Non-Invasive Urine Test for Bladder Cancer Could Eliminate Need for Painful Cystoscopy

However, many patients with microscopic amounts of blood in their urine don't actually have bladder cancer, yet they must undergo invasive tests like cystoscopy to rule it out. Other confirmatory methods like CT scans, intravenous pyelograms, X-rays, MRIs, ultrasounds, and urine cytology also have their limitations. Now, a non-invasive urine test with high sensitivity and negative predicted value (NPV) can help exclude these patients from undergoing unnecessary invasive cystoscopy procedures, thereby streamlining the diagnostic process.

KDx Diagnostics (Los Gatos, CA, USA) has developed the URO17 test, a non-invasive urine test with remarkable sensitivity and NPV for determining active bladder cancer and enhancing patient diagnosis. This test is based on a unique biomarker, Keratin 17 (K17), and is among the most accurate urine tests for bladder cancer. The test uses immunocytochemistry and is compatible with the majority of autostainer platforms commonly found in reference labs. Preliminary research indicates that the URO17 test has a 100% sensitivity and 96% specificity rate for identifying recurring bladder cancers and a 100% sensitivity and 92.6% specificity rate for identifying new cases of bladder cancer in patients with hematuria.

Currently, the URO17 test is available in the United States as a Laboratory Developed Test (LDT) through select reference laboratories and is sold as a CE-IVD kit outside the U.S. The test has received the Breakthrough Device Designation from the FDA and is currently in clinical trials for FDA approval. KDx Diagnostics aims to create additional tests based on the K17 biomarker for various platforms and sample types and plans to expand its range of cancer diagnostic tests. The company has obtained important patents in the U.S., the European Union, and South Korea for technologies that analyze K17 in urine to detect or rule out bladder cancer.

"These new patents complement our ongoing commercial efforts to provide non-invasive technologies for bladder cancer detection and demonstrate we've made groundbreaking advances," said Nam W. Kim, PhD, CEO and CTO at KDx, and coinventor of the patents. "We are focused on delivering cutting-edge solutions that address the needs of our customers and drive industry growth."

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