{"entity":{"id":"epi-procolon","kind":"drug","name":"Epi proColon (Septin 9 blood test for bowel cancer)","aka":["Septin 9 test","mSEPT9"],"tldr":"The first FDA-approved blood test for bowel cancer screening (2016), meant only for people who have been offered and declined the recommended screening tests.","summary":"The FDA approved Epi proColon on 12 April 2016 (PMA P130001; current applicant New Day Diagnostics). It detects methylated Septin 9 DNA in plasma by real-time PCR and is indicated \"to screen adults of either sex, 50 years or older, defined as average risk for CRC, who have been offered and have a history of not completing CRC screening\"; tests recommended in the USPSTF 2008 guidelines should be offered and declined first, and a positive result should be followed by diagnostic colonoscopy. Later blood tests (Shield in 2024, SimpleScreen CRC in 2026) were approved as screening options for average-risk adults without that restriction.","status":"approved","asOf":"2026-11-04","links":[{"label":"FDA PMA P130001","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130001"}],"tags":["test","screening-test"],"related":["shield","simplescreen-crc","cologuard","fda-device-databases"],"cancers":["colorectal"],"sections":["early-detection","diagnostics"],"technologies":["colorectal-screening"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["screening"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Epi proColon","modality":"Blood test for methylated Septin 9 DNA (colorectal screening)","mechanism":"Real-time PCR detects methylated Septin 9 DNA, a marker associated with colorectal cancer, in plasma.","approvals":[{"region":"US","year":2016,"indication":"Colorectal screening in average-risk adults 50 and older who have declined recommended screening (PMA P130001)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/epi-procolon/","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/"}],"collection":[{"id":"fda-device-databases","kind":"collection","name":"FDA medical device databases (PMA, 510(k), De Novo)","route":"/collections/fda-device-databases/"}],"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"section":[{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"},{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}],"technology":[{"id":"colorectal-screening","kind":"technology","name":"Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood)","route":"/technologies/colorectal-screening/"}],"term":[{"id":"screening","kind":"term","name":"Screening","route":"/terms/screening/"}]}}