Nucleix to Present Data Showcasing Performance and Clinical Utility of Bladder EpiCheck® Monitoring in Non-Muscle Invasive Bladder Cancer (NMIBC) Recurrence at AUA 2025

Data demonstrates utility of Bladder EpiCheck® to detect High-Grade recurrences that are missed by White Light Cystoscopy

SAN DIEGO & REHOVOT, Israel--(BUSINESS WIRE)--Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, will present data from an abstract describing the implications of applying the company’s 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 at the American Urological Association's (AUA) 2025 Annual Meeting in Las Vegas, Nevada.

“These findings further strengthen the growing real-world evidence supporting the performance of Bladder EpiCheck in NMIBC recurrence monitoring,” said Dr. Aharona Shuali, Vice President of Medical at Nucleix. “We are proud to see this test play an increasing role in advancing care for cancer patients.”

Details of the presentation are as follows:

Title: Bladder EpiCheck triggered Photodynamic Diagnosis biopsies detect High Grade recurrences missed by White Light Cystoscopy.
Presenter: 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
Format: Poster Session
Session Name: MP08: Bladder Cancer: Epidemiology & Evaluation I
Session Day and Time: Saturday, April 26, 2025, from 1:00 PM to 3:00 PM PT
Location: Casanova 505

These data were previously presented at the 46^th Annual European Association of Urology (EAU) Congress in March 2025.

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.