Natera’s Signatera MRD assay gained regulatory approval in Japan from the Pharmaceuticals and Medical Devices Agency for colorectal cancer use in the neoadjuvant setting. The decision effectively expands Signatera’s addressable market in Japan by doubling its scope for colorectal cancer patients, subject to launch timing and pricing. The approval was supported by evidence from the GALAXY arm of CIRCULATE-Japan, which showed benefit for MRD-positive patients receiving neoadjuvant chemotherapy. Natera plans to launch the assay by the end of the year following final pricing determination. Analysts note that the approval is currently limited to the neoadjuvant setting, but the move is still a meaningful step toward wider adoption of MRD-guided treatment decisions across colorectal oncology in Japan.