Natera has published clinical validation data for its Latitude™ tissue-free molecular residual disease (MRD) assay in colorectal cancer, reporting strong sensitivity, specificity, and prognostic value in one of the largest tfMRD datasets to date.
In an analysis of 195 patients from the GALAXY trial, the methylation-based ctDNA test demonstrated:
- 84.4% longitudinal sensitivity
- 97.2% sample-level specificity
- Median lead time of 4.6 months ahead of radiographic recurrence
MRD positivity was strongly associated with worse outcomes and identified high-risk patients who derived meaningful benefit from adjuvant chemotherapy, while MRD-negative patients saw little treatment advantage.
The publication supports a MolDX submission and potential Medicare reimbursement pathway—marking an important step toward broader clinical integration of tissue-free MRD testing in colorectal cancer.
The bigger shift: postoperative CRC management is increasingly being guided by real-time molecular surveillance rather than traditional staging alone.