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KDx Diagnostics And Lister Hospital Announce The Launch Of A Non-Invasive URO17® Urine Test For Bladder Cancer In The United Kingdom

SAN JOSE, Calif. and STEVENAGE, England, Dec.

SAN JOSE, Calif. and STEVENAGE, England, Dec. 5, 2021 /PRNewswire/ -- KDx Diagnostics, Inc. (KDx), and Lister Hospital (East and North Hertfordshire NHS Trust), Stevenage, UK, announced today the launch in the United Kingdom (UK) of KDx's URO17 ® test for detection of bladder cancer. This non-invasive urine test for bladder cancer is highly sensitive for identifying bladder cancer in patients with hematuria and recurrent bladder cancer during post-treatment monitoring.   

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 difficult and expensive, requiring invasive camera-based testing methodology. Excitingly, KDx's URO17 ® test has demonstrated 100% sensitivity and over 90% specificity in detecting bladder cancer in multiple peer-reviewed studies.  

"We are excited to have the non-invasive URO17 ® test available in the UK to determine with high confidence whether a patient has bladder cancer. Testing has shown the URO17 ® urine test can detect the presence or absence of bladder cancer with high sensitivity. We are confident that the application of URO17 ® in clinical practices can significantly improve patient care in the UK ," said Nam W. Kim, Ph.D., KDx's CEO, and CTO.

"Bladder cancer is expensive cancer to treat due to a high rate of recurrence, and it often requires invasive procedures to diagnose. KDx's URO17 ® urine test is revolutionizing how bladder cancer is detected, managed, and treated. We are excited that Lister Hospital in Stevenage is now a Core Lab offering URO17 ® test and that patients from all over the UK will have access to this test," said Sholeh Jahanfard, President and COO of KDx Diagnostics Inc.

Mr. Nikhil Vasdev - Consultant Urological Surgeon at Lister Hospital and Associate Medical Director for cancer services at East and North Hertfordshire NHS Trust, which runs the hospital - was the chief investigator and the lead author of a paper describing a recent study on URO17 ®. "We are pleased to be the first NHS trust in the UK and Europe to make URO17 ® test available for patients," said Mr. Vasdev, who is also a Senior Clinical Lecturer at the University of Hertfordshire. "Our ability to detect bladder cancer simply, accurately, and non-invasively using URO17 ® will greatly improve detection at an early stage when it can be treated most effectively while minimizing the number of unnecessary and invasive procedures in patients who are suspected of having bladder cancer," he added.

Dr. Michael Chilvers - Medical Director at East and North Herts NHS Trust, said: "I am really pleased that the partnership between KDx and this Trust has led to this major step forward in the non-invasive detection of bladder cancer, and undoubtedly to improved outcomes for our patients."

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. 

Lister Hospital, Stevenage, UK, is a tertiary referral center for urological cancers in Hertfordshire. It is part of East and North Hertfordshire NHS Trust, which runs four hospitals in the area including Lister.

Contact:Public RelationsKDx Diagnostics Inc.408-628-7715

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 with the Securities and Exchange Commission (the SEC). 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.

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SOURCE KDx Diagnostics Inc.