About Cologuard Test

By HighYa Research Team
Published on: Oct 31, 2016

If you’re 50 years or older and are at average risk for colon cancer, the Cologuard Test is a prescription-only, noninvasive colon cancer screen that you can take in the comfort of your home.

On top of this, Exact Science Corporation tells us that Cologuard doesn’t require any preparation, diet changes, medications, or time off. It simply works over three easy steps: 1) Get, 2) Go, 3) Gone.

Once the company receives your kit, we’re told their screening technology can help identify abnormal cells in the colon, making it potentially effective for precancer and cancer (more about this soon).

Colon cancer is a serious issue, and you’re looking to take some initiative by getting screened in advance. But is the Cologuard Test necessarily your best option? This is but one of the many important questions we’ll help answer in this review.

How Does Cologuard’s DNA Screening Work?

The Cologuard Test has been approved by the FDA since 2014 and can be prescribed by any licensed healthcare provider.

To help screen for colon cancer, we’re told that Cologuard works using “advanced DNA technology,” which identifies abnormal (precancerous or cancerous) cells in the lining of your colon, through your stool.

This way, colon cancer (or the potential for developing it) can be identified long before it enters the bloodstream and increases in severity.

Cologuard vs. Colonoscopy

How does this compare to a traditional colonoscopy? Whereas Cologuard detects abnormal cells via DNA screening, a colonoscopy involves inserting a thin flexible camera into your large intestine, looking for polyps, areas of bleeding, and so forth.

In other words, Cologuard is a DNA screen, compared to the visual inspection provided by a colonoscopy.

Important note: Compared to some of the other health screening kits like Counsyl, 23andMe, and Pathway Genomics, Cologuard is not a genetic test. Here’s how they word it in their FAQ:

“Cologuard does not provide information about DNA changes that are inherited or can be passed on to your children. Cologuard identifies DNA mutations that are acquired over time in cells lining the colon; these mutations can be associated with the presence of colon cancer or precancerous lesions.”

For more, Cologuard’s Patient Brochure and Doctor Discussion Guide are must-reads.

After you’ve discussed your risk level for colon cancer with your doctor (we’ll come back this thought again shortly), they’ll order the kit and have it shipped directly to your door.

Once received, you’ll open and unzip the plastic bag inside and pull out the contents. Don’t forget to keep the bag attached.

Then, the Cologuard collection process works over the following four steps:

Step 1: Sit

Raise the toilet lid and seat, place the included plastic bracket on the toilet rim, and then lower the seat onto the bracket. Next, you’ll unscrew the lid of the container and place the container into the hole in the bracket.

Finally, sit on the toilet and have a bowel movement into the container. Remove the container and place it on the counter.

Step 2: Scrape

Now, you’ll unscrew the cap on the small plastic tube and pull out the attached probe.

Next, scrape the surface of the stool sample until it lightly covers the end of the probe, and then place the probe back in the tube.

Step 3: Soak

Take the bottle of stool preservative and empty it into the container, covering the stool. Afterward, you’ll need to replace the lid on the container, making sure it’s straight and tightly closed.

Step 4: Ship

Fill out both labels using a ballpoint pen, including your full name, date of birth, and the sample collection date and time. Peel off one label and wrap it around the tube. Peel off other label and place it on the lid of the container.

Then, return the labeled components to the box, close the zippered bag, and seal the box.

Keep in mind that Cologuard’s lab will need to receive your sample within 72 hours of collection. As such, since it’s shipped prepaid overnight via UPS, the company recommends sending it within 24 hours.

From there, the company tells us your test results will be delivered to your doctor within two weeks.

What kinds of results might you expect? We’ll discuss this in a minute, but let’s first find out for whom the Cologuard Test might be ideal.

Who Shouldn’t Use the Cologuard Test?

According to the Cologuard website, their test should not be used by “high-risk individuals, including those with a history of colon cancer or polyps, IBD, certain hereditary cancer syndromes, or a family history of colon cancer.”

How can you determine your level of risk? The manufacturer recommends talking with your doctor, who can let you know more.

Even if you don’t fall into one of the above groups, you can’t use the Cologuard Test if you have blood in your stool from hemorrhoids, as well as during menstruation or other existing conditions, as this may result in a false positive.

Speaking of false positives…

How Accurate Are Cologuard’s Results?

Again, referencing what we learned on the test’s website:

“In a 10,000-patient clinical study, Cologuard found 92% of colon cancers. It also found 69% of high-risk precancers (high-grade dysplasia), those most likely to develop into cancer.”

On the other hand, in a clinical study of Cologuard (unknown if it’s the same one referenced above), “13% of people without cancer or precancer tested positive.” In other words, based on the company’s testing, it seems Cologuard results in about a 13% false positive rate.

What happens if your Cologuard Test results come back positive? The company recommends following up with a diagnostic colonoscopy.

Negative? While the company recommends continued screening at regular intervals, they note that Cologuard’s “performance when used for repeat testing has not been evaluated or established.”

In other words, it’s unclear if it can continue to provide effective colorectal screening beyond the first round of testing.

How Much Does the Cologuard Test Cost? Is It Covered by Insurance?

If you'd like to pay for Cologuard out of pocket, the maximum cost is $649. The test’s website indicates that 30+ states have legally mandated insurance companies to “cover colon cancer screening tests like Cologuard for fully-insured patients.”

This includes Medicare, Medicare, as well as many private insurers.

If you have questions about pricing, coverage, or anything else, Exact Science Corporation’s customer service department can be reached at 844-870-8870.

Given what we’ve learned so far, what are Cologuard’s patients saying?

Does the Cologuard Test Come With Solid Patient Reviews?

The screen can provide easy screening that’s more accurate than current tests, there seems to be some back-and-forth among authority websites about its overall value.

For example, a 2014 LA Times article puts it this way:

“… anyone testing positive with Cologuard should confirm the result with a colonoscopy. It also said that anyone testing negative should still be regularly screened "with a method appropriate for the individual patient," which in many cases means a colonoscopy.

This raises questions about the value of this "breakthrough test," which Exact Sciences is pricing at about $600 per patient — compared with $25 for the traditional stool blood exam …”

A more recent Health News Review article notes:

“… there’s ongoing debate about the appropriateness and cost-effectiveness of the test. While both the FDA and CMS (which recommended approving Medicare coverage of the test for enrollees) had approved the Cologuard test last year, the US Preventive Services Task Force (USPTF) recently concluded in its draft colon cancer screening guideline update that Cologuard should be used as an “alternative screening” tool in certain populations, rather than a “recommended” test.”

Together, this means that Cologuard occupies a middle ground between a colonoscopy, which you’ll need to have regardless of the results, and the existing FIT test, which provides less accurate results, but also costs a great deal less.

On top of this, many authority websites indicate that Cologuard might not necessarily improve screening rates or mortality rates.

Finally, despite the fact that Cologuard had been around about two years at the time of our research and is FDA approved, we found no direct patient feedback about the process or the results.

From a company perspective, Cologuard is brought to you by Exact Science Corporation based out of Madison, WI.

How Can You Know If the Cologuard Test Is Right for You?

Whether you’re concerned about colon cancer and are seeking professional feedback, or you’ve decided to get screened with a Cologuard Test, you’ll need to speak with your doctor first.

They’ll be able to provide feedback about all the available options, help you understand your risk level for colon cancer, and discuss any of your concerns.

So, given its accuracy and ease of use, if your insurance carrier covers all (or at least most) of the Cologuard Test, then it might be easy to justify the added cost compared to a traditional FIT test.

Whether you choose Cologuard or FIT, though, keep in mind that neither of these is intended to replace a colonoscopy. Instead—especially if you have a family history of colon cancer or other high-risk factors—they’re only designed to work as supplementary screening.

With so little online Cologuard patient feedback, why not be a pioneer, add your voice to the conversation, and help others shop smarter? Write your review below!

Read 104 Cologuard Test Customer Reviews and Complaints

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Average Customer Rating: 1.6
Rating Snapshot:
5 star: 9 4 star: 5 3 star: 3 2 star: 5 1 star:  82
Bottom Line: 16% would recommend it to a friend
Showing 1-11 of 104
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  • Very easy to do

    • By Cheryl Green,
    • Santa Maria, California,
    • Jun 10, 2017
    • Verified Reviewer

    My doctor recommended this test for me, and my insurance, Aetna HMO, covered the cost. I took the test, followed the easy to do instructions and sent it off. It has been a little over two weeks, and my doctor has not got the results yet. I hope the test results get to my doctor soon. He will let me know. Waiting...

    Bottom Line: Yes, I would recommend this to a friend

  • Very accurate, non invasive test.

    • By Steve Logan,
    • Columbus, MS,
    • Oct 6, 2017
    • Verified Reviewer

    I turned 50 a few months ago and did my first Cologuard test. Results were back in 2 weeks, and my doc informed me the test was positive. I then scheduled a colonoscopy which I just had done this morning, and they found and removed nine polyps. The colonoscopy wasn’t so bad but the prep work yesterday I wouldn’t wish on anybody. No way ever would I do a colonoscopy as a pure screening tool. Get a Cologuard test done first before you do that prep work for nothing.

    Bottom Line: Yes, I would recommend this to a friend

  • Taken about a year ago.

    • By David S.,
    • High Bridge, NJ,
    • Jul 14, 2018
    • Verified Reviewer

    I'm 74 and was never tested for colon cancer and would never have been if not for Cologuard. It's noninvasive and a wonderful alternative for those who have been putting this off. I highly recommend it, and it gave me great peace of mind.

    Bottom Line: Yes, I would recommend this to a friend

  • Quick and easy

    • By Jackie Q.,
    • Livonia, NY,
    • Sep 5, 2018
    • Verified Reviewer

    My experience with Cologuard was a positive one, especially because the results were NEGATIVE. I was SO relieved to not have to get a colonoscopy. The research shows that there can be significant issues with having the procedure when a person is 75 or older. My husband had a very bad experience when he had his first colonoscopy several years ago, and it took him a year or more to recover from it. So, I am very happy with my results, and I would definitely recommend the test to anyone who wants to avoid the unpleasantness of having to have an invasive procedure.

    Bottom Line: Yes, I would recommend this to a friend

  • Cologuard did me a favor!

    • By Elizabeth S.,
    • Boston, MA,
    • Nov 15, 2018
    • Verified Reviewer

    I was always avoiding a colonoscopy, so my MD mailed me Cologuard. The test was easy! I was quite shocked when it came back positive. After all, no family history for colon cancer and I had no plans of ever having a colonoscopy! However, much to my doctor's delight, I had to have one now. Well, I did, and while I didn't have cancer, I did have polyps that can turn into cancer. I had 5 polyps and they got them all. I was lucky, and honestly, I believe Cologuard saved me from a future with colon cancer in it. So with that being said, take a Cologuard test, it could save your life!

    Bottom Line: Yes, I would recommend this to a friend

  • I've completed both a colonoscopy and Cologuard

    • By Randy V.,
    • Tempe, AZ,
    • Mar 16, 2019
    • Verified Reviewer

    I've completed both a colonoscopy and Cologuard. I found Cologuard to be a simple and easy test to complete in the privacy of my home. I won't miss the 2 stage prep over the course of several hours. I won't miss waiting in the colonoscopy factory hoping the G.I. isn't running too late. I won't miss the Propofol twitching my heart. I won't miss getting into a gown and bearing my lower half to half the staff. I won't miss having to take time off work in addition to my wife having to be present and missing work as well. But most importantly to me is I can do this in another 3 years and not worry that a busy doctor missed something growing and it won't be discovered for another 10 years.

    Bottom Line: Yes, I would recommend this to a friend

  • For me - excellent

    • By Gary W.,
    • Indiana,
    • Jun 7, 2019
    • Verified Reviewer

    Honestly I don't see how this can only get a 1.6 rating and some calling it a scam. I get having mixed results but calling it a scam is totally irresponsible. I would say the right decision to use Cologuard is based on several factors determined by your doctor, family history and your diet. For me, I am 64 and believe it or not never had a colonoscopy, my family was horrified (3 nurses) by this fact but I just couldn't pull the trigger on the big C prep and probe test. Bottom line, no prep, read a few easy to understand instructions, when nature calls have a BM in a container, send it off via UPS drop off location and 2 weeks later (today) get your results. Piece of cake! Fortunately for me, the test was negative! So I am thrilled and highly recommend this option!

    Bottom Line: Yes, I would recommend this to a friend

  • Much better than a colonoscopy for me

    • By Lois D.,
    • Louisiana,
    • Sep 30, 2019
    • Verified Reviewer

    I hated my first colonoscopy taken about 15 years ago and vowed to never have another since I was well over 70 years and had no history of colon cancer anywhere in my family. When my doctor suggested the Colonguard, I accepted because it was non-evasive. The procedure was simple and easy to follow and I received the good news of a negative result within a week so I am very happy and would highly recommend it.

    Bottom Line: Yes, I would recommend this to a friend

  • Very good procedure

    • By Roscoe P.,
    • New York,
    • Nov 5, 2019
    • Verified Reviewer

    I recently had a Cologuard Test and would recommend it to others. It was easy and what I consider less risky than a standard colonoscopy, which has possibilities of contamination, colon tears, and reactions to the anesthesia they must give you before the procedure. I am a tenured healthcare provider and have no affiliation with Cologuard. However, my test came back negative, and it's the fact that it's 92% accurate when checking for colon cancer. Some of the reviews I read on here must be from the Colonoscopy Manufactures. They're worried that DNA tests will replace the old Guard and make EXPENSIVE outpatient procedures obsolete. This is my opinion. My medically educated opinion.

    Bottom Line: Yes, I would recommend this to a friend

  • Non-invasive vs. invasive testing

    • By Wendy Ettel,
    • Texas,
    • May 11, 2017
    • Verified Reviewer

    I asked my doctor about the Colonguard Test as I knew at 63 I was way overdue for a full colonoscopy. I also knew that I would eventually have to have one done regardless of the results of the Colonguard Test, so I had my doctor order it.

    I weighed the processes required for both tests, and the Colonguard process beats a colonoscopy hands down.

    Let's see, did I want to arrange to get to a hospital, wait for hours to check-in, ingest the most horribly thick sour-tasting purge liquid which would cause me to spend hours on a toilet and develop screaming hemorrhoids, run the risk of possible death from anesthesia or a perforated bowel? Or did I want to stay home and poop into a plastic bowel and become intimate with my bowel movement?

    Honestly, I didn't want to do either but had to make a choice. So even though I will now have to get a full colonoscopy anyway due to a positive test result, I believe I would have never arranged to get a colonscopy done if I had not done the Colonguard Test first. Now I know I MUST get the dreaded colonoscopy even though I've never had any symptoms. No more excuses!

    So, I'm glad I took the test and would recommend it, especially if you are like me and believe no news is good news.

    Bottom Line: Yes, I would recommend this to a friend

  • Better than a colonoscopy

    Even though I found my colonoscopy to be "not that bad," I did hate the prep day that preceded it. You can't eat anything, you drink tea (I hate tea) or have chicken broth, and also use laxative pills and liquids, so you spend late in the day long into the evening in your bathroom, just you and your friend, the toilet. Then the next day, depending on what time your appointment is, you have no food or water for several hours, you go in, and if you are lucky, you are properly sedated, and you don't remember most of what happened, but parts of the test can be uncomfortable.

    With the Cologuard, you have a few simple steps which are clearly outlined in the very well done brochure. You can choose which day you want to take the test, and once you finish and seal up the UPS box, you can take it over and drop it off (it's prepaid) and you wait for results. The Cologuard Kit is nicely done, it is an impressive little engineering feat, and makes dealing with a less than delightful situation less messy and seemingly more sanitary.

    I have taken this test TWICE. The first time I put the wrong date on the labels (my fault), and despite following the instructions exactly and getting the box back on time, the wrong date put me outside the 72-hour limit. And they failed to notify me of this, so after five days when I called them, I learned I had to take the test again.

    Since this was my fault, I did take it again and mailed it off today. Now I am learning that there is a high false positive (13%?) on this test and figure I will probably have to get a colonoscopy anyway. But if it does come back OK, I am going to trust it since my last colonoscopy was clear, no polyps, and I am old enough now to figure, the heck with it, I don't need any more colonoscopies. Check that one off.

    Bottom Line: Yes, I would recommend this to a friend

Showing 1-11 of 104

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