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Medical Devices

Cologuard - P130017

Image of the device.

This is a brief overview of information related to FDA’s approval to market this product.  See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Cologuard
PMA Applicant:  Exact Sciences Corporation
Address: 441 Charmany Drive, Madison, WI  53719
Approval Date: August 11, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130017a.pdf

What is it?  Cologuard is a laboratory test that measures DNA and blood in human stool that is not visibly apparent (occult hemoglobin). This test is for adults of either sex, 50 years or older, who are average-risk candidates for colorectal cancer screening.

How does it work? 

  • Patients are not required to undergo bowel prep or follow dietary or medication restrictions in order to complete the test.  The collection kit will either be mailed to patients directly at home or given to patients by their health care providers.
  • Patients follow the detailed instructions in the Cologuard Patient Guide received with the collection kit. The kit consists of a container for collection of stool for DNA testing and a separate sampler for collection of stool for hemoglobin testing (only one stool sample is required).  Both of these samples are required to obtain a Cologuard result. 
  • Each patient collects a stool sample at home and sends the sample to a qualified laboratory for processing and testing.
  • Every day, millions of cells are shed from the colon wall into the stool stream.  Over time, these cells release DNA.  Some of these cells may contain changes in their DNA, reflecting mutations found in advanced adenomas and cancer.  Advanced adenomas, if left untreated, may develop into cancer.
  • In the laboratory, patients’ stools are analyzed for the presence of 11 molecular markers, including hemoglobin and DNA markers, which may indicate the presence of colorectal cancer or advanced adenomas. Based on combined results of all the selected DNA markers and hemoglobin, a single qualitative Cologuard result, positive or negative, is determined. 
  • Cologuard results are sent to health care providers.  Patients with positive results are advised to undergo a diagnostic colonoscopy.  Negative Cologuard test results do not guarantee absence of cancer or advanced adenoma.  Health care providers should advise patients with a negative Cologuard test result to continue participating in a colorectal cancer screening program. 

When is it used?  Cologuard is for adults of either sex, 50 years or older, who are average-risk candidates for colorectal cancer screening. 

What will it accomplish?  Cologuard helps to determine if a patient may have colorectal cancer or advanced adenomas.

When should it not be used?  Cologuard should not be used to screen patients who are under 50 years of age or at higher risk for colorectal cancer.  Patients at higher risk for colorectal cancer include the following:

  • 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 places them at higher risk for colorectal cancer.
  • Patients who have been diagnosed with a relevant cancer syndrome passed on from their family (hereditary).

Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.

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Page Last Updated: 01/11/2016
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