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Signatera™ Receives Regulatory Approval in Japan as a Companion Diagnostic in Muscle-Invasive Bladder Cancer

NTRA
  • Natera's Signatera test received PMDA approval as a companion diagnostic for muscle-invasive bladder cancer (MIBC) to guide atezolizumab treatment.
  • This is Signatera's second PMDA authorization in Japan, following approval for colorectal cancer in June 2026.
  • The approval is based on data from the IMvigor011 phase III clinical trial involving over 20 Japanese sites.
  • Commercial launch of Signatera for MIBC in Japan is expected in the first half of 2027, pending final reimbursement & pricing.
  • Bladder cancer affects over 34,000 people annually in Japan, with 20–25% of new cases classified as muscle-invasive.
  • The launch follows FDA approval of Signatera as a CDx for MIBC & a Category 1 recommendation in NCCN guidelines for MRD-guided care.