Bladder Cancer Urine Test Eliminates Invasive Cystoscopy and Unnecessary Imaging

The most common symptom of bladder cancer is hematuria, or blood in the urine, and patients with hematuria need to be subjected to invasive cystoscopic procedures even though a large majority of patients with micro-hematuria will not have bladder cancer. Now, a non-invasive urine test with high sensitivity and negative predicted value (NPV) can assist in ruling out these patients for unnecessary cystoscopy and its invasive procedure and, in turn, reduce the work-up.

KDx Diagnostics Inc.’s (San Jose, CA, USA) URO17 bladder cancer diagnostic test is one of the most sensitive and specific urine tests for bladder cancer. The immunocytochemistry-based test 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 have also found that K17 is expressed in urothelial cancer and suggested that K17 is a highly accurate biomarker for underlying biopsy-confirmed urothelial cancer.

Unlike other urine-based tests, the URO17 assay can test people with visible or invisible haematuria. This means that people with early-stage cancers could be identified as early as possible. URO17 works with all standard immunohistochemistry systems and is intended to be used as a diagnostic tool to help identify people with haematuria or lower urinary tract symptoms with a suspicion of bladder cancer. It is also intended for monitoring recurrence in the urogenital tract during treatment follow up. Initial studies on the URO17 test have shown that the test has 100% sensitivity and 96% specificity in detecting recurrent bladder cancers in the monitoring population, and 100% sensitivity and 92.6% specificity in detecting new bladder cancers from patients with hematuria. KDx plans to develop tests based on the same biomarker for other platforms and sample types and expand its product line into other cancer diagnostic tests.

"Bladder cancer is expensive cancer to treat due to a high rate of recurrence, and it often requires invasive procedures to diagnose. KDx's URO17 urine test is revolutionizing how bladder cancer is detected, managed, and treated," said Sholeh Jahanfard, President and COO of KDx Diagnostics Inc.

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