- NCCN Category 1 recognition for Signatera-guided adjuvant treatment in muscle-invasive bladder cancer (MIBC)
- Marks third NCCN guideline recommendation on ctDNA-MRD testing, following positive guideline changes in merkel cell carcinoma and diffuse large b-cell lymphoma
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.”
For the first time, NCCN Guidelines recognize that personalized, tumor-informed ctDNA-MRD has emerged as a prognostic and predictive biomarker in MIBC – a significant step forward from previous guidance.
Signatera is based on personalized, tumor-informed, mPCR-NGS technology. This technology is patented and proprietary to Natera, and cited in numerous publications. In addition, Signatera was the MRD test used in the landmark IMvigor011 trial, which generated the Phase 3 evidence needed to move the field to this much stronger recommendation. That evidence is now reflected in a Category 1 recommendation for Signatera-guided adjuvant atezolizumab, initiated at MRD-positivity within 1 year post-cystectomy. Category 1 recommendations are NCCN’s highest designation.
“This guideline update marks an important turning point for patients with muscle-invasive bladder cancer,” said Matthew D. Galsky, M.D., deputy director of the Mount Sinai Tisch Cancer Center, director of Genitourinary Medical Oncology, and co-director of the Center of Excellence for Bladder Cancer at the Mount Sinai Tisch Cancer Center. “For the first time, NCCN has incorporated ctDNA-MRD testing into clinical decision-making following cystectomy. These recommendations are supported by prospective phase 3 evidence showing that a ctDNA-guided approach, using Signatera, can help guide post-surgical treatment decisions.”“These recommendations reflect years of work to generate the clinical evidence establishing MRD as a clinically actionable and predictive tool,” said Kevin Masukawa, Ph.D., vice president, life cycle management, oncology at Natera. “The IMvigor011 study is an important example of how Signatera-generated evidence can help change clinical practice, and we believe this guideline update is just the beginning of a broader shift toward MRD-guided cancer care.”
In May 2026, the U.S. Food and Drug Administration approved Signatera™ CDx as a companion diagnostic to identify patients with MIBC who are ctDNA-MRD positive and may benefit from treatment with adjuvant immunotherapy.
Source: BUSINESS WIRE. (2026). NCCN Recommends ctDNA-MRD Testing Using Signatera™ Technology in Landmark Bladder Cancer Guideline Update [Press release]. https://www.businesswire.com/news/home/20260623843077/en/NCCN-Recommends-ctDNA-MRD-Testing-Using-Signatera-Technology-in-Landmark-Bladder-Cancer-Guideline-Update.