Oxford Biodyn Regulatory News (OBD)

Oxford BioDynamics Plc

Oxford Biodynamics launches the 94% accurate EpiSwitch® Prostate Screeningblood test (PSE) for men with prostate cancer risk in the US and UK

· Validation completed in OBD's US CLIA-certified clinical laboratory ahead of time - enabling immediate launch of the EpiSwitch Prostate Screening (PSE) test

· PSE is designed to run alongside a standard PSA test

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

· Increased accuracy of diagnosis significantly reduces false positives, thus decreasing unnecessary referrals for invasive biopsies

Oxford, UK - 26 September, 2023 - Oxford BioDynamics, Plc (AIM: OBD, the Company), a biotechnology company developing precision medicine tests based on the EpiSwitch® 3D genomics platform, announces that validation of its EpiSwitch Prostate Screening (PSE) test in its US clinical (CLIA-certified) laboratory is now complete, ahead of schedule.

Coinciding with Prostate Cancer Awareness month, OBD has brought forward the launch of its highly accurate, 94% precision medicine test to make it immediately available to men being screened for prostate cancer. This includes those who have received an elevated prostate-specific antigen (PSA) result as well as many others where prostate cancer is a clinical concern.

EpiSwitch Prostate Screening test (PSE)

The current blood screening test, the PSA test, is only 55% accurate, and is considered an unreliable test by many doctors, including the NHS in the UK1. If results show an elevated PSA level, then patients face a dilemma - retest with PSA even with its low accuracy, or go for more invasive screening methods such as a prostate biopsy which has the potential for other health risks.1 Now there is an alternative.

The PSE test is the culmination of nearly a decade's long collaboration between OBD, Imperial College London, University of East Anglia, Imperial College NHS Trust and UK's leading prostate cancer experts as part of the PROSTAGRAM screening pilot. The results of this trial were published in the peer reviewed publication, Cancers2 in February this year.

The PSE test is designed to run alongside a standard PSA test, and combines the PSA score with five proprietary epigenetic biomarkers to predict, with 94% accuracy, the presence (or absence) of prostate cancer.2 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.

As well as very high accuracy, PSE has high specificity of 97% (PSA: 53%) and sensitivity of 86% (PSA: 64%), along with both high positive, 93% (PSA: 25%), and high negative, 95% (PSA: 86%), predictive values to assess the risk of prostate cancer in men.2 It has been validated as a laboratory developed test (LDT) in OBD's CLIA-certified testing laboratory in Frederick, Maryland.

More information is available at: www.94percent.com.

"PSE is a diagnostic prostate cancer test with unprecedented accuracy." said Mathias Winkler, M.D., F.R.C.S., Consultant Urologist and Surgeon, Charing Cross Hospital and Imperial College London. "Nine of 10 cancers are found compared to 3 of 10 with PSA alone. Likewise, false-positive results are reduced avoiding unnecessary anxiety and expense. This is clearly highly desirable for men who are health-conscious or at risk of prostate cancer. We are delighted to be part of the team evaluating and refining the test for use in particular risk groups (black men) and prospectively validating in a larger patient cohort compared to current standard of care."

The Company is continuing to work alongside the Norwich Medical School, University of East Anglia, and Imperial College NHS Healthcare Trust, with support from Prostate Cancer Research, to actively investigate the elevated prevalence of prostate cancer in the black population (link here).

The PSE test is being launched during Prostate Cancer Awareness month to introduce both physicians and patients to the benefits of this highly accurate blood test. Before today, following an elevated PSA result, men and their primary care physicians faced the cancer screening dilemma; retest PSA even with its low accuracy, schedule an MRI or send the patient, maybe needlessly, for an invasive biopsy.3 This is where the 94% accurate PSE can resolve the conundrum. Because PSA is just one component of the PSE test, PSE works with all PSA values from low to high as not all high PSA values will return a high likelihood result just as some low PSA values will.

"Although the traditional PSA has demonstrated clinical utility in prostate cancer screening and monitoring, it also has limitations that are well-described," said Dr. Phillip Pierorazio, Section Chief of Urology at Penn Presbyterian Medical Center, and Professor of Surgery at the Hospital of University of Pennsylvania. "A more sensitive and specific test would have the potential to increase diagnostic accuracy and address some of the current challenges with prostate cancer screening."

Patients should speak to their doctor about ordering the PSE test. 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.

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

UK immediate access

The PSE test will be immediately available to men in the UK using the US testing facility to process results initially. OBD is in the process of obtaining ISO15189 certification for a clinical lab within its Oxford, UK laboratory. Once certified, expected early in 2024, precision medicine tests, like EpiSwitch PSE, will be run there - shortening the overall turnaround time for results.

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

"There is a clear need in everyday clinical practice for a much more accurate blood test that can screen men for prostate cancer and accurately identify those at risk, while sparing those who up to now would be subject to unnecessary, expensive, and invasive procedures. It feels wholly appropriate that the early launch of the test coincides with Prostate Cancer Awareness month," said Dr Jon Burrows, OBD's Chief Executive Officer. "With the news today of the launch of another EpiSwitch-based product, we are continuing to improve patient health whilst also reducing the cost of care." 

Proof Sources

1. NHS Health A to Z. Prostate cancer: PSA testing (2021). https://www.nhs.uk/conditions/prostate-cancer/psa-testing

2. "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.

3. "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.

-Ends-

For more information:

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 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.