Veracyte achieved a milestone decision regarding Medicare coverage for its TrueMRD Monitoring Test to track Muscle-Invasive Bladder Cancer (MIBC). The Centers for Medicare & Medicaid Services’ Molecular Diagnostics Services Program granted this coverage. This test monitors cancer recurrence after patients receive definitive treatment with curative intent. Clinicians can order this whole-genome sequencing platform starting June 1, 2026. This launch introduces the first commercial molecular residual disease offering from Veracyte.
Marc Stapley shared the corporate perspective on this breakthrough.
“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’s chief executive officer also emphasized the deeper clinical impact of the decision.
“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.”
Clinical Evidence Supporting TrueMRD
Bladder cancer represents the sixth most common cancer in the United States. Doctors diagnose approximately 85,000 people each year with the disease. Furthermore, Muscle-Invasive Bladder Cancer (MIBC) accounts for roughly 25% of these new cases. Patients face a worse prognosis than individuals with non-muscle-invasive disease. Up to half of these patients experience recurrence within two years.
Current surveillance utilizes imaging tools that often fail to find early recurrence. Fortunately, the TrueMRD platform utilizes patient-specific tumor variants across the entire genome. A prospective study named PAGER evaluated 900 blood and tissue samples. The clinical trial tracked 112 patients treated with chemotherapy and radical cystectomy. TrueMRD detected recurrence a median of 131 days earlier than traditional imaging.
Other ongoing research includes the TOMBOLA trial and the NEO-BLAST trial. Experts use these trials to evaluate immunotherapy guidance and bladder-sparing approaches.
Matthew Galsky, M.D., commented on the limitations of current monitoring methods.
“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.”
The Professor of Medicine, Icahn School of Medicine at Mount Sinai, and Deputy Director, Mount Sinai Tisch Cancer Center, added his view on the changing environment.
“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.”
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News Source: Businesswire.com
