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KDx Diagnostics to Launch Clinical Study of Bladder Cancer Test in Hematuria Patients

NEW YORK — KDx Diagnostics said on Tuesday that it has signed an agreement to further the development of its noninvasive bladder cancer test URO17 in collaboration with Cardiff University, Cardiff and Vale University Health Board, or C&VUHB, and CellPath.

URO17 is a urine-based test that uses the oncoprotein keratin 17 as a biomarker to detect new and recurrent bladder cancer. It received CE marking and a breakthrough device designation from the US Food and Drug Administration in 2020.

Under the terms of the partnership, KDx will work with UK-based histopathology and cytology tools provider CellPath, Cardiff University, and C&VUHB to conduct a clinical study evaluating URO17 for the detection of bladder cancer in patients with hematuria, as well as to develop a home sample collection program for the test.

The work is being conducted through Clinical Innovation Accelerator, a technology-development program funded by the European Union and Welsh government. Campbell, California-based KDx will provide all technical components for the trial.

"Through our initial studies, we have shown that the URO17 test exhibited extremely high sensitivity and specificity in detecting bladder cancer from urine samples in both recurrent and new cancer," Nam Kim, KDx CEO and chief technology officer, said in a statement. "The study under the Accelerate program will examine the performance of URO17 in a real-life clinical setting in patients with hematuria, which will facilitate a wide distribution of the test throughout the UK and the rest of Europe. Furthermore, a development and launch of the URO17 home sample collection program will provide safe and cost-effective means for detecting new bladder cancer which is critical in the age of COVID-19 and beyond."