Natera Inc. (NASDAQ:NTRA) said Japan’s Ministry of Health, Labour and Welfare approved its Signatera molecular residual disease (MRD) test for patients with colorectal cancer in the adjuvant setting, making it the first PMDA-approved MRD test in the country.
The precision medicine company expects to launch Signatera commercially in Japan by the end of 2026, pending final pricing decisions.
The approval marks a key milestone in Natera’s international oncology expansion.
More than 150,000 people are diagnosed with colorectal cancer each year in Japan, making it one of the country’s most common cancers and highlighting the need for personalized treatment strategies.
Clinical Evidence And Medical Society Support Back Approval
The cancer test company said findings from the GALAXY clinical trial supported regulatory clearance.
The study showed that patients who tested MRD-positive following surgery experienced substantial benefit from adjuvant chemotherapy, while MRD-negative patients did not appear to benefit from the treatment.
The GALAXY trial analyzed 2,240 samples, making it one of the largest prospective studies evaluating MRD testing in resectable colorectal cancer.
The study forms part of the broader CIRCULATE-Japan platform, which involves thousands of patients and more than 150 institutions across Japan.
SRL To Lead Commercialization Efforts Across Japan
Commercial rollout of Signatera in Japan will be supported by SRL Inc., Japan’s largest reference laboratory and a member of H.U. Group Holdings.
As Natera’s exclusive business partner in Japan, SRL will help expand access to personalized MRD testing through its nationwide laboratory network.
On Tuesday, the National Comprehensive Cancer Network (NCCN) recognized Natera’s Signatera technology for muscle-invasive bladder cancer.
The recognition marks the third NCCN guideline recommendation for circulating tumor DNA (ctDNA) testing, which could enhance treatment protocols for patients, reflecting positively on Natera’s market position and growth potential.
NTRA Stock Price Activity: Natera shares were up 10.29% at $258.92 at the time of publication on Wednesday, according to Benzinga Pro data.
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