About Cologuard Test

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!

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58 Consumer Reviews for Cologuard Test

Average Consumer Rating: 1.7
Rating Snapshot:
5 star: 5 4 star: 3 3 star: 3 2 star: 3 1 star:  44
Bottom Line: 19% would recommend it to a friend
Showing 1-11 of 58
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  • Easy to use but an insurance warning

    • Minnesota,
    • Feb 2, 2019
    • Verified Reviewer

    The test was very easy to use. I tested positive so went for a colonoscopy. You should be aware Cologuard is "screening," which my insurance covers 100%, but colonoscopy was now "diagnostic," so not treated as preventive and I had a sizable bill for the procedure with a deductible, etc. You might be better off just getting the colonoscopy which will be coded as "screening" if it is your first time and avoid the cost if your Cologuard comes back positive.

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

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  • 1 out 1 people found this review helpful

    Torn on this test

    • East Rockaway, NY,
    • Feb 2, 2019
    • Verified Reviewer

    My husband has a defibrillator implanted and hasn’t had a colonoscopy in 16 years because it warrants the colonoscopy to be done in a hospital so they can turn his device off in the event of polyps, it could set off his defibrillator. So, his PCP recommended Cologuard. It came back positive. He went for the colonoscopy at the hospital, the doctor informed that there were many polyps (over 10), he stopped counting. So on the one hand, we’re glad Cologuard spotted this, but on the other hand, the anxiety caused over this was horrible, the waiting makes me nuts. So I thank Cologuard for finding something, but inevitably, a colonoscopy was still necessary. My advice is to just go get the colonoscopy. This Cologuard Test causes way too much worry, unless it comes back negative.

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

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  • 7 out 7 people found this review helpful

    Pushy and hungry. Do not do it.

    • Tampa, FL,
    • Feb 1, 2019
    • Verified Reviewer

    Three months ago, after questioning my doctor as to how this would yield valid results, I gave in and said go ahead order Cologuard by Exact Sciences knowing nothing about this product.

    I got home did some research and the next morning called my doctor and told them to cancel, due to so many negative reviews.

    Well every single day since then, I have received a call, which I have ignored. I also received the kit a while back which I threw away. This was a canceled order, but Cologuard by Exact Sciences is still pushing it. This outfit is very pushy and hungry for you to try their product which looks to be inexact, and questionable at best with no supporting documents when there is a positive result. I think the doctor and/or staff get a kickback on every order placed.

    Do NOT order Cologuard by Exact Sciences unless you want to be harassed on a daily basis.

    It has been now over a month, and I am still getting calls rolling straight to my voice box. They are extremely pushy and hungry to charge you for their Cologuard product.

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

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  • 5 out 5 people found this review helpful

    This test comes back with a lot of false positives and is not accurate

    • Florida,
    • Jan 10, 2019
    • Verified Reviewer

    I would not recommend this to anyone. I did the screening and it came back positive right before Christmas, ruined my holidays, I thought I was going to die of colon cancer. Turns out it was a false positive and now my insurance company is charging me $3,000.00 because they are saying it's pre-existing. Now I'm reading they are all coming back with a false positive. Save yourself the money and just do the colonoscopy, it was a breeze. This test is not accurate at all.

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

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  • 3 out 3 people found this review helpful

    Insurance does not cover it

    • New York City, NY,
    • Jan 10, 2019
    • Verified Reviewer

    This company is a total scam. It says on their website the test is covered by insurance - well, I'm here to tell you it DOES NOT. In fact, if your doctor orders it, Cologuard will expect you to pay for the test upfront. It's a total scam. I don't know how this company stays in business. AVOID them at all costs.

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

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  • 7 out 8 people found this review helpful

    Hell and back

    • Hell,
    • Jan 7, 2019
    • Verified Reviewer

    Omg, please choose a different method. Once you tell your doctor ok to this kit, you get phone bombed from this company. I didn't answer right away and they shouldn't have been calling, it was Christmas and New Years, but they really don't care, they will blow your phone up. Until you answer, or until you poop and send it in, this company needs to relax and give people time to read and review and wait until after a holiday!

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

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  • 10 out 10 people found this review helpful

    Test results positive...for what?

    • New Jersey,
    • Jan 5, 2019
    • Verified Reviewer

    Not good. I got test results back with a positive so I asked my doctor what am I positive for? She said the lab does not tell her, so I called the lab. They say they do not give the results, only a negative or a positive, so...do I have cancer DNA, blood in my stool or something else...assuming that the test has more than one specific test, the lab can tell which part of the test was positive. I am not happy with Cologuard!

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

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  • 2 out 2 people found this review helpful

    Rip off

    • Knoxville, TN,
    • Dec 29, 2018
    • Verified Reviewer

    My wife did this test in good faith that it would be covered on her yearly physical insurance plan, and she got a bill for $649.00 that we cannot afford to pay for. As I read and further investigate this product, it appears to be a legalized scam that others fall into as well.

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

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  • 6 out 7 people found this review helpful

    Total scam. AVOID!

    • Arkansas,
    • Dec 16, 2018
    • Verified Reviewer

    The doctor assured me that insurance covers this test. I also checked with Exact Sciences Cologuard website, which assures everyone that the ACA has mandated that all insurance plans must cover this procedure. So I said okay, what do I have to lose. Evidently, I have $649 to lose. Soon after, I am now getting endless bills from Exact Sciences for the test. I complained to my doctor. "Sorry, I thought it was covered." I complained to Cologuard and to Blue Cross Blue Shield. I filed an appeal. "Sorry, BCBS does not cover this test because it is not scientifically proven, and we don't pay for genetic testing."

    So, the doctors that are pushing this are probably getting some referral fee for these, and Exact Sciences assures you it is covered, just to get you to take this test, knowing you will be stuck with the bill once it is done. Also, the doctor's office confided that one of the problems with the test is the many false positives that come back. And then you get to take a full colonoscopy that is actually THREE TIMES as long as usual, so they can absolutely rule out a real cancer issue.

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

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  • 8 out 9 people found this review helpful

    False positive!

    • Illinois,
    • Dec 15, 2018
    • Verified Reviewer

    I opted for Cologuard as I have a high insurance deductible and was hoping to save money. The test came back POSITIVE. Like most people - I was scared and went for a colonoscopy. My colon was COMPLETELY CLEAR, not a single polyp!

    Because of this UNRELIABLE "test," I will be paying off medical bills for two years - not to mention recovering from the stress of a cancer scare. I will NOT recommend Cologuard to anyone!

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

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  • 5 out 6 people found this review helpful

    Expensive and "scamm-ish"

    • Arkansas,
    • Nov 16, 2018
    • Verified Reviewer

    As a prior submitter stated, I saw my PCP and he recommended the Cologuard test. He said I could do it at home and it's covered by insurance since it's a screening test. A couple of days later, I started getting phone calls explaining what I would receive in the mail. Once I received the package, I continued to get calls about when I would return it. It was easy to complete, so I sent it back in and several weeks later received a bill for $649.00. My insurance carrier stated they do not cover this test. I would have never done this had I known this. It will take me a while to pay this off. I should have checked with my insurance, but since my PCP told it was covered and the Cologuard staff kept calling me and knew my insurance plan, I assumed it was covered. My mistake.

    This company has the insurance information and the ability to get authorizations so as not to victimize folks when the insurance company denies the service.

    I am submitting a complaint to our State Attorney General.

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

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