Natera said Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) approved its Signatera liquid biopsy molecular residual disease (MRD) assay for colorectal cancer in the neoadjuvant setting. The approval, supported by evidence from the CIRCULATE-Japan trial program, expands use of Signatera for treatment decisions around perioperative chemotherapy. Natera plans to launch in Japan by the end of the year subject to pricing determinations, targeting a sizable colorectal cancer population that is comparable in case volume to the U.S. The company said the decision effectively doubles its addressable market for colorectal cancer, though it remains constrained to neoadjuvant use until broader indication expansions are pursued. The move may shift how oncologists operationalize MRD testing in earlier stages of management, where clinicians increasingly seek faster signals of residual disease to guide escalation or de-escalation. For MRD competitors, PMDA clearance reinforces the regulatory path for ctDNA assays beyond oncology adjuvant contexts.