On December 5, 2021 KDx Diagnostics, Inc. (KDx), and Lister Hospital (East and North Hertfordshire NHS Trust), Stevenage, UK, reported the launch in the United Kingdom (UK) of KDx’s URO17 test for detection of bladder cancer (Press release, KDx Diagnostics, DEC 5, 2021, View Source [SID1234596460]). This non-invasive urine test for bladder cancer is highly sensitive for identifying bladder cancer in patients with hematuria and recurrent bladder cancer during post-treatment monitoring.
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There are over 197,000 newly diagnosed cases of bladder cancer in Europe, and 430,000 globally, with 81,000 cases in the US alone. Accurate detection of new bladder cancer is difficult and expensive, requiring invasive camera-based testing methodology. Excitingly, KDx’s URO17 test has demonstrated 100% sensitivity and over 90% specificity in detecting bladder cancer in multiple peer-reviewed studies.
"We are excited to have the non-invasive URO17 test available in the UK to determine with high confidence whether a patient has bladder cancer. Testing has shown the URO17 urine test can detect the presence or absence of bladder cancer with high sensitivity. We are confident that the application of URO17 in clinical practices can significantly improve patient care in the UK," said Nam W. Kim, Ph.D., KDx’s CEO, and CTO.
"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. We are excited that Lister Hospital in Stevenage is now a Core Lab offering URO17 test and that patients from all over the UK will have access to this test," said Sholeh Jahanfard, President and COO of KDx Diagnostics Inc.
Mr. Nikhil Vasdev – Consultant Urological Surgeon at Lister Hospital and Associate Medical Director for cancer services at East and North Hertfordshire NHS Trust, which runs the hospital – was the chief investigator and the lead author of a paper describing a recent study on URO17. "We are pleased to be the first NHS trust in the UK and Europe to make URO17 test available for patients," said Mr. Vasdev, who is also a Senior Clinical Lecturer at the University of Hertfordshire. "Our ability to detect bladder cancer simply, accurately, and non-invasively using URO17 will greatly improve detection at an early stage when it can be treated most effectively while minimizing the number of unnecessary and invasive procedures in patients who are suspected of having bladder cancer," he added.
Dr. Michael Chilvers – Medical Director at East and North Herts NHS Trust, said: "I am really pleased that the partnership between KDx and this Trust has led to this major step forward in the non-invasive detection of bladder cancer, and undoubtedly to improved outcomes for our patients."