2017). Our assay successfully detected CD63‐positive EVs in urine samples from healthy donors and patients with benign urological conditions and bladder cancer. Notably, no prior studies in the LFIA system have yet included any benign samples to distinguish them from malignant conditions. In our study, the inclusion of benign samples showed an overlap in S/B ratios between the bladder cancer and benign groups, suggesting commonality in uEV profiles and highlighting the complexity of relying on CD63 alone as a biomarker for cancer detection (Figure 2h). This evidence concerns the gene CD63 and urinary bladder cancer.