Adding Bladder EpiCheck® to surveillance cystoscopies in high-risk non-muscle invasive bladder cancer (NMIBC) patients increased the detection of High-Grade recurrences by 65%
Bladder EpiCheck detects High-Grade recurrences that are missed by White Light Cystoscopy by identifying patients with a negative cystoscopy who should undergo photodynamic diagnosis (PDD)-guided biopsy
EDINBURGH, Scotland & SAN DIEGO & REHOVOT, Israel–(BUSINESS WIRE)–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, today announced data from an abstract featuring Nucleix’s Bladder EpiCheck® test presented at the 46th Annual European Association of Urology (EAU) Congress.
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.
About NHS Lothian
NHS Lothian is one of the 14 regions of NHS Scotland. It provides a comprehensive range of primary, community-based and acute hospital services for the populations of Edinburgh, Midlothian, East Lothian and West Lothian. The Lothian Region has the second largest residential population in Scotland, with more than 850,000 people, and its population is growing faster than anywhere else in Scotland. Across all areas of care, NHS Lothian seeks to provide specialist and general services fairly and efficiently and to the highest standards, and employs approximately 26,000 staff. NHS Lothian also provides services for patients in Borders and Fife, as well as a number of specialist services for patients across Scotland.
About Bladder EpiCheck®
Bladder EpiCheck® provides physicians and their patients with a simple, objective urine test for recurrent bladder cancer. The test analyzes subtle disease-specific changes in DNA methylation markers, with high sensitivity and specificity. Bladder EpiCheck is intended for use as a non-invasive method for detection of NMIBC recurrence in conjunction with standard of care methods. Bladder EpiCheck is CE-marked and available in Europe for primary and recurrent bladder cancer and upper tract urinary cancer, and FDA 510(k) cleared for bladder cancer recurrence in the United States. It is commercially available in Europe and in the United States.
About Nucleix
Nucleix is a liquid biopsy company revolutionizing cancer treatment with earlier disease detection at a time when intervention can bring the greatest impact for patients. Leveraging NGS-based and PCR-based technology to identify methylation changes, the Company’s pioneering testing approach uses methylation-based identification for early-stage and recurring cancer detection. The Company’s non-invasive EpiCheck® delivers highly accurate and sensitive results, all while providing a seamless testing option for physicians, patients, and the healthcare system. The Company is building an EpiCheck® franchise, beginning with the Bladder EpiCheck® kit, CE-marked and available in Europe for primary and recurrent bladder cancer and upper tract urinary cancer, and FDA 510(k) cleared for bladder cancer recurrence in the United States. The Company is advancing its Lung EpiCheck® test towards commercialization for high-risk individuals, while evaluating additional tests for other high-risk diseases. For more information, please visit: https://www.nucleix.com.
NUCLEIX, the NUCLEIX Logo, EPICHECK, LUNG EPICHECK and BLADDER EPICHECK are trademarks or registered trademarks of Nucleix Ltd.
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i Mariappan et al. Bladder EpiCheck triggered Photodynamic Diagnosis biopsies detect High Grade recurrences missed by White Light Cystoscopy. Abstract A0677 EAU25 conference |
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ii Fleshner N, Grossman HB, Berglund R, Hafron J, Inman B, Karsh L, Moses K, Saltzstein D, Shah A, Wright J, Witjes JA, Lotan Y. North American study and meta-analysis evaluating performance of Bladder EpiCheck®, a FDA cleared test, in non-muscle invasive bladder cancer recurrence. Bladder Cancer. 2025 Jan 15;10(4):278-289. |
Contacts
Contacts for inquiries or additional information:
Jake Robison
Inizio Evoke Comms
(619) 849-5383
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