Veracyte receives Medicare coverage for bladder cancer monitoring test

Veracyte Inc. (NASDAQ: VCYT) announced that its TrueMRD Monitoring Test received coverage from the Centers for Medicare & Medicaid Services' Molecular Diagnostics Services Program for patients with muscle-invasive bladder cancer. The test will be available for clinicians to order on June 1, 2026.

The TrueMRD Test is covered for recurrence monitoring following definitive treatment with curative intent in patients with muscle-invasive bladder cancer. This marks the commercial launch of Veracyte's first molecular residual disease offering and represents the first Medicare coverage decision for the company's whole-genome sequencing-based TrueMRD platform.

Muscle-invasive bladder cancer accounts for approximately 25% of all new bladder cancer diagnoses and carries a worse prognosis than non-muscle-invasive disease. Up to half of muscle-invasive bladder cancer patients experience recurrence within two years of initial treatment, according to the company.

The TrueMRD platform analyzes patient-specific tumor variants across the entire genome in every sample tested, unlike approaches that track a limited set of genetic targets. A prospective study published in European Urology evaluated over 900 blood and tissue samples from 112 patients with muscle-invasive bladder cancer and found that the TrueMRD test detected disease recurrence a median of 131 days earlier than imaging.

Bladder cancer is the sixth most common cancer in the United States with an estimated 85,000 people expected to be diagnosed each year. Current surveillance relies primarily on imaging, which may not detect recurrence until the disease has significantly progressed.

Information in this article is based on a company press release.

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