KDx Diagnostics, Inc. (KDx), Clinical Innovation Accelerator (CIA) a partner of the Accelerate programme, Cardiff University, Cardiff and Vale University Health Board (C&VUHB) and CellPath, have announced a partnership coordinated through the Accelerate programme to develop a non-invasive urine test for suspected bladder cancer patients..
Developing a non-invasive, accurate cancer detecting urine test
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
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.
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). KDx will be supplying all technical components for the project. The collaboration will also develop a home sample collection programme to reduce the need for patients to visit a clinic or hospital for testing.
Nam W. Kim, Ph.D., KDx’ CEO, and CTO, said:
“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.”
Professor Howard Kynaston from Cardiff and Vale University Health Board and Cardiff University explains:
“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.”
About KDx Diagnostics, Inc.
Founded in 2017, KDx is focused on developing non-invasive cancer tests to improve early detection and therapy decisions in cancer. The URO17™ bladder cancer test developed by KDx may prove to be the most sensitive and specific for bladder cancer developed to date. 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. The URO17™ bladder cancer test is for Research Use Only in the US.
Ventac Partners Ltd, UK
KDx is supported in commercial strategy and business development by Ventac Partners Ltd, UK.
About CellPath Ltd.
CellPath is a UK based independent company attuned to the needs of Cellular Pathology. They specialise in the manufacture and worldwide supply of consumables, equipment and services to the Histopathology and Cytology markets.
The CellPath name is synonymous with innovative, well-proven products, manufactured to the highest standard. With in-house state of the art injection moulding capability, they manufacture many of the plastic products that are used in the diagnosis of cancer.
The Accelerate programme is co-funded by the European Regional Development Fund, the Welsh European Funding Office and Welsh Government to foster and facilitate uptake of new innovations, and involves three University partners (Cardiff, Swansea and Trinity Saint David) and is led by the Life Science Hub, Cardiff Bay, Wales.
KDx Diagnostics Inc.
URO17 is a trademark of KDx.