This review summarizes recent developments in diagnostic and prognostic biomarkers for nonmuscle invasive bladder cancer (NMIBC). Although the number of new biomarkers increases continuously, none are included in practice guidelines. Most NMIBC biomarkers show a higher sensitivity than urinary cytology, but lower specificity. Some protein and chromosome markers have been approved for screening and follow-up of patients in combination with cystoscopy. The long interval required for validation, testing, and approval of the assays and the lack of standardization could explain present issues in biomarker research. To enhance the development of new biomarkers, a more structured approach is required.
Key points
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Urothelial carcinoma of the bladder (UCB) is the most expensive solid tumor to treat because of its high recurrence rate and the need of continued cystoscopic surveillance.
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Cystoscopy has a high sensitivity and specificity, but is a costly and invasive procedure; urinary cytology is noninvasive and highly specific and shows very low overall sensitivity, in particular in low-grade nonmuscle invasive bladder cancer (NMIBC).
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Several biomarkers may have better sensitivity than voided urinary cytology, but they are not accurate enough to replace cystoscopy and cytology.
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NMP22, BTA , ImmunoCyt/uCyt+ and UroVysion/FISH have been approved by the Food and Drug Administration for screening and follow-up of patients with NMIBC in combination with cystoscopy.
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The long interval required for validation, testing, and approval of the assays and the lack of standardization could explain the present failure of biomarkers to predict NMIBC development, recurrence, and progression.