Natera gains Japan approval for Signatera colorectal test

• Natera (NASDAQ:NTRA) received PMDA approval in Japan for its Signatera test in colorectal cancer adjuvant use.
• Signatera becomes the first MRD (minimal residual disease) test approved by Japan’s regulator for this indication.
• The company plans a commercial launch in Japan by the end of 2026, supported by strong clinical trial evidence and local medical society guidance.

Natera (NASDAQ:NTRA) said its Signatera test has received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency for use in colorectal cancer in the adjuvant setting.

The approval makes Signatera the first minimal residual disease test cleared by Japan’s regulator for this cancer indication, expanding its clinical use in a major oncology market.

“This approval marks an important milestone for Japanese patients with colorectal cancer,” said National Cancer Center Hospital East executive advisor Takayuki Yoshino in a statement supporting the clinical value of the test.

Natera said approval was supported by evidence from the GALAXY clinical trial, which showed that MRD-positive patients benefit from adjuvant chemotherapy while MRD-negative patients may not require it.

The company said colorectal cancer affects more than 150,000 people annually in Japan, creating demand for more personalized diagnostic tools in treatment planning.

Natera plans to launch Signatera commercially in Japan by the end of 2026, working with SRL, Inc. as its exclusive local diagnostic partner to support nationwide access.