SAN DIEGO & REHOVOT, Israel--(BUSINESS WIRE)--Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, today announced it has been informed it will receive national reimbursement approval from The Dutch Healthcare Authority (NZA) in the Netherlands, effective January 1, 2024, for its CE-marked Bladder EpiCheck® test for detection of primary or recurrent bladder cancer and upper tract urinary cancer.
“Until now, the Dutch NMIBC Care Path included only cystoscopy and cytology as tools for NMIBC monitoring – cystoscopy is a burdensome invasive procedure patients must undergo every few months, and cytology has low sensitivity,” said Dr. Toine van der Heijden, Oncological Urologist, Radboud University Nijmegen Medical Centre. “Our efforts in the last few years have led to non-invasive urinary tumor markers being reimbursed in the Netherlands next year. This addition to the NMIBC Care Pathway is an important step forward to reduce the burden on Dutch patients in a cost-effective manner.”
Bladder cancer is the fifth most common cancer in the western world, but the costliest to care for, due to the need for prolonged surveillance. As a result of the high recurrence rate of the disease, the current standard of care for 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.
“We have been using Bladder EpiCheck for NMIBC monitoring in Radboud for the past four years, alternating it with cystoscopy in patients from all risk groups,” said Fred Witjes, Professor of Oncological Urology at Radboud University Medical Center. “It has proven to be an excellent tool for non-invasive surveillance and highly appreciated by the patients who also liked the home urine collection solution offered by the company, sparing the drive to the medical center. Offering this patient-centered solution to all Dutch NMIBC patients via national reimbursement is a big step forward.”
Bladder EpiCheck is CE-marked in Europe (EU) 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.1 Overall specificity of Bladder EpiCheck in this population was 84%, ensuring a low rate of false positive results.
“We are appreciative of our collaboration with Professor Witjes and Dr. van der Heijden who took it as their mission to make this test more readily available to physicians and their patients,” said Aharona Shuali, M.D., Vice President of Medical Affairs at Nucleix. "The NZA’s decision to provide reimbursement for Bladder EpiCheck demonstrates the commitment for innovation in the Netherlands for this underserved cancer. We continue to work to advance national reimbursement in other European countries.”
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.
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 and BLADDER EPICHECK are trademarks or registered trademarks of Nucleix Ltd.
1 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