Natera MRD Test for Bladder Cancer Nabs Top-Level US Recommendation

The National Comprehensive Cancer Network has given Signatera a Category 1 recommendation in updated clinical practice guidelines.

Natera’s Signatera minimal residual disease (MRD) test has received a Category 1 recommendation in updated National Comprehensive Cancer Network clinical practice guidelines for muscle-invasive bladder cancer (MIBC.)

Specifically, the guidelines recommend Signatera-guided adjuvant atezolizumab, initiated at MRD-positivity within one year post-cystectomy in patients who have not previously received immune checkpoint inhibitor treatment. Category 1 is NCCN’s highest designation, reserved for recommendations backed by high-level evidence and uniform consensus.

“For the first time, NCCN has incorporated ctDNA-MRD testing into clinical decision-making following cystectomy,” Matthew Galsky, deputy director of the Mount Sinai Tisch Cancer Center, said in a statement. “These recommendations are supported by prospective phase 3 evidence showing that a ctDNA-guided approach, using Signatera, can help guide post-surgical treatment decisions.” It also marks the third NCCN guideline update to include circulating tumor DNA MRD testing, following previous additions in Merkel cell carcinoma and diffuse large B-cell lymphoma.

In May, the FDA approved Signatera CDx as a companion diagnostic to identify patients with MIBC who may benefit from adjuvant immunotherapy.