North American study and meta-analysis evaluating performance of Bladder EpiCheck

Document Type

Article

Publication Date

1-15-2025

Publication Title

Bladder Cancer

Abstract

BACKGROUND: Bladder EpiCheck (BE) is a novel methylation-based PCR urine test for the detection of non-muscle invasive bladder cancer (NMIBC) recurrences.

OBJECTIVE: We present the results of a North American study evaluating BE and meta-analysis of literature.

METHODS: A prospective, blinded, multicenter study was conducted in North America. Voided urine was collected from NMIBC patients prior to cystoscopic surveillance. BE testing was performed centrally. For the meta-analysis, a PUBMED search was performed to identify all published peer-reviewed clinical studies of BE for NMIBC surveillance.

RESULTS: In this study, 674 patients were enrolled of which 449 were included. Overall sensitivity was 67% (95%CI 58%-74%), specificity was 84% (80%-88%), PPV was 65% (57%-73%) and NPV was 85% (81%-89%). For high-grade (HG) recurrence, sensitivity was 77% (65%-85%) and NPV was 95% (92%-97%).In patients with negative cystoscopy and cytology at the first study visit, risk of subsequent recurrence in 12 months was 5.3 (2.7-10.3) times higher in patients with positive BE vs. negative BE (p <  0.0001). In patients with negative cystoscopy and equivocal cytology, BE was positive in 75-89% of those with later HG recurrence, with PPV of 42% (15%-72%)-63% (38%-84%).The meta-analysis included 7 studies and 1564 patients. Overall sensitivity was 82% (66-92%), HG sensitivity was 91% (82-95%), specificity was 85% (80-88%), PPV was 60% (55-64%) and HG NPV was 98% (97-99%).

CONCLUSIONS: The consistently strong performance of BE indicate that a positive test could improve timely disease recurrence detection and a negative test could rule-out HG disease. Furthermore, the low rate of false positive results, potentially minimizes unnecessary downstream procedures and patient anxiety.

Volume

10

Issue

4

First Page

278

Last Page

289

DOI

10.1177/23523735241304348

ISSN

2352-3735

PubMed ID

40035078

This document is currently not available here.

Find in My Library

Share

COinS