Crucial unmet needs for standardization and clinical integration of actionable biomarkers persist across the bladder cancer disease spectrum. To address these gaps, the International Bladder Cancer Group (IBCG) convened a global multidisciplinary panel to develop evidence-based consensus recommendations on biomarker use in bladder cancer. Recommendations were formulated across the disease spectrum using a modified Delphi process. In patients with asymptomatic microhaematuria, biomarker use should be guided by a risk-stratified approach. For patients with established non-muscle-invasive bladder cancer, no biomarker prospectively validated is available to guide intravesical therapy selection, although approved commercial tests might aid in adjudicating equivocal cytology or cystoscopy findings in patients with high-grade disease. In muscle-invasive bladder cancer, no validated biomarkers exist to guide the choice between bladder preservation and radical cystectomy, or to inform the choice of neoadjuvant therapy. Circulating tumour DNA is prognostic following neoadjuvant therapy and radical cystectomy, and provides predictive value for selecting patients who are most likely to benefit from adjuvant treatment with approved immunotherapy regimens. In addition, circulating tumour DNA has prognostic value in patients with metastatic urothelial carcinoma. The IBCG recommends assessing FGFR3 genomic alterations and HER2 immunohistochemistry in patients with locally advanced and/or metastatic bladder cancer to inform therapeutic selection. The IBCG consensus recommendations provide practical, stage-specific guidance on the use of biomarkers for diagnosis, risk stratification and treatment selection in patients with bladder cancer and define priorities for future validation and trial design.
Nature reviews. Urology. 2026 Aug 05 [Epub ahead of print]
Patrick J Hensley, Jeremy Y C Teoh, Roger Li, Shilpa Gupta, Laura Bukavina, Kent W Mouw, Niyati Lobo, Brigida Anna Maiorano, Wei Shen Tan, Piyush Agarwal, Hikmat A Al-Ahmadie, Trinity J Bivalacqua, Liang Cheng, Thomas W Flaig, Charles C Guo, Amir Horowitz, Wassim Kassouf, Max R Kates, Badrinath R Konety, Janet B Kukreja, Yair Lotan, David J McConkey, Laura S Mertens, Maria Carmen Mir, Marco Moschini, Andrea Necchi, Karima Oualla, Vignesh T Packiam, Bogdana Schmidt, Roger J Buckley, Ashish M Kamat
Departments of Urology and Pathology, University of Kentucky Markey Cancer Center, Lexington, KY, USA., S.H. Ho Urology Centre, Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China., Department of Genitourinary Oncology, Moffitt Cancer Center, Tampa, FL, USA., Department of Genitourinary Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, USA., Glickman Urological Institute, Cleveland Clinic, Cleveland, OH, USA., Department of Radiation Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA., Department of Urology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK., Department of Medical Oncology, Comprehensive Cancer Center, IRCCS San Raffaele Hospital, Milan, Italy., Department of Urology, Yale School of Medicine, New Haven, CT, USA., Department of Surgery, Section of Urology, University of Chicago, Chicago, IL, USA., Department of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA., Department of Pathology and Laboratory Medicine, Department of Surgery (Urology), Brown University Warren Alpert Medical School, the Legorreta Cancer Center at Brown University, Brown University Health, Providence, RI, USA., Department of Medicine, Division of Medical Oncology, University of Colorado Anschutz Medical Center, Aurora, CO, USA., Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA., Department of Immunology and Immunotherapy, Marc and Jennifer Lipschultz Precision Immunology Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA., Department of Surgery (Urology), McGill University Health Center, Montreal, Quebec, Canada., Johns Hopkins University, Baltimore, MD, USA., Allina Health Cancer Institute, Minneapolis, MN, USA., Division of Urology, Department of Surgery, University of Colorado Anschutz Medical Center, Aurora, CO, USA., Department of Urology, University of Texas Southwestern, Dallas, TX, USA., Department of Urology, University of Rochester Medical Center, Rochester, NY, USA., Department of Urology, Netherlands Cancer Institute, Amsterdam, the Netherlands., Department of Urology, Mount Sinai Icahn School of Medicine, Elmhurst/Queens Hospitals, New York, NY, USA., Department of Experimental Oncology, Unit of Urology, IRCCS San Raffaele Hospital, Milan, Italy., Department of Medical Oncology, IRCCS San Raffaele Hospital, Milan, Italy., Department of Medical Oncology, Hassan II University Hospital, Fez, Morocco., Division of Urologic Oncology, Rutgers Cancer Institute, New Brunswick, NJ, USA., Department of Surgery, Division of Urology, University of Utah, Salt Lake City, UT, USA., Division of Urology, North York General Hospital, Toronto, Ontario, Canada., Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. .