Nucleix's Bladder EpiCheck™, Urine Test for Monitoring Bladder Cancer, Chosen as Standard-of-Care by Radboud University Medical Center

Wednesday, January 30, 2019 General News
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Prof. Fred Witjes, Radboud University Medical Center: "Because of the exceptional, clinically-proven, high performance of Bladder EpiCheck, we can now substitute an invasive procedure for detecting recurrent bladder cancer with a simple urine test"

REHOVOT, Israel, Jan. 30, 2019 /PRNewswire/ -- Nucleix Ltd., a leading cancer detection and screening

company, announced today that Radboud University Medical Center (UMC) in Nijmegen, the Netherlands has chosen to add the Company's Bladder EpiCheck™, a urine test for the monitoring of bladder cancer, to its standard-of-care for the detection of recurrence of bladder cancer. Bladder EpiCheck's accurate performance allows for it to replace some of the standard invasive and unpleasant cystoscopy procedures. In addition, due to the precision of the innovative system, Radboud UMC can collect the urine samples from the patient's home, thus avoiding unnecessary visits to the hospital.

"Because of the exceptional, clinically-proven, high performance of Bladder EpiCheck, we can now substitute an invasive procedure for detecting recurrent bladder cancer with a simple urine test," stated Prof. Fred Witjes, Radboud UMC in Nijmegen and Chair of the European Association of Urology Guidelines for Muscle Invasive Bladder Cancer. "Furthermore, the system allows us, for the first time, to collect urine samples directly from the patient's home. Since in my clinical practice approximately 90% of follow-up cystoscopies are negative, currently patients are often needlessly travelling to the hospital and undergoing invasive procedures. With Bladder EpiCheck patients can avoid hospital visits, which will also save valuable hospital and healthcare resources. I'm looking forward to offering my patients this service, which will initially alternate with cystoscopy, and that first and foremost caters to the patient's comfort and convenience."

"We are very pleased to partner with Radboud University Medical Center in replacing cystoscopy with a precise urine test," stated Opher Shapira, Ph.D., CEO of Nucleix. "We believe that collecting samples from the patient's home is a significant improvement in patient care and excited that UMC has initiated this move.  At Nucleix we strive to develop innovative solutions for clear unmet medical needs, that meet the highest standards of the health system, while addressing patients' needs."

Bladder cancer is a highly recurrent disease, with a recurrence rate of approximately 70%, requiring frequent follow-up visits of up to 4 times per year. Today, most follow-up tests are done using an invasive procedure called cystoscopy (a scope is inserted through the urethra into the urinary bladder), performed in an outpatient setting. Cystoscopy is a costly procedure, that requires many resources, including physicians and nurses, a dedicated room, equipment, sterilization and antibiotics.

Bladder EpiCheck's high accuracy allows to significantly reduce the number of invasive follow-up procedures. The system demonstrated a clinically relevant and very 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. If the result of the urine test is negative, in approximately 85% of the time, the patient will not have to visit the hospital for a follow-up meeting.

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 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 CancerBladder cancer is the 5th 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 NucleixNucleix 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

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