Nucleix Announces Publication of Data on Methylation-Based Assay for Detecting High-Risk Non-Muscle Invasive Bladder Cancer in Journal of Clinical Pathology

Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, today announced the publication of an independent study in the Journal of Clinical Pathology evaluating the company’s urine-based Bladder EpiCheck® in patients diagnosed with high-grade non-muscle invasive bladder cancer (NMIBC). The findings support the use of the Bladder EpiCheck methylation biomarkers to detect bladder cancer recurrence in NMIBC patient populations that have undergone instillations.

The study evaluated 374 patients with a history of high-grade NMIBC who were followed for one year with voided urine cytology and white-light cystoscopy and biopsies, which is standard clinical practice according to European Association of Urology Guidelines. All patients were undergoing treatment with instillations and were selected for cystoscopy based on cytology results. In this study, patients were referred for cystoscopy and biopsies when within cytology categories of high-grade urothelial carcinoma (HGUC), suspicious for high-grade urothelial carcinoma (SHGUC) and atypical urothelial cells (AUC). One hundred and twenty-seven patients in the study (34%) had a pathologically proven recurrence.

“Monitoring for recurrence in patients with high-grade NMIBC undergoing instillations currently requires routine invasive cystoscopies, which are painful procedures for patients and require substantial resources from healthcare providers. Cytology is a routine urine test used in combination with cystoscopy to detect high-grade recurrences; however, it has inherent limitations, such as reader dependency and low sensitivity,” said Aharona Shuali, M.D., vice president of medical at Nucleix. “The purpose of this study was to determine if the Bladder EpiCheck test could perform similar to, or better than, cytology in identifying, at a molecular level, which patients have high probability of recurrence and should undergo a cystoscopy and biopsies, and which might be able to avoid these invasive procedures.”

The Bladder EpiCheck test was performed together with cytology in all cases and demonstrated a sensitivity of 95%, specificity of 85%, negative predictive value (NPV) of 97% and positive predictive value (PPV) of 76%. Bladder EpiCheck had approximately 90% concordance with HGUC and NHGUC categories, and a high EpiScore (≥90) was strongly correlated with HGUC category (41% vs. 3% in SHGUC, p=0.0001).

The study found that 33% of the negative patients were unnecessarily referred to cystoscopy and biopsy, a finding reflecting cytology’s specificity of 67%. The study demonstrates that if Bladder EpiCheck had been used to select patients for cystoscopy, instead of cytology, this number could have been reduced to 15%, as Bladder EpiCheck specificity was much higher (85%) while detecting 95% of the recurrences.

“These data demonstrate excellent performance of the Bladder EpiCheck test in accurately identifying recurrence vs. non-recurrence in the high-risk NMIBC patient populations without being impacted by the side effects of instillations,” said Dr. Francesco Pierconti, associate professor at the Agostino Gemelli University Hospital in Rome, Italy, and lead author of the study. “After two years of experience with Bladder EpiCheck in clinical routine with consistent excellent performance, we are now using it, instead of cytology, to select high-risk NMIBC patients for further workup with cystoscopy and biopsies, allowing us to safely avoid unnecessary procedures,” continued Dr. Pierconti, who also serves as professor in the Division of Anatomic Pathology and Histology at the Catholic University of the Sacred Heart in Rome, Italy.

The study titled, “Methylation study of the Paris system for reporting urinary (TPS) categories” has been published online and can be accessed here.

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 present. 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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