Israel-based cancer diagnostic tests company Nucleix has secured CE mark for the marketing of its Bladder EpiCheck test in the European Union (EU) countries.
Designed to aid urologists to monitor patients with bladder cancer, Bladder EpiCheck contains a panel of 15 DNA methylation biomarkers to detect the disease.
The proprietary biomarkers are said to be multiplexed in a real-time PCR analysis.
Nucleix co-founder and chief executive officer Elon Ganor said: "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.
"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."
The regulatory approval is based on the results from a clinical study conducted at select urology centres in Europe.
The multi-centre, prospective and blinded study was performed in more than 400 patients who were enrolled in their first year of follow up.
The results were reported as a comparision of the Bladder EpiCheck with the current gold standard follow up sequence of cystoscopy, cytology and pathology for the positives.
The study indicated that the test has 99% negative predictive value (NPV, excluding Ta-LG patients), 92% sensitivity (excluding Ta-LG patients) and 88% specificity.