There are many patients who are resistant to colonoscopy, and the good news is, there are currently screening tests that have been approved by the Federal Drug Administration (FDA) and recommended by the United States Preventive Services Task Force (USPSTF).

These are tests designed for patients resistant to colonoscopy. They include:

  • FIT
  • gFOBT
  • CT Colonography (virtual colonoscopy)

As of April 2016, there is a new kid on the block for colorectal cancer screening: a blood test. The blood test (Septin9 DNA test) is FDA-approved for colon cancer in people who refuse other forms of screening.

The test was not included in the most recent USPSTF modeling studies that were done to compare screening options, therefore was not recommended as a routine screening test except when referring to those populations who cannot be screened by other means.

Read more:

See all screening options

Read Fight CRC’s response to the USPSTF in June 2016 regarding the updated screening guidelines

About Epi proColon

In April 2016, the FDA approved Epi proColon, a blood test that can detect methylated Septin9 DNA, which has been linked with colorectal cancer. The approval came after two multi-center clinical studies assessing the test on thousands of patients.

Of the 10 people on the panel who voted on the FDA approval, 5 felt the test’s benefits outweighed its risk, 4 did not agree with the approval and 1 did not vote. This is because there are drawbacks to the test.

For example, there is a high false-positive rate (20% versus less than 5% with FIT). The test is 72% sensitive, as compared to FIT, which is 68% sensitive. In addition, the blood test is less specific than FIT at about 81% compared to 92-95%.

Who is this test for and does insurance cover it?

The test is designed for those who are 50 and older, average-risk for colorectal cancer and are unwilling or unable to be screened by another method (FIT, colonoscopy, etc.). You can think of it as a “last line” for colorectal cancer screening.

Insurance companies are currently paying for the test – on a case-by-case basis. Check with your specific insurance carrier.

If there are issues, why was it approved by the FDA?

The FDA wants to promote colorectal cancer screening. In reference to different screening options, you may have heard the quote “the best type of test is the one that gets done!

If you think this is a good option for you, ask your doctor!


USPSTF Recommendation Statement on Epi proColon 

AACR blog on FDA Approves Blood-Based Colorectal Cancer Screening Test

Cancer Therapy Advisory article, FDA Approves First-ever Blood-based Test for Colon Cancer despite split opinion 


Fight Colorectal Cancer has received funding from epigenomics (producers of Epi proColon). Funding has come in the form of unrestricted educational grants. We maintain ultimate authority over website content and the content written in this article. Fight Colorectal Cancer never recommends or endorses any specific physicians, products or treatments for any condition.

  • Was this information helpful?
  • yes   no

Leave a Reply

Your email address will not be published. Required fields are marked *