ArticleJournal of translational medicine2026
Role of Bladder EpiCheck
Article in Journal of translational medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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Who cites it
1 citing paper in PubMed.
- Urinary DNA Methylation Profiling Identifies a Biologically Distinct Subgroup of Low-Grade Urothelial Carcinoma with High-Grade-Associated Features.International journal of molecular sciences · 2026Article
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11 authors.
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Abstract
backgroundCystoscopy remains the gold standard for initial diagnostic assessment and follow-up in bladder cancer (BC) patients. Novel diagnostic tools and biomarkers are needed to minimize reliance on cystoscopies whenever possible. Bladder EpiCheck
methodsProspective case-control study between July 2018 and December 2024 including two cohorts: cohort 1 comprised individuals during primary diagnosis of BC (n = 254); cohort 2 included BC patients in follow-up for disease recurrence (n = 138). Overall, 415 voided urine samples were collected (n = 254 for cohort 1; n = 161 for cohort 2) and analyzed using BE test (Nucleix Ltd). Urine cytology was conducted whenever sufficient residual urine was available. Diagnostic performance of both techniques in detecting BC was compared.
resultsOverall, BE sensitivity (SN) for detecting primary BC and recurrent NMIBC was 73% and 55%, respectively. When limited to high-grade (HG) tumours, BE SN increased to 92% and 87%, respectively. BE showed comparable specificity (SP) to cytology in primary (99% vs. 100%) and in recurrent tumours (91% vs. 100%). Diagnostic performance of BE was significantly better than that of cytology in primary (p = 0.013) and recurrent patients (p = 0.023). BE and cytology SN increased progressively across higher NMIBC risk groups. However, BE SN ranged from 47% in low-risk to 93% in very-high risk NMIBC patients while cytology SN ranged from 0% to 79%. Strikingly, EpiScore values were higher in those BC patients in follow-up who progressed into a muscle-invasive disease (p < 0.001), and patients with an EpiScore ≥ 90 were more likely to present high/very-high risk NMIBC or MIBC (OR = 1.93; 95% CI: 1.01-3.67; p = 0.046), ≥T1 stage (OR = 2.00; 95% CI: 1.09-3.71; p = 0.026) and HG tumours (OR = 2.59; 95% CI: 1.27-5.29; p = 0.008).
conclusionsDuring initial diagnosis of BC, BE showed higher SN with similar SP compared with urine cytology. Diagnostic performance of BE increased gradually across EAU prognostic NMIBC factor risk classification, outperforming cytology in all risk groups. Moreover, EpiScore values are able to identify high risk BC patients, ≥T1 tumours and HG tumours.
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