September 23, 2019
1 min read

Cologuard Approved for Adults Aged 45 and Older

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Cologuard, a non-invasive colorectal cancer screening test, has been approved for use in at-risk patients aged 45 and older.

Previously approved in 2014 by the FDA for use in patients aged 50 years and older, the test uses a biomarker panel to analyze patients’ stool for 10 unique DNA markers as well as hemoglobin.

“With an increased trend in younger adults being diagnosed with colorectal cancer, an at-home, noninvasive screening option could be a choice that leads them to get screened,” Paul Limburg, MD, MPH, AGAF, chief medical officer of Exact Sciences and a gastroenterologist at the Mayo Clinic, told Healio Gastroenterology and Liver Disease. “It’s important for advocacy organizations and health care providers to continue working together to ensure at-risk populations have access to broadly recommended screening options.”

Paul Limburg
Paul Limburg

Cologuard’s (Exact Sciences) approval aligns with the ACS’s update to its colorectal screening guidelines in May 2018, which lowered the screening age from 50 to 45.

Cologuard’s original approval followed a 90-site prospective study of 10,000 patients in The New England Journal of Medicine. The test was included in the 2016 USPSTF’s Recommendation Statement for Colorectal Cancer.

“The goal of initiating colorectal cancer screening in a younger population is to facilitate screen-detection of both precancerous polyps and localized, more curable malignancies,” Limburg said. “This should help interrupt the recent trends observed for early-onset colorectal cancer incidence and mortality.” – by Eamon Dreisbach


Bibbins-Domingo K, et al. JAMA. 2016;doi:10.1001/jama.2016.5989.

Disclosure: Limburg serves as Chief Medical Officer for Exact Sciences through a contracted services agreement with Mayo Clinic. Limburg and Mayo Clinic have contractual rights to receive royalties through this agreement.