) has not been studied. Non-inferiority or superiority of the Cologuard Plus test’s programmatic sensitivity as compared to other recommended screening methods for CRC and APL has not been established.
• To ensure the integrity of the sample, the laboratory must receive the patient specimens within 144 hours of collection. Patients should send stool samples to the laboratory according to the instructions included in the Cologuard Plus Collection Kit.
• Patients should be advised of the caution listed in the Cologuard Plus Collection Kit instructions. Patients should NOT drink the preservative liquid.
• The risks related to using the Cologuard Plus 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. Fecal samples should be treated as if they are potentially infectious.

Rx only.