{"entity":{"id":"idea-tr2-ctdna-mrd-qualification","kind":"idea","name":"Formally qualify tumour-DNA blood tests as a surrogate endpoint for adjuvant trials","aka":[],"tldr":"If a blood test reliably shows whether cancer will come back after surgery, trials could use it instead of waiting years for relapse. Regulators have a process to bless such a test; oncology should use it.","summary":"FDA's Biomarker Qualification Program creates a drug-independent, context-of-use qualification for biomarkers. ctDNA clearance after adjuvant therapy correlates strongly with recurrence in colorectal, bladder and lung cancer, and trial-level meta-analysis is becoming possible as ctDNA-guided trials report. A consortium submission to qualify ctDNA clearance as a reasonably likely surrogate for disease-free survival in defined settings would let adjuvant trials read out in one to two years rather than five.","asOf":"2026-09-08","links":[{"label":"FDA Biomarker Qualification Program","url":"https://www.fda.gov/drugs/drug-development-tool-ddt-qualification-programs/biomarker-qualification-program"}],"tags":[],"related":["idea-ctdna-guided-adjuvant-crc","ctdna-mrd-to-adjuvant"],"cancers":[],"sections":[],"technologies":["mrd-testing","liquid-biopsy"],"targets":[],"drugs":["signatera"],"companies":[],"institutions":[],"pathways":[],"terms":["ctdna","mrd"],"trials":["imvigor011","dynamic","circulate-japan"],"people":[],"bottlenecks":["b-biomarker-validation","b-dormancy-mrd"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Trial-level correlation between ctDNA clearance rate and disease-free survival hazard ratio across adjuvant trials will be strong enough (R squared above 0.7) to support qualification in at least one tumour type by 2029.","rationale":"Pathological complete response and MRD in haematological cancers have been accepted for accelerated approval on similar reasoning; ctDNA has cleaner biology and is measured uniformly.","test":"Pool patient- and trial-level data from completed ctDNA-guided adjuvant trials (DYNAMIC, CIRCULATE, IMvigor011 and others) and run the surrogate validation analyses required for qualification.","maturity":"early-clinical","actor":"regulator","cost":"medium","horizonYears":4},"route":"/ideas/idea-tr2-ctdna-mrd-qualification/","neighbours":{"idea":[{"id":"idea-ctdna-guided-adjuvant-crc","kind":"idea","name":"ctDNA-guided adjuvant therapy as the default in stage II-III colon cancer","route":"/ideas/idea-ctdna-guided-adjuvant-crc/"}],"pairing":[{"id":"ctdna-mrd-to-adjuvant","kind":"pairing","name":"ctDNA MRD → adjuvant therapy decision","route":"/pairings/ctdna-mrd-to-adjuvant/"}],"technology":[{"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/"}],"drug":[{"id":"signatera","kind":"drug","name":"Signatera","route":"/drugs/signatera/"}],"term":[{"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/"}],"trial":[{"id":"circulate-japan","kind":"trial","name":"CIRCULATE-Japan (GALAXY / VEGA / ALTAIR)","route":"/trials/circulate-japan/"},{"id":"dynamic","kind":"trial","name":"DYNAMIC","route":"/trials/dynamic/"},{"id":"imvigor011","kind":"trial","name":"IMvigor011","route":"/trials/imvigor011/"}],"bottleneck":[{"id":"b-biomarker-validation","kind":"bottleneck","name":"Biomarkers are not validated or standardised","route":"/bottlenecks/b-biomarker-validation/"},{"id":"b-dormancy-mrd","kind":"bottleneck","name":"Dormant cells and minimal residual disease","route":"/bottlenecks/b-dormancy-mrd/"}],"paper":[{"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/"}],"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/"},{"id":"diagnostics-roadmap","kind":"roadmap","name":"Diagnostics roadmap: stains → gene panels → blood tests that decide treatment","route":"/roadmaps/diagnostics-roadmap/"},{"id":"trial-modernisation-roadmap","kind":"roadmap","name":"Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on","route":"/roadmaps/trial-modernisation-roadmap/"}],"cancer":[{"id":"resectable-nsclc","kind":"cancer","name":"Resectable stage I to III non-small-cell lung cancer","route":"/cancers/resectable-nsclc/"}]}}