Japan’s PMDA has approved Natera’s Signatera colorectal cancer molecular residual disease (MRD) assay for neoadjuvant use, supported by data from the GALAXY arm of the CIRCULATE-Japan program. Natera says the approval expands the assay’s use into a larger addressable population in Japan and sets up a launch timeline contingent on final pricing. Natera plans to seek follow-on expansion applications, including bladder cancer, after pricing and reimbursement steps. For clinicians and labs, the approval adds another MRD tool aimed at stratifying patients’ response to chemotherapy and guiding follow-up intensity.