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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44 Consumer Reviews for Cologuard Test

Average Consumer Rating: 1.6
Rating Snapshot:
5 star: 4 4 star: 3 3 star: 1 2 star: 1 1 star:  35
Bottom Line: 23% would recommend it to a friend
Showing 1-11 of 44
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  • Cologuard

    • New York,
    • Oct 17, 2018
    • Verified Reviewer

    I received the box in the mail last year. I went through the process and then mailed in a special mailing. I went to the doctor today, a yearly physical, and they never received the results. I am not sure if my insurance was billed. But all that for nothing. What a waste.

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

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  • Cologuard is a gimmick

    • Rio Rancho, NM,
    • Oct 13, 2018
    • Verified Reviewer

    I paid $600 for this test and results were positive, so had to have a colonoscopy anyway (free screening). Results negative/normal.

    So months of worrying that I had cancer and paying $600 for that.

    It is an easy test to do, but really bogus.

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

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  • Very expensive test

    • Washington,
    • Oct 8, 2018
    • Verified Reviewer

    My primary care doctor told me that now that I am 50, I need to be tested for colon cancer. She suggested the Cologuard test. She 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 a few weeks later received a bill for $580.00. Aetna does not cover this test. I would have never done this had I known this. It will take me a long time 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. Don't be pressured into doing this. A lot to pay for convenience.

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

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  • Okay, depending on aim

    • Massachusetts,
    • Oct 4, 2018
    • Verified Reviewer

    My GI doc suggested this as an okay sub for c-scope (have other surgeries pending and wanted to reduce sedation). PCP prescribes and Medicare pays, I was told. Instructions are clear but wordy, and not dummy enough, thought this dummy. Labels are difficult to remove, and I cannot imagine someone elderly using this easily. Worst of all, though, and maybe I am the only person on earth who does not know perfectly where his bottom is located, but if you site the receptacle as drawn in the instructions, you might well go not toward its center. Which makes for a terrible mess and cleanup and scrubbing, all while you're trying to efficiently follow the directions pronto for resealing and doing the extra swab. Eesh. Be sure the container is toward the back of the seat, not the middle as drawn. At least for me. What a bunch of (insert your word here).

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

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  • They are a scam

    • Nampa, ID,
    • Sep 14, 2018
    • Verified Reviewer

    Nothing they told me was accurate. First, you give them over $800. But, guess what? You still have to have the colonoscopy.

    My doctor laughed at my stupidity.

    They have a product for profit only. Just get the colonoscopy and forget these fakes.

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

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  • False positive but you should do it anyway

    • Los Angeles, CA,
    • Sep 8, 2018
    • Verified Reviewer

    I'm a 63-year-old male. My father had colon cancer (and survived). I took the Cologuard test (not that hard to do) and received a "positive" result. I went for a colonoscopy and the result was that I had a small polyp, it was not cancerous and I was all clear. I was told to return in three years for another colonoscopy. So the Cologuard "positive" was not accurate. My doctor said they may have detected the polyp as a "positive." A stressful process, but it's best to go through the whole process.

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

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  • 0 out 1 people found this review helpful

    Quick and easy

    • Livonia, NY,
    • Sep 5, 2018
    • Verified Reviewer

    My experience with Cologuard was a positive one, especially because the results were NEGATIVE. I was SO relieved to not have to get a colonoscopy. The research shows that there can be significant issues with having the procedure when a person is 75 or older. My husband had a very bad experience when he had his first colonoscopy several years ago, and it took him a year or more to recover from it. So, I am very happy with my results, and I would definitely recommend the test to anyone who wants to avoid the unpleasantness of having to have an invasive procedure.

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

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  • 0 out 1 people found this review helpful

    Terrible experience

    • Nutley, NJ,
    • Aug 29, 2018
    • Verified Reviewer

    Firstly, I can't imagine anyone who is elderly performing this task. I am an 82-year-old female who can read, write and understand and I found it very difficult to use this item. It is NOTHING like they show on the television ads. Secondly, the zipper portion of the plastic bag came off, and it was impossible to put back on. I will never do this again. They have got to come up with an easier testing method.

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

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  • 4 out 4 people found this review helpful

    Don't waste your money and INSURANCE may not pay. BCBS NO.

    • Texas,
    • Aug 11, 2018
    • Verified Reviewer

    I did Cologuard November 2017, it came back NEGATIVE.

    I did a colonoscopy in April 2018, and I had 13 polyps and now have to do another colonoscopy in one year. Basically, if I had BELIEVED the NEGATIVE test result, the polyps could still be growing into CANCER. DO NOT take the test. A waste of money! BCBS will not pay the claim, so I got a WASTED test and still have to pay over $600. What a WASTE! There should be a NEGATIVE on stars.

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

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  • 4 out 5 people found this review helpful

    Does a family history of colon cancer affect test results?

    • Maryland,
    • Aug 1, 2018
    • Verified Reviewer

    I have a family history of colon cancer through my grandfather. A doctor told me that it's basically a DNA test. Well, my DNA should show that colon cancer is present in my genes due to family history. Needless to say, my test results were positive. No explanations, only positive results which automatically means "get a colonoscopy." I don't disagree, nothing can substitute for a colonoscopy. What is bothering me is there is no information regarding my question about getting positive results because of family history. A live chat popped up on one website so I asked her my question. Before she would say one word. she asked if I was a professional, I said "no," and then responds by telling me that she is not allowed to discuss the test with me, only with medical professionals. She advised that I go to the patient page to ask my question, which only quotes the test company saying high-risk people need the colonoscopy.

    I asked if she could at least point me to where I could get an answer to my question. She only repeated the same scripted answer. What, it's illegal to speak to me about anything at all, including the weather, because I'm not a doctor? The company that makes the test does not explain what I'm asking. I am considered high-risk because of the family history and therefore, should skip the test and get the colonoscopy. I don't do as I'm told just because someone told me. I do it based on knowledge, and we must advocate for ourselves when you are on the money-making allopathic medicine train. And the knowledge I'm looking for is not accessible to a patient. If you can't back your test or results with proper answers to the patient, then you are not working for the patient, you're working for some other agenda. I was tested with Cologuard by Exact Sciences.

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

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  • 8 out 10 people found this review helpful

    BCBS denied claim - out of network

    • Georgia,
    • Jul 18, 2018
    • Verified Reviewer

    BCBS denied my claim saying Cologuard is not in the network. Had I known this, I would have gotten a covered colonoscopy. Cologuard has a preformatted letter to dispute, but BCBS still denies, out of network. Cologuard advertises that it is covered by most major insurers. BCBS isn't a major insurer? False or at the very least, very questionable advertising.

    First, a Cologuard rep says that they advised me to check with the insurer before doing the test. I did not receive any such advice. Since they claim to be recording all of their calls, I asked to hear the recording of them telling me that. No response.

    The second rep says that they left several messages and I didn't respond. The only messages I got were robocalls asking why I hadn't sent back the test yet and pressing me to do so.

    I offered to pay whatever negotiated price they have with "most major insurers" but this isn't acceptable to them, they want me to pay an exorbitant full retail price of $649.

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

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