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URO17 is a urine test for detecting bladder cancer in people with symptoms associated with malignancy, including blood in the urine (haematuria) or lower urinary tract symptoms. It is also indicated for detecting urogenital cancer recurrence in the urogenital tract during treatment follow up.

URO17 is an immunocytochemistry-based test that detects the presence of the oncoprotein keratin 17 (K17), which is a member of cytokeratin family of proteins. There is evidence suggesting that K17 is associated with poor prognosis in tumorigenesis of malignancies such as cervical, endometrial and lung. Studies also found that K17 is expressed in urothelial cancer and suggested that K17 is a highly accurate biomarker for underlying biopsy-confirmed urothelial cancer (Babu et al. 2018; Babu et al. 2020). ...more

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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...more

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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...more

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