NCCN adds Natera's Signatera to bladder cancer treatment guidelines

Natera, Inc. (NASDAQ: NTRA) announced that the National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines in Oncology for Bladder Cancer to include ctDNA-based molecular residual disease (MRD) testing in the treatment algorithm for patients with muscle-invasive bladder cancer (MIBC).

The updated guidelines recommend consideration of ctDNA-MRD testing for risk stratification and to guide adjuvant immunotherapy decisions after cystectomy in patients who have not previously received immune checkpoint inhibitor treatment. The recommendation specifies use of an FDA-approved, personalized, tumor-informed, multiplex PCR-NGS assay for ctDNA.

Natera's Signatera test received a Category 1 recommendation — NCCN's highest designation — for guiding adjuvant atezolizumab treatment when MRD-positivity is detected within one year post-cystectomy. The recommendation is based on data from the Phase 3 IMvigor011 trial, in which Signatera was used as the MRD test.

In May 2026, the U.S. Food and Drug Administration approved Signatera as a companion diagnostic to identify MIBC patients who are ctDNA-MRD positive and may benefit from adjuvant immunotherapy.

"For the first time, NCCN has incorporated ctDNA-MRD testing into clinical decision-making following cystectomy," said Matthew D. Galsky, M.D., deputy director of the Mount Sinai Tisch Cancer Center. "These recommendations are supported by prospective phase 3 evidence showing that a ctDNA-guided approach, using Signatera, can help guide post-surgical treatment decisions."

According to the company's press release, this marks the third NCCN guideline recommendation for ctDNA-MRD testing using Signatera technology, following previous guideline inclusions in Merkel cell carcinoma and diffuse large B-cell lymphoma.

You May Also Be Interested In

• Alphabet Sees FY26 Capex $195B To $205B, Saw $180B To $190B
• Sigma Lithium faces $540,000 in fines, begins TAC talks in Brazil
• Digital Brands Group announces 1-for-40 reverse stock split