FDA approves Natera Signatera CDx as companion diagnostic for muscle-invasive bladder cancer

Natera, Inc.

Natera, Inc.

NTRA

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  • Natera’s Signatera CDx secured FDA approval in May 2026 as a companion diagnostic for muscle-invasive bladder cancer.
  • The test identifies ctDNA-MRD-positive patients who may benefit from adjuvant immunotherapy.
  • NCCN updated its bladder cancer guidelines to incorporate personalized, tumor-informed ctDNA-MRD testing, citing Phase 3 IMvigor011 evidence.


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