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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31 Consumer Reviews for Cologuard Test

Average Consumer Rating: 1.6
Rating Snapshot:
5 star: 2 4 star: 3 3 star: 0 2 star: 1 1 star:  25
Bottom Line: 19% would recommend it to a friend
Showing 1-11 of 31
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  • Cologuard and BCBS

    • Lincoln, NE,
    • Jun 22, 2018
    • Verified Reviewer

    BCBS does not cover Cologuard and Cologuard is aware of this. You will end up paying $650.00 out of your pocket! Cologuard will tell you they have ways to get Blue Cross to pay, but they don't! Blue Cross is known for not paying claims, and Cologuard still accepts and processes the sample knowing that all Blue Cross customers are footing the bill. Don't do it if you can't afford the $650.00.

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

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  • 5 out 5 people found this review helpful

    False positive, a nerve-wracked six weeks!

    • 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

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  • 3 out 3 people found this review helpful

    Sketchy

    • Fairfax, VA,
    • Jun 11, 2018
    • Verified Reviewer

    GYN vs. GP recommended this test. GYN pushed for three years (Why? Seems odd). I already had a FIT test done by GP who knew nothing about Cologuard. After three years of neg FIT test, Cologuard came back positive with no details. Like others, they could not say if it was DNA or blood in the stool.

    I called and Cologuard gave me some lame excuses like talk to your doctor (who sent me the results with zero details), they won't provide diagnosis, the FDA recommends they don't give specific details and finally it was just DNA testing. So why exactly is Cologuard better than other known tests out there and what specifically are they testing for? The whole reason I took this was for the details.

    Additionally, since taking this test, I am now getting all kinds of spam from companies like "Life Line Screening," and it makes me wonder what they are doing with my personal information. It could just be a coincidence but, Facebook anyone?

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

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  • 5 out 5 people found this review helpful

    Skip this test - get a colonoscopy

    • Ypsilanti, MI,
    • May 20, 2018
    • Verified Reviewer

    Like many others here, my insurance paid $650 for the Cologuard testing. I received a call from the recommending physician about 10 days after mailing in the sample - positive for colon cancer. I scheduled an immediate colonoscopy at U of M, where they have some of the best gastroenterologists in the nation. After a thorough 3-day prep and a complete test, completely negative. My physician advised that Cologuard is known for false/positive results. Makes me wonder how many are shown as negative when they, in fact, have cancer. I will NEVER do this test again. Bite the bullet and get the real deal to know the entire story and sleep at night.

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

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  • 5 out 5 people found this review helpful

    Is Cologuard a valid alternative to a colonoscopy?

    After 10 years of annual FOBT/FIT tests at age 60, my primary care physician recommended to use Cologuard for more detailed test results. Being generally healthy and without a family history of colorectal issues, I was surprised that the Cologuard test result came back positive for some kind of problems in the colon. A follow-up colonoscopy was ordered. The finding was three tiny polyps that were unremarkable. The pathology report confirmed there were neither abnormal nor precancerous cells present, making the test result a false positive. My health insurance was all too eager to pay for Cologuard as preventive care and covered it 100%. The colonoscopy now is a follow-up procedure and consequently requires a copay, it no longer qualifies as a preventive procedure!

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

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  • 9 out 9 people found this review helpful

    Cologuard uses bribery to get patients to return kit

    • Kansas City, MO,
    • May 5, 2018
    • Verified Reviewer

    I was very surprised to get a "negative" result when I have a bleeding hemorrhoid and their instructions clearly say don't use the kit if you have a bleeding hemorrhoid. My doctor apparently didn't know Exact Sciences excluded patients with this condition when he ordered the test. So I set the kit aside for weeks presuming I'd get a positive result, not for cancer but for blood in my stool and decided not to participate.

    Exact Sciences robocalled me incessantly, and it wasn't until they offered me a $75 gift card in April to complete the test and return the kit in March, did I do so. It was easy and private but by the month of May, no gift card and bottom line, I don't trust my results.

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

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  • 16 out 16 people found this review helpful

    Cologuard is a bad test.

    • 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

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  • 17 out 17 people found this review helpful

    For me Cologuard was a waste of time and money

    • 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

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  • 15 out 16 people found this review helpful

    Do not recommend.

    Be advised that Select Health and many other insurance providers consider Cologuard an "Experimental or investigational" test and will deny coverage.

    Select Health pestered me with several robo-calls that it was time for colon screening, so I went to my doctor and was prescribed Cologuard. It took three tries of pooping in their pot and rushing it to the UPS depot to get a viable sample, then the claim was denied.

    Moral of the story: if you choose Cologuard, get prior approval from your insurance carrier. The bill is $649 for a lab test procedure. Outrageous! I have now had to go through the hassle of filing an appeal to my insurance company. Who knows how that will turn out!

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

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    • Mar 29, 2018

      C Langley

      It did not say anything about results, and whether a colonoscopy was needed. I'm researching false positives.

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  • 16 out 17 people found this review helpful

    Horrible false positive

    I would not suggest this test. They are liars. I sent in a sample, and there was a small spot of diarrhea after have a huge bowel movement that irritated my hemorrhoid causing it to bleed. I received a letter from them saying they couldn't do the test because there are no feces, just a small spot of diarrhea. In turn, they kept sending me letters to take their test again over $650 per test. Ripoff. I ignored the letters. They then sent a letter to the doctor that I was positive high-risk. What the heck. These people are total con artists and by other complaints, there are a lot of false positives.

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

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  • 14 out 15 people found this review helpful

    I would not waste money on Cologuard!

    • North Carolina,
    • Jan 30, 2018
    • Verified Reviewer

    http://www.latimes.com/business/la-fi-lazarus-20140822-column.html

    You can read the article above about the in-exactness of Exact Sciences' Cologuard. In addition, mine was not covered by insurance after the doctor stated that it would be. Does anyone know if doctors receive incentives from Exact Sciences to recommend their test?

    I would be careful when your doctor recommends this test, so you are not stuck with a $649 bill like I was.

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

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