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.
KDx Diagnostics Inc.
URO17 is a trademark of KDx.
KDx cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to planned clinical studies and meetings with regulatory agencies. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause KDx's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in KDx's business and other risks in KDx's filings with the Securities and Exchange Commission (the SEC). KDx's forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. KDx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
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SOURCE KDx Diagnostics Inc.