Natera Inc. has announced the publication of a clinical validation study for its Latitude™ tissue-free molecular residual disease (tfMRD) assay in colorectal cancer $(CRC)$ in npj Precision Oncology. The study builds upon data previously presented at the 2025 European Society for Medical Oncology GI Congress (ESMO GI). Latitude is a methylation-based test that detects circulating tumor DNA (ctDNA) without requiring tumor tissue, complementing Natera's existing tumor-informed Signatera™ test. The validation study analyzed 1,230 timepoints from 195 CRC patients enrolled in the GALAXY clinical trial. Key findings include a longitudinal sensitivity of 84.4% and a median lead time of 4.6 months ahead of radiographic recurrence. The test demonstrated 97.2% sample-level specificity and 92.1% patient-level specificity. MRD-positivity was associated with worse outcomes in both MRD and surveillance settings, and MRD-positive patients in high-risk stage II and stage III groups experienced significant benefit from adjuvant chemotherapy. Natera is preparing to submit these results to the Centers for Medicare & Medicaid Services' $(CMS)$ Molecular Diagnostics Services Program (MolDX) for reimbursement in CRC and is developing Latitude for additional cancer indications, expected to launch in 2026.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Natera Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260121444465) on January 21, 2026, and is solely responsible for the information contained therein.
Comments