Cologuard Pros and Cons

Find out if the at-home screening test for colon cancer is right for you

Cologuard is a non-invasive test for colon cancer that 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.

Cologuard is not a replacement for colonoscopy—the preferred method of screening—but may be appropriate for people who might otherwise avoid colon cancer screening. Cologuard is also less costly than a colonoscopy and may be fully covered by insurance.

Despite its convenience and ease of use, Cologuard may not detect early-stage precancerous growths. Because of this, the Food and Drug Administration (FDA) has approved its use for adults 45 and over who are at average risk of colon cancer. Cologuard should not be used in those at high risk; colonoscopy remains the preferred choice.

This article will describe the purpose of the Cologuard test, who is a good candidate for testing, and some of the benefits and drawbacks of its use. It will also walk you through how to use this simple at-home test and what the test results mean.

What to Know About Cologuard Tests - Illustration by Michela Buttignol

Verywell / Michela Buttignol

Purpose of a 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 detect colon 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 key sign of colon cancer—as well as 10 different gene mutations associated with colon cancer (including NDRG4BMP3, and KRAS mutations).

Cologuard is able to do so because the lining of the colon (large intestine) is shed several times a day, along with cells from precancerous polyps and cancerous tumors. 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

The gold standard of colon cancer screening is colonoscopy, a procedure typically performed under mild sedation by a gastroenterologist. It involves the insertion of a flexible scope, called a colonoscope, into the anus and rectum to directly check the colon for any signs of cancer.

Should I Use Cologuard? 

Cologuard is approved for use in adults 45 and over who are at average risk of colon cancer. A person at average risk has about a 4% chance of developing colon cancer.

The vast majority of colon cancers are sporadic, meaning that the genetic causes of cancer happen by chance after a person is born. By contrast, 5% of colon cancers are inherited, meaning that the cancer-related genetic mutations are passed from one generation to the next.

Having genetic mutations for cancer doesn’t mean you will get cancer but greatly increases 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 who do not have:

Choosing Colonoscopy 

For some people, a colonoscopy is a far better option than Cologuard. Clearly, those 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:

  • A change in bowel habits (meaning a change in the frequency, consistency, or color of stools or the ability to control bowel movements)
  • Blood in or on your stool
  • Diarrhea or constipation (including fluctuating bouts of diarrhea or constipation)
  • Feeling that your bowel isn't empty even after a bowel movement
  • Abdominal cramps, pain, or aches that won't go away
  • Unexplained weight loss

Cologuard vs. Colonoscopy

There are pros and cons to both Cologuard and 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 or anesthesia involved. 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 undergo bowel preparation a 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. The removal of polyps is 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:

  • Colonoscopy is recommended every 10 years starting from the age of 45.
  • Cologuard is recommended every one to three years starting from the age of 45.

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.

In terms of specificity (meaning the ability to correctly identify people without cancer), the Cologuard test is up to 87% accurate in detecting colon cancer (not precancerous polyps).

In terms of sensitivity (meaning the ability to correctly identify people with cancer), Cologuard is 92% accurate.

Accuracy of Colonoscopy

Because colonoscopy directly visualizes the colon, it can detect both cancerous tumors and precancerous polyps.

In terms of specificity, colonoscopy is up to 95% accurate when performed every 10 years. In terms of sensitivity, the test is up to 95% accurate.

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 (including flat polyps).

Cost and Insurance Coverage

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.

Even so, your actual out-of-pocket costs (meaning the amount not covered by insurance) may be the same. This is because both screening tests fall under the list of Essential Health Benefits (EHBs) prescribed by the Affordable Care Act (ACA).

EHBs are specific tests and procedures that under provisions of the ACA must be covered by health insurers in the United States, including Medicare, Medicaid, and private insurance.

This doesn’t mean that there will be no out-of-pocket expenses for provider visits and other care-related costs. But studies have shown that the average out-of-pocket costs for colonoscopy are only around $79.

Pros & Cons of Cologuard
  • 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 but not precancerous 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

  • Cost may be fully or near fully covered by insurance

Pros & Cons of Colonoscopy
  • Performed in a procedure room by a gastroenterologist

  • Involves bowel preparation and sedation

  • A high rate of accuracy in detecting cancerous tumors and precancerous 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

  • Cost may be fully or near fully covered by insurance

How to Use Cologuard

You will need a prescription from your healthcare provider to get a Cologuard kit. The kit with then 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 it, 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:

  • You should complete the test before the expiration date on the kit.
  • Try not to get urine on the sample. Empty your bladder before having a bowel movement.
  • Collect the sample when you know you can return it within one day.

To collect a stool sample: 

  1. Remove the large collection container and remove the lid.
  2. Place the container on the toilet bracket according to the instructions.
  3. Sit on the toilet and have a bowel movement into the container.
  4. Remove the container and place it on a counter.
  5. Next, take the enclosed sample tube and unscrew the lid. The lid has a long, stem-like probe with grooves.
  6. Scrape the surface of the stool with the probe until it covers the grooves.
  7. Put the probe back into the sample tube and screw the lid tightly.
  8. Next, open the bottle of the preservative and pour the entire contents into the collection container.
  9. Replace the lid of the collection container, screwing it tightly.
  10. Place both the collection container and sample tube into the return shipping box.
  11. Follow the instructions for packing and shipping the sample.
  12. Drop the box off at a UPS location, or call 844-870-8870 and ask the manufacturer to schedule a UPS pickup for you.

To see how a sample is collected, go to the Cologuard website for a step-by-step video guide.

Interpreting the 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 negative test means that no signs of blood or cancer-associated gene mutation were found in the sample.
  • A positive test means that Cologuard detected blood and gene mutations suggestive of cancer, indicating the need for further investigation with a colonoscopy.

A negative or positive result does not mean that the results are 100% accurate.

False-negative results (meaning that you have cancer even if the test suggests otherwise) may occur if the test is not performed properly.

False-positive results (meaning that you don’t have cancer even if the test suggests otherwise) may be due to the limitations of the test or because you have other causes of rectal bleeding. This is why a colonoscopy is needed to confirm a positive result.

False Positives and Negatives

A 2014 study in the New England Journal of Medicine reported that 13% of Cologuard results were false positives while 8% were false negatives.

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 Questions

  • Is Cologuard worth the effort?

    For some people, Cologuard is the best option for them. But Cologuard comes with some limitations when compared to traditional colonoscopy screenings. Talk to your healthcare provider about whether Cologuard is the best option for you or whether you should opt for a colonoscopy.

  • What are other alternatives to colonoscopy?

    There are other screening methods that can test for colon cancer and precancerous polyps:

15 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Cologuard. FAQs.

  2. National Cancer Institute. Screening tests to detect colorectal cancer and polyps.

  3. American Cancer Society. Key statistics for colorectal cancer.

  4. 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.

  5. 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
  6. Centers for Medicare and Medicaid Services. Screening of colorectal cancer - stool DNA testing.

  7. American Society of Clinical Oncologists. Colorectal cancer: risk factors and prevention.

  8. 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

  9. American Cancer Society. Do I have colorectal cancer? signs, symptoms and work-up.

  10. lmperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screeningN Engl J Med. 2014;370(14):1287-97. doi:10.1056/NEJMoa1311194

  11. 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

  12. 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

  13. 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 Mar;38(3):427-34. doi:10.1080/03007995.2021.2015157

  14. Centers for Medicare and Medicaid Services. Information on essential health benefits (EHB) benchmark plans.

  15. Cologuard. About colon cancer screening results with Cologuard.

By Lana Barhum
Lana Barhum has been a freelance medical writer since 2009. She shares advice on living well with chronic disease.