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KDx Diagnostics, Cardiff University, Cardiff and Vale University Health Board and Cellpath announce the start of the Accelerate project to develop a non-invasive URO17® urine test for bladder cancer in patients with hematuria

CAMPBELL, California and CARDIFF, Wales May 18, 2021 / PRNewswire / – KDx Diagnostics, Inc. (KDx), Clinical Innovation Accelerator (CIA), Cardiff University, Cardiff and the Vale C & VUHB University Health Board) and CellPath today announced a partnership to develop a non-invasive urine test for patients with suspected cancer of bladder through the Accelerate program. KDx Diagnostics Inc., located at Campbell, CA USA. The US has developed a non-invasive urine test, URO17 ® that has demonstrated high-precision bladder cancer detection in multiple independent studies, and will provide all the technical components for the project.

There are more than 197,000 newly diagnosed cases of bladder cancer in Europe and 430,000 worldwide, with 81,000 cases in the US alone. Accurate detection of a new bladder cancer is currently very difficult and expensive, and requires invasive camera-based testing methodology. The KDx URO17 ® test has demonstrated 100% sensitivity and greater than 90% specificity in detecting new and recurrent bladder cancer in multiple studies. During the Accelerate program, KDx will partner with CellPath Ltd, Newtown, UK, Cardiff University and C & VUHB to conduct a large clinical study to evaluate URO17 ® in the detection of a new bladder cancer in patients with hematuria (blood in the urine) and the development of a program of collection of samples at home that facilitates the detection of bladder cancer and reduces the need for patients to visit to a clinic or hospital for testing.

"We are very excited to partner with Cardiff University, Cardiff and Vale University Health Board and CellPath through the Accelerate program to validate and deliver URO17 ® tests in the UK Through our initial studies, we have shown that the URO17 test ® exhibited extremely high sensitivity and specificity for detecting bladder cancer from urine samples in both recurrent and new cancers The Accelerate program study will examine the performance of URO17 ® in a real-life clinical setting in patients with hematuria, facilitating a wide distribution of the test throughout the UK and the rest of Europe. In addition, the development and launch of the URO17 ® pr home collection program It will provide a safe and cost-effective means of detecting new bladder cancers that is critical in the era of COVID-19 and beyond. " said Nam W. Kim Ph.D., CEO and CTO of KDx.

Professor Howard Kynaston of Cardiff and the Vale University Health Board and Cardiff University said "There is an urgent need to develop accurate noninvasive tests, such as biomarkers, in the fight against cancer URO17 ® has enormous potential to distinguish between urinary symptoms due to bladder cancer and more benign causes, speeding up rapid diagnosis and reducing the need for evidence ".

About KDx Diagnostics, Inc.
Founded in 2017, KDx is focused on the development of non-invasive cancer tests to improve early detection and treatment decisions in cancer. The URO17 ® bladder cancer test developed by KDx may 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 to expand its product line to 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 business strategy and business development by Ventac Partners Ltd, UK.

About CellPath Ltd.
CellPath is an independent UK-based company that is tailored to the needs of cellular pathology. They specialize in the global manufacturing and supply of consumables, equipment and services for the histopathology and cytology markets.

The CellPath name is synonymous with proven and innovative products, manufactured to the highest standards. With in-house state-of-the-art injection molding capabilities, they manufacture many of the plastic products used in cancer diagnosis.

About Accelerate
The Accelerate program is co-funded by the European Regional Development Fund, the European Funding Office for Wales and the Government of Wales to encourage and facilitate the uptake of new innovations, and involves three partner universities ( Cardiff Swansea and Trinity Saint David ) and is run by Life Science Hub, Cardiff Bay, Wales.

Public Relations
KDx Diagnostics Inc.
[email protected]

URO17 is a registered trademark of KDx.

Forward-Looking Statements
KDx advises you that all statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements, in some cases, may be identified with terms such as "believe", "may", "will", "estimate", "continue", "anticipate", "design", "attempt", "expect", " "could", "plan", "potential", "predict", "seek", "should", "should", "contemplate", "project", "aim", "tend to" or the negative version of these Similar words and expressions. Such statements include, but are not limited to, statements regarding 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 results. achievements are materially different from future results, performance or achievements expressed or implied in the forward-looking statements in this press release, including the risks and uncertainties inherent in KDx's business and other risks in the presentations of KDx. KDx's forward-looking statements are based on your current expectations and involve assumptions that may be materialized or may turn out 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 refer only to the date they were made. KDx assumes no obligation to update such statements to reflect events that occur or circumstances that exist after the date they were made, except as required by law.

SOURCE KDx Diagnostics Inc.

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