According to the CDC, Colon Cancer deaths have been dropping steadily for two decades. That is mostly from older adults, while incidents and issues with younger (45-54) adults are on the rise. In the spring of 2021 official guidance moved screening recommendations shifted to now include regular checks for people 45-54.
Thankfully there are a number of easy screening options that are available that do not require invasive colonoscopy. One of those options is a Fecal immunochemical test (FIT), or a poop test, that can be done at home and sent into a lab. These are the same type of tests that are done by medical providers but the sample can be collected at home and then sent to a lab. One of the more popular providers of this service is Everlywell, which makes a test that can be purchased from Amazon, CVS, and other retail stores as well as ordered directly from them.
Is Everlywell Colon Screening FDA Approved?
Yes, the results are. It appears that the Everlywell test itself is not what needs to be FDA approved for FIT testing, but rather the lab conducting the test needs to be. The colon screening kit is simply a collection tool and Everlywell works with a series of FDA approved labs, some of which execute their own variation (or LDT – Lab developed test) of hte test but all are designed to meet FDA standards.
The FIT test the Everlywell conducts is one of a few screening options , there are other types (again the CDC describes the differences), but does seem to be lower cost than DNA screenings. One of those higher cost DNA tests is marketed under the Cologuard brand name and can be acquired for 10X the price of a Everlywell test.
Overall the FIT test results are proven to be accurate. How accurate is a question of which test is used. The problem with stating the overall accuracy of the Everlywell colon test is that it is conducted in the CLIA-certified (Clinical Laboratory Improvement Amendments) which have the ability to setup their own tests. While there are limited reasons to think that the CLIA tests are totally unreliable, because of their nature of being unique to individual labs, they are hard to study in aggregate. One paper from 2017 suggests that “Further studies are warranted prior to recommending FITs that are waived under CLIA” (source).
Taking an Everlywell Stool Sample
Similar to other stool sampling, the Everlywell test is easy to execute. There are a handful of recommendations on when, during the day, you should be taking the sample but generally speaking any time that you need to go to the bathroom is an option.
To get the sample all you need to do is prep your toilet, using the test kit to put down a barrier between the water and the air. This keeps the stool, or poop, in an accessible place so that you can use the testing swab. Once you get the swab covered in sample you apply it to the testing card, then drop the whole thing in a package and ship it off to the lab. The whole process of collecting a stool sample for a FIT test takes less than 5 minutes.
Who Can Take The Everlywell Colon Cancer Screening?
Unfortunately, if you are under 45 you can not use the Everlywell tests. They will sell you a test for sure, but when you go to register the test kit and input your birthday the registration will fail. This seems like a stupid regulation based product decision, which is made worse by Everlywell’s customer service and design on how to handle the issue. When I reached out to them via their contact page the response was underwhelming:
Unfortunately, the FIT Colon Cancer Screening Test is restricted to customers who are 45 years or older. This age restriction is based on screening recommendations that are outlined by public health organizations such as the American Cancer Society. Although the FIT Colon Cancer Screening Test cannot diagnose colon cancer on its own, the results are intended to be a first step in discussing your risk and additional testing options with your healthcare provider.
Even if you have a physician recommendation, Everlywell will not register or process the test. This is especially frustrating when considering that the limited alternatives include Cologuard, which is $600+ and rarely covered for those under 45, or the significantly less accurate LetsGetChecked.
They do try to call out in the product descriptions, but the copy writer for the product listing might want to try being more explicit than simply asking “Are you 45 or older”. Something like “you will not be able to register or use this kit if you are under 45 years old. Do NOT buy.”
Everlywell vs. LetsGetChecked
Since using an Everlywell test is not an option for younger patients, finding an alternative is useful. Of course the first step is to decide is you need a screening.
LetsGetChecked offers a similar alternative to Everlywell. They let you register and take the test regardless of age. We reviewed the ease of use for the LetsGetChecked colon test previously. From the age aspect comparing these two may be a non-starter if you are under 45, since LetsGetChecked will be the only real choice.
A doctor can help with this as the right note from them (based on typical symptoms) will result in a tests required for a diagnosis. This will sometimes include the Cologuard test as well as a colonoscopy, neither of which are offered by at home services. There are some studies that suggest over testing can lead to bad results, so although it feels normal to proactively check, it might not actually be best.
If you are looking for other screening test be sure to check out the Everlywell Food Sensitivity review. LetsGetChecked offers similar products and both services have a variety of tests beyond just the colon screening.