Oxford Biodyn Regulatory News (OBD)

Oxford BioDynamics receives reimbursement code forEpiSwitch® Prostate Screening (PSE) Test

 

·   EpiSwitch PSE boosts the predictive accuracy of current standard PSA test from 55%, to 94% for determining the presence or absence of prostate cancer

·   CPT PLA Code 0433U has been issued to Oxford BioDynamics for insurance reimbursement under Medicare, Medicaid and private payors

·   The CPT PLA Application for PSE was filed on July 5 and granted by the American Medical Association (AMA) less than 3 months after filing

·   New code available for use from 1 January 2024 for insurance reimbursement (Medicare, Medicaid or private payors)

·   A unique reimbursement code aids the billing process and reinforces physician confidence

Oxford, UK - 3 October 2023 - Oxford BioDynamics Plc (AIM: OBD, the Company), a biotechnology company developing precision medicine tests based on the EpiSwitch 3D genomics platform, confirms the assignment and publication of a Proprietary Laboratory Analysis 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 unique code, 0433U, was issued to Oxford BioDynamics for the 94% accurate EpiSwitch® Prostate Screening (PSE) test. The code was published on 29 September and payors will be able to bill for the test using the code from 1 January 2024. A miscellaneous code for high complexity molecular testing will be used for reimbursement until the unique code goes live.

The new CPT code provides a standardized billing mechanism for the PSE Test across all US healthcare providers, ensuring accurate reimbursement. This development ensures patients have greater access to the test by simplifying the reimbursement process and eliminating administrative complexity.

The PSE Test was launched on September 26, ahead of schedule, and has been made immediately available to men in the US and UK being screened for prostate cancer. It was launched as a Laboratory Developed Test (LDT) to provide immediate access for men where prostate cancer is a clinical concern and to generate clinical utilization for the test.

Despite the AMA's commitment to issuing CPT codes in a timely manner it is often a difficult task for companies to navigate the process and it can take up to 2 years.

OBD's management believes that the speed of issuance of the CPT code demonstrates that the payor groups recognize how important PSE is for screening, not only for the patients, but also for the savings to the medical industry.

"A unique code is critical to the reimbursement process," said Thomas Guiel, OBD's Chief Operating Officer. "With the code issued at this early stage of the test introduction, we are in a good place to drive adoption of this highly accurate test. Effective on 1 January for all requests for insurance reimbursement, whether from Medicare, Medicaid or private payors, this unique code will enable discussions regarding coverage decisions as well as negotiating the reimbursement rate."

As with the Company's previous test, the checkpoint inhibitor response test (CiRT), launched in early 2022 for prediction of response to checkpoint inhibitor therapy in cancer, a miscellaneous code for high complexity molecular testing will be used for reimbursement in the fourth quarter of 2023. A CPT PLA code is unique to the test, the lab and the manufacturer. The full (long) description for PSE is "Oncology (prostate), five DNA regulatory markers by quantitative PCR, whole blood, algorithm, including Prostate-Specific Antigen, reported as likelihood of cancer".

For more about EpiSwitch PSE, please visit www.94percent.com.

 

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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 and UK in September 2023.

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, which is available for purchase by the life science research community.

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.