OXFORD, England--(BUSINESS WIRE)--Oxford BioDynamics, Plc (AIM: OBD, the Company), a biotechnology company developing precision medicine tests based on the EpiSwitch® 3D genomics platform, today announced validation of its EpiSwitch Prostate Screening (PSE) blood test in its US clinical laboratory, resulting in the immediate access to its highly accurate PSE test to men with prostate cancer risk.
The PSE test is run alongside a standard PSA test to predict the presence or absence of prostate cancer with 94% accuracy.1 It is now available immediately in the US as part of a program to men being screened for prostate cancer, either with an elevated PSA result or where prostate cancer must be ruled out. The announcement coincides with Prostate Cancer Awareness Month (September).
“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.”
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.1
The PSE test has been validated as a laboratory developed test (LDT) in OBD’s CLIA-certified testing laboratory in Frederick, Maryland. The test is completed via a simple ordering system by a patient’s doctor with results available in five days after a blood sample is received.
Physicians and their patients can find out more information and order the PSE test at www.94percent.com.
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 UK2. Consequently, following an elevated PSA result, men and their doctors face the cancer screening dilemma; retest PSA even with its low accuracy, send the patient maybe needlessly for a more invasive biopsy (88% accurate) or do a MRI scan (49% accurate).3
In the US, nearly 1,000,000 patients undergo a prostate biopsy every year and only about a quarter of those who have a prostate biopsy due to an elevated PSA level are found to have prostate cancer.4,5 Biopsies can put patients at risk of erectile dysfunction, lower urinary tract infections, rectal bleeding, extended hospitalization and the rare occurrence of death due to procedural complications or post procedural infections.6-12
In contrast, the PSE test combines the PSA score with five epigenetic biomarkers to predict the presence or absence of prostate cancer. 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 treatment.
“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."
In the US, 1 in 7 men will get prostate cancer in their lifetime and every 15 minutes a life is lost due to the disease.13
How to order/get more info:
More information can be found at www.94percent.com.
Physicians and other healthcare providers should contact Oxford BioDynamics client services by emailing the team at Episwitch.PSE@myobdx.com.
References
[1] Pchejetski, D., et al. (2023). Circulating Chromosome Conformation Signatures Significantly Enhance PSA Positive Predicting Value and Overall Accuracy for Prostate Cancer Detection. Cancers, 15(3), 821. http://dx.doi.org/10.3390/cancers15030821
[2]NHS Health A to Z. Prostate cancer: PSA testing (2021). https://www.nhs.uk/conditions/prostate-cancer/psa-testing
[3] Hashim, U. A. et al (2017). Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. The Lancet. 389 (10071). https://doi.org/10.1016/S0140-6736(16)32401-1
[4] Vickers, A. et al (2010). Reducing Unnecessary Biopsy During Prostate Cancer Screening Using a Four-Kallikrein Panel: An Independent Replication, Journal of Clinical Oncology [online], 28:15. Available from: National Library of Medicine [accessed 21 September 2023]
[5] Bhanji Y, Allaway MJ, Gorin MA. Recent advances and current role of transperineal prostate biopsy. Urol Clin North Am 2021; 48: 25–33.
[6] Pinsky PF, Parnes HL, Andriole G. Mortality and complications after prostate biopsy in the Prostate, Lung, Colorectal and Ovarian Cancer Screening (PLCO) trial. BJU Int. 2014 Feb;113(2):254-9. doi: 10.1111/bju.12368. Epub 2013 Nov 21. PMID: 24053621; PMCID: PMC3873374.
[7] Rosario DJ, Lane JA, Metcalfe C, Donovan JL, Doble A, Goodwin L, Davis M, Catto JW, Avery K, Neal DE, Hamdy FC. Short term outcomes of prostate biopsy in men tested for cancer by prostate specific antigen: prospective evaluation within ProtecT study. BMJ. 2012 Jan 9;344:d7894. doi: 10.1136/bmj.d7894. PMID: 22232535; PMCID: PMC3253765.
[8] Loeb S, Carter HB, Berndt SI, Ricker W, Schaeffer EM. Complications after prostate biopsy: data from SEER-Medicare. J Urol. 2011 Nov;186(5):1830-4. doi: 10.1016/j.juro.2011.06.057. Epub 2011 Sep 23. PMID: 21944136; PMCID: PMC9840843.
[10] Quinlan MR, Bolton D, Casey RG. The management of rectal bleeding following transrectal prostate biopsy: A review of the current literature. Can Urol Assoc J. 2018 Mar;12(3):E146-E153. doi: 10.5489/cuaj.4660. Epub 2017 Dec 22. PMID: 29283091; PMCID: PMC5869041.
[11] https://www.health.harvard.edu/mens-health/prostate-biopsy-side-effects-are-common
[12] Fainberg J, Gaffney CD, Pierce H, Aboukhshaba A, Chughtai B, Christos P, Kashanian JA. Erectile Dysfunction is a Transient Complication of Prostate Biopsy: A Systematic Review and Meta-Analysis. J Urol. 2021 Mar;205(3):664-670. doi: 10.1097/JU.0000000000001398. Epub 2020 Oct 7. PMID: 33026920.
[13] American Cancer Society. Facts & Figures 2023. American Cancer Society. Atlanta, Ga. 2023.
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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.
