FDA approves 23andMe Inc. to distribute direct-to-consumer genetic test for colorectal cancer risk

Prevent Cancer Foundation® warns the test may have unintended consequences for cancer prevention

Published on January 25, 2019


Contact: Hayley Cooke

The Food and Drug Administration (FDA) just approved a new genetic test from the company 23andMe Inc., which will provide direct-to-consumer testing for an increased risk of colorectal cancer. The test evaluates DNA, looking for two genetic changes that indicate the hereditary condition MUTYH-associated polyposis, which is associated with a higher risk of colon cancer. The Prevent Cancer Foundation® advises anyone considering this form of genetic testing to consult with a health care professional, as receiving a negative result may give you a false sense of your cancer risk.

Although the 23andMe Inc. test may help some people identify their risk for the hereditary condition MUTYH-associated polyposis, you should know that a negative result from the test does not rule out the possibility of developing colorectal cancer. The test exclusively monitors for two genetic variants associated with higher risk of colorectal cancer, and does not test for any other genetic variants or syndromes that increase the risk of cancer, such as familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer, also known as  Lynch Syndrome.  

This test only provides a small amount of genetic information, and cannot predict your overall risk of developing colorectal cancer. Only 5-10 percent of cancer cases are caused by all inherited gene mutations. Genetic testing, regardless of result, should never take the place of colorectal cancer screenings, which should begin at age 45 for persons of average risk. Speak with your health care professional about which screening option is right for you.

You can also make healthy choices to lower your risk of colorectal cancer, such as exercising, limiting alcohol, never smoking, maintaining a healthy weight and eating a healthy diet.

“This genetic test for colorectal cancer is extremely limited, and has the potential to mislead people with negative results into believing they do not need recommended cancer screenings,” said Carolyn Aldigé, Founder and CEO of Prevent Cancer Foundation®. “With screening, we can actually prevent colorectal cancer by detecting and removing polyps before they become cancer, or we can detect cancer early, which saves lives.  Everyone needs to be vigilant about getting screened and leading a healthy lifestyle to prevent cancer.” 

In March 2018, the FDA approved a 23andMe Inc. direct-to-consumer genetic test for breast cancer, which looks for three BRCA1/BRCA2 breast cancer gene mutations most common in people of Ashkenazi (Eastern European) Jewish descent. This test also has the potential to give consumers a false sense of their cancer risk, regardless of result, and should not be taken in lieu of other breast cancer prevention and screening recommendations.

If you are considering genetic testing, the Prevent Cancer Foundation® recommends meeting with a genetic counselor. Your counselor will discuss the full picture of your health and risk factors (including family history), the pros and cons of genetic testing and your options after you do that test. You should check with your insurance company before meeting with a genetic counselor to see if the meeting and genetic testing are covered by your insurance.

For more information on how to reduce your risk of colorectal cancer, visit

Sign up to get the latest about cancer prevention and early detection directly in your inbox.