Breakthrough Blood Test for Diagnosing Chronic Fatigue Syndrome Shows 96% Accuracy
Researchers from the University of East Anglia (UEA) and Oxford BioDynamics have developed a blood test that demonstrates 96% accuracy in diagnosing Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). This advancement offers a potential objective diagnostic tool for a condition that has long lacked definitive biomarkers.
The test utilizes EpiSwitch® 3D Genomics technology to analyze the three-dimensional folding patterns of DNA within blood cells. By identifying specific epigenetic markers associated with ME/CFS, the test achieved 92% sensitivity and 98% specificity in a study involving 47 patients with severe ME/CFS and 61 healthy controls. These findings were published in the Journal of Translational Medicine on October 8, 2025.
ME/CFS is a debilitating disorder characterized by profound fatigue, cognitive impairments, and autonomic dysfunction. The absence of definitive diagnostic tools has historically led to misdiagnosis and delayed treatment. Current diagnostic methods rely on clinical evaluation and exclusion of other conditions, often resulting in prolonged diagnostic processes.
The EpiSwitch® technology focuses on epigenetic changes—modifications in gene regulation influenced by environmental and immune factors—rather than genetic mutations. By examining blood samples, researchers identified unique 3D DNA folding patterns that distinguish ME/CFS patients from healthy individuals. This approach has previously been applied to other conditions, such as prostate cancer, where the EpiSwitch® PSE test achieved 94% accuracy and reduced unnecessary biopsies by 79%.
The study also revealed that ME/CFS is strongly linked to immune system dysregulation and chronic inflammation. The 3D genomic mapping highlighted several biological pathways central to the disease, including interleukin-2 (IL-2) and IL-10 signaling, which control immune cell activation.
While the results are promising, experts caution that further research is needed to confirm the test's specificity to ME/CFS and its applicability for clinical use. Some studies have achieved similar accuracy but required complex laboratory workflows. The EpiSwitch® technology operates under ISO standards in accredited laboratories, ensuring assay reproducibility, stability, and scalability.
The development of a highly accurate blood test for ME/CFS could have profound social and societal implications. An objective diagnostic tool could facilitate earlier and more accurate diagnoses, enabling timely interventions and personalized management strategies. This advancement may also reduce the stigma associated with ME/CFS by providing tangible evidence of the condition, potentially improving patient validation and access to appropriate care.
In summary, the collaboration between UEA and Oxford BioDynamics has led to a significant breakthrough in ME/CFS diagnostics. While further validation is necessary, the EpiSwitch® blood test represents a promising step toward objective diagnosis and improved patient outcomes for those affected by this challenging condition.