Nucleix Presents Two Bladder EpiCheck® Studies at EAU20 Virtual Congress, Including Interim Data in Patients with Upper Tract Urothelial Cancer

Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, today announced two presentations featuring its Bladder EpiCheck® technology at the 35^th Annual European Association of Urology (EAU) Virtual Congress.

The first presentation, titled “Feasibility of the EpiCheck test in upper tract tumor: interim analysis of a prospective trial,” evaluated 47 patients who underwent an ureteroscopy for primary or recurrent upper tract urothelial cancer (UTUC) since June 1, 2018. For each patient, cytology and Bladder EpiCheck tests were performed on voided urine and selective urine (urine collected from the ureter) samples. In the study, 46% of patients were positive for UTUC as confirmed by endoscopic biopsy – half of which were high grade. This interim analysis reported a significantly higher overall sensitivity of Bladder EpiCheck compared to cytology in voided urine (75% vs 39%, p=0.03). Bladder EpiCheck also outperformed cytology in high-grade UTUC with a sensitivity of 89% vs. 64% and a negative predictive value (NPV) of 95% vs. 88% in voided urine.

“Accurately identifying patients with high-grade UTUC is critical, as the disease progression can be deadly and the standard treatment – removal of ureter and kidney – leads to major morbidity. Unfortunately, identifying the presence of high-grade UTUC today is done through ureteroscopy, a very complex procedure under general anesthesia that has low yield,” said Dr. Alberto Breda, head of the oncological urology unit and the kidney transplant team in Fundacio Puigvert, Barcelona, Spain and the lead investigator of the study. “We are encouraged that these data demonstrate the promise of Bladder EpiCheck’s ability to accurately rule-out high-grade upper tract urothelial cancer with a simple voided urine test. As a result, we hope to be able to identify more patients who can safely keep their kidney and undergo conservative treatment.”

The second presentation, titled “The diagnostic accuracy of Bladder EpiCheck in high-risk population,” evaluated the diagnostic accuracy of Bladder EpiCheck compared to cystoscopy and cytology, the current gold standard, among 167 consecutive patients with a history or suspicion of high-risk bladder cancer. The results of the study found that in patients with history of high-grade non-muscle invasive bladder cancer (NMIBC) undergoing follow-up, the diagnostic accuracy of the Bladder EpiCheck was higher than cytology and cystoscopy in terms of sensitivity (93.5%, 73.9% and 58.1%, respectively) and NPV (96.4%, 87.5%, 79.3%, respectively).

“We are encouraged by the independent evidence of our Bladder EpiCheck technology, and its potential role in improving UTUC and NMIBC management for the benefit of patients,” said Aharona Shuali, M.D., vice president of medical at Nucleix. “Bladder EpiCheck’s consistently excellent sensitivity and NPV in high-grade urothelial cancers allows urologists to start considering innovative approaches for managing these patients.”

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.

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

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