FDAnews
www.fdanews.com/articles/171923-biolights-bladder-cancer-test-secures-ce-mark

BioLight’s Bladder Cancer Test Secures CE Mark

July 1, 2015

BioLight’s CellDetect bladder cancer diagnostic test has won CE Mark approval, as well as European patent protection until 2027, the Israeli devicemaker said Tuesday.

In a multicenter clinical trial, the urine-based test achieved its primary endpoint of successful bladder cancer detection, with sensitivity rates of 84.4 percent and specificity rates of 82.7 percent, the company claims.

BioLight expects to submit a pre-investigational device exemption application to the FDA in the first half of 2016.

According to the devicemaker, bladder cancer is the fourth highest cancer among males in the U.S. and the seventh among males globally. It contains the highest recurrence rate of all cancers, ranging from 50 percent to 80 percent. — Jason Scott