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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.
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.
Shares ctDNA-guided adjuvant therapy as the default in stage II-III colon cancer, GALAXY: tumour DNA in blood four weeks after bowel cancer surgery predicts relapse tenfold, CIRCULATE-Japan (GALAXY / VEGA / ALTAIR), DYNAMIC.
Shares ctDNA MRD → adjuvant therapy decision, IMvigor011, Signatera, ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment.
Shares IMvigor011, DYNAMIC, Signatera, Dormant cells and minimal residual disease.
Shares IMvigor011, CIRCULATE-Japan (GALAXY / VEGA / ALTAIR), DYNAMIC, Diagnostics roadmap: stains → gene panels → blood tests that decide treatment.
Shares ctDNA MRD → adjuvant therapy decision, ctDNA-guided adjuvant therapy as the default in stage II-III colon cancer, GALAXY: tumour DNA in blood four weeks after bowel cancer surgery predicts relapse tenfold, DYNAMIC.
Shares ctDNA MRD → adjuvant therapy decision, CIRCULATE-Japan (GALAXY / VEGA / ALTAIR), DYNAMIC, Signatera.
Shares GALAXY: tumour DNA in blood four weeks after bowel cancer surgery predicts relapse tenfold, CIRCULATE-Japan (GALAXY / VEGA / ALTAIR), DYNAMIC, Signatera.
Shares ctDNA MRD → adjuvant therapy decision, IMvigor011, Signatera, Dormant cells and minimal residual disease.