Validation of a methylation-based, tissue-free MRD assay in colorectal cancer patients from the GALAXY study.

ABSTRACT: This study validates a methylation-based, tissue-free assay (Latitude^TM assay) for detecting molecular residual disease (MRD) in colorectal cancer (CRC), analyzing data from 195 patients (1230 timepoints) from the observational GALAXY study. The assay demonstrated that ctDNA-positivity correlated with significantly worse disease-free survival (DFS) in both the MRD (HR = 10.0, P < 0.001) and post-definitive treatment surveillance windows (HR = 31.9, P < 0.001). In the MRD window, the assay demonstrated a sensitivity of 58.5% (38/65), while the specificity in patients who did not receive adjuvant chemotherapy (ACT) was 100% (63/63). Longitudinally, relapse was detected with a sensitivity of 84.4% (54/64), with high specificity at the patient (92.1%; 116/126) and sample (97.2%; 619

SUBMITTER: Nakamura Y 

PROVIDER: S-EPMC12913904 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature