CE Mark Granted to Urine Test for Bladder Cancer

The new test performed with superior results over all other non-invasive tests examined in a European multi-center study for bladder cancer monitoring.

The European Union’s CE Mark was granted to Nucleix’s (Rehovot, Israel) Bladder EpiCheck test, aimed to help urologists to better monitor their bladder cancer patients. Bladder EpiCheck is a urine test that includes a panel of 15 proprietary biomarkers that are multiplexed in a real-time PCR analysis.

This regulatory approval follows the completion of a multi-center, prospective, and blinded clinical study that was performed in leading urology centers in Europe, with over 400 patients recruited in their first year of follow up. The study compared Bladder EpiCheck to the current gold standard follow up sequence (cystoscopy, cytology, and pathology for the positives). The Bladder EpiCheck results showed 99% Negative Predictive Value (NPV, excluding Ta-LG patients), 92% sensitivity (excluding Ta-LG patients), and 88% Specificity. Nucleix presented the results during the European Association of Urology (EAU) annual meeting (March 24-28, London, UK).

"These are important milestones for bladder cancer patients and urologists, adding an additional tool to their arsenal fighting bladder cancer," said Elon Ganor, Nucleix's co-founder and CEO, "These results show best-in-class performance for Bladder EpiCheck and will strongly support our launch in Europe."

Nucleix develops non-invasive molecular cancer diagnostic tests based on identification of subtle epigenetic changes in methylation patterns. Nucleix technology is based on a combination of a new biochemical assay in conjunction with sophisticated algorithms. The Nucleix pipeline includes a screening diagnostic blood test for early lung cancer detection.