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July 26, 2018
The results of the European multicenter study of the EpiCheck ™ urine test supporting the reduction of invasive procedures, were published in the journal European Urology Oncology
Nucleix Ltd., a leading cancer detection and screening company, today announced that the results of the European multicenter study with its urine test Bladder EpiCheck ™ for the detection of the recurrence of bladder cancer have been published in the European review. The results demonstrate the best performance of Bladder EpiCheck and support the reduction of invasive monitoring procedures.
Bladder EpiCheck TM for the non-invasive detection of recurrence of bladder cancer
-center, single-center, prospective, double-blind study was performed in five urology centers in Europe, out of 440 patients recruited in their first year of follow-up. The study compared the results of the EpiCheck bladder to the current gold standard tracking sequence (cystoscopy, cytology, and pathological verification). The EpiCheck bladder demonstrated a clinically relevant and high negative predictive value (NPV) with a NPV of 99.3% and a sensitivity of 91.7% (both excluding patients with low grade tumors) and a specificity of 88%. Cancers are essential for the applicability of a urine test in clinical decision making. A NPV of 99.3% means that a patient with a negative result at EpiCheck of the bladder is free from high grade cancer in 99.3% of cases. Therefore, allowing us to avoid cystoscopies, which are unpleasant invasive procedures, "commented Professor Fred Witjes, UMC Radboud in Nijmegen, the Netherlands and the main investigator of the study. "Bladder cancer is a very recurrent disease and the most expensive cancer for the entire life of a patient." Follow-up cystoscopies are needed up to four times a year in the early years, gradually reducing at an annual cystoscopy for the life of a patient.The EpiCheck bladder provides the best results in urinary tests for monitoring bladder cancer, and it is an important tool that can help reduce these follow-up cystoscopies. "
EpiCheck Bladder is a CE approved urine test for bladder cancer surveillance. has been clinically validated in several independent cohorts in major hospitals and laboratories across Europe. Bladder EpiCheck has shown in clinical trials the best performance of a non-invasive tool in detecting the recurrence of bladder cancer compared to the invasive standard of care. The test is objective, independent of the operator and requires standard laboratory equipment. Bladder EpiCheck is based on Nucleix's patented molecular biomarker technology, which combines new biochemical tests with sophisticated algorithms. The technology is based on the identification and badysis of subtle changes in DNA methylation patterns, a powerful tool for distinguishing cancer and healthy cells and therefore for the detection of tumors in the body.
"We are very pleased with the impressive results of a robust and multicenter European Bladder EpiCheck trial, and with the publication of data in the prestigious European Journal of Oncological Urology, providing a scientific validation for our Bladder EpiCheck Urine Test and its underlying technology, "said Opher Shapira, Ph.D., CEO of Nucleix. "The market penetration of Bladder EpiCheck looks promising, as several large hospitals and laboratories in Europe have already started using our kits, and we are currently developing additional tests for the detection of other types of cancer, such as lung and liver cancer. "
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