TIDMOBD
RNS Number : 5985N
Oxford BioDynamics PLC
26 September 2023
Oxford BioDynamics Plc
Oxford Biodynamics launches the 94% accurate EpiSwitch(R)
Prostate Screening
blood 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(R) 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 UK(1) . 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, Cancers(2) 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:
Oxford BioDynamics Plc Tel: +44 (0)1865 518910
Jon Burrows, CEO
Paul Stockdale, CFO
Shore Capital - Nominated Adviser Tel: +44 (0)20 7408 4090
Stephane Auton / Iain Sexton
Instinctif Partners - media UK Tel: +44 7890022814
Melanie Toyne-Sewell / Rozi Morris / /
Adam Loudon (UK & RoW media) +44 7580 993585
Tegwyn Collins /Mike Gaynes (US media) US Tel: +1 9178657226
/
+1 650 728 0227
OxfordBioDynamics@instinctif.com
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(R) CiRT (Checkpoint
Inhibitor Response Test) and EpiSwitch(R) 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(R) CST (Covid Severity Test) and the
first commercially available microarray kit for high-resolution 3D
genome profiling and biomarker discovery, EpiSwitch(R) 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(R), 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(R)
The 3D configuration of the genome plays a crucial role in gene
regulation. By mapping this architecture and identifying abnormal
configurations, EpiSwitch(R) 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(R) 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(R) 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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