FDA Approves New CRC Screening Test

This week, the U.S. Food and Drug Administration (FDA) approved Cologuard, the first stool-based colon screening test that detects the presence of blood and altered DNA that may indicate certain kinds of abnormal growths related to colon cancer or precursors to cancer. In a study of 10,000 people of average risk for colon cancer, Cologuard reportedly was able to accurately detect cancer 92% of the time when it was present in an individual’s body.

What is Cologuard?

Cologuard is a new colon cancer screening method. It is noninvasive, meaning it is done without putting any screening tool into the body, and looks at the DNA in your stool to determine if cancer or precancerous cells exist. This recently FDA approved test is becoming available in the majority of US states and territories.

What is the process for using this method of screening?

In the privacy of your own home, you’ll collect a stool sample utilizing a kit that is provided to you. Once you collect the sample, you’ll package it in a prepaid, preaddressed box. From there, the package will be shipped via UPS to the Exact Science Laboratory.


Do I need to do any sort of prep for this test?

No. You can maintain your normal diet and medications.

What is DNA testing?

DNA is continuously shed from cells in the intestinal lining, where it is then passed into the stool. If cancer or precancerous cells are present, abnormal cells will shed into the colon and stool along with normal cells. Exact Sciences then uses a molecular biology process to capture the DNA for further analysis.

FIT and FOBT tests look at stool too. How is the Cologuard test different?

FIT and FOBT are different than Cologuard in a few ways. First, FIT and FOBT are only able to detect if blood is present in the stool. Additionally, these tests are not entirely comprehensive. FOBT is more specific to finding blood from further up in the digestive tract, whereas FIT is more specific to finding blood coming from the lower gastrointestinal tract. Also, it is recommended that multiple bowel movements be reviewed for testing. FOBT also require a diet modification prior to taking the test. Cologuard only requires one bowel movement, addresses the entire digestive tract, does not require diet modifications and is able to look for blood and altered DNA.

If they find altered DNA and/or blood in my stool, will I still need to get a colonoscopy?

Yes. Unlike a colonoscopy, Cologuard cannot remove any growths in your colon or allow a doctor to visually see your colon.

How can I find a doctor that offers Cologuard?

Since this test was only recently approved by the FDA, not every doctor will have this test readily available. However, feel free to ask your doctor about getting the test. They can contact Exact Sciences to learn more. You can also contact Customer Support for Exact Sciences by calling 1-844-870-8870.

How fast will I have my results?

Results will be mailed to your doctor within 2 weeks from the time the sample is received at the laboratory.

Is Cologuard covered by insurance?

Cologuard is currently not covered by private or public health insurance, but Exact Sciences and the Centers for Medicare & Medicaid Services (CMS) are actively working to make this possible. Currently, the maximum out of pocket cost for Cologuard is $599.

How often should I use the Cologuard screening method?

The frequency at which this test should be conducted is something that will be determined over time as additional studies are performed. The Centers for Medicare and Medicaid Services are proposing that this test be covered once every 3 years for Medicare beneficiaries who meet certain criteria. However, a decision has yet to be finalized.

Can Cologuard replace the need to get a colonoscopy when I turn 50?

Cologuard is not intended to replace the use of colonoscopy but rather serve as another tool for clinicians to offer patients in an effort to get them screened.

Do I need to go through my doctor to have access to the Cologuard test?

Cologuard is only available to patients through a healthcare provider. A patient will then receive the kit in the mail at their home and the test results will then be mailed directly to the patient’s medical provider.



Since the specifics around Cologuard are technical in nature, we’re referring questions to or to their Customer Support Center at 1-844-870-8870 for more information. Also, the full press release can be found here. Don’t forget, the Colon Cancer Alliance serves as a source of information about colon health.  If you have additional questions about colon cancer screening or are in need of support, please contact our free Helpline at (877) 422-2030. We’re here to help!