FDA Expands Indicated Age Range for CRC Screening Tool

The FDA approved Cologuard, an at-home, noninvasive colorectal cancer screening test, to now include individuals aged 45 or older, expanding its use to a group of adults for which the disease has been on the rise in recent years, according to Exact Sciences Corporation. 

The test, designed to use a biomarker panel to analyze stool samples for certain DNA markers and blood, was first approved by the FDA in August 2014 for adults over 50 years of age. It was tested on 10,000 patients from 90 sites in a trial from which results were published in the New England Journal of Medicine in March 2014.

The approval expands on the FDA recommendation that colorectal cancer screenings begin at age 50, as cases of the cancer in younger adults have increased. Rates of colorectal cancer in adults under 55 years of age have increased annually from 2006 to 2015, according to the American Cancer Society (ACS), with more than 130,000 cases being diagnosed in Americans under 50 years of age. The ACS updated its screening guidelines in 2018 to include individuals aged 45 to 49 years, expanding on its previous indication for ages 50 and older.

"The increase has been striking in a broad context," said Xavier Llor, MD, medical director of the Colorectal Cancer Prevention Program and professor of medicine at Yale University in New Haven, Connecticut. "It’s a totally different trend when it comes to younger adults. Colon cancer is 1 cancer where screening does result in a decrease in diagnosis and mortality. It’s an obvious step to apply tools to younger individuals."

Allowing younger adults to use Cologuard means more people in this population will be screened, said Karen Simon, MD, a gastroenterologist at the Ventura County Gastroenterology Medical Group in Oxnard, California, adding that not all patients are aware of the change. Ventura County Gastroenterology Medical Group was involved in the testing of Cologuard for during its original trial.

"It’s an exciting opportunity," she said of the new approval. 

Simon said now insurance groups will begin covering the at-home test, making it available to more patients. The convenience of Cologuard also means it will appeal to a younger, working population who may struggle to take several days off of work for a colonoscopy.

Cologuard is indicated for adults of either sex who are at average risk for colorectal cancer. Of note, this screening is not a replacement for diagnostic or surveillance colonoscopies in high-risk individuals and positive tests should be followed with a diagnostic colonoscopy, according to a release issued by Exact Sciences. Patients should continue interval screenings following a negative result. 

Simon said she's seen Cologuard recommended to patients with reservations about a colonoscopy, those who are caretakers and can't afford the time a procedure would take, or those with other health problems which could worsen under a regular colonoscopy.

"It's never been the goal of the company to replace screening or diagnostic colonoscopy," she said. "What we know is a patient who has a barrier to screening doesn't get screened...The more we can relieve barriers and give people opportunities, the better off the patient will be ultimately."

Cologuard is indicated for adults of either sex who are at average risk for colorectal cancer. Of note, this screening is not a replacement for diagnostic or surveillance colonoscopies in high-risk individuals and positive tests should be followed with a diagnostic colonoscopy, according to the release. Patients should continue interval screenings following a negative result. 

Simon said she's seen Cologuard recommended to patients with reservations about a colonoscopy, those who are caretakers and can't afford the time a procedure would take, or those with other health problems which could worsen under a regular colonoscopy.

"It's never been the goal of the company to replace screening or diagnostic colonoscopy," she said. "What we know is patient who has barrier to screening doesn't get screened...The more we can relieve barriers and give people opportunities, the better off the patient will be ultimately."