Company Announcements

Oxford BioDynamics
("OBD" or the "Company" and, together with its subsidiaries, the "Group")

EpiSwitch Prognostic Covid Severity Test Study Published, with EpiSwitch Data Knowledge Analysis into Long COVID and Chronic Fatigue Syndrome 

Oxford, UK - 24 October 2024 - Oxford BioDynamics, Plc (AIM: OBD, the Company), a precision clinical diagnostics company bringing specific and sensitive tests to the practice of medicine based on OBD's EpiSwitch® 3D genomics platform, has announced the publication of a peer-reviewed paper in the European Society of Medicine presenting its prognostic Covid Severity Test (CST) and extended analysis of insights into the related conditions of Long COVID and Chronic Fatigue Syndrome or Myalgic Encephalomyelitis (CFS/ME)¹. 

The peer-reviewed Medical Research Archives (Volume 12, Issue 9) publication "Development and evaluation of blood-based prognostic biomarkers for COVID disease outcomes using EpiSwitch 3-dimensional genomic regulatory immuno-genetic profiling", in collaboration with the University of Oxford and Norwich Medical School, University of East Anglia, presents the development of a COVID severity test, previously presented in OBD pre-publications in BioRxiv (March 2021)^[2] and MedRxiv (June 2021) ^[3], with extended EpiSwitch Data Knowledge analysis into Long COVID/ Fatigue-dominant Post-COVID Syndrome (PCS), as well as CFS/ME.

EpiSwitch® prognostic test makes predictions based on a 6-marker model. In the study, it demonstrated a high positive predictive value for high-risk disease outcomes in the validation cohort. Moreover, within the validation cohort, two of the patients declared clinically to be mild cases were identified as high risk by the EpiSwitch® test and sadly subsequently died in hospital within 28 days of admission.

This suggests an early, pre-symptomatic detection by EpiSwitch systemic biomarkers of a hyperinflammatory state leading to fatal outcomes. The test for high-risk disease outcome demonstrated a positive predictive value (PPV) of 92.9%, 88% sensitivity, 87% specificity, and a balanced accuracy of 87.9% for all 116 patients used in this study.

Genome wide association studies (GWAS) define ten genetic loci uniquely associated with patients suffering fatigue-dominant PCS (Long COVID). Interestingly, these loci are also associated with fatigue syndromes such as ME/CFS, for which the largest risk of onset is associated with infectious diseases and sepsis-like conditions. Interrogating the EpiSwitch® Data and Knowledge Graph Space, which contains over a billion 3D-genomic EpiSwitch datapoints (chromosome conformation signatures) from more than 20 clinical studies and over 33 million Pubmed publications, all integrated with pathway databases, drug databases, dbSNP, eQTLs, Enhancer DBs, disease ontologies and transcription factor binding sites, reveals that 882 3D EpiSwitch markers are close to these ten fatigue-associated genes.

As a follow up to the work outlined in the publication, The London School of Hygiene and Tropical Medicine, Norwich Medical School, University of East Anglia and OBD have signed an agreement that provides OBD with access to a biobank of samples from CFS/ME patients for direct analysis and the identification of both diagnostic and prognostic blood biomarkers.

Clinical lead and co-author of the publication, Professor Dmitry Pshezhetskiy (University of East Anglia; ME/CFS specialist doctor, Royal Cornwall Hospitals NHS Trust) said: "The EpiSwitch platform has already delivered robust biomarkers and commercial tests for immuno-oncology (CiRT) and prostate cancer (PSE). I was directly involved in the development of the PSE test and have had the opportunity to appreciate the power of the EpiSwitch platform. I believe EpiSwitch is the one platform that is prepared to take on another heavy burden, ME/CSF, which has impacts affecting patients, healthcare and society. This is the tool that will develop the first robust diagnostic test and give us actionable insights for the effective treatment."

References:

^1.    Hunter, E., Pchejetski, D., et al., 2024. Development and evaluation of blood-based prognostic biomarkers for COVID disease outcomes using EpiSwitch 3-dimensional genomic regulatory immuno-genetic profiling. Medical Research Archives, [online] 12(9). https://doi.org/10.18103/mra.v12i9.5737

^2.     3D genomic capture of regulatory immuno-genetic profiles in COVID-19 patients for prognosis of severe COVID disease outcome. Ewan Hunter, Christina Koutsothanasi, Adam Wilson, Francisco C. Santos, Matthew Salter, Ryan Powell, Ann Dring, Paulina Brajer, Benedict Egan, Jurjen W. Westra, Aroul Ramadass, William Messer, Amanda Brunton, Zoe Lyski, Rama Vancheeswaran, Andrew Barlow, Dmitri Pchejetski, Peter A. Robbins, Jane Mellor, Alexandre Akoulitchev bioRxiv 2021.03.14.435295; doi: https://doi.org/10.1101/2021.03.14.435295

^3.     Development and validation of blood-based prognostic biomarkers for severity of COVID disease outcome using EpiSwitch 3D genomic regulatory immuno-genetic profiling. Ewan Hunter, Christina Koutsothanasi, Adam Wilson, Francisco C. Santos, Matthew Salter, Jurjen W. Westra, Ryan Powell, Ann Dring, Paulina Brajer, Benedict Egan, Matthew Parnall, Catriona Williams, Aemilia Katzinski, Thomas Lavin, Aroul Ramadass, William Messer, Amanda Brunton, Zoe Lyski, Rama Vancheeswaran, Andrew Barlow, Dmitri Pchejetski, Peter A. Robbins, Jane Mellor, Alexandre Akoulitchev medRxiv 2021.06.21.21259145; doi: https://doi.org/10.1101/2021.06.21.21259145

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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.