NEW YORK (GenomeWeb) – Nucleix said today that it has received a CE Mark for its Bladder EpiCheck test, which is intended to help urologists better monitor bladder cancer patients.
Bladder EpiCheck is a urine test that utilizes multiplexed real-time PCR to analyze a panel of 15 methylation markers.
The company said that the regulatory approval follows the completion of a multicenter, prospective clinical study performed across several European urology practices. Researchers recruited more than 400 patients and compared the results of Nucleix's assay to the current gold standard of cystoscopy, cytology, and pathology.
In the study, the assay showed a 99 percent negative predictive value, 92 percent sensitivity, and 88 percent specificity (excluding non-invasive low grade patients), the company said.
"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 Cofounder and CEO Elon Ganor said in a statement.
In addition to the EpiCheck bladder test, Nucleix said its current pipeline also includes a blood-based screening test for early lung cancer detection.