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Veracyte Secures Medicare Coverage for TrueMRD Monitoring Test in Muscle-Invasive Bladder Cancer
SOUTH SAN FRANCISCO, Calif., May 15, 2026--Veracyte Secures Medicare Coverage for TrueMRD Monitoring Test in Muscle-Invasive Bladder Cancer
About this update from Veracyte, Inc.
Marks the first Medicare coverage decision for Veracyte’s whole-genome sequencing-based TrueMRD platform and launch of the first test SOUTH SAN FRANCISCO, Calif., May 15, 2026--(BUSINESS WIRE)--Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, today announced that its 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 covered for recurrence monitoring following definitive treatment with curative intent in patients with MIBC. It will be available for clinicians to order on June 1, 2026, marking the commercial launch of Veracyte’s first molecular residual disease (MRD) offering and the only commercially available truly whole-genome MRD test to come to market, expanding the company’s reach into cancer recurrence monitoring. "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," said Marc Stapley, Veracyte’s chief executive officer. "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 each year.1 MIBC accounts for approximately 25% of all new bladder cancer diagnoses and carries a worse prognosis than non-muscle-invasive disease. 2 Up to half of MIBC patients experience 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 over 900 blood and tissue samples from 112 patients with MIBC treated with neoadjuvant chemotherapy and radical cystectomy. In this study...