Nucleix Expands EU Label Indication of Bladder EpiCheck® to Include the Detection of Primary Bladder Cancer and Detection of Primary and Recurrent Upper Tract Urinary Cancer

SAN DIEGO & REHOVOT, Israel--(BUSINESS WIRE)-- Nucleix a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, today announced that the company has expanded the European Union (EU) label indication of its Bladder EpiCheck^® test. Bladder EpiCheck detects DNA methylation patterns in urine that are associated with urothelial cancer.

The technology was initially indicated for use as a non-invasive method for the monitoring of tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer. The current update expands the label indication to also include aiding in the detection of primary bladder cancer and upper tract urothelial carcinoma (UTUC) in patients presenting with hematuria and/or other urinary tract symptoms and/or findings with a suspicion of malignancy, and the detection of recurrent UTUC, in conjunction with standard diagnostic procedures.

Bladder cancer is the fifth most common cancer in Europe with more than 200,000 new cases of the disease diagnosed annually.¹ With bladder cancer, patients typically experience symptoms of traces of blood in the urine, called hematuria, though this is not usually visible to the naked eye.² Up to 30% of adults will experience hematuria at some point in their life, so it is crucial to quickly and non-invasively determine if the symptom is associated with bladder cancer, to ensure a urological workup is conducted immediately.² Bladder EpiCheck demonstrated 88% sensitivity in detecting the primary high-risk bladder cancer, with a specificity of 98% or more.

“The current workup of hematuria is invasive, costly and usually performed too late, due to delayed referrals to urologists, all the while symptoms can worsen and diagnosis of the disease is delayed when treatment is critical,” said Eli Frydman, Ph.D. MBA, President EMEA of Nucleix. “With this expanded label indication and high specificity of Bladder EpiCheck in this population, we’re able to offer a cost-effective, non-invasive approach to triage hematuria patients and help identify bladder cancer early.”

Two recently published studies evaluated the performance of Bladder EpiCheck in the detection of primary and recurrent UTUC including 220 patients.^3,4 Bladder Epicheck showed high-grade sensitivity of 96-98% and specificity of 81-100% in urine collected from the ureter. One of the studies also reported high-grade sensitivity of 71% and specificity of 81% in bladder urine. In both studies, test sensitivity was higher than cytology.

“Identifying patients with high-grade UTUC early is critical – if missed, the disease can progress to metastases very quickly and the standard treatment, which is the removal of ureter and kidney, can lead to considerable morbidity,” said Aharona Shuali, M.D., Vice President of Medical Affairs at Nucleix. “We are encouraged by this expanded label indication because of its potential impact on patients. Bladder EpiCheck delivers highly accurate results in a non-invasive way and could play an important role in the diagnosis and follow-up of this disease, particularly in ruling-out high-grade disease.”

About Bladder EpiCheck^®

Bladder EpiCheck^® provides patients and clinicians with a simple, objective urine test to detect primary and recurrent bladder and upper urinary tract cancers. The test analyzes subtle disease-specific changes in DNA methylation markers, with sensitivity of 91-96% of high-grade cancers. Bladder EpiCheck^® demonstrated negative predictive value (NPV) of 99% for high-grade cancer, meaning that when receiving a negative Bladder EpiCheck^® result, there is 99% chance that no high-grade cancer is present.⁵ Overall specificity of Bladder EpiCheck^® is 84%, 81% and 98% for recurrent bladder cancer, UTUC and primary cancers, respectively, ensuring a low rate of false positive results. Bladder EpiCheck^® is intended for use as a non-invasive method for detection of urinary tract cancers in conjunction with standard methods. Bladder EpiCheck^® is CE-marked and commercially 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 NGS and PCR-based epigenetics, the Company’s pioneering testing approach uses methylation-based identification for early-stage and recurring cancer detection. The Company’s non-invasive EpiCheck^® platform delivers highly accurate and sensitive results, all while providing a seamless testing option for patients and the healthcare system. The Company is building an EpiCheck franchise, beginning with the Bladder EpiCheck^® testing kit, marketed in Europe for the detection of primary and recurrent bladder cancer and Upper Tract Urinary Cancer. The Company is 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 The International Agency for Research on Cancer (IARC). (n.d.). Global Cancer Observatory. Global Cancer Observatory. Retrieved June 9, 2022, from https://gco.iarc.fr
² Matulewicz, R. S., MD. (2016, October 11). Blood in the Urine (Hematuria). Nephrology | JAMA | JAMA Network. https://jamanetwork.com/journals/jama/fullarticle/2565751
³ Territo, A., et al. (2022). DNA methylation urine biomarkers test in the diagnosis of Upper Tract urothelial carcinoma: Results from a single-center prospective clinical trial. Journal of Urology. https://doi.org/10.1097/ju.0000000000002748
⁴ Pierconti, F., et al. (2021). Upper Urothelial Tract High-grade carcinoma: Comparison of urine cytology and DNA methylation analysis in urinary samples. Human Pathology. https://doi.org/10.1016/j.humpath.2021.09.007
⁵ Laukhtina, E., et al. (2022). Corrigendum to “Diagnostic Accuracy of Novel Urinary Biomarker Tests in Non–muscle-invasive Bladder Cancer: A Systematic Review and Network Meta-analysis” [Eur Urol Oncol 2021;4:927–42]. European Urology Oncology. https://doi.org/10.1016/j.euo.2022.01.003

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