REHOVOT, Israel, March 22, 2017 /PRNewswire/ —
Nucleix, an innovative cancer detection and screening company, announced today that it received the regulatory approval (CE Mark) for marketing its Bladder EpiCheck test in the European Union countries. The Bladder EpiCheck is aimed to help urologists to better monitor their bladder cancer patients.
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 more than 400 patients recruited in their first year of follow up. The test compared the results of the 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.
“We are very proud with this regulatory approval and with the study results. These 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” said Elon Ganor, Nucleix’s Co-founder and Chief Executive Officer. “These results show best-in-class performance for Bladder EpiCheck and will strongly support our launch in Europe starting these days during the annual meeting of the European Association of Urology.”
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 technology is based on a combination of a new biochemical assay in conjunction with sophisticated algorithms.
Our first product Bladder EpiCheck is a urine test for monitoring of bladder cancer, and includes a panel of 15 proprietary biomarkers that are multiplexed in a real-time PCR analysis.
Nucleix pipeline includes a screening diagnostic blood test for early lung cancer detection, using its proprietary and highly innovative epigenetic science.
Nucleix is backed OrbiMed and other leading investors.
Contact Nucleix at: email@example.com
Nucleix Website: http://www.nucleix.com