Oxford Biodyn Regulatory News (OBD)

Oxford Biodynamics opens clinical testing facility in the UKto perform EpiSwitch® Prostate Screening (PSE) blood test

· OBD commissions an ISO15189 clinical laboratory in its UK facility

· Clinical validation completed in OBD's clinical laboratory enabling immediate application of the EpiSwitch Prostate Screening (PSE) test

· Expands OBD's testing capacity and significantly shortens the turnaround time for tests ordered in the UK

· PSE provides a high accuracy second opinion for men receiving an accelerating or elevated PSA score

Oxford, UK - 3 April 2024 - Oxford BioDynamics, Plc (AIM: OBD, the Company), a biotechnology company developing precision medicine tests based on the EpiSwitch® 3D genomics platform, announces the completion of the clinical validation of its EpiSwitch Prostate Screening (PSE) test at the Company's newly commissioned ISO15189 UK clinical laboratory.

The launch of the 94% accurate1 precision medicine testing in the UK will cut in half the turnaround time for any PSE tests ordered by UK physicians. The test has been available in the UK since September 2023 but until now all samples were sent to OBD's US CLIA-certified lab for analysis and reporting prior to the opening of this UK-based clinical facility.

"The commissioning of a new clinical lab and the validation of PSE testing within that laboratory is an important milestone for the company" said Thomas Guiel, Chief Operating Officer. "The immediate benefit for our clients in the UK will be the significant reduction in the elapsed time from receipt of an order to result, which will now be 5 days or less. We are continually seeking to expand our markets and user base; having 2 labs will be necessary as demand grows for the PSE test."

EpiSwitch Prostate Screening test (PSE)

The PSE test combines the PSA score with five proprietary epigenetic biomarkers to predict, with 94% accuracy, the presence (or absence) of prostate cancer.1 Those with a PSE result of low likelihood of cancer can be placed on active surveillance and retested later without being referred for an invasive and often destructive biopsy. A high likelihood result would necessitate referral to a Urologist for further investigation. This minimally invasive blood test is designed to be run alongside a standard PSA test to boost PSA's low sensitivity (64%) and low positive predictive value (25%).2 For each patient, the EpiSwitch technology captures personal epigenetic biomarkers that represent a systemic fingerprint of specific regulatory network changes associated with prostate cancer.1

Patients should speak to their doctor about ordering the PSE test (www.94percent.com). Their doctor will submit a test requisition and arrange for a small sample of the patient's blood to be collected. Test results will be returned to the ordering physician within five days after the blood sample is received in the laboratory.

Please contact Oxford BioDynamics client services anytime by emailing the team at pse.test@myobdx.com. More information may be found at www.94percent.com.

Validation for other EpiSwitch tests, including CiRT

OBD will soon begin validating its other marketed precision medicine clinical test, the EpiSwitch Checkpoint Inhibitor Response Test (CiRT) (www.mycirt.com) within this new UK facility. The CiRT test is currently available in the UK, but testing is performed in OBD's US CLIA-certified facility. The validation of CiRT will be completed over the coming months which will be an important advance for OBD's partners and customers in the UK, including its strategic partner, Bupa UK. 

-Ends-

Proof Sources

1. "Circulating Chromosome Conformation Signatures Significantly Enhance PSA Positive Predicting Value and Overall Accuracy for Prostate Cancer Detection". Cancers. 2023; 15(3):821. Pchejetski D, Hunter E, Dezfouli M, et al.

2. "Should I have a PSA test?" National Health System - United Kingdom. https://www.nhs.uk/conditions/prostate-cancer/ "Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study". Lancet. Ahmed, Bosaily, Brown, et al.

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Notes to Editors

About Oxford BioDynamics Plc

Oxford BioDynamics Plc (AIM: OBD) is a global biotechnology company, advancing personalized healthcare by developing and commercializing precision medicine tests for life-changing diseases.

Its flagship products are the EpiSwitch® CiRT (Checkpoint Inhibitor Response Test) and EpiSwitch® PSE (EpiSwitch Prostate Screening test) blood tests. CiRT is a predictive immune response profile for immuno-oncology (IO) checkpoint inhibitor treatments, launched in February 2022. PSE is a blood test that boosts the predictive accuracy of a PSA test from 55% to 94% when testing the presence or absence of prostate cancer, which has been launched in the US via an early access program in September 2023; launch in the UK will follow in Q4 2023.

The Company's first commercial prognostic test, EpiSwitch® CST (Covid Severity Test), and the first commercially available microarray kit for high-resolution 3D genome profiling and biomarker discovery, EpiSwitch® Explorer Array Kit, which is available for purchase by the life science research community, were both launched in 2021.

The Company's product portfolio is based on a proprietary 3D genomic biomarker platform, EpiSwitch®, which can build molecular diagnostic classifiers for the prediction of response to therapy, patient prognosis, disease diagnosis and subtyping, and residual disease monitoring in a wide range of indications.

Oxford BioDynamics has participated in more than 40 partnerships with big pharma and leading institutions including Pfizer, EMD Serono, Genentech, Roche, Biogen, Mayo Clinic, Massachusetts General Hospital and Mitsubishi Tanabe Pharma.

The Company has created a valuable technology portfolio, including biomarker arrays, molecular diagnostic tests, bioinformatic tools for 3D genomics and an expertly curated 3D genome knowledgebase comprising hundreds of millions of data points from over 15,000 samples in more than 30 human diseases.

OBD is headquartered in Oxford, UK and is listed on AIM of the London Stock Exchange. It also has a commercial office in Gaithersburg and a clinical laboratory in Frederick, MD, USA, and a reference laboratory in Penang, Malaysia.

For more information, please visit the Company's website, www.oxfordbiodynamics.com, or follow OBD on Twitter (@OxBioDynamics) and LinkedIn.

About EpiSwitch®

The 3D configuration of the genome plays a crucial role in gene regulation. By mapping this architecture and identifying abnormal configurations, EpiSwitch® can be used to diagnose patients or determine how individuals might respond to a disease or treatment.

Built on over 10 years of research, EpiSwitch® is Oxford Biodynamics' award-winning, proprietary platform that enables screening, evaluation, validation and monitoring of 3D genomic biomarkers. The technology is fully developed, based on testing of over 15,000 samples in 30 disease areas, and reduced to practice.

In addition to stratifying patients with respect to anticipated clinical outcomes, EpiSwitch® data offer insights into systems biology and the physiological manifestation of disease that are beyond the scope of other molecular modalities. The technology has performed well in academic medical research settings and has been validated through its integration in biomarker discovery and clinical development with big pharma.