FDA approves first non-invasive DNA test for colorectal cancer

Big news in the colorectal cancer prevention and screening community yesterday! In a never-before-seen move, the Food & Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) jointly proposed Cologuard as a new option for colorectal cancer screening.

What is Cologuard?

toilet-fda-approved-cologuardCologuard, produced by Exact Sciences, is a non-invasive (not requiring insertion of instruments into the body), stool-based (you test your poo) DNA test designed to analyze the presence of blood and certain DNA mutations in a patient’s stool sample that can indicate cancer and/or precancerous polyps. Cells of DNA are released into the stool continuously as part of the digestive process. There are already at-home screening options that look for blood in the stool. The new Cologuard test also looks for blood and includes an additional analysis for abnormal DNA that may indicate there’s a tumor or polyp.

The test creates an option for those who refuse to get an invasive colonoscopy – those who experience no symptoms but need screened. It makes screening easier than ever – simply collect a sample of your poo (feces) and mail it in to determine if you’re at risk or showing signs of colorectal cancer. Don’t worry –you just need a small sample (less than a size of a quarter) for the test. (But be sure to carefully follow instructions & read the directions in the kit!)

“This approval offers patients and physicians another option to screen for colorectal cancer,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health. “Fecal blood testing is a well-established screening tool and the clinical data showed that the test detected more cancers than a commonly used fecal occult test.”[1]

You may have heard of similar non-invasive screening options, the FIT test and the fecal occult blood test (FOBT). The Cologuard test works in a similar way to an FOBT except that in addition to testing the stool sample for blood, the test can also detect certain genetic markers.

“Cologuard detects hemoglobin, a protein molecule that is a component of blood. Cologuard also detects certain mutations associated with colorectal cancer in the DNA of cells shed by advanced adenomas as stool moves through the large intestine and rectum.”1

And when it comes to reliability among the non-invasive screening tests, Cologuard is showing promise not only for detection of cancer, but detection of pre-cancerous polyps too. The method used by Cologuard is a different from a single marker fecal blood test (FOBT). This feature is promising because it’s reliable and it elevates the sensitivity of non-invasive tests to prevent cancer and identify the presence of precancerous polyps.

“Cologuard detected 92 percent of colorectal cancers and 42 percent of advanced adenomas in the study population, while the FIT screening test detected 74 percent of cancers and 24 percent of advanced adenomas.”

Receiving FDA Approval

Receiving FDA approval was no small task. Cologuard was subject to a prospective, multi-centered, pivotal trail, called the “DeeP-C Study.” This trial enrolled 12, 776 patients with over 90 sites. The results from this clinical trial in the community was essential to demonstrate safety and effectiveness to the FDA.

In March 2014, Fight Colorectal Cancer provided comments  to the FDA  providing input and support for innovative and reliable screening options. The panel’s recommendation for the test was positive.

The FDA and CMS’s relatively speedy approval will open new doors to the 23 million Americans yet to be screened for colorectal cancer.

Current Screening Guidelines

Although the U.S. Preventive Services Task Force guidelines (USPSTF) for colorectal cancer screening[2] have not changed to include stool DNA testing, the standard set by Medicare yesterday is sure to help this type of non-invasive testing gain traction.

“This is the first time in history that FDA has approved a technology and CMS has proposed national coverage on the same day,” said Patrick Conway, chief medical officer and deputy administrator for innovation and quality for CMS. “This parallel review represents unprecedented collaboration between the two agencies and industry and most importantly will provide timely access for Medicare beneficiaries to an innovative screening test to help in the early detection of colorectal cancer.”

This test is a solid option for patients to consider if you are not high risk, which means:  no family history; no history inflammatory bowel disease; and no symptoms. We encourage all in this scenario to discuss this with a doctor.

Below outlines CMS’s proposed guidelines for Cologuard:

“CMS proposes to cover the Cologuard test once every three years for Medicare beneficiaries who meet all of the following criteria:

  • age 50 to 85 years,
  • asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test (FOBT) or fecal immunochemical test (FIT), and
  • average risk of developing colorectal cancer (no personal history of adenomatous polyps, of colorectal cancer, or inflammatory bowel disease, including Crohn’s Disease and ulcerative colitis; no family history of colorectal cancers or an adenomatous polyp, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer).”

Patients:  Click here for instructions on using Cologuard.

Medical professionals:  Click here to get tools from Cologuard’s compliance program.


Patient Tips to Remember

While it’s exciting and encouraging to see FDA and CMS work together to expedite this option, it’s important to remember a few things:

  1. If the test is positive, your next step is colonoscopy.
  2. If you receive a negative result, CMS is recommending routine screening using Cologuard every three years.
  3. There are no dietary restrictions when providing a sample.
  4. Patients should not provide a sample to Cologuard if they have diarrhea, blood in their urine, bleeding hemorrhoids, bleeding cuts or wounds on their hands, rectal bleeding or menstruation.
  5. To ensure the integrity of the sample, the laboratory must process a patient’s sample within 72 hours. Be sure to follow the directions!
  6. The Cologuard blood test may come at a higher price tag for some patients depending on insurance. Costs may be between $400-600. Be sure to talk to your insurance provider and request that this test and the laboratory fees be covered.


80% by 2018 – Getting Closer

We see yesterday’s FDA & CMS joint-decision as the approval of a breakthrough in screening and we’re hopeful with more options we can get closer to the nationwide goal of seeing 80% screened by 2018.


Disclosure: Fight Colorectal Cancer has accepted funding for projects and unrestricted educational grants from Exact Sciences, the producers of Cologuard. We have ultimate authority over website content.



See all screening options for colorectal cancer.

Read our comments to the FDA regarding Cologuard

Read the FDA’S press release about Cologuard

Get instructions for using Cologuard.

Medical Professionals – get tools for the Cologuard compliance program

Fund the Fight – keep our voice heard.



[1] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm409021.htm 

[2] http://www.uspreventiveservicestaskforce.org/uspstf/uspscolo.htm