New 5-FU/Capecitabine Safety & Treatment Test

CAMBRIDGE, UK: EDX Medical Group plc (AQSE: EDX) ("EDX Medical" or the "Company"), which develops innovative digital diagnostic products and services supporting personalised treatments for cancer, heart disease and infectious diseases, has today announced a further important development in its cancer testing capability in collaboration with The University of Oxford.

EDX Medical has entered into an exclusive agreement with Oxford University Innovation Ltd (OUI), the company which manages Oxford University's patent portfolio, to in-license new intellectual property developed by researchers at Oxford and Birmingham Universities through research funded by Cancer Research UK (CRUK).

This will enable EDX Medical to develop a much-improved test to determine safety and dose management for individual patients receiving 5-fluorouracil (5-FU), capecitabine and related chemotherapy medications. These drugs are widely used in the first-line treatment of colorectal cancer, breast cancer and cancers of the upper gastrointestinal tract but carry serious adverse side effects for certain individuals.

The new test from EDX Medical will incorporate the detection of a number of proprietary genes associated with severe adverse reactions in addition to the four dihydropyrimidine dehydrogenase (DPYD) genetic variants currently tested. The enlarged gene panel will provide a more accurate and complete prediction of dose-related clinical risks. The new test will be available exclusively from EDX Medical.

The Board of EDX Medical believes the new test has the potential to benefit millions of patients worldwide. More than 10 million people globally receive some form of chemotherapy annually and in England alone, 38,000 patients receive fluoropyrimidine-based chemotherapy each year.

EDX Medical will develop the 5FU/capecitabine safety and treatment management test under its own brand through its ongoing collaboration with Thermo Fisher Scientific, EMEA Ltd. ("Thermo Fisher"), a world leading supplier of life sciences solutions and services.

Professor Sir Chris Evans, OBE, founder of EDX Medical plc, commented: "We are delighted to announce this very significant development in our cancer testing capability which will soon be available alongside a range of class-leading diagnostic products which are of tremendous benefit to those treating cancer and their patients.

"Oxford, Birmingham and CRUK have done a brilliant job in discovering new biomarkers which will enable us to improve the safe use of one of the world's most widely used yet potentially dangerous cancer medicines. We are proud to be in a position to translate their knowledge into a clinical diagnostic test that will prevent patients suffering debilitating drug reactions and at the same time will also help hospitals avoid the additional costs of care for patients who have suffered side effects."

Dr Mike Hudson, CEO, EDX Medical plc, said: "We are continuing to broaden our range of cancer testing solutions wherever we see a need to provide doctors with timely information on individual patient's biology which can translate to improved treatment and outcomes. By including several new gene targets, the new product is expected to set a new standard in this important area of pharmacogenomic drug safety, enabling a more complete and accurate prediction of dose-related side effects and clinical risks for patients of various ethnicities receiving 5-fluorouracil (5-FU) and capecitabine."

The board of directors of EDX Medical plc accept responsibility for this announcement.

About Fluoropyrimidine-based chemotherapy

Treatment with chemotherapies is a complicated balance between maximising effectiveness while minimising the effects of toxicity on the patient. Fluoropyrimidines are chemotherapy drugs used to treat numerous cancers (including breast, colorectal and gastric cancers) but cause severe or life-threatening adverse effects for an estimated 10-40% of patients. These effects include nausea, vomiting, diarrhoea, inflammation of the mouth and gut, low white blood cells (neutropenia) and even death.

Patients with rare gene variants in the dihydropyrimidine dehydrogenase (DPYD) enzyme are significantly more likely to experience these adverse effects because they metabolise fluoropyrimidine-based chemotherapy drugs more slowly and between 0.5 and 2% of people will die from genetic susceptibility to 5-FU. Testing for the presence of these DPYD gene variants before patients start fluoropyrimidine-based chemotherapy enables clinicians to exclude patients from 5-FU treatment for whom the risk of life-threatening acute toxicity is confirmed. However, the ability to identify patients at risk of non-life threatening but severe adverse reactions is associated with additional genes not currently tested.

The Clinical Pharmacogenetics Implementation Consortium (CPIC) currently recommends minimal testing of four variants of the DPYD gene, though recognises that at least 40-50% of patients continue to have severe toxicity after 5-FU or Capecitabine even if they test negative for the four DPYD variants. This is even further marked in more ethnically diverse populations where additional genes beyond DPYD variants are considered to be significant. The importance of including representative ethnicities and avoiding health inequalities is increasingly recognised.

The next generation tests from EDX Medical will include all four genetic variants of DPYD recommended in the CPIC clinical guidelines, along with additional genes involved in adverse reactions. The expanded panel gives broader coverage, enables improved risk and dose management for patients of broader ethnic backgrounds and addresses key adverse reactions that materially impact patient quality of life.