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<p>This study validates a methylation-based, tissue-free assay (Latitude<sup>TM</sup> 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, <i>P</i> &lt; 0.001) and post-definitive treatment surveillance windows (HR = 31.9, <i>P</i> &lt; 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%; 619/637) levels. Median lead time from first circulating tumor DNA (ctDNA)-positive result to relapse was 4.6 months. For high-risk stage II and III CRC, ctDNA-positive patients benefited from ACT (adj.HR = 0.014, <i>P</i> &lt; 0.0001), unlike ctDNA-negative patients. These findings highlight the robust prognostic and predictive capabilities of this tissue-free MRD assay in CRC patients.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月19日

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  • Yoshiaki Nakamura,
  • Johannes G. Reiter,
  • Prashanthi Natarajan,
  • Joshua Babiarz,
  • Preethi Srinivasan,
  • Jayashree Joshi,
  • Yu Lin,
  • Tzu-Chun Chen,
  • Nathan Liang,
  • Su Maw,
  • Ehsan Haghshenas,
  • Garima Kushwaha,
  • Boris Gutman,
  • Ilker Tunc,
  • Wen-Ching Chan,
  • Antony Tin,
  • Yuefan Huang,
  • Sara L. Bristow,
  • Meenakshi Malhotra,
  • Shruti Sharma,
  • Stephanie A. Sanchez,
  • Adham Jurdi,
  • Minetta C. Liu,
  • Trupti Kawli,
  • Matthew Rabinowitz,
  • Alexey Aleshin,
  • Daisuke Kotani,
  • Oki Eiji,
  • Takayuki Yoshino

摘要

This study validates a methylation-based, tissue-free assay (LatitudeTM 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%; 619/637) levels. Median lead time from first circulating tumor DNA (ctDNA)-positive result to relapse was 4.6 months. For high-risk stage II and III CRC, ctDNA-positive patients benefited from ACT (adj.HR = 0.014, P < 0.0001), unlike ctDNA-negative patients. These findings highlight the robust prognostic and predictive capabilities of this tissue-free MRD assay in CRC patients.