- EpiSwitch Prostate Screening (PSE) is designed to run alongside
a standard PSA test
- PSE boosts PSA predictive accuracy from 55% to 94%1 for
determining the presence or absence of prostate cancer
- PSE is immediately available to men in the US using a
centralized high-complexity CLIA-certified lab facility in
Frederick, Maryland,
- Increased accuracy of diagnosis should significantly reduce
false positives and in turn unnecessary referrals for more invasive
procedures with longer term health risks
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.
[9]
https://prioritymensmedical.com/blog/can-a-prostate-biopsy-lead-to-erectile%20dysfunction/#:~:text=Four%20weeks%20after%20the%20biopsy,maintained%20a%20healthy%20erectile%20function.
[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.
-Ends-
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.
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For more information: Oxford BioDynamics Plc Jon
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728 0227 Melanie Toyne-Sewell / Gina Tilly / Jack Kincade (UK &
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