Pivotal Study Evaluating Performance of Bladder Epicheck, an FDA Cleared Test, in Non-Muscle Invasive Bladder Cancer

Document Type

Conference Proceeding

Publication Date

5-2024

Publication Title

Journal of Urology

Abstract

NTRODUCTION AND OBJECTIVE: Bladder cancer is the 5th most common cancer in the US. NMIBC surveillance with cystoscopy and cytology is invasive and operator dependent. Bladder EpiCheck (BE) is an accurate non-invasive & objective novel methylation-based PCR urine test included in the EAU guidelines that could potentially augment NMIBC surveillance. These are the results of the FDA pivotal study for BE’s 510K clearance. METHODS: A prospective, blinded, multicenter, 3-visit study in11 centers in USA and Canada. NCT02700464 Adult bladder cancer patients within 12 months of TURBT and under cystoscopic surveillance, were eligible. Patients planned for cystectomy or chemoradiation were excluded. The gold standard (GS) positive was either positive cystoscopy confirmed by pathology or positive cytology(HGUC and SHGUC). All others were considered GS negative. Voided urine was collected prior to cystoscopy. The first GS positive visit was used for analysis and if all visits were negative, the last negative visit was used for analysis. Wash urine samples were excluded. BE detects methylation patterns of 15 loci in urine cell DNA associated with urothelial carcinoma. BE testing was performed on ABIÒ 7500 Fast Dx PCR (Thermo Fisher) at two central CLIA-certified laboratories in the US.RESULTS: 674 subjects were enrolled and 449 were included in analysis (Figure 1). Median age was 71 (38-93), 79% were male, 47%had history of ≥1 recurrence and 51% were treated with instillations since last TURBT. Overall sensitivity, specificity, NPV and PPV were67%, 84%, 85%, 65%, respectively. HG sensitivity and NPV were 77%and 95% (Table 1). Performance was statistically different by grade, but not impacted by any other factor including, sex, smoking history, occupational risk, time from last instillation treatment. In patients with a negative GS, the rate of subsequent recurrence at one of the two first study visits was 53% compared to 10% of subjects with positive and negative BE, respectively. CONCLUSIONS: BE performance could improve timely disease recurrence detection and compliance with NMIBC surveillance. BE’s high HG NPV supports the use as a rule-out test for HG disease. With high specificity and PPV, BE’s false positive rates are low, potentially minimizing unnecessary downstream procedures and patient anxiety.

Volume

211

Issue

5S

First Page

e990

Comments

American Urological Association Annual Meeting, May 3-6, 2024, San Antonio, TX

DOI

10.1097/01.JU.0001008712.53259.7d.07

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