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 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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  • Tricked

    I was told by my doctor that this was a good way to have the test in a non-invasive manner and that it was paid by insurance. My insurance (Blue Cross) refuses to pay, and now I am stuck with a $600 bill.

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

  • Unsuspected and tricked!

    My doctor prescribed Cologuard as a non-invasive test that would be paid in full by my insurance. Exact Sciences never advised me to contact my insurance nor informed me of my substantial out-of-pocket cost for Cologuard before sending me the kit or processing the sample. My insurance (United HealthCare) will not pay; it considers Exact Sciences to be out of network.

    I am beyond shocked that unsuspecting patients like me are billed $649 when I would never have done this test had I known my out-of-pocket charge for this non-mandatory test.

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

  • Beware of high test cost; uncomfortable test

    I was afraid to undergo a colonoscopy (bad decision, in retrospect), so I asked my doctor about the Cologuard Test. The doctor said "they" would check to see if my insurance covered it and next thing I know, the test shows up on my doorstep. Assuming it was covered (another bad move, in retrospect), I went ahead and did the test. Well, my insurance has refused to pay and now I'm being charged $649 by the company!

    I would never have taken the test had I know I would be charged such an exorbitant amount. I called the company, and it is very hard to get a hold of anyone in their billing department. It took them five days to call me back and then I wasn't home, so they left me a message and want me to call again. Will I have to wait another 5 days? It is very frustrating!

    In addition, I found the test uncomfortable (I won't go into details here, but it was not as easy as they say). Needless to say, I would not recommend this test to anyone; get a colonoscopy instead. That's what I wish I had done!

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

  • False positives or negatives

    My next door neighbor took the test, and it came back positive. He had the colonoscopy which indicated absolutely no problem, so it was a FALSE POSITIVE.

    My wife and I took the test, and both came back positive! So three people within a hundred feet all took the test, and all came back positive. Really, what are the odds? Both of our doctors recommend we have a colonoscopy. Gee, what a way to drum up business.

    I then read the instructions for the test again and found that false NEGATIVES are also possible, so in my opinion, the test is a $600 waste of Medicare money. The only thing it really does is scare you into having the colonoscopy, which makes the doctors richer, which is why they probably recommend the test.

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

  • I feel tricked

    • By Edward Scott,
    • North Carolina,
    • Jul 9, 2017
    • Verified Reviewer

    My primary care physician recommended a colon cancer screening and suggested using Cologuard by Exact Sciences. He said it would be covered and I assumed Exact Sciences would obtain prior authorization from my insurance. My insurance has refused to pay anything, and Exact Sciences has now billed me $649.00. Exact Sciences does not inform patients that not all insurances cover Cologuard nor do they contact insurances to obtain prior authorization. I was not informed of this, and I was not informed of what my financial obligation would be should my insurance decline coverage.

    If I had known I would not have chosen Cologuard and would have chosen a colonoscopy which would have been at no cost and fully covered by my insurance. I feel tricked.

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

  • Marketing promises insurance pays - you are paying 100%

    • By Thomas Stich,
    • Oakland County, MI,
    • Aug 9, 2017
    • Verified Reviewer

    My spouse and I used this test. The first concerning sign came four weeks after using the tests when we received letters from Exact Sciences requesting us to contact our insurance to convince them to pay for this service.

    I work for a high-tech company headquartered in Silicon Valley with an office in Michigan. Our insurance doesn't pay for Cologuard at all, even after explaining to the insurance and HR benefits person that taking off a day from work for colonoscopy and the distraction for preparation while I am on critical projects will benefit the company. The advertisements for Cologuard and Exact Sciences website convinces you that there is no doubt insurances pay. The sad reality is, you pay 100% out of your pocket ($649) while co-pays for colonoscopy range from $0 to a maximum of $350 for my insurance.

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

  • Poor experience

    • By L Hawk,
    • Hayward, CA,
    • Aug 21, 2017
    • Verified Reviewer

    Six months ago I completed all the necessary paperwork to obtain the Cologuard Test. My physician filled out his portion, and the forms were mailed to Exact Sciences. I never received the kit or heard from them.

    I recently called, and Exact Sciences and the woman said that I was not in their system. She said it would be better to have the doctor fax everything to them. One month ago I again visited with my physician, and we completed the forms a second time, but the MD's office faxed them to Exact Sciences. I was standing right there and watched them fax the forms.

    Now it's one month later and again no kit. I just called Exact Sciences and spoke to the same lady. All she does is give excuses.

    I give up! Very bad customer service. No follow-up. They do not care to solve the problem.

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

  • Warning: stay away from this Cologuard Test!

    • By Sue Kuchler,
    • North Carolina,
    • Aug 31, 2017
    • Verified Reviewer

    After celebrating my 50th birthday, my doctor recommended a check for colon cancer. Two options were presented; the traditional colonoscopy, which is covered 100% by insurance, or an experimental test that the Cologuard rep appears to pawn off as covered by insurance.

    This is NOT covered by insurance, and the bill will knock you to the floor!

    Their customer service reps will not budge, will not work with you and repeat over and over, "Our pamphlet emphasizes in huge bold dark letters to check with insurance prior to ordering the test." That right there, folks, appears to indicate they KNOW good and well that this isn't covered, why else the "bold, huge letters" unless it's verbiage for CSR later when the bill arrives!

    Do yourself a favor and opt for the traditional colon cancer screening! Your pocketbook will thank you!

    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

  • Doctor misinformed on process

    • By Susan Hull,
    • Ohio,
    • Sep 20, 2017
    • Verified Reviewer

    I would rather endure a colonoscopy than to use Cologuard again. I found customer service of little help when trying to explain that my doctor's office was misinformed of the billing process with insurance. I was not told of the hundred dollar reduced-fee for paying cash until after the fact which was of no help to me. Very dismayed by the whole thing and I really didn't feel that anyone listened except for the very first young man who helped me with a possible appeal. Everyone just wanted to be right and tell me I was wrong.

    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

Showing 1-11 of 104

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