KDx Diagnostics announces FDA Breakthrough Device designatio
CAMPBELL, Calif., Jan. 8, 2020 /PRNewswire/ -- KDx Diagnostics, Inc. (KDx), announced today that the Food and Drug Administration (FDA) has granted "Breakthrough Device" designation for its URO17™ Bladder Cancer Recurrence Test. This revolutionary new test exploits a novel cancer marker that could dramatically improve the accuracy and sensitivity of non-invasive bladder cancer testing.
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.
About KDx Diagnostics, Inc.
Founded in 2017, KDx is focused on developing non-invasive cancer tests to improve early detection and therapy decisions in cancer. The URO17™ bladder cancer test developed by KDx may prove to be the most sensitive and specific test for bladder cancer developed to date. KDx plans to develop tests based on the same biomarker for other platforms and sample types and expand its product line into other cancer diagnostic tests.
KDx Diagnostics Inc.
URO17 is a trademark of KDx.
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SOURCE KDx Diagnostics Inc.