Colorectal, gastroesophageal, pancreatic, and hepatobiliary cancers, with weight on ctDNA after resection.
In the phase 2/3 DYNAMIC-III trial published in Nature Medicine on October 20, 2025, 702 of 968 evaluable patients with stage III colon cancer were ctDNA-negative 5 to 6 weeks after surgery; 3-year recurrence-free survival was 87% if ctDNA-negative and 49% if ctDNA-positive, de-escalation in the ctDNA-negative group did not meet non-inferiority (85.3% versus 88.1%), and escalation in the ctDNA-positive group did not improve 2-year recurrence-free survival (51% versus 61%).
Nature Medicine
In the phase 3 ALTAIR trial published in Nature Medicine on June 8, 2026, 243 patients with resected colorectal cancer who became tumor-informed ctDNA-positive without radiographic disease were randomized to trifluridine/tipiracil or placebo; median disease-free survival was 9.30 versus 5.55 months (HR 0.79; P = 0.107), so the primary endpoint was not met.
Nature Medicine
The MolDX billing article A58434, in the revision effective January 1, 2026, lists Signatera, Guardant Reveal, and Oncodetect for the diagnosis of progression, recurrence, or relapse in advanced colorectal cancer.
CMS MolDX
In the same DYNAMIC-III analysis published in Nature Medicine on October 20, 2025, patients with stage III colon cancer whose ctDNA stayed positive after treatment had a 3-year recurrence-free survival of 14%, compared with 79% among patients who cleared ctDNA.
Nature Medicine
ClinicalTrials.gov lists ADAPT-MRD (NCT06966440) as a recruiting randomized trial that started June 1, 2025, assigning patients after resection of pancreatic cancer to ctDNA-guided adjuvant therapy or standard adjuvant therapy.
ClinicalTrials.gov
An ASCO 2025 interim analysis of 112 patients with resected stage I to III pancreatic adenocarcinoma reported that landmark postoperative ctDNA positivity predicted recurrence (HR 2.39; 95% CI 1.14 to 5.01), and longitudinal positivity was associated with shorter disease-free survival (HR 3.13).
Journal of Clinical Oncology
The ASCO 2025 preliminary MONSTAR-SCREEN-3 report enrolled 22 patients with gastric cancer and 8 with esophageal cancer among 114 patients across 15 cancer types.
Journal of Clinical Oncology
In the final MRD analysis of the observational BESPOKE CRC study presented at ASCO GI 2025, ctDNA positivity in the postoperative window was associated with inferior disease-free survival in stage II disease (HR 10.4) and stage III disease (HR 10.1) among patients with a result in that window.
Journal of Clinical Oncology
In the observational alpha-CORRECT cohort of 124 patients with stage III colorectal cancer presented at ASCO GI 2025, a tumor-informed assay using up to 200 variants found that ctDNA positivity during surveillance was associated with recurrence (HR 49.6; 95% CI 16.6 to 148.3), with a median lead time of 10.4 months before a clinical diagnosis of recurrence.
Journal of Clinical Oncology