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

Adding Bladder EpiCheck to cystoscopy for non-muscle invasive bladder cancer (NMIBC) surveillance and, if positive, performing biopsy under photodynamic diagnosis (PDD), significantly improved detection of high-grade disease, facilitating earlier intervention with potentially better patient outcomes

SAN DIEGO & REHOVOT, Israel--(BUSINESS WIRE)--Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, today announced that European Urology Oncology published results of a clinical study demonstrating the implications of implementing Bladder EpiCheck® in conjunction with standard-of-care (SoC) white light cystoscopy (WLC) for non-muscle invasive bladder cancer (NMIBC) surveillance in high-grade recurrence. The article was published online in European Urology Oncology.

The results demonstrated superior Bladder EpiCheck sensitivity in detecting high-grade recurrences, specifically in patients with stage 0is (cases with carcinoma in situ [CIS] without papillary tumors [Tis]), versus current SoC WLC. Bladder EpiCheck outperformed WLC across all measures of sensitivity. The analysis included 231 high-grade NMIBC patients followed up for a median of 16 months with 316 surveillance visits of both WLC and Bladder EpiCheck. Two events of progression to muscle invasive bladder cancer (MIBC), 28 high-grade NMIBC recurrences and seven low-grade NMIBC recurrences occurred within 6 months of a surveillance visit. Bladder EpiCheck detected 92% of these events, including 90% of high-grade NMIBC/MIBC cases and 100% of low-grade NMIBC cases versus 62%, 63%, and 57%, respectively, detected by WLC. Importantly, Bladder EpiCheck detected 92% of Tis cases, where WLC detected 38%. These results underscore the ability of Bladder EpiCheck to detect high-grade recurrences that were missed by WLC by identifying NMIBC patients with a negative surveillance cystoscopy who should undergo biopsy.

“CIS is one of the more aggressive forms of bladder cancer, with up to a 60% risk of progressing to muscle-invasive disease (stage II) if left untreated,” said Professor Param Mariappan, Consultant Urological Surgeon at Western General Hospital, Edinburgh (NHS Lothian), who led this project and is a member of the European NMIBC and MIBC Guidelines Committees. “If CIS recurrence at stage 0 (Tis) is missed and the tumor is detected only after it has progressed to stage I or stage II, removal of the bladder by cystectomy is usually the recommended treatment and patients’ five-year survival rates might significantly decrease. The findings from this study are significant because they demonstrated that Bladder EpiCheck can open a vital window of tumor detection at an earlier disease stage allowing for earlier intervention, potentially avoiding bladder removal, and better outcomes.”

"We are excited to see the results from this impressive study and believe that Bladder EpiCheck is poised to significantly improve care management for NMIBC patients," said Chris Hibberd, Chief Executive Officer of Nucleix.

Earlier data from this study was presented at the 46^th Annual European Association of Urology (EAU) Congress and the American Urological Association's (AUA) 2025 Annual Meeting.

About Bladder EpiCheck®

Bladder EpiCheck® provides physicians and their patients with a simple, objective urine test for recurrent bladder cancer. The PCR 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.