Nucleix Announces Initial Positive Results in Detection of Upper Tract Urothelial Carcinoma With Its Bladder EpiCheck Urine Test

REHOVOT, Israel, January 23, 2019 /PRNewswire/ --

Nucleix Ltd., a leading cancer detection and screening company, announced today preliminary results from an ongoing prospective, single-center study, indicating the effectiveness of Bladder EpiCheck™ urine test in detecting Upper Tract Urothelial Carcinoma (UTUC). The data were published in the World Journal of Urology as a "letter to the editor^[1]" by the principal investigator of the study, Dr. Alberto Breda, Fundació Puigvert, Barcelona, Spain.

Bladder EpiCheck is already CE approved for monitoring bladder cancer, and the new study will evaluate its potential role in the diagnosis and surveillance of UTUC. The trial is a prospective, single-center study that will include 80 patients with suspected primary or recurrent UTUC. Urine samples from the bladder and the upper urinary tract will be collected by ureteroscopy and will be analyzed by both EpiCheck and urinary cytology. Primary endpoints include assessment of sensitivity, specificity, and positive and negative predictive values, in high and low-grade tumors, as well as comparison with cytology. Preliminary results from urine samples of six patients demonstrated 100% sensitivity in high grade UTUC (3/3) patients and specificity of 100%, correctly identifying the healthy patient (1/1).

"There is a substantial unmet need in UTUC diagnosis and follow-up for the identification of patients with high-grade and invasive cancer," said Dr. Alberto Breda. "Based on Bladder EpiCheck's proven ability to detect high-grade tumors in bladder cancer with a high sensitivity of 90%, coupled with these encouraging feasibly results, we believe that Bladder EpiCheck could be an effective non-invasive test for easier and better detection and surveillance of UTUC than what is currently available."

"With these promising initial results in UTUC, we are expanding the scope of our lead product into a new indication," stated Opher Shapira, Ph.D., CEO of Nucleix. "Bladder EpiCheck has potential to grow substantially beyond the monitoring of bladder cancer. With such an excellent track record, Bladder EpiCheck could, in the future, also be effective for primary diagnosis of urothelial cancers, and even offer a good alternative for bladder cancer screening in high-risk populations."

About Upper Tract Urothelial Cancer (UTUC) 

Urothelial carcinomas (UCs) include lower urinary tract carcinomas (bladder and urethra: 90-95% of the cases) and upper urinary tract ones (renal pelvis and ureter: 5-10% of cases). Urothelial carcinoma in one area is a risk factor for developing it in the other area, thus bladder cancer patients are at a high risk of developing upper tract cancer, which is reflected in their surveillance (e.g. routine CT). Currently, there are no optimal solutions for diagnosis and staging of UTUC. CT imaging offers good specificity, but limited sensitivity of around 80%. Cytology is a poor diagnostic tool in this disease and has limited ability to differentiate between high and low-grade tumors. Therefore, ureteroscopies are routinely required for diagnosis and the determination of the stage and grade of the cancer. However, these procedures are complex as they are performed under general anesthesia in the operating room. Furthermore, up to 60% of the biopsies achieved during ureteroscopies are inconclusive. Therefore, an alternative diagnostic method is needed both for initial diagnosis as well as for patient follow-up.

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 new 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 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 http://www.nucleix.com

1. Gallioli A. et al. (2019). Towards the future of upper tract urothelial carcinoma surveillance: lessons learnt from bladder cancer urinary biomarkers. World Journal of Urology https://doi.org/10.1007/s00345-018-2611-1

SOURCE Nucleix