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FDA Approval: Multi-target stool DNA test (Cologuard) for Colorectal Cancer
FDA approved Multi-target stool DNA test (Cologuard), a noninvasive screening test, for certain people with colorectal cancer. What was approved, the evidence, and what it does and doesn't mean.
Original commentary from the Cancer Explained editorial team.
Historical context: this page explains an event dated 2014. It was published as an explainer on July 12, 2026 and is not breaking news.
Please note: this page is educational only — it is not medical advice, and it does not speculate about anyone’s health beyond reliable public reporting. For questions about your own health, talk with your healthcare team.
A screening test, not a treatment
The FDA approved Cologuard on August 11, 2014. It is a device, not a drug, cleared under premarket approval P130017 to Exact Sciences of Madison, Wisconsin. The FDA granted it priority review in June 2013 as a first-of-a-kind device, and an advisory panel reviewed it in March 2014.
The approved use is narrow and worth reading twice. Cologuard screens adults aged 50 and over who are at typical average risk of colorectal cancer. A positive result may mean colorectal cancer or an advanced adenoma, a large or high-risk polyp, and it must be followed by a diagnostic colonoscopy. The FDA states in the same paragraph that Cologuard does not replace diagnostic colonoscopy, nor surveillance colonoscopy in people at high risk.
What it looks for
Colorectal cancer usually grows from a polyp over years, and cells shed from that polyp or tumor pass into the stool. Cologuard collects a whole bowel movement at home in a kit that is mailed to a lab.
The lab runs two kinds of test on it. One looks for DNA changes: methylation of the NDRG4 and BMP3 genes, meaning chemical tags that switch genes off, and mutations in KRAS. The other looks for hidden blood, using an antibody test for hemoglobin. An algorithm combines them into one positive or negative result.
The trial, and the trade it makes
The pivotal study, called DeeP-C, enrolled 12,766 people at 90 sites. After exclusions, mostly people who never had the colonoscopy, 10,023 were analyzed. Their average age was 64. Every participant had the stool test and then a colonoscopy, so the colonoscopy result acted as the truth against which the test was scored. Sixty-five had colorectal cancer.
Cologuard found 60 of those 65 cancers. That is a sensitivity of 92.3%. For advanced adenomas it found 322 of 760, a sensitivity of 42.4%. Among people with neither, it correctly returned negative 86.6% of the time.
A subgroup of 9,989 people also did a standard fecal immunochemical test, or FIT, which looks only for blood. Cologuard beat FIT on finding cancers, 92.3% against 73.8%, and on finding advanced adenomas, 42.4% against 23.8%. Both gaps were statistically significant.
The cost of that sensitivity is on the other side of the ledger. Specificity was 86.6% for Cologuard against 94.9% for FIT. In plain terms, about 13 in 100 people without cancer or an advanced adenoma got a positive Cologuard result and were sent for a colonoscopy they did not need. Our page on stool tests for colorectal cancer compares the options.
Where the guidelines put it now
The USPSTF issued its current colorectal screening recommendation in May 2021, after this approval. It recommends screening all adults aged 50 to 75, a grade A, and screening adults aged 45 to 49, a grade B. For adults 76 to 85 it advises a selective offer.
The USPSTF calls this test sDNA-FIT and lists it as one acceptable strategy among several. Its modeling found that annual FIT or annual sDNA-FIT gains more life-years than sDNA-FIT every three years, and that annual sDNA-FIT leads to more colonoscopies than annual FIT. Whatever the stool test, an abnormal result requires a colonoscopy to make sense of it. Our guide to colorectal cancer screening walks through the choices.
Why screening this cancer works so well
Colorectal cancer is unusual: screening can prevent it, not just find it early, because a polyp removed during a colonoscopy never becomes a cancer.
The stage numbers show what timing buys. The American Cancer Society projects 158,850 new US cases and 55,230 deaths in 2026, a figure SEER carries. Five-year relative survival is 91.3% when the cancer is still confined to the bowel wall, 75.2% once it has reached nearby lymph nodes, and 16.9% once it has spread further. Only 34% are found while still confined. Those are group averages from people diagnosed between 2016 and 2022, not predictions for anyone.
When to get checked
Screening exists because early colorectal cancer usually causes nothing. Do not wait for symptoms. But take these to a doctor at any age:
- Blood in the stool, or stools that look black or tarry
- A change in bowel habit lasting more than three weeks
- Stools that have become narrow and stay that way
- Belly pain or cramping that does not settle
- Weight loss you cannot explain
- Fatigue, or a blood test showing iron-deficiency anemia with no clear cause
Rectal bleeding blamed on hemorrhoids is worth a second look, particularly under 50, where rates have been rising. Our list of colorectal cancer symptoms has more.
What this does not mean
- Cologuard is a screening test. It cannot diagnose anything. A positive result means a colonoscopy is needed.
- A negative result is not a clean bill of health. The test missed 5 of 65 cancers in the trial and more than half of advanced adenomas.
- The FDA approved it for average-risk adults aged 50 and over. It was not evaluated in people with a personal history of colorectal cancer or other high-risk conditions.
- Higher sensitivity than FIT came with lower specificity. More cancers found, and more false alarms.
- The 2014 approval has been supplemented many times since. Labeling and intended use can change.
Sources
- FDA, Summary of Safety and Effectiveness Data, PMA P130017 (Cologuard) — https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130017B.pdf
- FDA openFDA device PMA API record for P130017 — https://api.fda.gov/device/pma.json?search=pma_number:%22P130017%22&limit=5
- U.S. Preventive Services Task Force, Colorectal Cancer: Screening (18 May 2021) — https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/colorectal-cancer-screening
- SEER Cancer Stat Facts, Colorectal Cancer — https://seer.cancer.gov/statfacts/html/colorect.html
How this article was prepared
An AI-assisted editorial system helped prepare this page. No named medical reviewer has reviewed it unless one is listed.
The National Cancer Information Foundation publishes Cancer Explained. This page is for learning. It is not medical advice and does not suggest a test or treatment.
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Put the story in context
Prevention, possible warning signs, screening, and diagnosis
This story relates to Colorectal cancer. The information below is general: it does not reveal anything else about a public person’s health, and not every point applies to every cancer. Personal advice depends on age, symptoms, family history, exposures, and medical history.
Prevention and risk reduction
Not every cancer can be prevented. Avoiding tobacco, protecting skin from ultraviolet radiation, limiting alcohol, staying active, and receiving recommended HPV or hepatitis B vaccination can lower the risk of certain cancers. A risk factor is not a prediction or a cause in one individual.
Symptoms and possible early signs
Possible signs vary and are often caused by conditions other than cancer. Changes worth discussing include a new lump, unexplained bleeding or weight loss, a persistent cough, lasting bowel or bladder changes, a changing skin spot, or symptoms that persist or worsen. Some early cancers cause no symptoms.
Screening and early detection
Screening looks for certain cancers before symptoms begin. Recommended tests exist only for some cancers and depend on age and risk. Screening can have benefits and harms; it is not the same as evaluating a new symptom, and there is no single routine scan or blood test that reliably screens for every cancer.
How cancer is diagnosed
Diagnosis may involve a history and exam, imaging, laboratory tests, and often a biopsy. Pathology can identify the cancer type and may test biomarkers that guide treatment. Symptoms, screening results, tumor markers, or online stories alone cannot confirm cancer.
Learn about this story’s cancer topic
A public story may encourage questions, but it should not be used to estimate your risk or choose testing. Contact a healthcare professional about a persistent or concerning change. Seek urgent care for severe or rapidly worsening symptoms.