Natera IncSignatera received PMDA approval for colorectal cancer, enabling market entry in Japan.

Natera announced that its Signatera test has received regulatory approval from Japan's Pharmaceuticals and Medical Devices Agency for use in the adjuvant setting for colorectal cancer, making it the first molecular residual disease test approved by the PMDA. The approval was supported by evidence from the GALAXY clinical trial, part of the CIRCULATE-Japan platform involving over 150 Japanese institutions and analysis of 2,240 samples, which showed that MRD-positive patients benefit from adjuvant chemotherapy while MRD-negative patients do not. Natera expects to commercially launch Signatera for colorectal cancer in Japan by the end of 2026, pending final pricing and reimbursement. More than 150,000 people are diagnosed with colorectal cancer in Japan each year, a burden comparable to that of the United States. The Japan Society of Clinical Oncology and the Japanese Society of Medical Oncology have issued guidance recommending MRD testing in colorectal cancer.
Natera IncSignatera received PMDA approval for colorectal cancer, enabling market entry in Japan.