Natera won Japan approval for its Signatera colorectal cancer MRD test in the neoadjuvant setting, backed by position statements from the Japan Society of Clinical Oncology and Japan Society of Medical Oncology. The regulator’s decision was supported by evidence from the GALAXY arm of the CIRCULATE-Japan trial, which reported benefit for MRD-positive patients after neoadjuvant chemotherapy. Separately in the U.S., the National Comprehensive Cancer Network (NCCN) added Signatera to its muscle-invasive bladder cancer guidance as a companion diagnostic category for MRD-positive patients post-cystectomy. The inclusion followed IMvigor011 trial data linking ctDNA MRD positivity to improved disease-free and overall survival with Tecentriq versus placebo. Together, the updates show MRD testing gaining formal guideline placement across tumor types, with regulators and major clinical societies increasingly tying MRD status to treatment stratification.
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