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Home » European Union Grants CE Mark to Nucleix's Bladder EpiCheck
European Union Grants CE Mark to Nucleix's Bladder EpiCheck
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March 22, 2017
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
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