NEW YORK – KDx Diagnostics announced late on Tuesday that it has received the CE mark for its urine-based URO17 Bladder Cancer Recurrence test for bladder cancer.
As a result, the test can be marketed in Europe and other countries that recognize the designation.
The test leverages a novel cancer biomarker that may improve the accuracy and sensitivity of noninvasive bladder cancer testing and received breakthrough device designation from the US Food and Drug Administration earlier this year.
KDx CMO Shahram Gholami said in a statement that the current gold standard for diagnosing bladder cancer requires a camera to be inserted into the bladder, which can be painful. The Campbell, California-based company believes its 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."