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KDx Diagnostics Inks Multiple European Distribution Partnerships for Bladder Cancer Test

NEW YORK – KDx Diagnostics announced on Friday that it has entered into multiple strategic partnerships with European distributors for its noninvasive bladder cancer test.

LabForce, a Swiss company that distributes reagents and laboratory equipment for life science research and clinical diagnostics, will distribute KDx's URO17 Test in Switzerland, while MCT Lifesciences, a UK-based firm that supplies medical devices and disposables to National Health Services hospitals and clinics, will distribute the test in the UK, KDx Diagnostics said in a statement. 

"These partnerships will provide healthcare professionals with easier access to the URO17 CE-IVD test, ultimately benefiting patients by enabling earlier detection and timely intervention for bladder cancer in Europe and outside the USA," KDx President and COO Sholeh Jahanfard said in a statement. 

The immunocytochemical test received CE marking in Europe in 2020 and is available as a laboratory-developed test through some reference laboratories in the US. According to its website, the test is based on the Keratin 17 biomarker co-invented by KDx and Stony Brook Medical Center and uses an antibody developed by KDx that is compatible with most autostainer platforms.  

The assay received breakthrough device designation from the US Food and Drug Administration in 2020. 

The Los Gatos, California-based company plans to develop tests based on the same biomarker for other platforms and sample types, along with expanding its product line into other cancer diagnostic tests, it said.