Nucleix's Non-Invasive Bladder EpiCheck™ Biomarker Test Allows for Personalized Monitoring of Bladder Cancer

REHOVOT, Israel, Feb. 21, 2019 /PRNewswire/ -- Nucleix Ltd., a leading cancer detection and screening company, announced today that Bladder EpiCheck™, its biomarker-based non-invasive urine test for the detection of non‐muscle invasive bladder cancer (NMIBC), was shown to be an effective rule-out test for NMIBC recurrence, thereby minimizing the need for invasive cystoscopies. The analysis, spearheaded by Prof. Shahrokh F. Shariat, Head of the Urology Department in Vienna, adjunct professor in Weil Cornel, NY and UT Southwestern, TX, was recently published in BJU International^[1].

"NMIBC is a highly recurrent disease that requires a long term follow-up. Due to the limited predictive accuracy of risk assessment capabilities today the follow-up regime relies on the patient's history, and current guidelines suggest standardized follow-up of patients with NMIBC," explained Prof. Shariat. "Different biomarkers have been offered for NMIBC monitoring via non‐invasive urine‐based molecular tests, but none of them reached sufficient diagnostic accuracy to become standard-of-care. Our analysis demonstrated that adding Bladder EpiCheck to patient information significantly improves the accuracy of predicting the presence of high-grade cancer from 72.7% to 94.9%. Such high predictive accuracy allows physicians to use Bladder EpiCheck as a rule-out test, to properly select high-risk patients for invasive cystoscopy and reduce 80% of cystoscopies without missing a single high-grade cancer."

Prof. Shariat and his team performed an independent analysis of the data from the recent Bladder EpiCheck Phase 3 study led by Prof. Fred Witjes, Radboud UMC in Nijmegen, in order to assess the performance of Bladder EpiCheck and its impact on clinical decision making. A total of 357 patients were included in the analyses, which confirmed the high diagnostic accuracy and performance of the Bladder EpiCheck test. The negative predictive value (NPV) of 99.3% for high grade cancers, was the same as that obtained in the previous analysis, meaning that less than 1 percent of negative results are false. This provides physicians and patients with a very high certainty that no tumor recurrence is present if the test is negative, thus highly outperforming the currently available urinary‐based biomarkers and cystoscopy.

"We are very pleased with the results of the analysis published in BJU International," said Opher Shapira, Ph.D., CEO of Nucleix. "We strive to develop meaningful tools that can make a real impact on the practice of medicine and on patients. These findings demonstrate how using Bladder EpiCheck for personalized medicine can improves patients' lives while alleviating the economic burden of bladder cancer."

About Bladder EpiCheck
Bladder EpiCheck is a CE approved urine test for monitoring bladder cancer that was clinically validated in several independent cohorts in leading hospitals and labs throughout Europe. Bladder EpiCheck has shown in clinical trials best performance of a non-invasive tool in detection of bladder cancer recurrence when compared to the invasive standard-of-care. The test demonstrated a high negative predictive value (NPV) of 99%, indicating that if the test is negative there is a 99% chance that the patient does not have a dangerous tumor. This is coupled with a low rate of false positive results (Specificity of 88%). The test is objective, operator-independent and requires standard laboratory equipment. Bladder EpiCheck is based on Nucleix's proprietary molecular biomarker technology, which combines innovative biochemical assays and sophisticated algorithms. The technology is based on identification and analysis of subtle changes in DNA methylation patterns, a powerful tool for distinguishing between cancer and healthy cells and thus for detection of tumors in the body.

About Bladder Cancer
Bladder cancer is the 5^th highest incidence cancer in the EU and is characterized with high disease recurrence rate requiring a frequent follow-up schedule. The standard follow-up includes cystoscopy- a procedure of inserting a tube with a camera through the opening of the urethra into the urinary bladder to visually inspect for the presence of cancer.  Bladder cancer is the most expensive cancer to treat on a per patient basis because of around 70% recurrence rate, costing the EU approximately €5 Billion per year.

About Nucleix
Nucleix Ltd. develops, manufactures and markets innovative, non-invasive, molecular cancer diagnostic tests. Its highly sensitive and specific tests are based on identification of subtle changes in methylation patterns. Nucleix's technology is based on a combination of a new biochemical assay in conjunction with sophisticated algorithms. The Company's pipeline includes CE Mark Bladder EpiCheck, for the non-invasive detection of bladder cancer based on a urine test; Lung EpiCheck, a screening diagnostic blood test for early detection of lung cancer; Liver EpiCheck, a blood test for liver cancer detection in patients with cirrhosis; and Pan Cancer EpiCheck, a molecular diagnostic tool for early detection of multiple cancer types in blood samples, all based on Nucleix's proprietary and innovative epigenetic platforms. Investors in the Company include OrbiMed and other leading investors. Please visit www.nucleix.com

Reference

[1] D'Andrea et al. (2019) Diagnostic accuracy, clinical utility and influence on decision‐making of a methylation urine biomarker test in the surveillance of non‐muscle‐invasive bladder cancer. BJU International.  https://doi.org/10.1111/bju.14673

SOURCE Nucleix

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