Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA and precision medicine, today announced that the National Comprehensive Cancer Network® (NCCN®) has updated its Clinical Practice Guidelines in Oncology for Bladder Cancer to include tumor-informed multiplex PCR circulating tumor DNA (ctDNA)-based molecular residual disease (MRD) testing in the treatment algorithm for patients with MIBC.

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.