Results from Pivotal Clinical Study Demonstrate Potential of Nucleix’s Bladder EpiCheck® to Improve Disease Recurrence Detection in Non-Muscle Invasive Bladder Cancer (NMIBC) Surveillance

May 6, 2024 |

4 min read

Nucleix announced that the results from the company’s North American pivotal clinical study evaluating the performance of Bladder EpiCheck® as a non-invasive and objective novel methylation-based PCR urine test for the surveillance of non-muscle invasive bladder cancer (NMIBC) recurrence were presented in a podium presentation at the American Urological Association (AUA) Annual Meeting 2024 in San Antonio, Texas.

Results from the study supported Bladder EpiCheck’s 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use as a non-invasive method to monitor for tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with NMIBC

Data presented at the American Urological Association (AUA) Annual Meeting 2024 further shows strong anticipatory positive signal

SAN DIEGO & REHOVOT, Israel--(BUSINESS WIRE)-- Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, announced that the results from the company’s North American pivotal clinical study evaluating the performance of Bladder EpiCheck^® as a non-invasive and objective novel methylation-based PCR urine test for the surveillance of non-muscle invasive bladder cancer (NMIBC) recurrence were presented in a podium presentation at the American Urological Association (AUA) Annual Meeting 2024 in San Antonio, Texas. The data presented demonstrated Bladder EpiCheck’s potential to improve timely disease recurrence detection and compliance with NMIBC surveillance.

“The results from our pivotal clinical study not only underscore the potential of Bladder EpiCheck as a non-invasive method for tumor recurrence detection in patients previously diagnosed with NMIBC but also signal a transformative shift in NMIBC surveillance,” said Aharona Shuali, MD, MBA, Vice President of Medical Affairs at Nucleix. “The sensitivity, specificity and high predictive values demonstrated by Bladder EpiCheck are consistent with our European study and further support the utilization of the test to monitor for tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with NMIBC. These data supported Bladder EpiCheck’s 510(k) clearance from the U.S. Food and Drug Administration (FDA) in May 2023.” Dr. Shuali added, “A strong anticipatory positive signal was demonstrated in patients with a positive Bladder EpiCheck result, despite negative cystoscopy and cytology, meaning these patients are at increased risk for recurrence in the following year.”

“Due to its high recurrence rate, bladder cancer requires frequent and long-term surveillance with cystoscopy, and this is a burden both for patients and health systems,” said Brant Inman, MD, MS, Chin-Hardie Chair of Urologic Oncology and Professor of Urology and Oncology at Western University (London, Canada). “The performance of Bladder EpiCheck in this clinical trial demonstrates its potential to be used as a non-invasive test for detecting bladder cancer recurrence. Ongoing research will determine if Bladder EpiCheck can be used to replace some cystoscopies and thereby reduce the burden of bladder cancer surveillance for patients and health systems alike.”

During the AUA Annual Meeting on May 5, 2024, these results were presented by Dr. Inman in a podium presentation titled “Pivotal Study Evaluating Performance of Bladder EpiCheck, an FDA cleared test, in Non-Muscle Invasive Bladder Cancer.”

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 soon 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.