Medicare Coverage Granted for Veracyte’s Test for Muscle-Invasive Bladder Cancer

Veracyte Inc.’s TrueMRD Monitoring Test has received coverage from the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostics Services Program (MolDX) for patients with muscle-invasive bladder cancer (MIBC). The TrueMRD Test is now covered for recurrence monitoring following definitive treatment with curative intent in patients with MIBC.

The TrueMRD Monitoring Test is Veracyte’s first molecular residual disease (MRD) offering and the only commercially available truly whole-genome MRD test to be marketed, thus expanding the company’s reach into cancer recurrence monitoring, according to executives.

“Securing Medicare coverage and launching our first TrueMRD Test are significant milestones for Veracyte and important steps in enabling access to our MRD testing platform,” Veracyte CEO Marc Stapley stated. “This decision validates the clinical utility of our TrueMRD testing approach and the rigor of our whole-genome sequencing MRD workflow while also positioning us to support clinicians with earlier detection of recurrence and more informed treatment decisions for patients with muscle-invasive bladder cancer. We see tremendous opportunity to expand our TrueMRD platform across multiple cancer types over the coming years.”

Bladder cancer is the sixth most common cancer in the United States with an estimated 85,000 people expected to be diagnosed annually.¹ MIBC accounts for approximately 25% of all new bladder cancer diagnoses and carries a worse prognosis than non-muscle-invasive disease,² with up to half of MIBC patients experiencing recurrence within two years of initial treatment.³ Current surveillance relies primarily on imaging, which may not detect recurrence until the disease has significantly progressed.

Veracyte’s TrueMRD platform is supported by expanding clinical evidence, including PAGER, a pivotal prospective study published in European Urology that evaluated more than 900 blood and tissue samples from 112 patients with MIBC treated with neoadjuvant chemotherapy and radical cystectomy. In this study, the TrueMRD MIBC Test detected disease recurrence a median of 131 days earlier than imaging. The TrueMRD platform is being used in significant ongoing research in MIBC, including the TOMBOLA trial, which is evaluating ctDNA-guided use of adjuvant immunotherapy with check point inhibitors, and the NEO-BLAST trial, which aims to spare patients from unnecessary surgery. This study investigates whether MIBC patients who have no remaining cancer after neoadjuvant therapy can safely opt for active surveillance rather than immediate radical cystectomy.

“Surveillance for muscle-invasive bladder cancer relies heavily on imaging right now, which has real limitations in detecting early recurrence. A whole-genome MRD test that can help identify disease recurrence, often months before imaging, gives clinicians a powerful new tool,” stated Matthew Galsky, M.D., professor of Medicine, Icahn School of Medicine at Mount Sinai and deputy director of the Mount Sinai Tisch Cancer Center. “The expanding clinical evidence behind Veracyte’s MRD platform is compelling, and Medicare coverage brings this test to patients at a pivotal time when the landscape of treatment for muscle-invasive bladder cancer is rapidly changing with the development of more effective systemic therapies and expanding bladder-sparing approaches.”

Unlike approaches that track a limited set of genetic targets, TrueMRD analyzes patient-specific tumor variants across the entire genome in every sample tested. This whole-genome, tumor-informed approach has the potential for tracking tumor clonality and molecular evolution longitudinally, which may be especially important for patients who initially respond to therapy but then experience recurrent disease.

Veracyte is a global diagnostics company whose molecular tests assess the unique biology of each patient’s tumor to help clinicians answer essential questions about cancer care. Veracyte’s Diagnostics Platform combines broad genomic and clinical data, advanced bioinformatics and artificial intelligence, and a powerful evidence-generation engine to support continued innovation and pipeline development. The company’s portfolio includes the Afirma Genomic Sequencing Classifier test, Decipher Bladder Genomic Classifier test, Decipher Prostate Genomic Classifier test, Prosigna Breast Risk of Recurrence test, and the TrueMRD Monitoring Test for MIBC.

References
¹ National Cancer Institute, Surveillance, Epidemiology and End Results (SEER) Program. SEER Cancer Stat Facts: Common Cancer Sites. https://seer.cancer.gov/statfacts/html/common.html
² Attanasio G, et al. Histological and immunohistochemical approaches to molecular subtyping of muscle-invasive bladder cancer. Frontiers in Oncology. 2025.
³ Esteban-Villarrubia J, et al. Current and Future Landscape of Perioperative Treatment for Muscle-Invasive Bladder Cancer. Cancers (Basel). 2023;15(3):566.