About Cologuard Test

By HighYa Staff

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 69 Cologuard Test Customer Reviews and Complaints

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Average Consumer Rating: 1.7
Rating Snapshot:
5 star: 6 4 star: 4 3 star: 3 2 star: 3 1 star:  53
Bottom Line: 19% would recommend it to a friend
Showing 1-11 of 69
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  • Sorry I did this test

    • Edison, NJ,
    • Apr 19, 2019
    • Verified Reviewer

    My doctor ordered the test because I have never had a colonoscopy and has been after me for 20 years to have one. They kept calling me and sending letters even after I had done the test and gotten the results. One letter offered me $ 50.00 if I would do the test and since I had already done it, I called them and said asked why I was not offered the $50.00 before? They said no problem and they sent me the $50.00. The results were positive. After agonizing 7 months over the results, I finally had the colonoscopy and I am left with serious side effects from it.

    I never should have done it. I don't know how the FDA can approve such a test without any detail of the results. A true scam.

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

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  • 1 out 1 people found this review helpful

    Do not take this Cologuard Test

    • Cazenovia, NY,
    • Apr 13, 2019
    • Verified Reviewer

    I got screwed. The doctor said in my physical that since not been 10 years from the last colonoscopy then I had to take Colon jerk test because insurance covered it. Came back positive (which it will even if you have a hemorrhoid ) as it detects any blood (DNA). So I called BCBS and specifically asked on a tape-recorded line and was told that the follow-up colonoscopy would be a covered prescreening based on the fact that nothing was found. Nothing was found, I got billed $1695 because the "false positive DNA genetic lab test of Colon guard" was the prescreening benefit for colon cancer, so everything after is diagnostic even though there was nothing to diagnosis. STAY AWAY. And you will never get the results of what they tested or anything to show where their error was for a false positive.

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

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  • 3 out 3 people found this review helpful

    OMG, if you want a thousand phone calls, sign up!

    • Saint Louis, MO,
    • Apr 3, 2019
    • Verified Reviewer

    My doctor suggested the Cologuard Test as an option vs. a colonoscopy, and I was on the fence. Then the phone calls started. Night, day, even SUNDAY. Calling, calling, calling. I read up on the test and a lot of insurance companies don't pay for Cologuard and you are stuck with the bill, the LAST THING I WANT! Plus, I don't appreciate getting bugged CONTINUOUSLY! They sent the kit without me even okaying it! TERRIBLE! Run run run RUN AWAY from these kinds of tactics!

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

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  • 1 out 3 people found this review helpful

    I'm glad I did it

    • Kansas,
    • Mar 30, 2019
    • Verified Reviewer

    I'm 67 and fully intended never to have a colonoscopy. When I told and told my PCP that, he talked me into at least doing the Cologuard test. It was easy to do and the instructions were thorough. The test came back abnormal; necessitating a follow-up colonoscopy. Just my luck. I had to wait 30 days for that, which was pretty stressful. I ended up having 4 polyps removed, one of which was precancerous. The gastro said it would likely have been full blown cancer within a year or two. I suppose just going for the colonoscopy in the first place would have been the best thing to do, but...

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

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  • 3 out 3 people found this review helpful

    "Too Much"

    • Houston, TX,
    • Mar 22, 2019
    • Verified Reviewer

    I followed the instructions, did the sample, mailed it in. Within a couple of days, my doctor's office called and said Cologuard could not give a positive or negative reading. I asked why? She said Cologuard said the sample was "too much."

    Come on! Nowhere did I see in the instructions anything about the size of the sample.

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

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  • 2 out 4 people found this review helpful

    Don't do the test

    • Georgia,
    • Mar 17, 2019
    • Verified Reviewer

    My doctor talked me into getting this test sent to my house. Once I got the box, I opened the box and pulled everything out. Once I read the brochure, I said no way to this test. They want you to go to the bathroom in a cup, then scape your poop to get a sample, then put this fluid over it, and box and send it in. I think it is gross, nasty, and a waste of time to do this test. I called the next day to cancel this test, and to send the box back, I was told to just throw it away or keep it if I want to. I am 52 years old, and I think I will take my chances of getting cancer. I refuse to do this test.

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

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  • 1 out 3 people found this review helpful

    I've completed both a colonoscopy and Cologuard

    • 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

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  • 5 out 5 people found this review helpful

    SCAMMERS

    • Pennsylvania,
    • Mar 14, 2019
    • Verified Reviewer

    First of all, the day I received the test the incessant phone calls began from Exact Sciences. Calls came in twice a day, 3 or 4 times a week, annoying me usually at work. I only agreed to this test because my doctor kept annoying me about a colonoscopy. (I have seen first hand some real tragic complications patients have experienced as a result of a colonoscopy, therefore, have avoided this test.) Of course, now my doctor wants me to have a colonoscopy because the test results have come back as positive.

    I have checked and insurance will not pay for both. No colonoscopy for me! I can't afford it.

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

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  • 4 out 4 people found this review helpful

    No respect or consideration for patients. RUN from this outfit!

    • Fort Worth, TX,
    • Mar 10, 2019
    • Verified Reviewer

    During a recent physical, I VERY mistakenly agreed to a Cologuard exam. Had I known what was coming I would have MUCH RATHER HAD THE COLONOSCOPY! I was told by my doctor I would be receiving a test kit in the mail from them and all I would need to do. Although I NEVER gave these yay-hoos my cell phone number, my doctor apparently did. There was NO NEED AT ALL for these people to call me almost immediately I began getting persistent calls from their ROBODIALER! All hours of the day and night. No consideration for whether they were calling at a bad time. No indication what they wanted. Immediately wanting ME to punch in responses on my keypad to prove who I was when THEY CALLED ME! No indication how long the call would last. Hanging up in frustration and anger the machine would call me back. Of course, a machine wouldn’t know the inconvenience, frustration, and anger they would cause and OBVIOUSLY they don’t care!

    I finally called them to tell them to stop harassing me with a robo dialer, and you guessed it, to get to a real person I first had to navigate through their automated system. I was assured they would call me no more, but the calls continued! The second time I called to tell them to stop I threatened to sue them if that darn machine called me again! AND I WILL! Now, on to leave my doctor a scathing review for sending me to and giving my number to these sleaze-balls!

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

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  • 5 out 5 people found this review helpful

    False positive

    • Jackson, OH,
    • Mar 4, 2019
    • Verified Reviewer

    I tried to take the easy way out and have the Cologuard Test instead of a colonoscopy and it was a big mistake. My test came back positive on December 20th and I had to wait until today, February 25th, worrying about having cancer and raising my blood pressure, all to find out it was completely negative. Also after my insurance paid for the Cologuard, it wouldn’t pay for the colonoscopy. If you are needing a colonoscopy, don’t try to take the easy way out. It’s not worth the stress and cost.

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

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  • 8 out 8 people found this review helpful

    SCAM!

    • Arizona,
    • Feb 25, 2019
    • Verified Reviewer

    After having my PCP docs recommend a colonoscopy for so long (I am 62), I finally decided to do a Cologuard. It came back positive, of course (I read that a huge percentage, if not 100%, come back positive). I called Cologuard and asked them which of the two tests or both came back positive...they refused to answer. I said, hold on, IF you actually did the two separate tests, you must have the results available, so why the refusal to disclose? I offered to pay for mailing...but would think them emailing the SPECIFIC results that resulted in a "positive" would be easy...IF they were legit. Was it blood in the stool sample, or "bad DNA?" They claim to test eleven DNA "biomarkers," so I asked them to send me OR MY DOCTOR the specific results on those too. They again refused. I accused them of being a TOTAL SCAM, and still believe that to this day.

    I followed up by purchasing a Fecal Immunochemical Test (FIT) for $20 from eBay, which tests for blood in the stool, quite accurate. Results: NEGATIVE. So the Cologuard test result must be from the very likely bogus "DNA" test, why else would the hucksters at Cologuard refuse to send me OR my doctor the specifics of the results?

    Now I will do a colonoscopy, which is NOT risk-free. about one in 1000 has a serious problem, like perforation of the bowel. The people at Cologuard are unethical, dishonest and greedy, IMO.

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

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