Natera published validation data showing its tissue‑free Latitude methylation MRD assay prognosticates disease‑free survival in colorectal cancer and reported high longitudinal sensitivity for relapse detection. Separately, the company submitted its Signatera MRD assay to the FDA for premarket approval as a companion diagnostic to guide adjuvant immunotherapy in muscle‑invasive bladder cancer. The Latitude study leveraged prospectively collected samples from the GALAXY cohort and showed ctDNA positivity associated with markedly worse outcomes, while Signatera’s PMA submission is supported by Phase III IMvigor011 data that linked MRD positivity to benefit from atezolizumab. Natera emphasized the potential of MRD‑guided treatment decisions to spare low‑risk patients unnecessary adjuvant therapy. Why it matters: Robust clinical validation and regulatory filings for MRD assays accelerate the incorporation of ctDNA into treatment‑decision algorithms and could reshape adjuvant therapy use, trial designs, and diagnostics reimbursement.
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