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Important Risk Information

  • Cologuard Plus
  • SimpleScreen CRC

Indications for use

Cologuard® and Cologuard Plus® are FDA-approved tests 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)/advanced precancerous lesions (APL) and should be followed by a colonoscopy. The Cologuard and Cologuard Plus tests are indicated to screen adults of either sex, 45 years or older, who are at average risk for CRC. These tests are not a replacement for a diagnostic or surveillance colonoscopy in high-risk individuals.

Do not use Cologuard products if you have:

  • Had adenomas, which are a type of colon polyp that can sometimes become cancer
  • inflammatory bowel disease (IBD) or other hereditary syndromes
  • a personal or first-degree family history of colorectal cancer
  • or a positive result from another colon cancer screening method within that test's recommended screening interval

Talk to your healthcare provider if any of these situations apply to you.


Cologuard results should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for a colonoscopy.


A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their healthcare provider when they need to be tested again.


False positives and false negatives can occur. It is important to talk to your doctor about your test results.


Do not provide a sample if you have diarrhea or have blood in your urine or stool.


The risks related to using the Cologuard collection kit are low, with no serious adverse events reported among people in a clinical trial. You should be careful when opening and closing the lids to avoid the risk of hand strain.


Please read the Instructions for Use and talk to your healthcare provider to see if a Cologuard test is right for you. This product is available by prescription only.


Refer to the Cologuard Patient Brochure or the Cologuard Plus Patient Brochure for additional information about the benefits and risk of using each version of the Cologuard product for CRC screening.

Indications for use

The SimpleScreen™ CRC test is a qualitative, in vitro diagnostic test intended to detect molecular signals associated with colorectal cancer. SimpleScreen CRC utilizes circulating cell-free DNA from plasma of peripheral whole blood collected in the SimpleScreen CRC blood collection kit.


SimpleScreen CRC is FDA-approved and indicated for colorectal cancer screening in adults aged 45 years and older who are at average risk for the disease. Patients with a positive result should be followed by colonoscopy. SimpleScreen CRC is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals.

Precaution

Based on data from clinical studies, SimpleScreen CRC has limited detection of Stage I (57%) colorectal cancer (64% when U.S. 2020 Census age-sex adjusted) and does not detect 87% of advanced precancerous lesions (86% when U.S. 2020 Census age-sex adjusted). One out of 10 patients with a negative SimpleScreen CRC result may have a precancer that would have been detected by a screening colonoscopy.

Contraindications and Limitations

The SimpleScreen CRC test is not indicated for patients who have the following:


  • A personal history of colorectal cancer (CRC), advanced precancerous lesions (APL), or other related cancers
  • Family history of CRC, defined as having one or more first-degree relatives (parent, sibling, or child) diagnosed with CRC at any age
  • Positive result on another CRC screening method within the last six months, or:
    • A fecal occult blood test (FOBT) or a fecal immunochemical test (FIT) within the last 12 months
    • A FIT-DNA test within the last 36 months
  • Personal history of any of the following high-risk conditions for CRC:
    • Inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and Crohn’s disease
    • Relevant hereditary cancer syndromes including but not limited to: hereditary non-polyposis colorectal cancer syndrome (HNPCC) or Lynch syndrome, familial adenomatous polyposis (FAP or Gardner’s), Familial Hyperplastic Polyposis, Peutz-Jeghers syndrome, MUTYH-associated polyposis (MAP), Cowden’s syndrome, Juvenile polyposis syndrome, serrated polyposis syndrome, Turcot’s/Crail’s syndrome, Cronkhite-Canada syndrome, or Neurofibromatosis

Providers should discuss the most appropriate screening test to use with patients depending on their medical history and individual circumstances. SimpleScreen CRC may produce a false negative or false positive result. A false negative result may occur when the SimpleScreen CRC test does not detect colorectal cancer or advanced precancerous lesions although a colonoscopy would identify either of these findings. A negative result does not guarantee the absence of colorectal cancer or advanced precancerous lesions, and patients should continue participating in colorectal cancer screening programs at the appropriate guideline-recommended intervals. A false positive result may occur when the SimpleScreen CRC test generates a positive result while a colonoscopy will not find colorectal cancer or advanced precancerous lesions.


Refer to the SimpleScreen CRC Patient Information Sheet and SimpleScreen CRC Patient Brochure for additional information about the benefits and risks of using the SimpleScreen CRC test.


Rx only. IVD.


Developed and manufactured by Freenome, LLC. Distributed by Abbott.