Nucleix, an Israeli company focused on developing innovative non-invasive molecular cancer diagnostic solutions, has announced positive preliminary results for one of their products, Bladder EpiCheck, a CE approved urine test for monitoring bladder cancer. The screening tool uses proprietary epigenetic technology and managed 100% accuracy in the initial testing for Upper Tract Urothelial Carcinoma (UTUC).
“With these promising initial results in UTUC, we are expanding the scope of our lead product into a new indication“, noted Opher Shapira, Ph.D., CEO of Nucleix. “Bladder EpiCheck has the 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“.
Urothelial carcinomas (UCs) include lower urinary tract carcinomas (of the bladder and urethra, approximately 90% of the cases) and upper urinary tract ones (renal pelvis and ureter, around 10% of cases). Patients suffering from urothelial cancer often see their disease spread to other areas of the urinary tract.
Current options for diagnosis are limited. CT imaging provides good specificity but is limited in sensitivity (around 80%). Cytology cannot clearly differentiate between high and low-grade tumors and ureteroscopies are frequently needed in order to set a diagnosis and determine the stage and grade of cancer.
Bladder EpiCheck can identify and analyze subtle changes in DNA methylation patterns. It checks among 15 biomarkers and determines whether the pattern is consistent with bladder cancer presence or absence.
Radboud University Medical Center (UMC) in Nijmegen has decided to adopt Bladder EpiCheck as it’s its standard-of-care for the detection of recurrence of bladder cancer.
“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. “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 traveling to the hospital and undergoing invasive procedures. With Bladder EpiCheck, patients can avoid hospital visits, which will also save valuable hospital and healthcare resource”.
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