Oxford BioDynamics Secures First Paid Access Agreement for EpiSwitch Orion Platform in Psoriatic Arthritis Biomarker Study

EpiSwitch Orion Tackles Psoriatic Arthritis Treatment Challenges with Predictive Biomarkers

The OPTIMISE programme represents a pivotal commercial application of Oxford BioDynamics' EpiSwitch Orion platform to address the clinical challenge of biologic therapy selection in psoriatic arthritis. Currently, treatment involves trial-and-error due to the absence of predictive tools that identify effective therapies for individual patients prior to treatment initiation. Led by NDORMS at the University of Oxford, the study aims to develop blood-based genomic biomarkers capable of forecasting treatment response, potentially revolutionizing clinical decision-making in this patient group.

Utilizing clinical samples and data from the OPTIMISE trial, which enrolled 240 psoriatic arthritis patients randomized to receive secukinumab (anti-IL-17A) or adalimumab (anti-TNF), the collaboration leverages EpiSwitch Orion's 3D genomics technology to identify biomarkers for patient stratification and optimized therapy selection. This directly addresses the unmet medical need highlighted by Oxford BioDynamics CEO Richard Compton as central to the platform's mission.

Advanced Genomic Data Processing with EpiSwitch Orion

EpiSwitch Orion is a cloud-based 3D genomics discovery platform that converts standard genome sequencing data, including legacy whole genome datasets, into actionable insights. Its core advantage lies in revealing the genome's three-dimensional structure, uncovering disease-associated variants undetectable by traditional methods. The platform reportedly deciphers 90-95% of disease-associated variants in non-coding regions, which conventional sequencing and genome-wide association studies (GWAS) typically miss.

Backed by the world’s largest curated 3D genomics knowledgebase—featuring over 1.1 million anchor points and 15 million high-confidence genomic connections—validated across 15,000+ patient samples spanning 50+ diseases and nearly two decades of data, EpiSwitch Orion enables rapid identification of therapeutic targets, predictive classifiers, and precision interventions. For OPTIMISE, approximately 240 whole-genome sequenced patient samples will be analyzed using machine learning to develop predictive models for secukinumab and adalimumab responses.

Oxford BioDynamics’ Diagnostic Portfolio and New Revenue Model

Oxford BioDynamics currently markets two diagnostic blood tests based on its proprietary 3D genomic biomarker platform: the EpiSwitch PSE (Prostate Cancer Detection Test), which improves PSA screening accuracy from 55% to 94%, and the EpiSwitch CiRT (Checkpoint Inhibitor Response Test), delivering 85% accuracy in predicting immuno-oncology checkpoint inhibitor responses.

The company is expanding its pipeline into oncology, neurology, inflammation, hepatology, and animal health. The introduction of a paid-access revenue model through EpiSwitch Orion diversifies its commercial approach beyond direct test sales. Under the OPTIMISE agreement, Oxford BioDynamics will receive compensation for laboratory biomarker discovery and genomic data processing, establishing a service-based commercial model for the platform.

Structure and Funding of the OPTIMISE Research Collaboration

The OPTIMISE programme ("Optimising Psoriatic Arthritis Therapy with Immunological Methods to Increase Standard Evaluation") is funded by the UK Department of Health and Social Care via the National Institute for Health and Care Research (NIHR), integrating it into the UK’s translational research infrastructure. The collaboration includes the University of Oxford’s Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (lead), University of Glasgow, King's College London, and Guy's and St Thomas' NHS Foundation Trust, providing access to extensive clinical expertise and patient cohorts.

This government-funded framework underscores recognition of Oxford BioDynamics’ EpiSwitch Orion as a valuable translational genomics tool within the UK clinical research ecosystem. Financial terms of the agreement remain undisclosed.

Comprehensive Technical Role of Oxford BioDynamics in OPTIMISE

Oxford BioDynamics’ responsibilities encompass sample processing, genomic and qPCR laboratory analyses, bioinformatics, machine learning model development, statistical evaluation, and validation studies. The programme has two strands: one focuses on identifying biomarkers predictive of secukinumab response using the EpiSwitch 1M whole-genome array and qPCR platform, aiming to develop compact qPCR assays validated in independent cohorts. The second strand applies EpiSwitch Orion and machine learning to approximately 240 whole-genome sequenced samples to build predictive models for both secukinumab and adalimumab.

Beyond analytics, Oxford BioDynamics provides scientific, technical, project management, computational, and analytical support, positioning itself as a central technical partner responsible for delivering predictive classifiers as the programme’s primary output.

Market Potential and Competitive Edge of EpiSwitch Orion

CEO Richard Compton highlighted a significant untapped market, estimating around 15,000 genomics Principal Investigators with samples, genomes, and grant funding as potential platform users. This suggests a target customer base comprising academic research institutions and pharma/biotech companies with genomic datasets.

The platform’s unique ability to translate 2D genomic data into 3D regulatory insights—providing “an understanding of Biology in 3D that they have never had before”—differentiates it from traditional sequencing and GWAS methods by analyzing non-coding regions and genome architecture. The OPTIMISE psoriatic arthritis biomarker study serves as a high-profile proof-of-concept validating this approach for broader therapeutic and research applications.

Operational Infrastructure Supporting the OPTIMISE Collaboration

Oxford BioDynamics operates laboratories and facilities across Oxford, UK (headquarters and UK labs), Maryland, USA (clinical laboratory), and Penang, Malaysia (reference laboratory). This geographic footprint supports the company’s diagnostic test offerings and the technical requirements of the OPTIMISE programme, including whole-genome sequencing, qPCR, bioinformatics, and computational analysis. Proximity to the University of Oxford facilitates efficient collaboration with UK academic and clinical partners.

Strategic Importance of the First Paid Platform Access Agreement

This agreement marks the first instance of a third party paying for EpiSwitch Orion platform access, a significant milestone in its commercialisation. Prior to this, the platform had not generated direct external revenue. CEO Richard Compton described the deal as "significant for us commercially," establishing a reference point and proof-of-concept for the platform’s market value. This precedent may accelerate future licensing and access discussions with research institutions, pharmaceutical, and biotech companies. Financial terms remain undisclosed, with further updates promised in scheduled financial reports.

Regulatory and Clinical Translation Outlook for Psoriatic Arthritis Biomarkers

The OPTIMISE programme addresses a major unmet need in psoriatic arthritis, where biologic therapy selection currently relies on trial-and-error due to lack of predictive biomarkers. Secukinumab and adalimumab, targeting IL-17A and TNF respectively, have distinct mechanisms and variable patient responses. The biomarker discovery aims to produce "compact classifiers" predictive of treatment response, potentially enabling clinical implementation.

While validation studies in independent cohorts are planned, the announcement does not specify regulatory timelines or interactions with agencies such as the UK MHRA or European regulators. Successful clinical translation will likely require additional validation and regulatory approval before routine use.

Financial Disclosure and Investor Information

The company has not disclosed financial terms of the OPTIMISE agreement, indicating that further commercial progress will be reported in scheduled financial statements. This limits investors’ ability to assess the agreement’s commercial impact or forecast revenue potential from EpiSwitch Orion based on this initial transaction. The estimated 15,000 potential genomics Principal Investigators provide a market size indication, but without pricing or revenue data, financial modeling remains challenging. Investors should monitor future financial disclosures for updates.