RNS Number : 1251T

EDX Medical Group PLC

20 June 2024

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.

20 June 2024

EDX Medical Group plc · EDX

(AQSE: EDX)

("EDX Medical" or the "Company")

NEW DEVELOPMENT IN GROUP CANCER TESTING STRATEGY

CAMBRIDGE, UK: EDX Medical Group plc, which develops innovative digital diagnostic products and services supporting personalised treatments for cancer, heart disease and infectious diseases, today announces a strategic expansion of its cancer testing capability.

EDX Medical is to launch comprehensive hereditary germline cancer testing products and services designed to accurately predict if family members of cancer patients are at increased risk from the disease.

The first test to be made available to health professionals in the UK is a pan-cancer test which achieves 99% sensitivity and identifies mutations in 70 genes known to be associated with cancers which have a strong inherited, genetic component including prostate, breast, colorectal, pancreatic and ovarian cancers in a single test.

EDX Medical's comprehensive hereditary germline cancer testing products will enable doctors to advise family members of cancer patients on lifestyle choices and actions they can take to delay or prevent onset of the disease. Family members include grandparents, parents, children, siblings and other blood relatives.

The test will be available later this summer through private healthcare providers and via specific NHS Genetic and Genomic Testing Centres in cases where family members of cancer patients can be screened for genetic risk of cancer. In addition, EDX Medical will provide a support service for healthcare professionals with the test.

Professor Sir Chris Evans, OBE, founder of EDX Medical plc, commented: "We are delighted to announce the launch of this test which we believe to be the highest quality hereditary cancer test available anywhere in the world.   The fact that this single test covers all the known genes associated with inherited cancer risk will be enormously reassuring for people who have a close family member with or who have survived cancer.

"This is an important development in the EDX Medical cancer strategy to ensure increasing accessibility to excellent diagnostic products for doctors and their patients in the UK. The Comprehensive Hereditary Germline Cancer Test is the first in a series of new precision cancer tests to be launched by EDX in the coming months".

Dr Mike Hudson, CEO of EDX Medical, said: "This is an excellent, comprehensive test based on the latest clinical and scientific knowledge.  Testing family members of cancer patients must be a key part of a National Cancer Prevention and Management Strategy.

"This test enables doctors to identify important genetic risks shared by patients and their families, to take preventative action before the onset of disease, or to make well-informed clinical decisions and ensure access to modern medicines with greater chances of long-term survival should cancer occur later."

Many cancers are known to be associated with specific gene mutations which can be inherited. Approximately 1 in 8 (12.5%) cancer patients have at least one inherited gene mutation which can now be safely screened for before any signs of disease.

The benefits of comprehensive hereditary cancer testing are that early detection enables those at risk to take preventative action to reduce risk or delay the disease occurrence.  In the event of cancer at a subsequent time, the availability of this genetic profile will assist quick and well-informed decision-making and access to modern medicines with greater chances of long-term survival.

About Hereditary Genetic Testing for Cancer

Overall, around 12.5% of new cancer cases each year are associated with inherited genetic mutations.  Examples include:

Prostate Cancer:  8% associated with inherited gene mutations, 80% of which are treatable.

Breast Cancer: 12.5% associated with inherited gene mutations, where early knowledge can lead to better treatment options and improved survival

Colorectal Cancer: 14.5% of patients could benefit from hereditary screening and personalised treatment

Pancreatic Cancer: 14.5% of patients have inherited mutations, of which almost 80% can be targeted by new medicines available via clinical trials.

Ovarian Cancer: 20% of patients exhibit known mutations, of which 70% could have been identified in advance by Comprehensive Hereditary Screening.

In the UK alone, there are approximately 375,000 new cancer cases diagnosed every year of which around 35,000 are associated with specific, existing known genetic risks. For the families of these patients being able to screen and test for these genetic risks enables much improved planning and eventual treatment if required. Identifying at-risk family members is one of the most important benefits of testing for inherited genetic mutations.

Cancer is a common condition with approximately one in two people developing it in in their lifetime. It usually develops when there is a fault (mutation) in the genetic machinery controlling cell division and this occurs at random during life. However, sometimes these gene mutations are inherited from a parent, and people carrying these genes often have an elevated chance of experiencing cancer throughout their lives, particularly if inheriting from both parents.

Being born with one inherited faulty gene does not mean that a person will definitely develop cancer, and even if they have 'mutations' from both parents, other factors in their lifestyle may limit the risk of cancer in some cases. However, they do have a higher risk of developing particular types of cancer (breast, ovarian, colorectal and prostate cancer) than other people and may also develop cancer at a younger age (genetic predisposition to cancer).

A test for genes associated with cancer is based on the analysis of DNA to identify the presence or absence of a genetic mutations that are known to be associated with cancer.

The best hereditary cancer gene tests are based on identifying panels of multiple genes since genes and the pathways controlled by them frequently interact and extended analysis is needed in order to provide the greatest amount of clinically relevant information.

EDX Medical has also announced the acceleration of the development of another range of cancer testing products through the existing collaborative agreement with Thermo Fisher Scientific EMEA Ltd., a world leader in supplying life sciences solutions and services. The Company and Thermo Fisher are currently working on several joint projects to develop commercial clinical assays, utilising Thermo Fisher's Q-PCR technologies.

The Company also confirms that an earlier distribution agreement with Guardant Health Inc., announced on October 5, 2023, has been discontinued.

The Board of directors of EDX Medical plc accepts responsibility for this announcement.

ENDS

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Notes for Editors:

About EDX Medical Group plc  www.edxmedical.com  

EDX Medical Group Plc develops innovative digital diagnostic products and services, enabling cost effective and timely delivery of personalised treatment for cancer, heart disease and infectious diseases. The company 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 operates a molecular biology and diagnostics laboratory in Cambridge, UK, and 100%-owned subsidiaries "Hutano Diagnostics Ltd", based in Oxford and "Torax Biosciences Ltd" in Ireland which are pioneering the development of novel multiplex point of care tests.  

EDX Medical conducts diagnostic assay development and validation to ISO 13485 and provides testing and genomic sequencing services accredited to ISO 15189 by the United Kingdom Accreditation Service (UKAS).