The updated treatment algorithm for certain bladder cancers now includes the use of blood-based DNA testing to help guide post-surgical treatment decisions.
The National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines in Oncology for Bladder Cancer to include circulating tumor DNA (ctDNA)-based molecular residual disease (MRD) testing in the treatment algorithm for patients with muscle-invasive bladder cancer, according to an announcement from Natera.
The updated guidelines recommend 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. The guidelines specify the use of a Food and Drug Administration (FDA)-approved, personalized, tumor-informed, multiplex PCR-next-generation sequencing assay for ctDNA.
Clinical Evidence for Testing
Signatera, a test developed by Natera, received a Category 1 recommendation for guiding adjuvant atezolizumab treatment, which is initiated when a patient tests positive for MRD within one year of a cystectomy. Category 1 recommendations are the highest designation from the NCCN, according to the release.
The recommendation is supported by evidence from the IMvigor011 trial. This phase 3 study provided the data necessary to demonstrate that a ctDNA-guided approach can help guide post-surgical treatment decisions.
“This guideline update marks an important turning point for patients with muscle-invasive bladder cancer,” says Matthew D Galsky, MD, 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, in a release. “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.”
Regulatory Status and Guidelines
In May 2026, the FDA approved Signatera CDx as a companion diagnostic to identify patients with muscle-invasive bladder cancer who are ctDNA-MRD positive and may benefit from treatment with adjuvant immunotherapy.
“These recommendations reflect years of work to generate the clinical evidence establishing MRD as a clinically actionable and predictive tool,” says Kevin Masukawa, PhD, vice president, life cycle management, oncology at Natera, in a release. “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.”
This update represents the third NCCN guideline recommendation for ctDNA-MRD testing, following previous inclusions for Merkel cell carcinoma and diffuse large B-cell lymphoma.
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