KDx Diagnostics Announces CE Marking for Innovative Non-invasive URO17™ Bladder Cancer Test
Jun 30, 2020, 22:18 ET
CAMPBELL, Calif., June 30, 2020 /PRNewswire/ -- KDx Diagnostics, Inc., announced today that it has received Conformité Européene (CE) Marking for its innovative and proprietary urine-based test (the URO17™ test) for bladder cancer. 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.
"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."
About KDx Diagnostics Inc.
Founded in 2017, KDx is focused on developing diagnostic and prognostic tests to improve early detection and therapy decisions in cancer. KDx' URO17™ bladder cancer test may be the most sensitive and specific for bladder cancer developed to date. KDx can develop tests based on the same biomarker for other platforms and sample types and plans to expand its product line both by offering new formats of the bladder cancer test as well as tests for other cancers. Additional information is available at WWW.URO17test.com.
Contact:
Public Relations
KDx Diagnostics Inc.
408-628-7715
[email protected]
URO17 is a trademark of KDx.
Forward-Looking Statements
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SOURCE KDx Diagnostics Inc.
