CAMPBELL, California and CARDIFF, Wales, May 18, 2021 / PRNewswire / – KDx Diagnostics, Inc. (KDx), Clinical Innovation Accelerator (CIA), Cardiff University, Cardiff and Vale University Health Board C & VUHB) and CellPath, today announced a partnership to develop a non-invasive urine test for patients with suspected bladder cancer as part of the Accelerate program. KDx Diagnostics Inc., located at Campbell, California, USA, has developed a non-invasive urine test, URO17® which has shown high precision detection of bladder cancer in several independent studies, and will provide all the technical components of the project.
There are over 197,000 newly diagnosed cases of bladder cancer Europe, and 430,000 worldwide, with 81,000 cases in the United States alone. The accurate detection of new bladder cancer is currently very difficult and expensive, requiring invasive camera-based testing methodology. URO17 from KDx® The test has demonstrated 100% sensitivity and more than 90% specificity in detecting new and recurring bladder cancer in several studies. During the Accelerate program, KDx will partner with CellPath Ltd, Newtown, UK, Cardiff University and C & VUHB to conduct large clinical study to assess URO17® in the detection of new bladder cancer in patients with hematuria (blood in their urine) and to develop a home sample collection program that will facilitate the detection of bladder cancer and reduce the need for patients to go to a clinic or hospital for tests.
“We are delighted to partner with Cardiff University, Cardiff and Vale University Health Board and CellPath through the Accelerate program to validate and deliver URO17® UK testing. Thanks to our first studies, we have shown that URO17® test has shown extremely high sensitivity and specificity in detecting bladder cancer from urine samples in recurrent and new cancers. Accelerate Program Study to Examine URO17 Performance® in a real clinical setting in patients with hematuria, which will facilitate wide distribution of the test across the UK and the rest of Europe. In addition, a development and launch of the URO17® The home sample collection program will provide a safe and cost-effective means to detect new bladder cancer that is critical in the age of COVID-19 and beyond. ” Nam W. Kim, Ph.D., CEO of KDx and CTO.
Professor Howard Kynaston of Cardiff and Vale University Health Board and Cardiff The university said: “There is an urgent need to develop precise non-invasive tests, such as biomarkers, in the fight against cancer. URO17® has enormous potential to distinguish between urinary symptoms due to bladder cancer and milder causes, speeding up rapid diagnosis and reducing the need for unnecessary invasive testing. “
About KDx Diagnostics, Inc.
Founded in 2017, KDx focuses on the development of non-invasive cancer tests to improve early detection and treatment decisions in cancer. URO17® The 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 to expand its product line to other diagnostic cancer tests. URO17® The bladder cancer test is for research only in the United States.
Ventac Partners Ltd, United Kingdom
KDx is supported in business strategy and business development by Ventac Partners Ltd, UK.
About CellPath Ltd.
CellPath is an independent UK based company geared to the needs of cell pathology. They specialize in the manufacturing and global supply of consumables, equipment and services to the histopathology and cytology markets.
The name CellPath stands for innovative and proven products manufactured to the highest standards. With state-of-the-art internal injection molding capability, they manufacture many plastic products used in cancer diagnosis.
The Accelerate program is co-funded by the European Regional Development Fund, the Welsh European Funding Office and the Welsh Government to foster and facilitate the adoption of new innovations, and involves three partner universities (Cardiff, Swansea and Trinity Saint David) and is run by the Life Science Hub, Cardiff Bay, Wales.
KDx Diagnostics Inc.
URO17 is a registered trademark of KDx.
KDx cautions 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 by words such as “believe”, “may”, “will”, “estimate”, “continue”, “anticipate”, “conceive”, “intend” , “Expect”, “” could “,” plan “,” potential “,” predict “,” seek “,” should, “” would “,” consider, “plan”, “target”, “tend towards “or the negative version of such words and expressions. These statements include, but are not limited to, statements relating to planned clinical studies and meetings with regulatory bodies. Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause KDx’s actual results, whether performance or achievements will differ materially from future results, performance or achievements expressed or implied in the forward-looking statements in this press release. press releases, including the risks and uncertainties inherent in KDx’s business and other risks in KDx’s deposits. KDx’s forward-looking statements are based on its current expectations and involve assumptions that could 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 assumes no obligation to update these 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.