{"entity":{"id":"simplescreen-crc","kind":"drug","name":"SimpleScreen CRC","aka":[],"tldr":"The second FDA-approved blood test for bowel cancer screening, from Freenome, sold by Abbott from late 2026.","summary":"Freenome's blood test was approved by the FDA on 24 July 2026 for average-risk adults aged 45 and older, based on the PREEMPT CRC study of more than 48,000 participants, in which sensitivity for colorectal cancer was 79.2%, specificity for advanced neoplasia 91.5%, and sensitivity for advanced precancerous lesions 12.5% (JAMA 2025). Abbott holds US commercial rights. Like Shield, the test is intended for people who decline stool tests or colonoscopy: guidelines still rank it below colonoscopy and FIT because it misses most precancerous polyps and therefore prevents fewer cancers.","status":"approved","asOf":"2026-09-24","links":[{"label":"PREEMPT CRC (JAMA 2025)","url":"https://doi.org/10.1001/jama.2025.7515"},{"label":"FDA approval (MedTech Dive)","url":"https://www.medtechdive.com/news/freenome-secures-fda-nod-for-blood-based-colorectal-cancer-test/826290/"},{"label":"Freenome","url":"https://www.freenome.com"}],"tags":["test"],"related":["shield","cologuard-plus"],"cancers":["colorectal"],"sections":[],"technologies":["colorectal-screening","liquid-biopsy","methylation-profiling"],"targets":[],"drugs":[],"companies":["freenome","abbott"],"institutions":[],"pathways":[],"terms":["cfdna","screening","sensitivity-specificity"],"trials":["preempt-crc"],"people":[],"bottlenecks":[],"keyPapers":["paper-preempt-crc-shaukat-jama-2025"],"journals":[],"dependsOn":[],"notes":["What a result means: a positive result needs a colonoscopy; a negative result is reassuring for cancer but says little about polyps, so the test should be repeated on schedule."],"brand":"SimpleScreen","modality":"Blood-based colorectal cancer screening test (cfDNA methylation and protein)","mechanism":"Multiomics plasma assay combining cell-free DNA methylation with protein biomarkers and machine learning to classify colorectal cancer signal.","approvals":[{"region":"US","year":2026,"indication":"Colorectal cancer screening in average-risk adults aged 45 and older"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/simplescreen-crc/","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/"}],"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":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"}],"company":[{"id":"abbott","kind":"company","name":"Abbott Laboratories","route":"/companies/abbott/"},{"id":"freenome","kind":"company","name":"Freenome","route":"/companies/freenome/"}],"term":[{"id":"cfdna","kind":"term","name":"Cell-free DNA (cfDNA)","route":"/terms/cfdna/"},{"id":"screening","kind":"term","name":"Screening","route":"/terms/screening/"},{"id":"sensitivity-specificity","kind":"term","name":"Sensitivity and specificity","route":"/terms/sensitivity-specificity/"}],"trial":[{"id":"preempt-crc","kind":"trial","name":"PREEMPT CRC","route":"/trials/preempt-crc/"}],"paper":[{"id":"paper-preempt-crc-shaukat-jama-2025","kind":"paper","name":"Clinical validation of a circulating tumor DNA-based blood test to screen for colorectal cancer (PREEMPT CRC)","route":"/key-papers/paper-preempt-crc-shaukat-jama-2025/"}]}}