Signatera™ CDx Approved by the FDA as a Companion Diagnostic in Muscle-Invasive Bladder Cancer (MIBC)
The FDA approved Natera's Signatera CDx as a companion diagnostic for use with adjuvant atezolizumab in muscle-invasive bladder cancer (MIBC). This marks the first FDA-approved use of personalized molecular residual disease (MRD) testing to guide treatment decisions in this setting, validating Natera's Treatment on MRD (TOMR) approach.
Key figures
- Drug Name
- Signatera CDx
- Mibc us diagnoses
- 30000
- Mr negative 2yr os
- 97%
- Mibc global diagnoses
- 150000
AI analysis
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.