AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that Signatera has received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

This approval supports the use of Signatera for patients with colorectal cancer (CRC) in the adjuvant setting and makes Signatera the first PMDA-approved MRD test in Japan. Natera expects to commercially launch Signatera for CRC in Japan by the end of 2026, subject to final pricing determination.

More than 150,000 people are diagnosed with CRC in Japan each year,¹ making it one of the country’s most common cancers. This disease burden is comparable to that of the United States and highlights the need for more individualized tools to help Japanese clinicians inform adjuvant treatment decisions. Approval of Signatera fulfills this unmet need.

Commercialization of Signatera will be supported by an existing position statement from the Japan Society of Clinical Oncology (JSCO) and guidance from the Japanese Society of Medical Oncology (JSMO), which recommend the use of MRD testing in CRC.

“This approval marks an important milestone for Japanese patients with colorectal cancer,” said Takayuki Yoshino, M.D., executive advisor to hospital director and director, department of global oncology, National Cancer Center Hospital East, chairman of JSCO, president of JSMO, and program director of the CIRCULATE-Japan Project. “Clinicians and medical societies in Japan deeply value the strength of the clinical evidence on Signatera, demonstrating its ability to inform treatment decisions.”

Regulatory approval was supported by positive 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. With analysis of 2,240 samples, this is one of the largest and most comprehensive prospective studies of MRD testing in resectable CRC and is part of the CIRCULATE-Japan platform involving thousands of CRC patients and >150 Japanese institutions.

SRL, Inc., the largest reference lab in Japan and member of H.U. Group Holdings, provides diagnostic services to hospitals and healthcare providers across Japan through an extensive nationwide laboratory network. As Natera’s exclusive business partner for Signatera in Japan, SRL will support the commercialization of the test and help expand access to personalized MRD testing for patients and clinicians across the country.

“As one of Japan’s leading diagnostic service providers, we are committed to supporting the successful launch of Signatera later this year, and helping ensure that clinicians can incorporate this important new testing into routine practice,” said Makoto Matsumoto, president and CEO of SRL, Inc.

“We are grateful to the investigators and patients who helped build the clinical evidence supporting this milestone,” said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology at Natera. “As we prepare for commercial launch in CRC, we remain committed to expanding global access to Signatera across additional cancer types, with muscle-invasive bladder cancer representing our next planned submission in Japan.”