European Union Grants CE Mark to Nucleix's Bladder EpiCheck
Nucleix received the CE mark for marketing its bladder EpiCheck test.
The device is designed to aid urologists to better monitor bladder cancer patients.
The device includes a panel of 15 proprietary biomarkers that are multiplexed in a real-time PCR analysis.
The clearance was based on the clinical results showing a 99 percent negative predictive value, 92 percent sensitivity and 88 percent specificity. — Cynthia Jessup