Natera, Inc. announced that it has received written confirmation from the CMS Molecular Diagnostics Services Program (MolDX) that the Signatera molecular residual disease (MRD) test has met coverage requirements for patients with muscle invasive bladder cancer (MIBC), effective April 19, 2022. To its knowledge, this represents the first coverage expansion to occur under the foundational local coverage determination (LCD) for MRD testing in solid tumors (LCD L38779), which was published in December 2021. The decision by CMS in MIBC is based on evidence from multiple published validation studies.

A study published in Nature, based on the phase III randomized IMvigor010 trial, showed that patients who tested MRD-positive after radical cystectomy received significant benefit from adjuvant immunotherapy, while MRD-negative patients derived no benefit from additional systemic therapy. Another study published in the Journal of Clinical Oncology found that serial testing with Signatera detected metastatic recurrence with 100% sensitivity and 98% specificity. Both studies showed that on-treatment monitoring with Signatera can provide an early assessment of therapy effectiveness, whether in the neoadjuvant or adjuvant settings.

This decision adds to the existing Medicare coverage for Signatera in colorectal cancer and for pan-cancer immunotherapy monitoring.