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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  • Updated review

    Was wrong, showed a false positive

    • By Tina,
    • New York,
    • Nov 9, 2017
    • Verified Reviewer

    Thanks to a program in New York state, a cancer screening program covered my cost (my insurance would NOT cover both a Cologuard and a colonoscopy even if I got a positive test).

    Anyway had the a REAL exam today (colonoscopy), and it was NEGATIVE. After 40 days of worry and stress, it was nothing.

    Do not waste your time and insurance money on this test. Swallow your pride to do the REAL test, then you are sure, otherwise, stick to FIT test, which you can do at home. I am glad this nightmare is over and am so thankful for the gastroenterology team for their amazing support. This is what they do, they see with their eyes. Don't trust a stranger across the world looking at your poop under a microscope, who knows if they are hung over or poorly paid, and who knows what credentials they have.

    Obviously, they were wrong with me and many others with FALSE POSITIVES.

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

    • Previous review
    • Oct 7, 2017

    Deceitful

    If you test positive, you are forever scarred with a positive even if the follow up is negative.

    Bottom line, more cost. All about money and not about health. Now if I get a colonoscopy, it will cost most of my deductible, which is $10,000. So I am now waiting until January 2018 so I can put that toward my deductible.

    (read moreread less...)

  • Cologuard is a bad test.

    • By Tom Martin,
    • Boston, MA,
    • Apr 10, 2018
    • Verified Reviewer

    I took a Cologuard Test earlier this year and got my results back in March.

    They said I tested positive for CRC, however, my doctor couldn't tell me if the positive came from DNA or blood in the stool. Colorguard only tells the Primary Care Physician if the result is positive or negative, nothing more. I was referred for a colonoscopy by my PCP, based on the positive result from Cologuard.

    I stressed over the Cologuard test results for three weeks while I waited for my colonoscopy. After my colonoscopy procedure was finished, the surgeon gave me my results: everything was normal, and they did NOT find a single polyp! I also found out I was the surgeon's 9th patient who was normal after testing positive by Cologuard.

    This test is a waste of time and money; don't do it. Just bite the bullet and get the colonoscopy. Cologuard is an expensive test, you don't know how they come up with their conclusions, and it's unreliable, in my opinion. Based on what I experienced and what I was told, all I can say is I'd hate to be the guy whose Cologuard came back negative. Blow off this garbage test and get the colonoscopy.

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


  • False positive, a nerve-wracked six weeks!

    • By Myra K.,
    • California,
    • Jun 18, 2018
    • Verified Reviewer

    So, every year I take a fecal smear test along with my annual mammogram. It has always been negative. This year my physician prescribed the Cologuard test. I was a little shocked that they wanted the whole stool sample, kind of an icky process to be sure. I was shocked and stunned when it came back positive!

    I live in a rural area, the nearest place to acquire a colonoscopy is Las Vegas 100 miles away. I called around, and the first appointment I could get for the consult was six weeks out. Six weeks! I don't know about you, but my head can do a lot of magical and terrifying things in six weeks time. I was checking my will, saying goodbye to my friends, crying and scared. It was pretty awful! The test said, "you have a biomarker for cancer!" Since it's a cancer test and it was coming back positive, it was not a leap to think I had cancer! All I could see was a colostomy bag in my future.

    So I did the gruesome prep and the day of the colonoscopy came. It was completely normal! No polyps, no indication of cancer at all. False positive! My surgeon said that false positives are the NORM for Cologuard. So, I say buyer beware.

    It was a horrible experience for $650 to boot. Look out, this test is bull!

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


  • Terrible

    1. Received "positive" Cologuard. However, they don't tell you if it's for blood or cancer DNA.

    2. Took fecal occult and got negative, so that left cancer DNA.

    3. Had colonoscopy negative, not even a small polyp.

    Don't waste your money - they can't tell you one way or another why you get an appositive result, and false positives are common enough that it's a waste of time.

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


  • For me Cologuard was a waste of time and money

    • By Michael Dunn,
    • North Carolina,
    • Feb 15, 2018
    • Verified Reviewer

    I have Crohn's disease which means I have a high risk of colon cancer. My doctor has ordered a colonoscopy every second year. This past year I asked if there was another option as the most difficulty I have with Crohn's is after the exam. He recommended Cologuard.

    When I got the kit, I seriously debated whether to take the test or not because there were so many disclaimers about false positives and false negatives. I called them, concerned if insurance would cover the cost, and, as I remember the conversation, they said they would work out a reduced payment if I had a problem with insurance. Later they told me I was mistaken. Regrettably, I sent the specimen in.

    The results were positive, which meant I had to get the colonoscopy anyway. Also, my insurance company denied the claim for payment, stating "we believe this test is investigational and not medically necessary for you at this time." I even sent a form appeal letter provided by Exact Sciences, and insurance still denied the claim.

    So I had to pay the $649 out of pocket.

    I then had the colonoscopy which was negative, no issues. Considering the strong disclaimer on false positives and false negatives, I have concluded no matter what the results, I'd be forced to get a colonoscopy anyway, so why waste the time and money.

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


  • False positive

    The test was easy but worthless. It gave a positive result and after many delays had to have a colonoscopy. I had a small non-cancerous polyp. Too much stress and cost for that false positive. No family history or risks for colon cancer. Just get a colonoscopy.

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


  • Results not trustworthy

    • By Layla,
    • Virginia,
    • Nov 21, 2017
    • Verified Reviewer

    Just get the colonoscopy. I wasted time with this test. Even if you test negative, they recommend going anyhow for the colonoscopy. I am going for my colonoscopy early January 2018 due to a positive result. The test does not even specify if it is DNA cancer markers they found or blood. Nothing like the real thing.

    This is a game changer for this in marketing to capitalize off of people’s fears to make money. I feel suckered and used. Just do a colonoscopy and be sure. This is a scam, believe me.

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


  • Test results positive...for what?

    • By Jonathan D.,
    • 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


  • Don't take this test!

    • By Carol Kau,
    • Milwaukee, WI,
    • Jan 2, 2018
    • Verified Reviewer

    Don't waste your own money or your insurance benefits on this test! It's inaccurate, at best, and the company's whole practice is a sham!

    People fall for this scam because they think that they'll get the same peace of mind as having a colonoscopy without having to go through with the colon prep and the colonoscopy itself. WRONG! The company takes over a week from the time they receive the test to run it and even longer to get the results of it to you, the patient. If the results are "negative," which could be wrong, you'll receive a letter in the mail stating so. If they're positive, which could also be wrong, you won't get the results, but rather, you'll get a phone call from your doctor's office telling you this and telling you to schedule a colonoscopy ASAP!

    Long after you've had that colonoscopy and spent sleepless nights worrying, you'll get a form letter from the company telling you that your results were positive and that your doctor was informed of the results. You'll never get the actual graph of those results sent to you.

    I have urged everyone I know not to subject themselves to this company's practices or to subject their insurance carrier to the high cost ($649.00) of this highly inaccurate, misleading test.

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


  • Hell and back

    • By Brian S.,
    • 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


  • Positive result without identification of source blood or DNA

    • By Frank K.,
    • Phoenix, AZ,
    • Jun 26, 2018
    • Verified Reviewer

    Stool DNA-biomarkers with hemoglobin immunoassay and not state which one is applicable in Patient Report to the doctors, so if you have a positive result, you may be unnecessarily subjected to a lot of additional testing and expense that was not necessary if they stated which marker was for your test. I called them and asked for the information and was told it is not available. I reported this to the FDA.

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


Showing 1-11 of 104

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