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:
- The ascending colon, which attaches to the small intestine and runs along the lower-right part of the abdomen.
- The transverse colon, which runs across the midsection, just underneath the stomach,
- The descending colon, which runs down the left side of the abdomen, and
- 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.
“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.”
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!
The 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!