On March 25, 2025 NHS Lothian, Scotland’s second largest health authority providing a comprehensive range of primary, community-based and acute hospital services, and Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported data from an abstract featuring Nucleix’s Bladder EpiCheck test presented at the 46th Annual European Association of Urology (EAU) Congress (Press release, Nucleix, MAR 25, 2025, View Source [SID1234651445]).
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The abstract titled "Bladder EpiCheck triggered Photodynamic Diagnosis biopsies detect High Grade recurrences missed by White Light Cystoscopy"i describes the implications of implementing the Bladder EpiCheck urine test as an adjunct to routine surveillance by white light cystoscopy in all high-risk non-muscle invasive bladder cancer (NMIBC) patients. In 316 patients undergoing surveillance from July 2023 until August 2024, 38 cancers were detected, of which 29 were high-grade and 13 were carcinoma in situ (CIS), an aggressive form of bladder cancer often missed by white light cystoscopy, that can progress to muscle-invasive cancer if left untreated. White light cystoscopy detected 17 (59%) of the high-grade cases and 4 (31%) of the CIS cases versus 28 (97%) and 12 (92%), respectively, detected by Bladder EpiCheck and confirmed by photodynamic diagnosis (PDD) biopsies. Specificity was 97% (261/270) for cystoscopy and 94% (253/270) for Bladder EpiCheck. Additionally, Bladder EpiCheck was able to detect 65% more high-grade disease recurrences compared to white light cystoscopy (28 vs. 17), by performing biopsy under PDD in patients with a negative white light cystoscopy and a positive Bladder EpiCheck result. Nine of the 16 (56%) patients that were missed by white light cystoscopy but detected with Bladder EpiCheck and PDD had CIS.
The abstract was presented by Professor Param Mariappan, Consultant Urological Surgeon at Western General Hospital, Edinburgh (NHS Lothian) and member of the European Non-Muscle Invasive Bladder Cancer (NMIBC) and Muscle Invasive Bladder Cancer (MIBC) Guidelines Committees. Professor Mariappan established the Edinburgh Bladder Cancer Surgery (EBCS) Effectiveness and Efficiency Programme (EBCS-EEP) in 2006 to improve the care of patients with bladder cancer by implementing evidence-based interventions in a systematic manner while using real-world data to inform outcomes and process. Adding Bladder EpiCheck to routine high-risk NMIBC surveillance is part of this ongoing project to improve early detection of high-grade disease recurrences.
"The ability of Bladder EpiCheck, a non-invasive urine test, to precisely identify the patients whose cancer is missed by cystoscopy, and refer them for additional workup, makes it a very effective tool for the NHS," said Professor Mariappan. "This allows us to detect and treat aggressive disease early, while containing budget and resources that are limited. Early detection allows us to treat such patients conservatively and potentially to improve patient outcome and avoid significant costs of late treatment, such as cystectomies."
"These data add an important new layer to the robust and constantly growing body of real-world evidence of Bladder EpiCheck performance and clinical utility in NMIBC monitoring," said Dr. Aharona Shuali, Vice President of Medical at Nucleix. "We are proud that leading centers, such as NHS Lothian, are choosing this test to enhance patient care."
These results are consistent with a recently published paper by Fleshner et al. in the journal Bladder Cancerii, that described a strong anticipatory positive signal for Bladder EpiCheck in NMIBC surveillance patients with a negative cystoscopy and cytology, showing a five times higher risk of recurrence in 12 months in patients who had a positive Bladder EpiCheck result versus a negative result.