Natera Publishes Validation Study for tfMRD in Colorectal Cancer

Natera announced the publication in npj Precision Oncology of the validation study for its Latitude tissue-free molecular residual disease assay, or tfMRD, in colorectal cancer, or CRC. The peer-reviewed publication builds upon data that was previously presented at the 2025 European Society for Medical Oncology GI Congress, or ESMO GI. The study analyzed 1,230 timepoints from 195 CRC patients who participated in the GALAXY clinical trial, one of the largest and most comprehensive tfMRD studies in resectable CRC. The scale and rigor of this dataset, combined with excellent clinical performance, provides support for submission to the Centers for Medicare & Medicaid Services' Molecular Diagnostics Services Program. Key findings from the publication include: High sensitivity: longitudinal sensitivity of 84.4%, with median lead time of 4.6 months ahead of radiographic recurrence; high specificity: 97.2% sample-level specificity and 92.1% patient-level specificity, providing strong actionability when an MRD-positive is observed; robust prognostic value: MRD-positivity was associated with worse outcomes in both the MRD and surveillance settings; clear predictive value for adjuvant chemotherapy benefit: In high-risk stage II and stage III patients, those who were MRD-positive following surgery experienced a significant benefit from ACT, compared to MRD-negative patients, who observed no meaningful treatment benefit. Latitude is a methylation-based test that detects circulating tumor DNA without the need for tumor tissue.