By Clinical Research News Staff

June 11, 2026 | A novel urine-based liquid biopsy developed at Stanford University is showing remarkable accuracy in predicting bladder cancer recurrence and may soon reshape how clinical trials enroll and treat patients. The test, developed by urologic oncologist Joseph Liao, M.D., and colleagues, filters out age-related background mutations in urine to produce a cleaner, more reliable signal for detecting residual cancer after surgery and immunotherapy. 

Bladder cancer is the fourth most common cancer in men and sixth most common overall, with roughly 70,000 Americans diagnosed with the non-muscle-invasive form each year. The current standard of care—endoscopic surgery followed by BCG immunotherapy and lifelong cystoscopy surveillance—is burdensome, costly, and imprecise. BCG can cause significant discomfort and flu-like symptoms, faces recurring global supply shortages, and doesn’t work for every patient. Yet under the current protocol, nearly all eligible patients receive it. 

Liao’s team set out to change that. Their urine tumor DNA (utDNA) test, published recently in Cell, analyzed 261 patient samples and identified three distinct molecular response classes: those cured by surgery alone, those who respond to BCG following surgery, and those who respond to neither. The key innovation is the removal of what the researchers call “clonal cystopoiesis” — benign, age-related somatic mutations that accumulate in bladder tissue and have previously caused false positives in other utDNA tests. By subtracting this background noise, the Stanford team’s test produces a high-confidence signal: patients with detectable tumor DNA after completing BCG faced near-certain recurrence, while those who cleared the tumor DNA had excellent outcomes. 

The clinical implications are significant. If roughly a third of patients are cured by surgery alone, a third by surgery plus BCG, and a third by neither, precision-guided treatment could spare many patients from an ineffective and unpleasant therapy and preserve a scarce drug supply for those most likely to benefit. 

Now, the team is preparing to translate these findings into prospective clinical trials. The utDNA test is being converted into a CLIA-certified assay that can be processed by any appropriately certified laboratory, clearing the path for broader clinical use. Once certification is complete, Stanford plans to launch both treatment escalation and de-escalation trials. In the escalation arm, patients who remain utDNA-positive after surgery and BCG, indicating minimal residual disease, would receive alternative or intensified treatment ahead of expected recurrence. The de-escalation arm would explore sparing surgery-only responders from BCG altogether. 

FDA approval is described as “on the horizon,” though Liao notes that a commercial industry partner would likely accelerate the path to market. Ongoing research is also exploring urine RNA analysis, AI-enhanced endoscopic imaging, and the test’s applicability to monitoring responses to chemotherapy and other immunotherapies. 

For Deborah Borfitz’ full story, including details on the science behind clonal cystopoiesis and what this means for the future of precision oncology in bladder cancer, visit Diagnostics World.