{"entity":{"id":"cologuard-plus","kind":"drug","name":"Cologuard Plus","aka":[],"tldr":"The updated Cologuard, approved in 2024, which keeps the high cancer detection rate while causing fewer false alarms.","summary":"Cologuard Plus was approved by the FDA in October 2024 and launched in 2025. In the BLUE-C study (NEJM 2024, more than 20,000 participants) sensitivity for colorectal cancer was 93.9% versus 67.3% for FIT, sensitivity for advanced precancerous lesions was 43.4% versus 23.3%, and specificity for advanced neoplasia was 90.6% versus 94.8%, a roughly 30% reduction in false positives compared with the original Cologuard. The test is used every three years in average-risk adults aged 45 and older. Exact Sciences, now being acquired by Abbott, positions it against blood tests such as Shield, whose sensitivity for precancerous polyps is much lower.","status":"approved","asOf":"2026-09-10","links":[{"label":"BLUE-C (NEJM 2024)","url":"https://doi.org/10.1056/NEJMoa2310336"},{"label":"Exact Sciences: Cologuard Plus","url":"https://www.exactsciences.com/"}],"tags":["test"],"related":["cologuard","shield"],"cancers":["colorectal"],"sections":[],"technologies":["colorectal-screening","methylation-profiling"],"targets":[],"drugs":[],"companies":["exact-sciences"],"institutions":[],"pathways":[],"terms":["fit-test","screening","sensitivity-specificity"],"trials":["blue-c"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["What a result means: the same as Cologuard, with fewer people sent for a colonoscopy they did not need."],"brand":"Cologuard Plus","modality":"Next-generation multitarget stool DNA colorectal cancer screening test","mechanism":"Redesigned stool test measuring methylated DNA markers (LASS4, LRRC4, PPP2R5C, ZDHHC1) and faecal haemoglobin with a new algorithm, replacing the mutation markers of the original test.","approvals":[{"region":"US","year":2024,"indication":"Colorectal cancer screening in average-risk adults aged 45 and older"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/cologuard-plus/","neighbours":{"drug":[{"id":"cologuard","kind":"drug","name":"Cologuard","route":"/drugs/cologuard/"},{"id":"shield","kind":"drug","name":"Shield","route":"/drugs/shield/"},{"id":"simplescreen-crc","kind":"drug","name":"SimpleScreen CRC","route":"/drugs/simplescreen-crc/"}],"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/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":"screening","kind":"term","name":"Screening","route":"/terms/screening/"},{"id":"sensitivity-specificity","kind":"term","name":"Sensitivity and specificity","route":"/terms/sensitivity-specificity/"}],"trial":[{"id":"blue-c","kind":"trial","name":"BLUE-C","route":"/trials/blue-c/"}],"target":[{"id":"ppp2r5c","kind":"target","name":"PPP2R5C","route":"/targets/ppp2r5c/"}]}}