Oxford Biodyn Regulatory News (OBD)

Oxford BioDynamics plc

("Oxford BioDynamics" or "OBD" or the "Company")

OBD and UEA develop breakthrough diagnostic test for Chronic Fatigue Syndrome

· First-in-class blood test for Chronic Fatigue Syndrome achieves high 96% accuracy

· Offers hope as a reliable test, avoiding lengthy diagnosis delays and misdiagnosis

· Peer-reviewed study published in Journal of Translational Medicine

Oxford, UK - 08 October 2025 - Oxford BioDynamics Plc (AIM: OBD), a precision clinical diagnostics company bringing specific and sensitive tests to the practice of medicine based on its EpiSwitch® 3D genomics platform, is pleased to announce the development of a new highly accurate blood test to diagnose Chronic Fatigue Syndrome (CFS), also known as Myalgic Encephalomyelitis (ME).

Chronic Fatigue Syndrome is a serious and often debilitating long-term illness characterised by extreme fatigue that affects 400,000 people in the UK and millions worldwide. It is poorly understood and has long lacked a reliable diagnostic test.

Lead University of East Anglia (UEA) researcher, Prof Dmitry Pshezhetskiy, said:

"We know that some patients report being ignored or even told that their illness is 'all in their head'. With no definitive tests, many patients have gone undiagnosed or misdiagnosed for years.

"This is a significant step forward. For the first time, we have a simple blood test that can reliably identify ME/CFS - potentially transforming how we diagnose and manage this complex disease. Additionally, understanding the biological pathways involved in ME/CFS opens the door to developing targeted treatments and identifying which patients might benefit most from specific therapies."

With 96% accuracy (92% sensitivity, 98% specificity), the new blood test offers hope for a definitive and timely diagnostic tool for ME/CFS. The full study, conducted by scientists at UEA, OBD, the London School of Hygiene & Tropical Medicine, and Royal Cornwall Hospitals NHS Trust, has been accepted for publication in the Journal of Translational Medicine1.

OBD Chief Scientific Officer, Alexandre Akoulitchev, said:

"With this breakthrough, we are proud to enable a first-in-class test that can address an unmet need for a quick and reliable diagnostic for a complex, challenging-to-identify illness.

"Chronic Fatigue Syndrome is not a genetic disease you're born with. That's why using EpiSwitch 'epigenetic' markers, which can change during a person's life, unlike fixed genetic code, has been key to achieving this level of accuracy. The EpiSwitch platform behind this test, together with OBD's vast 3D genomic EpiSwitch Knowledgebase, has already proven its ability to deliver practical, rapid blood diagnostics that are accessible at scale."

Using OBD's EpiSwitch® 3D genomics biomarker technology and advanced bioinformatic-AI suite, the team identified unique markers based on how DNA is consistently folded in blood from ME/CFS patients. This looked beyond the linear DNA code investigated by a previous DecodeME study, the largest genetic investigation of the disease to date2. UEA and OBD revealed hundreds of additional changes in CFS/ME patients, including sites found by DecodeME, which now provide a deeper understanding of the disease.

Going forward, the Company aims to identify an appropriate partner to co-develop or license the test, and bring it into the clinic as soon as possible.

The breakthrough also provides a basis for developing a similar test for post-Covid syndrome ('long Covid'), a debilitating condition triggered by exposure to the Covid-19 virus which shares overlapping symptoms with ME/CFS.

This approach, using OBD's EpiSwitch technology, has previously shown success in identifying disease-specific blood-based biomarkers in highly complex inflammatory and neurological conditions such as fast ALS (amyotrophic lateral sclerosis), rheumatoid arthritis, and certain cancers. OBD's EpiSwitch PSE blood test is already used in the UK and US for detecting prostate cancer with leading 94% accuracy. In August, OBD announced its collaboration with Google Cloud to deliver the proprietary EpiSwitch Knowledgebase and AI-powered analytical tools-used to deliver insights in this CFS/ME study-in a secure, globally accessible environment to the benefit of pharma and biotech partners3.

The peer-reviewed manuscript, titled "Development and validation of blood-based diagnostic biomarkers for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) using EpiSwitch® 3-dimensional genomic regulatory immuno-genetic profiling", is publishing online today in the Journal of Translational Medicine1.

-Ends-

References

1  Hunter, E., Alshaker, H., et al (2025). Development and validation of blood-based diagnostic biomarkers for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) using EpiSwitch® 3-dimensional genomic regulatory immuno-genetic profiling. J Transl Med. DOI: 10.1186/s12967-025-07203-w

A copy of the paper is available via the following Dropbox link here: https://obdx.co/9g2

2 Genetics Discovery Team, et al (2025). Initial findings from the DecodeME genome-wide association study of myalgic encephalomyelitis/chronic fatigue syndrome. medRxiv, Preprint. https://doi.org/10.1101/2025.08.06.25333109

3 Oxford BioDynamics plc (2025). Oxford BioDynamics and Google Cloud Agree to Collaborate and Help Accelerate Cloud-Based Analytical Frameworks for Precision Medicine. Regulatory News Service. https://otp.tools.investis.com/clients/uk/oxford_biodynamics_plc/rns/regulatory-story.aspx?cid=2040&newsid=1976564

For further information please contact:

Notes for Editors

About Oxford BioDynamics Plc

Oxford BioDynamics Plc (AIM: OBD) is an international biotechnology company, advancing personalized healthcare by developing and commercializing precision clinical diagnostic tests for life-changing diseases.

Currently OBD has two commercially available products: the EpiSwitch® PSE (EpiSwitch Prostate Screening test) and EpiSwitch® CiRT (Checkpoint Inhibitor Response Test) blood tests. PSE boosts the predictive accuracy of a PSA test from 55% to 94% when testing the presence or absence of prostate cancer. CiRT is a highly accurate (85%) predictive response test to immuno-oncology checkpoint inhibitor treatments.

The tests are based on OBD's proprietary 3D genomic biomarker platform, EpiSwitch® which enables screening, evaluation, validation and monitoring of biomarkers to diagnose patients or determine how individuals might respond to a disease or treatment.

OBD's clinical smart tests have the potential to be used across a broader range of indications, and new tests are being developed in the areas of oncology, neurology, inflammation, hepatology and animal health.

The Group's headquarters and UK laboratories are in Oxford, UK. Its US operations and clinical laboratory are in Maryland, USA, along with a reference laboratory in Penang, Malaysia.

OBD is listed on the London Stock Exchange's AIM (LSE: OBD). For more information, please visit the Company's website, www.oxfordbiodynamics.com, X (@OxBioDynamics) or LinkedIn.