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.

To begin, let’s discuss the basics.

What is Colon Cancer? Can It Be Prevented?

What Does the Colon Do?

The colon (more commonly known as the large intestine) is the last part of the digestive system where fluids and salt are reabsorbed, and waste is prepared for elimination. This is also where probiotic bacteria play their biggest role.

Overall, the colon consists of four parts:

  1. The ascending colon, which attaches to the small intestine and runs along the lower-right part of the abdomen.
  2. The transverse colon, which runs across the midsection, just underneath the stomach,
  3. The descending colon, which runs down the left side of the abdomen, and
  4. The sigmoid colon, which attaches to the rectum.

How Does Colorectal Cancer Start?

It’s here in the rectum where most colorectal cancers begin, usually as a growth on the inner lining, called a polyp.

Hyperplastic and inflammatory polyps are quite common but aren’t precancerous, while adenomatous polyps sometimes morph into cancer, and are labeled as precancerous.

If cancer eventually takes hold in one of these polyps, it can grow into the wall of the colon and rectum, eventually making its way into the bloodstream, lymph nodes, and eventually to other organs.

Is Colon Cancer Preventable?

According to the American Cancer Society, there are approximately 135,000 new cases of colorectal cancer each year, which means men and women have a 1-in-21 risk of developing the disease at some point in their life.

While the death rate for colorectal cancer continues to decline, it’s still the third leading cause of cancer-related deaths in the United States, although it’s also one of the most treatable—if caught early.

And this is exactly what the Cologuard Test promises to do. But exactly how does it work?

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!

he different parts that make up the Cologuard TestThe different parts that make up the Cologuard Test, including plastic bracket, collection container, tube and probe, preservative, and detailed Patient Guide. Image credit: Cologuard.

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?

None of the HighYa staff ordered a Cologuard Test, so we can’t speak from a firsthand perspective.

However, while it’s clear that 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 Next: Sugar Versus Artificial Sweeteners: What’s Better for You?

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Read 82 Cologuard Test Customer Reviews and Complaints

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Average Consumer Rating: 1.6
Rating Snapshot:
5 star: 7 4 star: 4 3 star: 3 2 star: 5 1 star:  63
Bottom Line: 17% would recommend it to a friend
Showing 1-11 of 82
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  • 0 out 1 people found this review helpful

    A waste of time

    • North Carolina,
    • Aug 13, 2019
    • Verified Reviewer

    This company is a money grabber.

    I do not recommend this company to anyone. Rip off. A step people need to avoid. It is best just to get the colostomy and get it over with.

    Doctors and the rest of that system are pirates. Beware, they will take your money. Getting rich.

    Bottom Line: No, I would not recommend this to a friend

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  • 0 out 1 people found this review helpful

    Wish I would never have used Cologuard

    • Louisiana,
    • Aug 12, 2019
    • Verified Reviewer

    Once you get the box they begin calling you nonstop to send it back. Got a false positive and then had pay for a colonoscopy.

    Wish I would have just been tough and went with colonoscopy to begin with - just didn't want to drink the colon prep liquid.

    After getting the news that the Cologuard came back positive obviously I was worried that I had colon cancer. Big waste of time and money using this product. Never again.

    Bottom Line: No, I would not recommend this to a friend

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  • 1 out 2 people found this review helpful

    Undo stress!

    • Ohio,
    • Jul 31, 2019
    • Verified Reviewer

    I completely regret doing this and wish I would have read the reviews prior. My like many others came back positive. I fretted for weeks until being able to get a colonoscopy. My colonoscopy came back perfect. I am relieved now, but will never get those weeks back that I did nothing but worry, stress, and cry thinking I had colon cancer. This test is not the easy way out...just do the regular colonoscopy. It isn't that hard. I feel bad that my insurance company had to pay for both because this Cologuard Test is so inaccurate. If I could give 0 stars, I would do that. This company is deserving of NO star.

    Bottom Line: No, I would not recommend this to a friend

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  • 4 out 5 people found this review helpful

    Is absolutely not worth the time

    • Saint Louis, MO,
    • Jul 26, 2019
    • Verified Reviewer

    As a former cancer survivor, when I got my positive Cologuard results I panicked. Got a colonoscopy five days later and they found no polyps or cancer. I asked the doctor how reliable the test was and he said the older you get the worse the results. The same thing happened to my friend a month ago. Might as well just bite the bullet and get a colonoscopy. You’ll end up with one anyway. My vote is don’t bother. It’s not reliable.

    Bottom Line: No, I would not recommend this to a friend

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  • 4 out 5 people found this review helpful

    Harassment to a new level

    • Massachusetts,
    • Jul 22, 2019
    • Verified Reviewer

    The company is relentless in phone calls and letters. I have asked that they stop contacting me and yet they continue. After reading all of these reviews, I am not sure I will even bother with the test. I did do the cards which are offered by another company and the result was negative. The cards need to be done annually and Cologuard every 3 years. The three-year timeframe was the selling point for me. I am regretting my decision due to the relentlessness of the company. I can read and I can follow directions. Just stop the phone calls.

    Bottom Line: No, I would not recommend this to a friend

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  • 9 out 10 people found this review helpful

    Horrible

    • Saratoga, NY,
    • Jun 19, 2019
    • Verified Reviewer

    Had the test done, came back positive and had to have a colonoscopy.

    They found nothing, not even a polyp. This test is junk! I will never have this again. Complete waste of time and insurance money. If I could give 0 stars I would.

    Bottom Line: No, I would not recommend this to a friend

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  • 1 out 4 people found this review helpful

    For me - excellent

    • 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

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  • 5 out 5 people found this review helpful

    Joy Joy

    • Montgue, CA,
    • May 29, 2019
    • Verified Reviewer

    The test is awkward. Hard to sit and go with the way this sits on your toilet. And everyone is right - TOO many phone calls. If I have a question I will call you. GEES. Of course today I get the results - positive. I also agree that they should inform the doctor of what part was positive. Fecal blood or DNA. Now Doctor wants a colonoscopy, sorry I can't afford it. And the Dr's office told my husband!

    Bottom Line: No, I would not recommend this to a friend

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  • 8 out 8 people found this review helpful

    False positive, take a breath.

    • Maine,
    • May 1, 2019
    • Verified Reviewer

    Like too many on this review site, I received a false positive result, "Abnormal" after having the Cologuard test done. My doctor then ordered an urgent colonoscopy performed two weeks later (7-day diet changes for prep etc.). Results, NORMAL, no POLYPS. Doctor shared, "I don't know just I feel about this test, we do get a lot of false positives, but also those with questionable polyps..." After receiving my Cologuard results till having exam my nerves were pushed to a point I never should have experienced. So I give this testing a ZERO. I'm incredibly grateful I missed this cancer diagnosis. At 60 years I do now advocate to go and have the colonoscopy at a Gastroenterology Center Specialist, not by your general M.D. Btw, my doctor has performed 35,000 in his career!

    I had no family history of colon cancer. My previous baseline colonoscopy was done ten years earlier (age 50) by the same physician and I didn't have any polyps. My 85-year-old mother had to have one for what turned out to be gastric irritation due to her daily aspirin regime, but no polyps!

    So I felt pretty good about turning down having another one at 60 and finally agreed to take the Cologuard test to appease my doctor.

    Although this hasn't been a pleasant emotional experience I now recognize how important it is to have that 10-year screening as 60+ is when rogue cells of cancer can show their ugly selves. IF you still refuse to have a colonoscopy I'd have the stool testing for blood only. That's been around for years and can detect possible cancers.

    So if you've just gotten back the results as positive, DON'T let your mind run away, chances are it's incorrect or just precancerous and you've caught it in time.

    Bottom Line: No, I would not recommend this to a friend

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  • 9 out 9 people found this review helpful

    Don’t waste your money

    • Florida,
    • May 1, 2019
    • Verified Reviewer

    If you have hemorrhoids your test will come back positive. Then you have to get a colonoscopy to make sure it’s not cancer. Then you have to pay for your colonoscopy because now it’s diagnostic instead of a screening. I only wish I was told all this before I did the Cologuard Test. The Cologuard Test is about $650.00. Colonoscopy is about $4,000.00, which would you rather pay for?

    Bottom Line: No, I would not recommend this to a friend

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  • 6 out 7 people found this review helpful

    Don't bother

    • New Jersey,
    • Apr 30, 2019
    • Verified Reviewer

    The minute my provider ordered the test I got phone bombed! Relentless phone calls about the product. The test kit arrived, self-explanatory really. I got everything back in the box and found the box won't fit in the UPS boxes located throughout our towns. It's about 1 inch too big. I was not going to drive to a UPS store. Cologuard should have planned for this eventuality. Now, me and my box came home and I proceeded to deal with the UPS telephonic computer to set up a pick up at my home. No, the website was not helpful. 30 minutes later, I had my pick up scheduled. I wish I had read the reviews before I got involved with this product. I can hardly wait for the next chapter.

    Bottom Line: No, I would not recommend this to a friend

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