Japan's PMDA approves Signatera for colorectal cancer MRD testing, the first PMDA-approved MRD test

Natera/Signatera

Natera obtained Japanese regulatory approval for Signatera in the adjuvant colorectal cancer setting, with commercial launch expected in late 2026 pending pricing and reimbursement finalization. This was the first PMDA approval of any MRD test in Japan.

• Approval in Japan's regulated market validates Signatera's clinical utility in colorectal cancer.
• Represents geographic expansion; Natera expects revenue contribution from Japan in 2026.
• Follows European IVDR certification achieved earlier in 2026.