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The pivotal study for the first stool DNA test, showing it found more cancers than the standard stool blood test at the cost of more false positives.
In 9,989 evaluable participants (NEJM 2014), sensitivity for colorectal cancer was 92.3% for the multitarget stool DNA test versus 73.8% for FIT, sensitivity for advanced precancerous lesions 42.4% versus 23.8%, and specificity 86.6% versus 94.9% among participants with non-advanced or negative findings. The FDA approved Cologuard on the basis of these data in August 2014 and Medicare covered it the same day, the first parallel FDA-CMS review.
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.
Shares Exact Sciences (Abbott), Sensitivity and specificity, Faecal immunochemical test (FIT), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood).
Shares Cologuard, Exact Sciences (Abbott), Sensitivity and specificity, Faecal immunochemical test (FIT).
Shares Cologuard, Exact Sciences (Abbott), Faecal immunochemical test (FIT), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood).
Shares Multitarget stool DNA testing for colorectal-cancer screening, Faecal immunochemical test (FIT), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Colorectal cancer.
Shares Sensitivity and specificity, Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), DNA methylation profiling, Colorectal cancer.
Shares Cologuard, Multitarget stool DNA testing for colorectal-cancer screening, Faecal immunochemical test (FIT), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood).
Shares 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.