Full title: Urine molecular marker testing for the diagnosis of urothelial carcinoma

Authors: Lidia García Pérez, Lena Arnal Artiaga, Estefanía Herrera Ramos, Pedro de Pablos-Rodríguez, Renata Linertová

Contact person: Lidia García Pérez (lidia.garciaperez@sescs.es)

KEY POINTS

• Bladder EpiCheck® (Nucleix Ltd., Israel) is a CE–IVD marked in vitro diagnostic medical device for primary and recurrent bladder cancer, as well as upper urinary tract cancer.

• Bladder EpiCheck® analyzes 15 methylation biomarkers and detects the presence of urothelial neoplastic cells based on their methylation profiles. The test is performed on urine samples processed by centrifugation and DNA extraction from the cellular sediment.

• Bladder cancer is the fifth most common type of cancer in Spain. Upper urinary tract cancer is a rare type of carcinoma.

• Bladder EpiCheck® could potentially reduce the number of cystoscopies during cancer follow-up, thereby reducing patient discomfort and the risk of complications associated with this invasive procedure. It could also be used as an alternative to urine cytology.

• A meta-analysis estimated a sensitivity of 0.81 and a specificity of 0.87 for detecting non–muscle-invasive bladder cancer. Sensitivity and specificity are higher in high-grade tumors. Few studies have assessed the technology in patients with upper urinary tract cancer.

• The implementation of the technology would have minimal ethical, social, legal, political, cultural, economic, organizational, or health impact.

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