True or False: The FDA approved biomarkers are highly sensitive and specific for Low Grade Urothelial cell Carcinomas.

• A. True
• B. Not Determined
• C. False
• D. Sometimes

Answer: (C)

Understanding sensitivity and specificity helps explain this. Sensitivity is how often a test will be positive when the disease is present, and specificity is how often it will be negative when the disease is absent. For low-grade urothelial carcinomas, tumor cells shed into urine less consistently and with subtler changes, making it hard for biomarkers to be both highly sensitive and highly specific. FDA-approved urine tests show variable performance: they may help with higher-grade disease, but their ability to detect low-grade tumors with near-perfect accuracy is not reliable. Because no single biomarker consistently delivers both high sensitivity and high specificity for low-grade disease, the statement is not accurate. In clinical practice, results are interpreted alongside other tests and the patient’s risk factors, rather than relying on one biomarker alone.