Tuesday, November 17, 2020
KDx Diagnostics, Inc. (KDx), and Lister Hospital , Stevenage, UK, announced a joint publication describing how KDx's URO17™ test performed in patients with hematuria (blood in urine). URO17™ test, based on an exciting new bladder cancer marker, is urine-based and non-invasive and was able to detect the presence of bladder accurately in hematuria.
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 currently very difficult and expensive, requiring invasive camera-based testing methodology. Excitingly, the data showed KDx's URO17™ test had 100% sensitivity and 92.6% specificity in detecting new bladder cancer in patients with hematuria in this study.
"Previously, we have shown that the URO17™ test exhibited 100% sensitivity and 96% specificity in detecting recurrent bladder cancer from urine samples (Babu et. al., 2018). This study confirms the accuracy of URO17™ in detecting bladder cancer in the same matrix (non-invasive urine samples), but importantly expands on the previous findings by demonstrating that URO17™ test can be reliably used to detect new bladder cases in patients with hematuria," said Nam W. Kim, Ph.D., KDx' CEO, and CTO.
"We are delighted with this publication, which documents our successful collaboration with Mr. Nikhil Vasdev in this important study. Together with our recent CE Marking for the URO17™-IVD test, this publication and our collaboration position us to bring this important test to patients in UK and Europe," said Sholeh Jahanfard, President and COO of KDx.
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 – is the chief investigator and the lead author of the study. "We are pleased to be the first group in Europe to report on the high accuracy of URO17™ test in detecting the presence of bladder cancer in patients who have not been previously diagnosed with the disease," 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," he added.
Dr. Michael Chilvers, Medical Director at East and North Hertfordshire NHS Trust and also a co-author of the URO17™ publication, said: "I am extremely proud of our urology department being at the forefront of this groundbreaking publication in Europe. URO17™ shows real promise in improving bladder cancer patient care."
