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!

Read Next: Sugar Versus Artificial Sweeteners: What’s Better for You?


Read 97 Cologuard Test Customer Reviews and Complaints

Write a Review
Average Customer Rating: 1.6
Rating Snapshot:
5 star: 9 4 star: 4 3 star: 3 2 star: 5 1 star:  76
Bottom Line: 16% would recommend it to a friend
Showing 1-11 of 97
Sort reviews by:

  • 4 out 4 people found this review helpful

    Never got results and they were positive...

    • Connecticut,
    • Nov 20, 2019
    • Verified Reviewer

    I never wanted to have a colonoscopy. I had a far removed cousin who had one and had a tear as a result and sadly died.

    Okay, so now I felt every year my gyn and my internist would ask me "Have you had a colonoscopy" and finally I went to a gastroenterologist and told her my qualms and anxieties so we reached a compromise. I would do the non-invasive Cologuard Test and depending on the results would then decide how to proceed or not.

    In end of July I received my kit and by August I had done the test.

    The test itself is simple to follow and they give you great step-by-step instructions and on phone help whenever you need it.

    One opens the box and takes out the various pieces. One piece is to place under one's toilet seat. Another is a collection container that fits into that after the seat has been put down. You go to the bathroom as you normally would and then you take a scraping from the sample to put into a vial. Then you pour a bottle of preservative over the sample in the large container. Label the vial and sample box (all are supplied and easy to write on and stick on samples).

    Then you close the box and put on the return label. I called for FedEx to pick up and then it was all done. That part was great. I couldn't say enough good things.

    After numerous phone calls and emails and a letter or two from the people at Cologuard. I have to say they were exhaustive in their pre-testing attention. A few weeks to a month passed, I received a letter saying the results had been sent to my Gastroenterologist. I called - the machine gave me different prompts and I used the prompt that said: "If you want to talk with a clinician regarding your test results press this number."

    I left a message. I heard nothing. I forgot about it and felt if it was a bad result that I would have heard.

    I left another message and was now feeling after a week and no response that I should call Cologuard. I called and they were able to tell me that a fax HAD been sent to my doctor. Hmmm. The next day I called the office and this time I spoke with the receptionist. She checked out my file. "No, they hadn't received any results for me." I called Cologuard again. I was told they would resend. They also said I could receive my own results IF I filled up a form and this I did and faxed them in. A day later I received a fax back. They needed the forms resent as the fax was not complete. I decided to instead send the info by email. The next day I called the doctor's office and left a message with the receptionist. I received a call from the doctor who left a message as my phone was not with me. She said I should call the office to discuss how I'd like to proceed with my results. Well, I still didn't have my results so I called back and no answer. I got another message that said to call the office and the PA would let me have my results. I called a few times and she was with a patient. Finally she reached me to tell me that the results were positive and I should schedule a colonoscopy. That was when I called back Cologuard and told them that I just got the results now 4 months later. I asked them about the fax which apparently was the incorrect fax number (though I don't know how this would have happened - unless someone was handwriting the fax number from the doctor's office, or they misread the fax number at Cologuard). But it happened. I asked if they do a follow-up call, especially when a result is positive and they said they did.

    So no matter what happened I am going to have to face a colonoscopy and the stress is unimaginable. It is made many times worse as the result was positive and because all these months have passed. I think this test has potential but for me it would have been far less stressful had I just gone ahead and had the bloody colonoscopy. I have to wait a month before I could be scheduled so in all it will be over 5 months from when I received the test to the colonoscopy. I think they need to make sure the doctor has received positive test results. I think the patient also should be told their results. Thankfully to me, I followed through until I got an answer.

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

    Help others find the most helpful reviews

    Was this review helpful?

    yes no

  • 4 out 5 people found this review helpful

    Not recommended

    • Phoenix, AZ,
    • Nov 14, 2019
    • Verified Reviewer

    Unfortunately, I feel scammed by Cologuard and my insurance. Even after an inquiry to both before pursuing the Cologuard option neither party informed me that if your preventative services cover both the Cologuard and colonoscopy and if Cologuard comes back positive it negates the colonoscopy as a preventative screen covered by your plan. So, choose colonoscopy. Otherwise, you will pay out of pocket for the colonoscopy anyway if Cologuard comes back positive. The Cologuard is not worth it. It’s a scam to take money and the insurance now takes your money for the colonoscopy. Just get the colonoscopy if you are concerned or want to be checked. Don’t give Cologuard the money!

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

    Help others find the most helpful reviews

    Was this review helpful?

    yes no

  • 6 out 6 people found this review helpful

    I would NOT recommend this!

    • Whittier, CA,
    • Nov 8, 2019
    • Verified Reviewer

    I would NOT recommend this test. My test came back positive and scared me to death. I had a follow-up Colonoscopy which was normal. Get a Colonoscopy and not this test! The Colonoscopy was not bad. You are asleep. The only thing that is not pleasant is the liquid you have to take the night before. I'm normally not a complainer but again this is not a test I would recommend. As a last comment, my insurance paid a good portion but I still had to pay $258.00.

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

    Help others find the most helpful reviews

    Was this review helpful?

    yes no

  • 2 out 10 people found this review helpful

    Very good procedure

    • New York,
    • Nov 5, 2019
    • Verified Reviewer

    I recently had a Cologuard Test and would recommend it to others. It was easy and what I consider less risky than a standard colonoscopy, which has possibilities of contamination, colon tears, and reactions to the anesthesia they must give you before the procedure. I am a tenured healthcare provider and have no affiliation with Cologuard. However, my test came back negative, and it's the fact that it's 92% accurate when checking for colon cancer. Some of the reviews I read on here must be from the Colonoscopy Manufactures. They're worried that DNA tests will replace the old Guard and make EXPENSIVE outpatient procedures obsolete. This is my opinion. My medically educated opinion.

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

    Help others find the most helpful reviews

    Was this review helpful?

    yes no

  • 4 out 4 people found this review helpful

    Scam

    • Pennsylvania,
    • Oct 31, 2019
    • Verified Reviewer

    My husband and I received a voicemail on our cell phones about a Cologuard Test being in the mail. One of us then received notification of an estimated delivery date from UPS. Neither of us had requested this test or discussed it with our health care provider. Like, total news to us!

    We contacted Exact Sciences via a Web chat and talked with "Nick". When Nick discovered that I'm a person, not a health care provider, he (?) shut the chat down.

    This feels very much like a scam. How did these people get our names, phone numbers, e-mail addresses? My name on my medical records is unique. Did my PCP order this? Did Medicare? Does my PCP get a benefit form completed tests? Does the proctologist get a benefit when a patient comes in for a full colonoscopy after a 'positive' result, even if that result was a false positive?

    I suspect this is a major scam on the patient and insurance companies with a tangible benefit to physicians or providers in general.

    Don't do it.

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

    Help others find the most helpful reviews

    Was this review helpful?

    yes no

  • 8 out 8 people found this review helpful

    Cologuard misrepresents

    • Newark, DE,
    • Oct 30, 2019
    • Verified Reviewer

    One day ago I had a colonoscopy at a local medical center. Much to my great relief, the procedure showed that I was healthy. Colonoscopy was indicated, however, due to a positive Cologuard Test. Two previous colonoscopies in two earlier decades showed a healthy colon. I had no reason to believe anything had changed prior to using Cologuard.

    Although I'd recently turned 75, my new medical provider - a nurse practitioner - thought I should have either a Cologuard Test or colonoscopy. I opted for Cologuard. After getting the results, my anxiety was off the charts.

    In Cologuard's patient information, the frequency of false positives and false negatives is not clearly reported. Furthermore the patient information does not provide any indication that Cologuard might be less useful in senior populations. At the conclusion of my colonoscopy yesterday, my board-certified gastroenterologist informed me that false positives with Cologuard were 40% for people in my age range! I was beyond shocked and angry!

    Exact Sciences is making lots of money at the financial and emotional expense of the public. They need to revisit the science behind their product and come clean in reporting as much to medical professionals and the public at large. And the FDA needs to issue guidelines and warnings to providers and consumers to insure unnecessary anxiety.

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

    Help others find the most helpful reviews

    Was this review helpful?

    yes no

  • 5 out 5 people found this review helpful
    Updated review

    Update

    • Lansing, MI,
    • Oct 24, 2019
    • Verified Reviewer

    Be aware - If your Cologuard comes back positive (and it may be a false positive) you will now need a "diagnostic" colonoscopy, instead of a routine screening colonoscopy and your insurance may no longer cover it in full. Just get the colonoscopy, it's not that bad.

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

    Help others find the most helpful reviews

    Was this review helpful?

    yes no
    • Previous review
    • Oct 23, 2019

    Counts as your 1 colonoscopy per year on insurance

    My insurance considers a Cologuard Test a colonoscopy and NO ONE will tell you this! When my husband's Cologuard Test came back positive he of course needed a colonoscopy. Surprise! The insurance would not cover the colonoscopy because he already had one this year - the Cologuard Test! One of the few things insurance will cover before the giant deductibles and cologuard manged to screw it up. Don't waste and time and money with this test, just get a colonoscopy.

    (read moreread less...)

  • 2 out 3 people found this review helpful

    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

    Help others find the most helpful reviews

    Was this review helpful?

    yes no

  • 3 out 3 people found this review helpful

    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

    Help others find the most helpful reviews

    Was this review helpful?

    yes no

  • 0 out 4 people found this review helpful

    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

    Help others find the most helpful reviews

    Was this review helpful?

    yes no

  • 2 out 2 people found this review helpful

    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

    Help others find the most helpful reviews

    Was this review helpful?

    yes no

Showing 1-11 of 97

Write a Review for Cologuard Test!

Share your experience to help others shop smarter & discover great products.

Write a Review