Natera, Inc. (NASDAQ: NTRA) announced that its Signatera test has received regulatory approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for use in colorectal cancer patients in the adjuvant setting.

According to a press release from Natera, Signatera is the first PMDA-approved molecular residual disease (MRD) test in Japan. The company expects to commercially launch the test in Japan by the end of 2026, pending final pricing determination.

More than 150,000 people are diagnosed with colorectal cancer in Japan each year, according to 2023 incidence data from the National Cancer Center Japan. The Japan Society of Clinical Oncology and the Japanese Society of Medical Oncology have both issued guidance recommending MRD testing in colorectal cancer.

The PMDA approval was supported by data from the GALAXY clinical trial, which analyzed 2,240 samples as part of the CIRCULATE-Japan platform involving more than 150 Japanese institutions. The trial showed that patients who test MRD-positive after surgery benefit from adjuvant chemotherapy, while MRD-negative patients do not.

SRL, Inc., a member of H.U. Group Holdings and described as Japan's largest reference laboratory, will serve as Natera's exclusive commercial partner for Signatera in Japan.

"This approval marks an important milestone for Japanese patients with colorectal cancer," said Takayuki Yoshino, M.D., of the National Cancer Center Hospital East and chairman of the Japan Society of Clinical Oncology.

Natera's chief medical officer, Alexey Aleshin, M.D., noted that the company plans to submit Signatera for muscle-invasive bladder cancer as its next regulatory filing in Japan.