Natera IncNCCN guidelines now recommend Signatera for bladder cancer, a regulatory/guideline endorsement that expands its use.

The National Comprehensive Cancer Network has updated its Clinical Practice Guidelines in Oncology for Bladder Cancer to recommend ctDNA-MRD testing using tumor-informed multiplex PCR technology for patients with muscle-invasive bladder cancer. The updated guidelines state that the Panel recommends the consideration of ctDNA-MRD testing as a tool for risk stratification and to determine the use of adjuvant immunotherapy after cystectomy in patients who have not received previous immune checkpoint inhibitor treatment using an FDA-approved, personalized, tumor-informed, multiplex PCR-NGS assay for ctDNA. This marks the first time NCCN Guidelines recognize personalized, tumor-informed ctDNA-MRD as a prognostic and predictive biomarker in MIBC, and the recommendation is supported by Phase 3 evidence from the IMvigor011 trial, which used Signatera. The guideline includes a Category 1 recommendation for Signatera-guided adjuvant atezolizumab initiated at MRD-positivity within one year post-cystectomy, representing NCCN's highest designation. Natera announced the update, noting that Signatera is based on its proprietary personalized, tumor-informed, mPCR-NGS technology and was recently approved by the FDA as a companion diagnostic for this indication.
Natera IncNCCN guidelines now recommend Signatera for bladder cancer, a regulatory/guideline endorsement that expands its use.