Breakthrough diagnostic test for Chronic Fatigue Syndrome

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

Oxford BioDynamics Plc, 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 Medicine.

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 date. 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 partners.