Natera, Inc., a global leader in cell-free DNA testing, 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 our 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.
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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 is great news for patients with bladder cancer, who face uncertain treatment decisions throughout the patient journey,” said Solomon Moshkevich, general manager of oncology at Natera. “This is also a milestone for Natera, representing the first new disease indication to be covered under the foundational LCD. We look forward to working with Medicare and with the oncology community to continue incorporating Signatera MRD assessment into standard care for patients with solid tumors.”
Bladder cancer is the sixth most common cancer in the United States1 and MIBC represents 20-25% of the newly diagnosed cases.2 Patients previously treated for MIBC have a high rate of recurrence, with 50% experiencing distant recurrence post-cystectomy.3 Of these, 90% of recurrences develop in the first 3 years.4,5
“To balance the risks versus benefits of adding systemic treatments like chemotherapy to radical cystectomy, we need measures to identify which patients indeed harbor micrometastatic disease, which would allow refined shared medical decisions,” said Matthew Galsky, M.D., professor of medicine (hematology and medical oncology), director of genitourinary medical oncology, co-director of the Center of Excellence for Bladder Cancer at the Tisch Cancer Institute and associate director for translational research at the Tisch Cancer Institute.