On January 8, 2020 KDx Diagnostics, Inc. (KDx), reported that the Food and Drug Administration (FDA) has granted "Breakthrough Device" designation for its URO17 Bladder Cancer Recurrence Test (Press release, KDx Diagnostics, JAN 8, 2020, View Source [SID1234552887]). This revolutionary new test exploits a novel cancer marker that could dramatically improve the accuracy and sensitivity of non-invasive bladder cancer testing.

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Bladder cancer is the 6th most common cancer in the US, and 81,000 people are newly diagnosed with the disease annually. Moreover, bladder cancer has a relatively high recurrence rate and is one of the most expensive patients to treat, in part because patients must be regularly monitored for recurrence.

KDx has published data (Babu et al., 2018) showing the URO17 test exhibited 100% sensitivity and 96% specificity in detecting recurrent bladder cancer from urine samples. While this was an initial study, these rates are among the best ever reported for a non-invasive test.

"The FDA’s designation of Breakthrough Device for our URO17 test validates our excitement about the potential of our test to improve bladder cancer treatment with attendant major impact in the marketplace for bladder cancer diagnostics. Breakthrough Device designation significantly enhances our ability to conduct the necessary clinical trials for approval and expedites the review process. We look forward to working closely with the FDA during this next exciting phase of product development," said Nam W. Kim, Ph.D., KDx’ Co-Founder and CEO.