Cell-free DNA and precision medicine company Natera Inc (NASDAQ:NTRA) announced on Wednesday that its Signatera test has received regulatory approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for use in colorectal cancer in the adjuvant setting, making it the first PMDA-approved molecular residual disease (MRD) test in Japan.

This approval is supported by evidence from the GALAXY clinical trial, which demonstrated that patients who test MRD-positive after surgery derive significant benefit from adjuvant chemotherapy, while those who test MRD-negative derive no benefit from adjuvant chemotherapy.

More than 150,000 people are diagnosed with colorectal cancer in Japan each year, making it one of the country's most common cancers.

Natera expects to launch Signatera commercially in Japan by the end of 2026, subject to final reimbursement and pricing decisions, with adoption supported by guidance from Japanese oncology societies recommending MRD testing in colorectal cancer.