A Study Published in European Urology Oncology Demonstrated Bladder EpiCheck® Can Detect High-Grade Bladder Cancer Recurrences Missed by White Light Cystoscopy

Adding the Bladder EpiCheck urine test to standard white light cystoscopy (WLC) surveillance for non-muscle invasive bladder cancer (NMIBC), with positive results prompting biopsy under photodynamic diagnosis (PDD), significantly increased detection of high-grade disease, a study published in European Urology Oncology reports.

The multicenter analysis followed 231 patients with high-grade NMIBC for a median of 16 months, encompassing 316 surveillance visits in which both WLC and Bladder EpiCheck were used. Within six months of a surveillance visit there were two progressions to muscle-invasive bladder cancer (MIBC), 28 high-grade NMIBC recurrences and seven low-grade recurrences. Bladder EpiCheck detected 92% of these events overall, including 90% of high-grade NMIBC/MIBC cases and 100% of low-grade NMIBC cases, compared with detection rates of 62%, 63% and 57% respectively for WLC.

The test notably improved detection of carcinoma in situ (Tis), identifying 92% of Tis cases versus 38% detected by WLC. Researchers say this capability can identify patients with negative cystoscopy who should undergo biopsy, enabling earlier intervention.

“CIS is one of the more aggressive forms of bladder cancer, with up to a 60% risk of progressing to muscle-invasive disease if left untreated,” said Professor Param Mariappan, who led the project. He said earlier detection of Tis could reduce the likelihood of cystectomy and improve patient outcomes.

Bladder EpiCheck is a PCR-based urine assay that analyzes DNA methylation markers to detect recurrent bladder cancer. It is CE-marked in Europe for primary and recurrent bladder and upper tract urinary cancers and has FDA 510(k) clearance in the United States for bladder cancer recurrence. The test is commercially available in Europe and the U.S.

The study’s earlier findings were presented at the 2024 European Association of Urology Congress and the 2025 American Urological Association Annual Meeting.

Nucleix, the developer of Bladder EpiCheck, uses methylation-based testing to detect early-stage and recurring cancers and is advancing additional tests, including Lung EpiCheck, toward commercialization.