How to cite: Cole A. “Why Biomarkers Matter Now.” Grand Rounds in Urology. August 2026. Accessed Oct 2026. https://grandroundsinurology.com/why-biomarkers-matter-now/
Summary
In this presentation from the UroCancer Interdisciplinary Forum 2026, Adam Cole, MD, FS, TruCore Pathology, Little Rock, Arkansas, reviews the current and emerging biomarker landscape in bladder cancer, emphasizing that expanding treatment options requires more accurate tools for diagnosis, risk stratification, surveillance, and treatment selection. He begins by discussing currently available urine-based molecular diagnostics, explaining that first-generation assays such as nuclear matrix protein 22 (NMP22), bladder tumor antigen, ImmunoCyt™, and UroVysion® fluorescence in situ hybridization (FISH) improved upon urine cytology but remain limited by false-positive results and variable specificity. Newer assays, including CxBladder® and UroAmp, offer improved molecular characterization and may reduce the frequency of surveillance cystoscopy in selected patients.
Dr. Cole reviews emerging technologies, including next-generation sequencing, long non-coding RNAs, microRNAs, artificial intelligence-assisted diagnostics, and home-based urine testing platforms that combine multiple biomarkers to improve diagnostic performance. He notes that future testing will likely rely on multi-marker panels rather than individual biomarkers.
Dr. Cole highlights fibroblast growth factor receptor 3 (FGFR3) as both a diagnostic and therapeutic biomarker. He explains that FGFR3 immunohistochemistry may help pathologists distinguish difficult low-grade from high-grade papillary urothelial tumors and identify patients who should undergo confirmatory genomic sequencing for potential targeted therapy. In contrast, he describes programmed death-ligand 1 (PD-L1) testing as increasingly limited because multiple scoring systems and companion diagnostic assays reduce consistency across clinical practice.
Dr. Cole considers circulating tumor DNA as the biomarker with perhaps the greatest future potential. He reviews tumor-informed minimal residual disease assays, explains their role in monitoring treatment response and recurrence, and summarizes emerging evidence demonstrating that ctDNA-negative patients have substantially better outcomes following definitive therapy, while persistently positive patients may benefit from treatment intensification. He stresses that although no biomarker currently has sufficient prospective evidence to mandate routine clinical use across all settings, ctDNA is likely to play an increasingly important role in the precision management of bladder cancer.
ABOUT THE AUTHOR
Adam Cole, MD, FS, is the founder and Chief Executive Officer of TruCore Pathology in Little Rock, Arkansas. He is a board-certified Pathologist with a focus in Genitourinary and Molecular Pathology and serves in the United States Air Force Reserves as a Lieutenant Colonel and Squadron Commander of the 44th AMDF/301FW at Eglin Air Force Base.
Dr. Cole earned a bachelor’s degree in Microbiology at the University of Arkansas in Fayetteville, where he graduated with honors. Following this, he completed his master’s degree in Health Science at Duke University in Durham, North Carolina. He earned his medical degree in Anatomic and Clinical Pathology from Louisiana State University Health Sciences Center in Shreveport and completed his residency in Pathology at the University of Arkansas for Medical Sciences.
In 2015, Dr. Cole partnered with Lumea to develop a more robust pathology process. By utilizing digital pathology and propriety sampling techniques, he discovered that more tissue could be preserved while improving cancer detection, reducing turnaround times and simplifying genomic testing. As active surveillance becomes more prevalent and guidelines from the National Comprehensive Cancer Network (NCCN) continue to evolve, Dr. Cole continues to be a leader in this field.
