On June 30, 2020 KDx Diagnostics, Inc., reported that it has received Conformité Européene (CE) Marking for its innovative and proprietary urine-based test (the URO17 test) for bladder cancer (Press release, KDx Diagnostics, JUN 30, 2020, View Source [SID1234561592]). CE marking establishes that a diagnostic test meets the requirements of the European Medical Devices Directive, a necessary qualification step for commercialization of a diagnostic test in the European Union and other CE Mark territories.
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"This CE marking confirms for our investors and people at risk for bladder cancer that the URO17 test can be commercialized in Europe, and we are very excited about bringing this new non-invasive test to the market there," said Nam W. Kim, Ph.D., CEO of KDx. "As bladder cancer is among the most prevalent cancer worldwide with ~ 550,000 new cases annually and a high recurrence rate requiring frequent retesting, this is a significant market opportunity."
"We are pursuing this opportunity throughout the world," said Sholeh Jahanfard, President and COO of KDx, "and we are very excited that the FDA awarded Breakthrough Device designation for our test for a related indication based on now published data (Babu et al., 2018) showing 100% sensitivity and 96% specificity for detecting recurrent bladder cancer from urine samples."
"The current ‘gold standard’ for diagnosing bladder cancer requires the use of an in-bladder camera procedure that is at best uncomfortable and often painful," said Shahram S. Gholami, M.D., CMO of KDx "and we believe our test offers the promise of greatly reducing if not, in time, eliminating the need for such an expensive and tedious procedure by virtue of an automated test requiring only a non-invasive urine sample."