Nucleix of Rehovot, has received the CE Mark of approval to market Bladder EpiCheck in the European Union countries. Based on epigenetics, the inexpensive, noninvasive Bladder EpiCheck urine test helps urologists to better monitor their bladder-cancer patients.
The EU regulatory approval follows the completion of a multi-center, prospective and blinded clinical study of 400 patients in leading urology centers in Europe. The results of the test, which compared the results of the Bladder EpiCheck to the current gold standard follow-up sequence of cystoscopy, cytology and pathology, were presented last week at the annual European Association of Urology meeting in London.
Because bladder cancer has a high rate of recurrence, patients must be monitored invasively every few months after initial treatment. Nucleix therefore saw a need for a noninvasive “liquid biopsy” assay using body fluids rather than body tissues.
Bladder EpiCheck is Nucleix’s first product. Next in the product pipeline is Lung EpiCheck, a molecular diagnostic screening to detect lung cancer in blood samples, based on the same epigenetics platform.
Elon Ganor, Nucleix’s cofounder and CEO, said the European regulatory approval and the study results “are important milestones for bladder-cancer patients and urologists, adding an additional tool to their arsenal fighting bladder cancer. It is a proof of Nucleix’s unique scientific innovations in epigenetics.”