{"entity":{"id":"tumour-informed-assay","kind":"term","name":"Tumour-informed versus tumour-naive ctDNA assays","aka":["Tumour-informed MRD","Tumour-agnostic ctDNA assay","Personalised ctDNA panel"],"tldr":"A tumour-informed blood test is built for one patient: the tumour is sequenced first and the test then hunts for that patient's own mutations in blood. A tumour-naive test uses the same fixed panel, often of methylation marks, for everyone, so it needs no tumour sample and returns faster.","summary":"Tumour-informed assays (Signatera, RaDaR) sequence the resected tumour, choose a set of clonal mutations, and track them in plasma at high depth, which gives high specificity and lets a positive be called on very few molecules; the cost is a tumour sample, a bespoke panel per patient and a longer first turnaround. Tumour-naive assays (Guardant Reveal and most multi-cancer tests) apply a fixed panel of mutations and methylation or fragmentation features to every sample, so they work without tissue and from the first draw, at the price of having to distinguish tumour signal from clonal haematopoiesis and other background. Trials so far have used tumour-informed tests for treatment decisions (DYNAMIC used a tumour-informed approach; IMvigor011 used Signatera), while screening tests are necessarily tumour-naive. Head-to-head sensitivity comparisons are few, and results are not interchangeable between assays.","asOf":"2026-09-21","links":[{"label":"IMvigor011: ctDNA-guided adjuvant atezolizumab in muscle-invasive bladder cancer (NEJM 2025), tumour-informed Signatera","url":"https://europepmc.org/article/MED/41124204"},{"label":"CMS article A58456: MolDX minimal residual disease testing for solid tumour cancers (lists covered tests)","url":"https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=58456"}],"tags":[],"related":["ctdna-tests","imvigor011","dynamic"],"cancers":[],"sections":["diagnostics"],"technologies":["mrd-testing","liquid-biopsy","mced","cfdna-methylation-testing"],"targets":[],"drugs":["signatera","radar-mrd","guardant-reveal","galleri"],"companies":[],"institutions":[],"pathways":[],"terms":["ctdna","mrd","cfdna","clonal-haematopoiesis"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"category":"Biomarkers","wikipediaChecked":"2026-09-22"},"route":"/terms/tumour-informed-assay/","neighbours":{"roadmap":[{"id":"ctdna-tests","kind":"roadmap","name":"ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment","route":"/roadmaps/ctdna-tests/"}],"trial":[{"id":"bespoke-crc","kind":"trial","name":"BESPOKE CRC","route":"/trials/bespoke-crc/"},{"id":"circulate-us","kind":"trial","name":"CIRCULATE-US","route":"/trials/circulate-us/"},{"id":"dynamic","kind":"trial","name":"DYNAMIC","route":"/trials/dynamic/"},{"id":"imvigor011","kind":"trial","name":"IMvigor011","route":"/trials/imvigor011/"}],"section":[{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"}],"technology":[{"id":"cfdna-methylation-testing","kind":"technology","name":"Cell-free DNA methylation tests","route":"/technologies/cfdna-methylation-testing/"},{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"},{"id":"mrd-testing","kind":"technology","name":"MRD / molecular residual disease testing","route":"/technologies/mrd-testing/"},{"id":"mced","kind":"technology","name":"Multi-cancer early detection (MCED)","route":"/technologies/mced/"}],"drug":[{"id":"galleri","kind":"drug","name":"Galleri","route":"/drugs/galleri/"},{"id":"guardant-reveal","kind":"drug","name":"Guardant Reveal","route":"/drugs/guardant-reveal/"},{"id":"radar-mrd","kind":"drug","name":"RaDaR","route":"/drugs/radar-mrd/"},{"id":"signatera","kind":"drug","name":"Signatera","route":"/drugs/signatera/"}],"term":[{"id":"cfdna","kind":"term","name":"Cell-free DNA (cfDNA)","route":"/terms/cfdna/"},{"id":"ctdna","kind":"term","name":"Circulating tumour DNA (ctDNA)","route":"/terms/ctdna/"},{"id":"mrd","kind":"term","name":"Minimal / molecular residual disease (MRD)","route":"/terms/mrd/"}],"pathway":[{"id":"clonal-haematopoiesis","kind":"pathway","name":"Clonal haematopoiesis (CHIP)","route":"/pathways/clonal-haematopoiesis/"}],"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"paper":[{"id":"paper-reinert-ctdna-ultradeep-sequencing-colorectal-jama-oncol-2019","kind":"paper","name":"Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer","route":"/key-papers/paper-reinert-ctdna-ultradeep-sequencing-colorectal-jama-oncol-2019/"},{"id":"paper-ctrak-tn-tissue-free-mrd-jamaoncol-2026","kind":"paper","name":"c-TRAK TN analysis: tissue-free versus tumour-informed ctDNA assays for residual disease in early triple-negative breast cancer","route":"/key-papers/paper-ctrak-tn-tissue-free-mrd-jamaoncol-2026/"},{"id":"paper-tie-ctdna-minimal-residual-disease-stage-ii-colon-sci-transl-med-2016","kind":"paper","name":"Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer","route":"/key-papers/paper-tie-ctdna-minimal-residual-disease-stage-ii-colon-sci-transl-med-2016/"},{"id":"paper-magbanua-ispy2-ctdna-neoadjuvant-ann-oncol-2021","kind":"paper","name":"Circulating tumor DNA in neoadjuvant-treated breast cancer reflects response and survival","route":"/key-papers/paper-magbanua-ispy2-ctdna-neoadjuvant-ann-oncol-2021/"},{"id":"paper-henriksen-ctdna-stage-iii-colorectal-improve-it-ccr-2022","kind":"paper","name":"Circulating tumor DNA in stage III colorectal cancer, beyond minimal residual disease detection, toward assessment of adjuvant therapy efficacy and clinical behavior of recurrences","route":"/key-papers/paper-henriksen-ctdna-stage-iii-colorectal-improve-it-ccr-2022/"},{"id":"paper-dynamic-nejm-2022","kind":"paper","name":"DYNAMIC: a blood test safely halved chemotherapy use after surgery for stage II colon cancer","route":"/key-papers/paper-dynamic-nejm-2022/"},{"id":"paper-galaxy-signatera-nat-med-2023","kind":"paper","name":"GALAXY: tumour DNA in blood four weeks after bowel cancer surgery predicts relapse tenfold","route":"/key-papers/paper-galaxy-signatera-nat-med-2023/"}],"biomarker":[{"id":"ctdna-mrd-positive","kind":"biomarker","name":"ctDNA MRD positivity (molecular residual disease after curative treatment)","route":"/biomarkers/ctdna-mrd-positive/"}]}}