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On October 4, 2024, the U.S. Food and Drug Administration (FDA) approved “Cologuard Plus” for colorectal cancer screening. Cologuard Plus is a “next-generation” update of the currently available Cologuard multitarget stool DNA test. This new version includes more-recently identified markers of colorectal neoplasia, and like the original Cologuard, it also includes a test for fecal hemoglobin.
Approval of Cologuard Plus was based on a clinical trial showing 94% sensitivity for colorectal cancer and 43% sensitivity for advanced precancerous lesions (NEJM JW Gen Med Apr 1 2024 and N Engl J Med 2024; 390:984). That study also showed that Cologuard Plus was substantially more sensitive — but slightly less specific — than a fecal immunochemical te…