Oxford Biodyn Regulatory News (OBD)

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

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

· CPT PLA Code 0332U issued to Oxford BioDynamics Plc and NEXT Bio-Research Services LLC.

· New code available for use from 1 October 2022 for insurance reimbursement (Medicare, Medicaid or private payors)

· A unique reimbursement code will engender physician confidence and aid the billing process

Oxford, UK - 5 July 2022 - Oxford BioDynamics Plc (AIM: OBD, the Company), a biotechnology company developing precision medicine tests for immune health based on the EpiSwitch 3D genomics platform, confirms the assignment and publication of a Proprietary Laboratory Code (PLA Code) by the American Medical Association's CPT (Current Procedural Terminology) Editorial Board (https://www.ama-assn.org/practice-management/cpt/cpt-pla-codes). 

The code, 0332U, was issued for the EpiSwitch® CiRT (Checkpoint-inhibitor Response Test) to Oxford BioDynamics Plc and its partner lab NEXT Bio-Research Service LLC. With the publication of the code on 1 July, payors are on notice that the new code will be available for use on and after 1 October 2022 for the billing of the test.

"Assignment of this unique code is a critical step in the reimbursement process," said Thomas Guiel, OBD's Chief Operating Officer. "This code will be effective on 1 October for all requests for insurance reimbursement, whether from Medicare, Medicaid or private payors."

The Checkpoint inhibitor Response Test (CiRT) was launched at the end of February 2022 as a Laboratory Developed Test (LDT). By launching the test as an LDT, the Company was able to provide immediate access to early adopters and generate clinical utilization for the test. During this early phase, a miscellaneous code has been used for reimbursement, which requires increased communication with and explanation to payors. 

The newly-published CPT PLA code is unique to OBD as manufacturer, the Company's test and the lab. The full unique description the editorial board assigned to the EpiSwitch® CiRT (Checkpoint-inhibitor Response Test) 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".

Jon Burrows, OBD's Chief Executive Officer said: "Gaining a unique CPT code and descriptor for EpiSwitch® CiRT in the US only four months after its launch is yet another validation of the importance of this predictive test, the underlying EpiSwitch® technology and the value it brings to the healthcare system and oncologists."

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.