CMS covers ctDNA test for patients with MIBC


The Centers for Medicare and Medicaid Services (CMS) is covering the Signatera molecular residual disease (MRD) test for use in patients with muscle-invasive bladder cancer (MIBC), according to Natera, the developer of the assay.1

Specifically, Signatera is a custom-built test for circulating tumor DNA (ctDNA) that helps clinicians monitor treatment through MRD assessment.

"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," Matthew Galsky, MD, 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, stated in a news release.

Multiple published studies supported the CMS coverage decision by demonstrating the accuracy of Signatera and its potential to provide an early indication of treatment efficacy. For example, a study published in the Journal of Clinical Oncology included 68 patients with localized advanced bladder cancer whose tumors underwent Signatera ctDNA analysis following cystectomy.2

Signatera showed 100% and 98% specificity, correctly identifying all cases of metastatic relapse during the monitoring period. The test also showed a median lead time of 96 days over radiographic imaging. Further, among patients who were ctDNA positive before or during treatment (high-risk), the “dynamics of ctDNA during chemotherapy was associated with disease recurrence (P = .023), whereas pathologic downstaging was not,” according to the researchers.

"This is great news for patients with bladder cancer, who face uncertain treatment decisions throughout the patient journey," Solomon Moshkevich, general manager of Oncology at Natera, stated in the news release. "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."


1. Medicare Extends Coverage of Natera's Signatera™ MRD Test to Muscle Invasive Bladder Cancer. Published online July 18, 2022. Accessed July 18, 2022.

2. Christensen E, Birkenkamp-Demtröder K, Sethi H, et al. Early Detection of Metastatic Relapse and Monitoring of Therapeutic Efficacy by Ultra-Deep Sequencing of Plasma Cell-Free DNA in Patients With Urothelial Bladder Carcinoma. J Clin Oncol. 2019;37(18):1547-1557. doi: 10.1200/JCO.18.02052.

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