Bladder EpiCheck Urine Methylation Test and Photodynamic Diagnostic Cystoscopy for the Surveillance of High-Risk Non-Muscle-Invasive Bladder Cancer – Expert Commentary

Non-muscle invasive bladder cancer (NMIBC) has one of the highest local recurrence rates of any malignancy. The current standards of care for NMIBC surveillance are white light cystoscopy and urine cytology. However, novel surveillance tests are needed to improve the detection of recurrent NMIBC. A recent study by Cochetti et al. examined the performance of Bladder EpiCheck (BE), a urine test that assesses 15 methylation biomarkers and photodynamic diagnosis (PDD)-guided cystoscopy for surveillance of high-risk NMIBC.


Forty patients were monitored for non-muscle-invasive bladder cancer. All patients underwent UC and cystoscopy with PDD in the operating room and a BE test immediately before cystoscopy. All patients underwent intravesical instillations within 40-60 days before the visit. 16 patients had BCG instillations, and 24 patients had mitomycin C instillation. All patients had histological results. 18 patients had positive findings, 10 patients had Ta-LG, 2 patients had Ta-HG, one patient had T1-LG, 4 patients had carcinoma in situ (4), and one patient had T2-HG. The area under the curve (AUC) for BE testing was 0.95. BE detected NMIBC recurrence with a sensitivity of 100% and a specificity of 90.9%. For PDD, the AUC was 0.51, with a sensitivity and specificity of 61% and 41%, respectively. The investigators included a proposed algorithm for combining BE urine testing with urine cytology.

This prospective study demonstrated the feasibility of integrating a non-invasive urine methylation test, urine cytology, and photodynamic diagnosis cystoscopy to detect NMIBC recurrences. Further validation of the diagnostic performance of these modalities in larger prospective trials is warranted.

Written by: Bishoy M. Faltas, MD, Director of Bladder Cancer Research, Englander Institute for Precision Medicine, Weill Cornell Medicine, New York City, New York

References:

  1. Cochetti G, Rossi de Vermandois JA, Maulà V, Cari L, Cagnani R, Suvieri C, Balducci PM, Paladini A, Del Zingaro M, Nocentini G, Mearini E. Diagnostic performance of the Bladder EpiCheck methylation test and photodynamic diagnosis-guided cystoscopy in the surveillance of high-risk non-muscle invasive bladder cancer: A single centre, prospective, blinded clinical trial. Urol Oncol. 2021 Dec 12:S1078-1439(21)00483-X. doi: 10.1016/j.urolonc.2021.11.001. Online ahead of print. PMID: 34911649

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