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

Natera, Inc.

Natera, Inc.

NTRA

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  • Natera won FDA clearance for Signatera CDx as companion diagnostic to guide adjuvant atezolizumab (Tecentriq) use in muscle-invasive bladder cancer.
  • Approval lets clinicians target immunotherapy to ctDNA MRD-positive patients, expanding Signatera use into FDA-regulated treatment selection.
  • Decision follows Phase III IMvigor011 results published in October 2025 showing improved survival outcomes in MRD-positive patients treated with immunotherapy.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Natera Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 202605151245BIZWIRE_USPR_____20260514_BW529026) on May 15, 2026, and is solely responsible for the information contained therein.

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