This announcement contains inside information as stipulated under the UK version of the Market Abuse Regulation No 596/2014 which is part of English law by virtue of the European (Withdrawal) Act 2018, as amended.  On publication of this announcement via a regulatory information service, this information is considered to be in the public domain.

11th April 2025

EDX Medical Group plc

AQSE: EDX

("EDX Medical" or the "Company")

NEW HIGHLY ACCURATE TESTICULAR CANCER TEST

CAMBRIDGE, UK: EDX Medical Group plc, which develops innovative digital diagnostic products and services supporting personalised treatments for cancer, cardiovascular and infectious diseases, announces that the Company is to launch a new highly accurate early detection test for testicular cancer.

The test, which will be launched in the UK within weeks, features exceptional sensitivity in a broad range of men across ethnicities and ages, and also detects cancer recurrences at ultra-high accuracy with 100% sensitivity following treatment and during ongoing surveillance of testicular cancer survivors.

The EDX Medical test ("TC100") involves the taking of a simple blood sample which is sent to EDX Medical for laboratory analysis.

Multiple specific tumour biomarkers are analysed and, using a proprietary AI-powered algorithm, a detailed report is prepared for clinicians to help determine the presence or absence of disease and to help guide treatment if required.

Over 30 study reports have confirmed the accuracy and potential clinical usefulness of the test, encompassing its use in primary diagnosis, early detection, metastatic disease and recurrence of both seminoma and non-seminoma testicular cancer.

Combining proprietary M371 micro-RNA biomarker analysis with the classic three serum biomarkers AFP - Alpha-fetoprotein, HCG - Human Chorionic Gonadotrophin and LDH - Lactate Dehydrogenase, the new "TC100" assay provides exceptional accuracy and sets a new standard for testicular cancer testing.

The TC100 test reports on the three tumour biomarkers currently included in the NHS testicular cancer treatment pathway as part of the analysis and for ease of reference.

The test provides up to 99% sensitivity and 96% specificity in primary diagnosis and 100% in monitoring recurrence. The test, which is to be used by health professionals as an aid to their clinical diagnosis, will be available to all private sector and public healthcare providers within several weeks. 

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There are around 2,500 new cases of testicular cancer in the UK every year and 50,000 survivors of testicular cancer who could benefit from accurate post-treatment monitoring.  Notable survivors in the UK who campaign for greater awareness of the disease include actor Jack James Ryan, formerly of Coronation Street, radio presenter Chris Stark and former Welsh international footballer, John Hartson.

Professor Sir Chris Evans, OBE, founder of EDX Medical Group plc, says:  "Testicular cancer is a nightmarish thought for young men and there has been a lack of awareness over what to do and an unwillingness to get tested.

"We are delighted to launch in the UK now the best test ever made. Given that this disease affects boys from 15 years old to men in their early forties, there are many who could benefit from testing in terms of reassurance and this particularly applies to people who have been diagnosed and need checked on a regular basis."

Dr Mike Hudson, CEO, EDX Medical, said: "The highly sensitive "TC100" testicular cancer test will help doctors to accurately identify testicular cancer early and better manage the safe and effective care of their patients. The quick confirmation of early signs of disease, the absence of cancer following treatment and to monitor any signs of recurrence during surveillance will help minimise scans, biopsies and the unnecessary use of toxic chemotherapy, significantly improving quality of life for patients." 

Actor Jack James Ryan, who campaigns on behalf of the Teenage Cancer Trust, commented: "There's still such a huge stigma around testicular cancer especially with the process of getting physically checked in the private parts and that needs to change. Even after your initial check you need to be scanned if there are concerns, so you still don't know the outcome of what you have been worried about.

"Being able to give a simple blood sample that is then analysed and that tells you with a high degree of certainty whether you have this cancer or not - as opposed to the physical examinations - would eliminate the awkward and uncomfortable physical process that so many young men shy away from. By making the process of detection easier and more casual - and very accurate - it'll convince more young men to get tested quicker and in turn will save lives. This really is a game changer!"

Dr Karen Robb, Director of Programme Implementation for Cancer at Movember, the leading men's health charity, commented: "This test is a great step and a part of the bigger picture to improve early diagnosis. During Testicular Cancer Awareness Month, Movember is reminding young men to 'Know Thy Nuts' - that means getting familiar with what's normal for your body and speaking up if something doesn't feel right. Early detection starts with awareness, and knowing your risks can save your life."

Leading Michelin-starred chef and restaurateur, Andreas Antona, was diagnosed with testicular cancer in 2012 and believes early testing will be life-saving for young men.

He said: "We all say that if we knew then what we know now, we'd have made different decisions and how true that is when it comes to cancer. Early detection will undoubtedly save young men's lives and prevent much unnecessary suffering by earlier intervention. This type of testing can also give great peace of mind and help someone live life without worrying about cancer all the time."

The directors of EDX Medical accept responsibility for the contents of this announcement.

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Notes for Editors:

About EDX Medical Group 

EDX Medical Group plc is listed on the Apex Segment of the AQSE Growth Market (TIDM: EDX).

EDX Medical was founded by Professor Sir Christopher Evans, OBE, a medical and life sciences entrepreneur with more than 30 years of experience, together with CEO, Dr Mike Hudson.

By translating clinical insights into pragmatic solutions combining advanced biological and digital technologies, EDX Medical seeks to cost effectively improve the detection and characterisation of disease in order to personalise treatment in a timely fashion. Early disease detection and biologically-based personal treatment optimisation is considered to be the most impactful way of reducing deaths and lowering the cost of healthcare globally.

EDX Medical Group provides doctors, hospitals and insurers/payers with access to a portfolio of the best clinical diagnostics products and services. The Company operates its own facilities in Cambridge and Oxford, UK, and has strategic product and technology partnerships with organisations such as Thermo Fisher EMEA Ltd, a world leader in supplying life sciences solutions and services.

EDX Medical conducts product development, validation and distribution to ISO 13485 and provides PCR and genomic sequencing services accredited to ISO 15189 by the United Kingdom Accreditation Service (UKAS).