Oxford Biodyn Regulatory News (OBD)

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

OBD's Oxford Lab accredited by UKAS to run EpiSwitch® Clinical Tests in the UK

· OBD's facility in Oxford has been accredited by UKAS as clinical lab under the ISO 15189 standard

· Clinical validation of EpiSwitch CiRT has been completed in the Oxford lab, further improving the test result turnaround time

· All orders for both CiRT and PSE in the UK and Europe will be processed within the UK lab

Oxford, UK - 9 May 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, announces that its UK facility in Oxford has been accredited by the United Kingdom Accreditation Service (UKAS) as a clinical laboratory under the ISO 15189 standard.

The Company is also pleased to confirm the successful completed validation of its EpiSwitch Checkpoint Inhibitor Response Test (CiRT) as a clinical test in this UK laboratory. CiRT is OBD's best-in-class stratification tool that empowers clinicians to identify which patients are likely to respond to a widely used class of immunotherapies: immune checkpoint inhibitors. The CiRT blood test is already available in the UK, but up to now, testing was performed in OBD's US CLIA-certified facility. 

Thomas Guiel, Chief Operating Officer of OBD, said:

"The immediate benefit for cancer patients seeking a CiRT test in the UK will be the significant reduction in the elapsed time from receipt of an order to result, which will now be 3-5 days. UKAS accreditation of our clinical lab in the UK under ISO15189 is a significant milestone that underscores our dedication to delivering high-quality and timely diagnostic testing to support healthcare providers and patients in the UK and Europe, meeting the stringent ISO requirements for patient testing and data security."

The successful validation of CiRT in the UK is an important advance for OBD's British partners and customers, including its strategic partner, Bupa UK1.

This milestone completes OBD's strategy to implement clinical testing operations at its UK base, commissioned in April 2024.

More information on CiRT may be found at www.myCiRT.com.

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References

1: Oxford BioDynamics Plc. (Oct 2023). Bupa UK to cover EpiSwitch® CiRT for customers. https://otp.tools.investis.com/clients/uk/oxford_biodynamics_plc/rns/regulatory-story.aspx?cid=2040&newsid=1726458

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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 Cancer Detection 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.