Nucleix Bladder EpiCheck® Now Available in France via the Association Francaise d'Urologie (AFU) Registry for Surveillance of Recurrence of Bladder Cancer

23 Oct 2023
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Clinical Result
Nucleix Bladder EpiCheck® is a non-invasive CE marked test for detection of primary or recurrent bladder cancer, and U.S. FDA 510(k) cleared for bladder cancer recurrence, in conjunction with standard of care methods Association Francaise d'Urologie (AFU) Registry of the Therapeutic Management and Follow-up of Non-Muscle-Invasive Bladder Cancer (TVNIM-AFU) will evaluate the diagnostic performance of selected biomarkers in patients in France SAN DIEGO & REHOVOT, Israel--(BUSINESS WIRE)-- Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, today announced participation in the Association Francaise d'Urologie (AFU) Registry of the Therapeutic Management and Follow-Up of Non-Muscle-Invasive Bladder Cancer (TVNIM-AFU). The registry will evaluate the diagnostic performance of selected urine biomarkers in French patients and compare them to the results of bladder endoscopies (cystoscopy) performed over two years for routine follow-up of NMIBC. The registry is open to all urologists who are members of the AFU to include patients undergoing tumor resection. NMIBC has an estimated incidence of 16,500 new cases each year in France1, three quarters of which are diagnosed at an early stage where the cancer does not invade the bladder muscle. The risk of recurrence is as high as 78% over five years2, so frequent surveillance is required in order to promptly detect high-grade recurrence of the disease, and to treat it in time and prevent progression to life-threatening disease. The current standard of care surveillance involves frequent and invasive cystoscopies that patients endure up to four times a year for at least five years and, in some cases, for the remainder of their life. Bladder EpiCheck is a highly sensitive urine test that analyzes subtle disease-specific changes across 15 methylation markers that are associated with bladder cancer, allowing for the detection of urothelial cancer; The test is CE marked in Europe and available throughout the EU for primary and recurrent bladder cancer and upper tract urinary cancer, and is U.S. FDA 510(k) cleared for bladder cancer recurrence in the United States. The CE-marked test results obtained across multiple EU studies demonstrated sensitivity of 91% and negative predictive value (NPV) of 99% for high-grade recurrent bladder cancer, meaning that a negative Bladder EpiCheck result rules out high-grade recurrent disease with 99% probability.3 Overall specificity of Bladder EpiCheck in this population was 84%, ensuring a low rate of false positive results. “This patient-centric initiative demonstrates the AFU's commitment to improve NMIBC surveillance by offering patients access to innovative, accurate and non-invasive tools, such as Bladder EpiCheck,” said Professor Yann Neuzillet, Urologist, Head of the Bladder Group of the Oncology Committee, and General Secretary, AFU. “We are pleased to have been selected by the AFU to participate in this important and large-scale program that is expected to generate robust real-world evidence that could be leveraged across Europe to assess the utility of the test,” said Aharona Shuali, M.D., Vice President of Medical Affairs, Nucleix. Bladder EpiCheck testing will be performed by Inovie Gen-Bio, a network that conducts molecular biology and genetic testing across France. “This strategic collaboration allows us to offer patients diagnosed with NMIBC the convenience of getting this objective and non-invasive urine test five minutes from home, in one of our 626 city labs across the country,” said Dr. Pierre-Jean Lamy, Medical Oncogetic biologist, Chief Scientific Officer, Inovie Group. 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: . NUCLEIX, the NUCLEIX Logo, and EPICHECK are trademarks or registered trademarks of Nucleix Ltd. ___________________________ 1 Data GLOBOCAN 2020Graph production: Global Cancer Observatory ( ) © International Agency for Research on Cancer 2023 2 3 Laukhtina et al. Diagnostic Accuracy of Novel Urinary Biomarker Tests in Non–muscle-invasive Bladder Cancer: A Systematic Review and Network Meta-analysis Eur Urol Oncol 2021 Dec;4(6):927-942; and corrigendum at Eur Urol Oncol. 2022 Jan 19;S2588-9311(22)00004-9. doi: 10.1016/j.euo.2022.01.003
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