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!

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Read 90 Cologuard Test Customer Reviews and Complaints

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Average Consumer Rating: 1.6
Rating Snapshot:
5 star: 8 4 star: 4 3 star: 3 2 star: 5 1 star:  70
Bottom Line: 17% would recommend it to a friend
Showing 1-11 of 90
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  • Another false positive

    • Colorado,
    • Oct 17, 2019
    • Verified Reviewer

    I had a colonoscopy at 50, which came back normal. I took the Cologuard Test about six months before the recommended 10-year re-exam. It came back as abnormal and my doctor immediately ordered a colonoscopy. After two weeks of stressing out, I woke up after the procedure and the staff said everything was perfect - no samples were taken during the procedure. For me, not such a big deal as I was due for the exam but for others do additional testing if you get a positive result.

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

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  • Consider your options

    • South Carolina,
    • Oct 1, 2019
    • Verified Reviewer

    I normally have a once a year "smear" test but have recently been out of the US for 2 years. This year a new doctor signed me up for Cologuard and I proceeded. I did not read any reviews prior to the test. Results came back positive with resulting anxiety on my part. The doctor immediately recommended a colonoscopy. I asked if I could take the traditional 3-day FIT smear test. The doctor ordered one up from Labcorp that I had to pick up and return. It was a tube-type test which maybe could have been one day but I had asked for 3 days and unlike the other "smear" test, 3 results came back versus the traditional one result? Whatever, they were all within normal limits. Thus I would investigate all of my options and somewhat initially relax if you do Cologuard and have a positive result.

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

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  • Much better than a colonoscopy for me

    • 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

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  • Worst customer service ever

    • Florida,
    • Sep 27, 2019
    • Verified Reviewer

    I wish I never contacted them. Save your money. A total scam IMO. And the worst customer service ever. Tried to get my results and put through total hell. Such idiots answering the phones and so unhelpful. I would never recommend using them. Save your money.

    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 be fooled by Cologuard's "cutesie" advertisements!

    • Sarasota, FL,
    • Sep 22, 2019
    • Verified Reviewer

    Was excited to find a non-invasive way to check for colon cancer but would never, never do this again or recommend to anyone. It is a scam, totally a way for Exact Sciences and the doctors to make more money at the patient's expense. Take note of the reviews. Notice that the majority of the reviews come back with a positive. They then go through more expensive, invasive testing and extreme stress for them and their families only to find that it was a false positive. In my case also, I changed Primary Physicians after the test was ordered but before I performed the test. The doctors who ordered it canceled the test and I was told the new doctor would have to place a new order which would cost me $649.00 as my insurance company would only pay for one test every three years. All that needed to be done was to change who the results were sent to. I gave them all the information, my new doctor offered to call, etc., but they refused to do it.

    DO NOT GET TAKEN BY THOSE "CUTESIE" ADVERTISEMENTS ON TV!

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

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  • 4 out 4 people found this review helpful

    Not worth the anxiety

    • Morehead City, NC,
    • Sep 20, 2019
    • Verified Reviewer

    I am 75 years old, have had 3 sigmoidoscopies, and 2 colonoscopies since age 44, all with negative results. In between colonoscopies, I have used the BioIQ Fit test with negative results. This year my GP recommended Cologuard with, guess what, a positive reading. So I had another colonoscopy yesterday with, guess what, a negative reading. My evaluation, a waste of time and money.

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

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  • 7 out 7 people found this review helpful

    Very negative

    • Dalton, GA,
    • Sep 12, 2019
    • Verified Reviewer

    My doctor proposed that I take the Cologuard Test. Although I read through the brochure many times I went ahead and did the test. I got a "positive colon cancer" result. I have been in intense anxiety ever since. I went ahead and made my appointment with my specialist, he was great and reassured me as best he could. What this experience has done to myself and my family is beyond words. Both of us have experienced severe anxiety, increase in blood pressure and difficulty sleeping. I had my appointment with the surgeon this week (lived under the cloud of the positive diagnosis for a month and a half) where he found absolutely nothing! Praise God for this but I must ask why the Cologuard is even used? I discovered that there is a 41% false positive for this test. There is no telling how much insurance companies have paid for a largely inaccurate test. The pain and suffering, both mental, emotional and physical that patients go through should not happen. I have been so sick over this that I haven't been able to function in my normal manner. Not to mention the difficulty of telling my little grand-sons that Nana has something wrong with her tummy and must go to another doctor to find out if we can fix it. I told them in the most gentle way without alarming them but as it turns out it was a conversation that I should not have had to have. I would tell anyone who has been recommended to take a Cologuard Test to say a resounding NO!

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

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  • 5 out 6 people found this review helpful

    Not recommended

    • Louisville,
    • Sep 6, 2019
    • Verified Reviewer

    I thought I’d skip the nasty prep of a colonoscopy, and do the Cologuard route. My test came back 96% positive. Waited for 3 weeks on pins and needles to get a colonoscopy done. The colonoscopy found 2 polyps...no cancer. Never again for Cologuard. Do the colonoscopy. If I would have done the colonoscopy in the first place, the wait and worry game wouldn’t have happened. They would have found the polyps, removed them, and done!

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

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  • 5 out 7 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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  • 5 out 7 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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  • 9 out 10 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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