On May 18, 2021 KDx Diagnostics, Inc. (KDx), Clinical Innovation Accelerator (CIA), Cardiff University, Cardiff and Vale University Health Board C&VUHB) and CellPath, reported a partnership to develop a non-invasive urine test for suspected bladder cancer patients through the Accelerate programme (Press release, KDx Diagnostics, MAY 18, 2021, View Source [SID1234580226]). KDx Diagnostics Inc., located in Campbell, CA, USA, has developed a non-invasive urine test, URO17 that has shown high accuracy detection of bladder cancer in multiple independent studies, and will provide all technical components for the project.
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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 currently very difficult and expensive, requiring invasive camera-based testing methodology. KDx’s URO17 test has demonstrated 100% sensitivity and over 90% specificity in detecting new and recurrent bladder cancer in multiple studies. During the Accelerate programme, KDx will be partnering with CellPath Ltd, Newtown, UK, Cardiff University and C&VUHB to conduct a large clinical study to evaluate URO17 in the detection of new bladder cancer in patients with hematuria (blood in their urine), and to develop a home sample collection programme that will facilitate detection of bladder cancer and reduce the need for patients to come into a clinic or a hospital for testing.
"We are excited to partner with Cardiff University, Cardiff and Vale University Health Board and CellPath through the Accelerate programme to validate and provide URO17 tests in the UK. Through our initial studies, we have shown that the URO17 test exhibited extremely high sensitivity and specificity in detecting bladder cancer from urine samples in both recurrent and new cancers. The study under the Accelerate programme will examine the performance of URO17 in a real-life clinical setting in patients with hematuria, which will facilitate a wide distribution of the test throughout the UK and the rest of Europe. Furthermore, a development and launch of the URO17 home sample collection programme will provide safe and cost-effective means for detecting new bladder cancer which is critical in the age of COVID-19 and beyond." said Nam W. Kim, Ph.D., KDx’ CEO, and CTO.
Professor Howard Kynaston from Cardiff and Vale University Health Board and Cardiff University said "There is an urgent need to develop accurate non-invasive tests, such as biomarkers, in the fight against cancer. URO17 has tremendous potential to distinguish between urinary symptoms due to bladder cancer and more benign causes, speeding up rapid diagnosis and reducing need for unnecessary invasive tests."