Table of ContentsView AllTable of ContentsPurposeWhen to UseHow it WorksInterpreting ResultsCostPros and ConsCologuard vs. ColonoscopyFrequently Asked Questions
Table of ContentsView All
View All
Table of Contents
Purpose
When to Use
How it Works
Interpreting Results
Cost
Pros and Cons
Cologuard vs. Colonoscopy
Frequently Asked Questions
Cologuardis a non-invasive test forcolon cancerthat you can perform in the comfort of your own home. It checks for evidence of cancer in a small sample of stool (poop) that you mail to a lab.
This article describes the Cologuard test, how it works, how to interpret results, how much it costs, and the pros and cons of the Cologuard test.
Verywell / Michela Buttignol
What Is the Cologuard Test?
Cologuard is one of six approved methods for colon cancer screening in the United States, including one of three stool-based tests.It is used to detectcolon cancer, also known as colorectal cancer, which is the third most common cause of cancer deaths in the United States.
Fortunately, with routine screening starting from age 45, the risk of colon cancer and colon cancer deaths can be greatly reduced.
Cologuard has gained popularity since its approval in 2014. The FDA approval was granted in part to improve rates of colon cancer screening, which, prior to Cologuard’s release, stood at 65%.By 2019, the rate increased to nearly 70%, with Cologuard accounting for 14% of all screening methods.
The Cologuard test is able to detect blood in a sample of stool—a keysign of colon cancer—as well as 10 differentgene mutationsassociated with colon cancer (including NDRG4, BMP3, and KRAS mutations).
Cologuard is able to do so because the lining of thecolon(large intestine) is shed several times a day, along with cells from precancerouspolypsand canceroustumors. These cells end up in the stool along with traces of blood from bleeding tumors.
While Cologuard is not the preferred method for colon cancer screening, it remains a highly important and accurate tool for detecting cancer in people at average risk.
Gold Standard Screening Method
How to Prepare for a Colonoscopy and Bowel Cleanout
Who Should Use the Cologuard Test?
Despite its convenience and ease of use, Cologuard may not detect early-stageprecancerousgrowths. Because of this, the Food and Drug Administration (FDA) has approved its use for adults 45 and over who are ataveragerisk of colon cancer. A person at average risk has about a 4% chance of developing colon cancer.
Cologuard should not be used in people at high risk for colon cancer; colonoscopy remains the preferred choice.
Having genetic mutations for cancer doesn’t mean you will get cancer but it does greatly increase your risk.
Choosing Cologuard
Cologuard is approved for use in people at average risk of colon cancer. The U.S. Preventive Services Task Force (USPSTF) defines this as adults 45 and over whodo nothave:
Choosing Colonoscopy
For some people, a colonoscopy is a far better option than Cologuard. People who have a personal or family history of colon cancer or colon polyps, a known genetic disorder linked to colon cancer, or inflammatory bowel disease are at high risk and should get a colonoscopy.
A colonoscopy might also be recommended for people who have signs and symptoms of colon cancer, including:
Colon Cancer Symptoms
How Does the Cologuard Test Work?
You will need a prescription from your healthcare provider to get a Cologuard kit. The kit will be shipped directly to your home and includes a larger collection container, a smaller specimen tube, a bottle of preserving liquid, labels, and instructions.
If you have any questions about how to use the kit, you can speak with your healthcare provider or call Cologuard Customer Care at 1-844-870-8870.
There are a few things you should know before performing the test:
To collect a stool sample:
Interpreting Cologuard Test Results
After the lab gets your sample, they will evaluate it and send the results directly to your healthcare provider within two weeks. Test results will either be negative or positive.
A positive result does not mean you have cancer. A colonoscopy is needed to confirm a positive result because it could be afalse-positive result(meaning that you don’t have cancer even if the test suggests otherwise). False positive results may be due to the limitations of the test or because there is anothercause of rectal bleeding.
It is also possible to get afalse-negative result(meaning that you have cancer even if the test suggests otherwise). This may occur if the test is not performed properly.
False Positives and NegativesA 2014 study in theNew England Journal of Medicinereported that 13% of Cologuard results were false positives while 8% were false negatives.
False Positives and Negatives
A 2014 study in theNew England Journal of Medicinereported that 13% of Cologuard results were false positives while 8% were false negatives.
How Much Does it Cost?
On paper, there is an enormous difference in the cost of Cologuard versus the cost of colonoscopy. In the United States, the Cologuard kit is roughly $500, while the average cost of a colonoscopy is around $2,125.
This doesn’t mean that there will benoout-of-pocket expenses for provider visits and other care-related costs. But studies have shown that the average out-of-pocket costs for a colonoscopy are around $79.
Cologuard Pros and Cons
There are pros and cons to both Cologuard and colonoscopy.
Can be performed in the privacy of your own home
Involves a stool sample that is shipped to a lab
A high rate of accuracy in detecting cancerous tumors butnotprecancerous polyps
Recommended for adults at average risk of colon cancer
Recommended every one to three years starting from age 45
Would require a colonoscopy if a positive result is returned
Costs around $500
Involves bowel preparation and sedation
A high rate of accuracy in detecting cancerous tumorsandprecancerous polyps
Considered the gold standard for all risk categories
Recommended every 10 years starting from age 45
Can remove polyps during the procedure to reduce the cancer risk
Average cost of $2,125
Cologuard Test vs Colonoscopy
The main difference is that Cologuard is non-invasive. Cologuard involves collecting a stool sample in the privacy of your home and mailing it to a lab. There is no sedation oranesthesiainvolved. With that said, if a positive result is returned, a colonoscopy would be needed.
By contrast, a colonoscopy is an outpatient procedure in which you need to undergobowel preparationa day before to remove all traces of stool. On the day of the procedure, you will be sedated, and the healthcare provider will examine your colon and remove any polyps they find. Theremoval of polypsis a preventive measure to reduce your risk of colon cancer.
Test Accuracy
Another difference is in the accuracy of the two tests. Of the two, colonoscopy is more accurate and needs to be performed less often as a result.
According to the USPSTF:
Accuracy of Cologuard
As an indirect method of testing, Cologuard doesn’t detect precancerous polyps well and is best suited for detecting larger, more advanced cancerous tumors.
Thespecificity(ability to correctly identify peoplewithoutcancer) of the Cologuard test is up to 87%.
The sensitivity (ability to correctly identify peoplewithcancer) of Cologuard is 92%.
Accuracy of Colonoscopy
Because colonoscopy directly visualizes the colon, it can detect both cancerous tumors and precancerous polyps.
Colonoscopy has up to 95% specificity and an average sensitivity of about 93%.
Limitations of ColonoscopyWhere colonoscopy can sometimes fall short is in finding polyps or smaller tumors on the right side of the colon. The right side is where the colon will bend and curve, often obscuring smaller growths (includingflat polyps).
Limitations of Colonoscopy
Where colonoscopy can sometimes fall short is in finding polyps or smaller tumors on the right side of the colon. The right side is where the colon will bend and curve, often obscuring smaller growths (includingflat polyps).
11 Possible Causes of Blood in Stools
Summary
Cologuard is a noninvasive screening tool for colon cancer and precancerous polyps. It looks for cancer-related genetic mutations and evidence of blood in the stool. The test is collected in the privacy of your own home. Once you have a sample ready, you send it to the lab for testing.
Cologuard has gained popularity because it’s less invasive and more convenient than going in for a diagnostic colonoscopy. It also comes with drawbacks, including concerns about accuracy and the need for more frequent testing.
A Word From Verywell
Both Cologuard and colonoscopy come with pros and cons. When it comes to the best option for you, it is important to understand the benefits and drawbacks of each screening method.
Reach out to your healthcare provider about any concerns you may have about Cologuard or colonoscopy, as well as your personal risks for colon cancer.
Frequently Asked QuestionsThere are other screening methods that can test for colon cancer and precancerous polyps:Cologuard: A stool sample test for blood and genetic markers for cancer)Fecal immunochemical testing: A stool sample test for bloodFecal occult blood testing: A stool sample test for bloodSigmoidoscopy: Uses a flexible scope to view the lower third section of the colonComputed tomography (CT) colonography: Advanced X-ray imaging technology
There are other screening methods that can test for colon cancer and precancerous polyps:Cologuard: A stool sample test for blood and genetic markers for cancer)Fecal immunochemical testing: A stool sample test for bloodFecal occult blood testing: A stool sample test for bloodSigmoidoscopy: Uses a flexible scope to view the lower third section of the colonComputed tomography (CT) colonography: Advanced X-ray imaging technology
There are other screening methods that can test for colon cancer and precancerous polyps:
15 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.National Cancer Institute.Screening tests to detect colorectal cancer and polyps.American Cancer Society.Key statistics for colorectal cancer.Centers for Disease Control and Prevention (CDC).Vital signs: colorectal cancer screening test use—United States, 2012.MMWR Morb Mortal Wkly Rep. 2013;62(44):881-888.Fisher DA, Princic N, Miller-Wilson LA.Utilization of a colorectal cancer screening test among individuals with average risk.JAMA Netw Open.2021;4(9):e2122269. doi:10.1001/jamanetworkopen.2021.22269Centers for Medicare and Medicaid Services.Screening of colorectal cancer—stool DNA testing.Cologuard.Cologuard frequently asked questions.American Society of Clinical Oncologists.Colorectal cancer: risk factors and prevention.US Preventive Services Task Force, Davidson KW, Barry MJ, et al.Screening for colorectal cancer: US Preventive Services Task Force recommendation statement.JAMA. 2021;325(19):1965-1977. doi:10.1001/jama.2021.6238American Cancer Society.Do I have colorectal cancer? Signs, symptoms and work-up.Cologuard.About colon cancer screening results with Cologuard.lmperiale TF, Ransohoff DF, Itzkowitz SH, et al.Multitarget stool DNA testing for colorectal-cancer screening.N Engl J Med. 2014;370(14):1287-97. doi:10.1056/NEJMoa1311194Fisher DA, Princic N, Miller-Wilson LA, Wilson K, Limburg P.Healthcare costs of colorectal cancer screening and events following colonoscopy among commercially insured average-risk adults in the United States.Curr Med Res Opin. 2022;38(3):427-34. doi:10.1080/03007995.2021.2015157Centers for Medicare and Medicaid Services.Information on essential health benefits (EHB) benchmark plans.Knudsen AB, Zauber AG, Rutter CM, et al.Estimation of benefits, burden, and harms of colorectal cancer screening strategies: modeling study for the US Preventive Services Task Force.JAMA. 2016;315(23):2595-2609. doi:10.1001/jama.2016.6828Clark BT, Parikh ND, Laine L.Yield of repeat forward-view examination of the right side of the colon in screening and surveillance colonoscopy.Gastrointest Endosc. 2016;84(1):126-132. doi:10.1016/j.gie.2015.12.030
15 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.National Cancer Institute.Screening tests to detect colorectal cancer and polyps.American Cancer Society.Key statistics for colorectal cancer.Centers for Disease Control and Prevention (CDC).Vital signs: colorectal cancer screening test use—United States, 2012.MMWR Morb Mortal Wkly Rep. 2013;62(44):881-888.Fisher DA, Princic N, Miller-Wilson LA.Utilization of a colorectal cancer screening test among individuals with average risk.JAMA Netw Open.2021;4(9):e2122269. doi:10.1001/jamanetworkopen.2021.22269Centers for Medicare and Medicaid Services.Screening of colorectal cancer—stool DNA testing.Cologuard.Cologuard frequently asked questions.American Society of Clinical Oncologists.Colorectal cancer: risk factors and prevention.US Preventive Services Task Force, Davidson KW, Barry MJ, et al.Screening for colorectal cancer: US Preventive Services Task Force recommendation statement.JAMA. 2021;325(19):1965-1977. doi:10.1001/jama.2021.6238American Cancer Society.Do I have colorectal cancer? Signs, symptoms and work-up.Cologuard.About colon cancer screening results with Cologuard.lmperiale TF, Ransohoff DF, Itzkowitz SH, et al.Multitarget stool DNA testing for colorectal-cancer screening.N Engl J Med. 2014;370(14):1287-97. doi:10.1056/NEJMoa1311194Fisher DA, Princic N, Miller-Wilson LA, Wilson K, Limburg P.Healthcare costs of colorectal cancer screening and events following colonoscopy among commercially insured average-risk adults in the United States.Curr Med Res Opin. 2022;38(3):427-34. doi:10.1080/03007995.2021.2015157Centers for Medicare and Medicaid Services.Information on essential health benefits (EHB) benchmark plans.Knudsen AB, Zauber AG, Rutter CM, et al.Estimation of benefits, burden, and harms of colorectal cancer screening strategies: modeling study for the US Preventive Services Task Force.JAMA. 2016;315(23):2595-2609. doi:10.1001/jama.2016.6828Clark BT, Parikh ND, Laine L.Yield of repeat forward-view examination of the right side of the colon in screening and surveillance colonoscopy.Gastrointest Endosc. 2016;84(1):126-132. doi:10.1016/j.gie.2015.12.030
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
National Cancer Institute.Screening tests to detect colorectal cancer and polyps.American Cancer Society.Key statistics for colorectal cancer.Centers for Disease Control and Prevention (CDC).Vital signs: colorectal cancer screening test use—United States, 2012.MMWR Morb Mortal Wkly Rep. 2013;62(44):881-888.Fisher DA, Princic N, Miller-Wilson LA.Utilization of a colorectal cancer screening test among individuals with average risk.JAMA Netw Open.2021;4(9):e2122269. doi:10.1001/jamanetworkopen.2021.22269Centers for Medicare and Medicaid Services.Screening of colorectal cancer—stool DNA testing.Cologuard.Cologuard frequently asked questions.American Society of Clinical Oncologists.Colorectal cancer: risk factors and prevention.US Preventive Services Task Force, Davidson KW, Barry MJ, et al.Screening for colorectal cancer: US Preventive Services Task Force recommendation statement.JAMA. 2021;325(19):1965-1977. doi:10.1001/jama.2021.6238American Cancer Society.Do I have colorectal cancer? Signs, symptoms and work-up.Cologuard.About colon cancer screening results with Cologuard.lmperiale TF, Ransohoff DF, Itzkowitz SH, et al.Multitarget stool DNA testing for colorectal-cancer screening.N Engl J Med. 2014;370(14):1287-97. doi:10.1056/NEJMoa1311194Fisher DA, Princic N, Miller-Wilson LA, Wilson K, Limburg P.Healthcare costs of colorectal cancer screening and events following colonoscopy among commercially insured average-risk adults in the United States.Curr Med Res Opin. 2022;38(3):427-34. doi:10.1080/03007995.2021.2015157Centers for Medicare and Medicaid Services.Information on essential health benefits (EHB) benchmark plans.Knudsen AB, Zauber AG, Rutter CM, et al.Estimation of benefits, burden, and harms of colorectal cancer screening strategies: modeling study for the US Preventive Services Task Force.JAMA. 2016;315(23):2595-2609. doi:10.1001/jama.2016.6828Clark BT, Parikh ND, Laine L.Yield of repeat forward-view examination of the right side of the colon in screening and surveillance colonoscopy.Gastrointest Endosc. 2016;84(1):126-132. doi:10.1016/j.gie.2015.12.030
National Cancer Institute.Screening tests to detect colorectal cancer and polyps.
American Cancer Society.Key statistics for colorectal cancer.
Centers for Disease Control and Prevention (CDC).Vital signs: colorectal cancer screening test use—United States, 2012.MMWR Morb Mortal Wkly Rep. 2013;62(44):881-888.
Fisher DA, Princic N, Miller-Wilson LA.Utilization of a colorectal cancer screening test among individuals with average risk.JAMA Netw Open.2021;4(9):e2122269. doi:10.1001/jamanetworkopen.2021.22269
Centers for Medicare and Medicaid Services.Screening of colorectal cancer—stool DNA testing.
Cologuard.Cologuard frequently asked questions.
American Society of Clinical Oncologists.Colorectal cancer: risk factors and prevention.
US Preventive Services Task Force, Davidson KW, Barry MJ, et al.Screening for colorectal cancer: US Preventive Services Task Force recommendation statement.JAMA. 2021;325(19):1965-1977. doi:10.1001/jama.2021.6238
American Cancer Society.Do I have colorectal cancer? Signs, symptoms and work-up.
Cologuard.About colon cancer screening results with Cologuard.
lmperiale TF, Ransohoff DF, Itzkowitz SH, et al.Multitarget stool DNA testing for colorectal-cancer screening.N Engl J Med. 2014;370(14):1287-97. doi:10.1056/NEJMoa1311194
Fisher DA, Princic N, Miller-Wilson LA, Wilson K, Limburg P.Healthcare costs of colorectal cancer screening and events following colonoscopy among commercially insured average-risk adults in the United States.Curr Med Res Opin. 2022;38(3):427-34. doi:10.1080/03007995.2021.2015157
Centers for Medicare and Medicaid Services.Information on essential health benefits (EHB) benchmark plans.
Knudsen AB, Zauber AG, Rutter CM, et al.Estimation of benefits, burden, and harms of colorectal cancer screening strategies: modeling study for the US Preventive Services Task Force.JAMA. 2016;315(23):2595-2609. doi:10.1001/jama.2016.6828
Clark BT, Parikh ND, Laine L.Yield of repeat forward-view examination of the right side of the colon in screening and surveillance colonoscopy.Gastrointest Endosc. 2016;84(1):126-132. doi:10.1016/j.gie.2015.12.030
Meet Our Medical Expert Board
Share Feedback
Was this page helpful?Thanks for your feedback!What is your feedback?OtherHelpfulReport an ErrorSubmit
Was this page helpful?
Thanks for your feedback!
What is your feedback?OtherHelpfulReport an ErrorSubmit
What is your feedback?
