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The study behind Cologuard Plus: the new stool test caught 94% of bowel cancers and produced fewer false alarms than the original.
Among 20,176 participants with colonoscopy as the reference (NEJM 2024), sensitivity for colorectal cancer was 93.9% for the next-generation test versus 67.3% for FIT, sensitivity for advanced precancerous lesions 43.4% versus 23.3%, and specificity for advanced neoplasia 90.6% versus 94.8%. Specificity was higher than in the original DeeP-C study, which translates into fewer unnecessary colonoscopies per cancer found.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares Exact Sciences (Abbott), Sensitivity and specificity, Faecal immunochemical test (FIT), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood).
Shares Cologuard Plus, Exact Sciences (Abbott), Faecal immunochemical test (FIT), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood).
Shares Cologuard Plus, Sensitivity and specificity, Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), DNA methylation profiling.
Shares Cologuard Plus, Exact Sciences (Abbott), Faecal immunochemical test (FIT), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood).
Shares Sensitivity and specificity, Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), DNA methylation profiling, Colorectal cancer.
Shares Faecal immunochemical test (FIT), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Colorectal cancer.
Shares Exact Sciences (Abbott), Faecal immunochemical test (FIT), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Colorectal cancer.
Shares Faecal immunochemical test (FIT), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Colorectal cancer.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/