Oxford Biodyn Regulatory News (OBD)

Oxford BioDynamics Plc

US reimbursement code for Checkpoint Inhibitor Response Test(EpiSwitch® CiRT) now available

· EpiSwitch CiRT is a first-of-its-kind precision medicine blood test that predicts a patient's most likely response to Immune Checkpoint Inhibitor (ICI) therapy

· CPT PLA Code 0332U now available for insurance reimbursement under Medicare, Medicaid and private payors

Oxford, UK - 3 October, 2022 - Oxford BioDynamics Plc (AIM: OBD, the Company), a biotechnology company developing precision medicine blood tests for immune health based on the EpiSwitch 3D genomics platform, confirms the availability of its Proprietary Laboratory Code (PLA Code) 0332U, assigned by the American Medical Association's CPT Editorial Board, from 1 October, 2022.

The code was issued for the EpiSwitch® CiRT to Oxford BioDynamics and its partner lab NEXT Bio-Research Service in July, and as expected, is now available for the billing of the test under Medicare, Medicaid and private payors.

"The availability of our unique reimbursement code is another milestone for us as well as the patients and their doctors," said Thomas Guiel, OBD's Chief Operating Officer. "We are continuing our efforts to create a wider use of our predictive test within the healthcare system, and so facilitate a better understanding of the application of checkpoint inhibitors. Current testing modalities lack the sensitivity, specificity and accuracy to identify those most likely to benefit from this class of therapy - the CiRT blood test is a first of its kind test that addresses all of these short-comings."

The full unique description for EpiSwitch® CiRT is "Oncology (pan-tumor), genetic profiling of 8 DNA-regulatory (epigenetic) markers by quantitative polymerase chain reaction (qPCR), whole blood, reported as a high or low probability of responding to immune checkpoint-inhibitor therapy".

The predictive test was launched in the US in February 2022, initially as a Laboratory Developed Test (LDT) to enable immediate access to early adopters and generate clinical utilization for the test, with a miscellaneous code used until now.

For more about EpiSwitch CiRT, please visit www.myCiRT.com

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Notes for 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 product is EpiSwitch® CiRT (Checkpoint Inhibitor Response Test) for cancer, a predictive immune response profile for immuno-oncology (IO) checkpoint inhibitor treatments, launched in February 2022.

In March 2021, the Company launched its 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.

The Company has developed a proprietary 3D genomic biomarker platform, EpiSwitch®, which can build molecular diagnostic classifiers for 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 10,000 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, MD, USA and a reference laboratory in Penang, Malaysia.

For more information, please visit the Company's website, www.oxfordbiodynamics.com, or follow on Twitter or 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 10,000 samples in 30 disease areas, and reduced to practice.

In addition to stratifying patients with respect to anticipated clinical outcome, 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.