KDx Diagnostics, Cardiff University, Cardiff And Vale University Health Board And Cellpath Announce Initiation Of Accelerate Project To Develop A Non-Invasive URO17® Urine Test For Bladder Cancer In Hematuria Patients

Campbell, CA and Cardiff /PRNewswire/ - KDx Diagnostics, Inc. (KDx), Clinical Innovation Accelerator (CIA), Cardiff University, Cardiff and Vale University Health Board C&VUHB) and CellPath, announced today a partnership to develop a non-invasive urine test for suspected bladder cancer patients through the Accelerate programme. 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.

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."

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.

About Accelerate
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.

URO17 is a registered trademark of KDx.

Forward-Looking Statements
KDx cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will," "estimate," "continue," "anticipate," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would," "contemplate," project," "target," "tend to," or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to planned clinical studies and meetings with regulatory agencies. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause KDx's actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in KDx's business and other risks in KDx's filings. KDx's forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. KDx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

https://www.kdxdiagnostics.com/