{"entity":{"id":"cologuard","kind":"drug","name":"Cologuard","aka":[],"tldr":"A home stool test done every three years that looks for cancer DNA and hidden blood; a positive result means you need a colonoscopy.","summary":"Cologuard (Exact Sciences) was approved by the FDA on 11 August 2014 (PMA P130017) for average-risk adults, the first stool DNA screening test. In the pivotal DeeP-C study (NEJM 2014, 9,989 participants) sensitivity for colorectal cancer was 92.3% versus 73.8% for FIT, sensitivity for advanced precancerous lesions 42.4% versus 23.8%, and specificity 86.6% versus 94.9%. It is a USPSTF-endorsed option at a three-year interval, covered by Medicare, and by 2024 more than 16 million tests had been performed. Its weakness is the false-positive rate, which sends about one in eight negative-for-cancer people to colonoscopy, and its limited detection of polyps compared with colonoscopy.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Cologuard","links":[{"label":"FDA PMA P130017","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130017"},{"label":"DeeP-C (NEJM 2014)","url":"https://doi.org/10.1056/NEJMoa1311194"},{"label":"USPSTF colorectal cancer screening (2021)","url":"https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/colorectal-cancer-screening"}],"tags":["test"],"related":["cologuard-plus","shield"],"cancers":["colorectal"],"sections":[],"technologies":["colorectal-screening","methylation-profiling"],"targets":[],"drugs":[],"companies":["exact-sciences"],"institutions":[],"pathways":[],"terms":["fit-test","screening","ppv"],"trials":["deep-c"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["What a result means: negative means repeat in three years; positive means a diagnostic colonoscopy, and most positives turn out not to be cancer."],"brand":"Cologuard","modality":"Multitarget stool DNA colorectal cancer screening test","mechanism":"Stool sample analysed for methylated NDRG4 and BMP3, mutant KRAS, and faecal haemoglobin, combined by an algorithm into a positive or negative result.","approvals":[{"region":"US","year":2014,"indication":"Colorectal cancer screening in average-risk adults aged 50 and older (later 45 and older)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/cologuard/","neighbours":{"drug":[{"id":"cologuard-plus","kind":"drug","name":"Cologuard Plus","route":"/drugs/cologuard-plus/"},{"id":"shield","kind":"drug","name":"Shield","route":"/drugs/shield/"}],"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"early-onset-colorectal","kind":"cancer","name":"Early-onset colorectal cancer (under 50)","route":"/cancers/early-onset-colorectal/"}],"technology":[{"id":"colorectal-screening","kind":"technology","name":"Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood)","route":"/technologies/colorectal-screening/"},{"id":"methylation-profiling","kind":"technology","name":"DNA methylation profiling","route":"/technologies/methylation-profiling/"},{"id":"multitarget-stool-rna-test","kind":"technology","name":"Multitarget stool RNA test (ColoSense)","route":"/technologies/multitarget-stool-rna-test/"}],"company":[{"id":"exact-sciences","kind":"company","name":"Exact Sciences (Abbott)","route":"/companies/exact-sciences/"}],"term":[{"id":"fit-test","kind":"term","name":"Faecal immunochemical test (FIT)","route":"/terms/fit-test/"},{"id":"ppv","kind":"term","name":"Positive predictive value (PPV)","route":"/terms/ppv/"},{"id":"screening","kind":"term","name":"Screening","route":"/terms/screening/"}],"trial":[{"id":"deep-c","kind":"trial","name":"DeeP-C","route":"/trials/deep-c/"}],"paper":[{"id":"paper-imperiale-multitarget-stool-dna-screening-nejm-2014","kind":"paper","name":"Multitarget stool DNA testing for colorectal-cancer screening","route":"/key-papers/paper-imperiale-multitarget-stool-dna-screening-nejm-2014/"}],"idea":[{"id":"idea-crc-screening-uptake-and-age-extension","kind":"idea","name":"Treat screening uptake, not test sensitivity, as the thing to optimise, and settle the age extension with a trial rather than a model","route":"/ideas/idea-crc-screening-uptake-and-age-extension/"}]}}