FDA has approved the Exact Sciences Corp. noninvasive colorectal cancer screening test, Cologuard, for eligible average-risk individuals ages 45 and older, expanding on its previous indication for ages 50 and older.
Backed by science and clinical research in collaboration with Mayo Clinic, Cologuard is a stool DNA-based colorectal cancer screening test for average-risk individuals. Cologuard uses a biomarker panel that analyzes a person’s stool sample for 10 DNA markers, as well as blood in the stool (hemoglobin).
Last year, the American Cancer Society updated its colorectal cancer screening guidelines to include people between the ages of 45 to 49. The prior ACS recommendation called for screening to begin at age 50 (The Cancer Letter, June 1, 2018).
The label expansion, or broadening of the population for whom Cologuard is FDA-approved, extends screening to approximately 19 million average-risk people in the U.S. ages 45-49.
“About three million people have been screened for colorectal cancer with Cologuard, with nearly half of those surveyed saying they were previously unscreened. With the FDA now approving the use of Cologuard for this vulnerable 45-49 age group, we are giving health care providers a sensitive, noninvasive option that has the potential to help combat the rise of colorectal cancer rates among this younger group of people,” Exact Sciences Chair and CEO Kevin Conroy said in a statement.
Exact Sciences has designed a nationwide user-navigation system that provides 24/7 phone and online support to help people through the process of collecting and returning their samples.
