Press release
Natera Publishes Clinical Validation of Latitude™ Tissue-Free MRD Test in Colorectal Cancer
Study reports high sensitivity and specificity, enabling MolDX submission and path to reimbursement in CRC AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc.
About this update from Natera, Inc.
[{"type":"text","content":"\nStudy reports high sensitivity and specificity, enabling MolDX submission and path to reimbursement in CRC\n\n\n AUSTIN, Texas--(BUSINESS WIRE)--\nNatera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the publication in npj Precision Oncology of the validation study for its Latitude tissue-free molecular residual disease assay (tfMRD) in colorectal cancer (CRC). The peer-reviewed publication builds upon data that was previously presented at the 2025 European Society for Medical Oncology GI Congress (ESMO GI).\n\n\nThe 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’ (CMS) Molecular Diagnostics Services Program (MolDX). Key findings from the publication include:\n\n\n\nHigh sensitivity: longitudinal sensitivity of 84.4%, with median lead time of 4.6 months ahead of radiographic recurrence.\n\n\n\nHigh specificity: 97.2% sample-level specificity and 92.1% patient-level specificity, providing strong actionability when an MRD-positive is observed.\n\n\n\nRobust prognostic value: MRD-positivity was associated with worse outcomes in both the MRD (HR: 10, p","length":2234,"tagName":"div"}]