Independent Review, Published in International Journal of Molecular Sciences, Supports Accuracy and Performance of Nucleix’s Bladder EpiCheck® Urine Test in Detecting Non-Muscle Invasive Bladder Cancer Recurrence

Analysis of Data Showed High Diagnostic Accuracy and High Performance in NMIBC Surveillance for Bladder EpiCheck® through Identification of DNA Methylation in Urine

SAN DIEGO & REHOVOT, Israel--(BUSINESS WIRE)--Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, today announced a published independent review of Bladder EpiCheck studies which showed high diagnostic accuracy and high performance for surveillance of disease recurrence in patients with non-muscle invasive bladder cancer (NMIBC). The publication, titled “The Bladder EpiCheck Test as a Non-Invasive Tool Based on the Identification of DNA Methylation in Bladder Cancer Cells in the Urine: A Review of Published Evidence,” was published in the International Journal of Molecular Sciences.

The review analyzed data from five prospective, blinded, single-arm cohort studies of Bladder EpiCheck for NMIBC detection. The review focused on data from populations of patients in surveillance for histologically proven NMIBC. Notably, Bladder EpiCheck showed a high sensitivity and negative predictive value (NPV) in several studies and a higher sensitivity and NPV than cytology in all studies. Authors concluded Bladder EpiCheck had the greatest diagnostic power in patients with high-grade NMIBC, and it could be used as a monitoring tool to extend time between cystoscopies.

“Patients with NMIBC are at high risk for recurrence, making surveillance critical to identify recurrence, progression, or localization in different areas of the urinary tract. However, quarterly cystoscopies are invasive and painful for patients, which places a high burden on them and on healthcare systems,” said Aharona Shuali, M.D., vice president of medical at Nucleix. “We are pleased that this review of Bladder EpiCheck demonstrates how the test’s high sensitivity and NPV in detection of high-grade disease makes it a meaningful option to safely reduce frequency of cystoscopies.”

The review noted that some positive cases of Bladder EpiCheck with negative cystoscopy and positive/negative cytology results, seem to present DNA methylation changes. These ‘false-positive’ cases of Bladder EpiCheck could identify a genetic high-risk population that may relapse in the near future and deserves close clinical attention. Bladder EpiCheck negative cases could be based on a more stable methylation pattern, which authors propose could represent a population of high-risk bladder cancer patients with an inferior risk of progression.

“We need a test with high accuracy for NMIBC, especially for high-grade NMIBC, to help avoid unnecessary cystoscopies,” said Mariangela Mancini, M.D., consultant urological surgeon at the University of Padua in Padua, Italy, and lead author of the study. “The high performance demonstrated by the current evidence, combined with Bladder EpiCheck’s non-invasive nature, could make it an invaluable tool in the future for follow-up of bladder cancer patients. Furthermore, having a safe alternative for follow-up that does not require patients to come to the hospital, could be even more valuable during the COVID-19 pandemic.”

About Bladder EpiCheck®

Bladder EpiCheck provides patients and clinicians with a simple, objective urine test to detect recurrence of bladder tumors. The test analyzes subtle disease-specific changes in DNA methylation markers, allowing for the detection of 92% of the high-risk (non Ta-LG) cancers. Bladder EpiCheck® demonstrated negative predictive value (NPV) of 99% for high-risk cancer, meaning that when receiving a negative Bladder EpiCheck® result, there is 99% chance that no high-risk cancer is present¹. Bladder EpiCheck® is intended for use as a noninvasive method for monitoring of tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer. Bladder EpiCheck® is CE-marked and available in Europe. The test is not available for sale 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 PCR-based epigenetics, our pioneering testing approach uses methylation-based identification for early-stage and recurring cancer detection. Our non-invasive EpiCheck® platform delivers highly accurate and sensitive results, all while providing a seamless testing option for patients and the healthcare system. We are building an EpiCheck franchise, beginning with our Bladder EpiCheck testing kit marketed in Europe for bladder cancer recurrence. We are advancing a Lung EpiCheck test toward commercialization for high-risk individuals, while advancing additional tests for high-risk diseases. For more information, please visit: https://www.nucleix.com.

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¹ Witjes et al. European Urology Oncology 2018;1:307–313