TIDMOBD
RNS Number : 3939V
Oxford BioDynamics PLC
05 April 2023
Oxford BioDynamics Plc
Business update - plan to launch Prostate Screening EpiSwitch(R)
test by end of 2023; sales progress for flagship EpiSwitch(R)
CiRT
-- Acceleration of final development and launch of PSE clinical
test in both UK and US, for availability in Q4 2023
-- Flagship EpiSwitch CiRT (Checkpoint inhibitor Response Test)
continuing to gain traction in the US, posting record orders in
November and December 2022, and January and March 2023
-- Leased US lab space for own CLIA-certified LDT testing facility
-- Commenced certification of clinical testing facility within existing Oxford base
-- OBD will present both tests in a key note address at the
13(th) World Clinical Biomarker & Companion Diagnostics Europe
Summit
Oxford, UK - 5 April, 2023 - Oxford BioDynamics, Plc (AIM: OBD,
"OBD" or the "Company" and, together with its subsidiaries, the
"Group"), a biotechnology company developing precision medicine
tests based on the EpiSwitch(R) 3D genomics platform, announces
updates on its PSE and CiRT tests.
Prostate Screening EpiSwitch (PSE)
In order to meet demand and accelerate the delivery of the
Prostate Screening EpiSwitch (PSE) blood test as announced by the
Company on 6 February 2023, OBD has embarked on standing up
clinical testing facilities in both the UK and US.
The Group first discussed PSE in its final results on 24 January
2023. Following the publication of the results involving OBD's
technology in the multi-disciplinary NHS PROSTAGRAM study using
blood to detect prostate cancer on 6 February 2023, there has been
unprecedented levels of interest in and demand for access to the
PSE test.
Final product development work on PSE is proceeding well and
launch of the test in the US and the UK is now anticipated in the
last calendar quarter of 2023. To support the planned launch, the
Group has recently leased 7,800 sq ft of lab space in Frederick,
Maryland, USA and commenced build-out of a dedicated clinical
testing lab in its existing 24,000 sq ft facility in Oxford, UK.
The facility in Frederick contains already-configured lab and
office space into which the Group will transfer new and existing
staff and equipment. In due course, the lab will be accredited by
Maryland Dept of Health under the Clinical Laboratory Improvements
Act (CLIA). The new Oxford, UK lab facility will offer the PSE test
in an ISO15189 clinical laboratory.
EpiSwitch CiRT
OBD's EpiSwitch CiRT the first-of-its-kind blood test which
predicts an individual patient's therapeutic response to checkpoint
inhibitor immunotherapy, continues to gain traction in the US,
posting record monthly orders in March 2023. EpiSwitch CiRT was
launched in the US in February 2022 and made available to the UK in
June 2022. A unique CPT PLA reimbursement code for the test has
been available for use by US payors since October 2022, meaning
that the test can be paid for by health insurers.
The Group's sales and market access team has continued to
generate positive growth in orders from US physicians. Uptake of
the test is growing, through both new and repeat orders. It took 9
months from launch for the first 100 CiRT tests to be ordered; the
200-test milestone was achieved after just 4 more months with March
2023 setting another new record.
CiRT tests are processed by the Group's partner laboratory, Next
Molecular Analytics, with typical turn-around-times of 3-4 days.
Reimbursements from payors are being received at rates in the range
anticipated by the Group, with several payors now routinely
reimbursing in as little as 2-3 weeks from claim submission.
"It is encouraging to see OBD's EpiSwitch(R) CiRT being ordered
and utilized more and more as early-adopter oncologists understand
the power of knowing a patient's likely response to checkpoint
inhibitor therapy in the continuum of their care," said Dr Jon
Burrows, OBD's Chief Executive Officer. "The overwhelming response
to the success of our PSE test in the clinical research assay in
the PROSTAGRAM study has enforced the need for the Group to make
every effort to bring this test to market as soon as practically
possible."
References
[1] Feb RNS re:PSE
[2] 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
[3] Oxford BioDynamics Plc. (2022). EpiSwitch CiRT.
https://www.mycirt.com
[4] Hunter, E., et al. (2021). Development and validation of
blood-based predictive biomarkers for response to PD-(L)-1
checkpoint inhibitors: evidence of a universal systemic core of 3D
immunogenetic profiling across multiple oncological indications.
MedRxiv, 2021.12.21.21268094.
For further details please contact:
Oxford BioDynamics Plc
Jon Burrows, CEO
Paul Stockdale, CFO +44 (0)1865 518910
Shore Capital
Nominated Adviser and Broker
Stephane Auton
John More +44 (0)20 7408 4090
Instinctif Partners +44 (0)20 7457 2020
Melanie Toyne-Sewell/ Rozi Morris/ OxfordBioDynamics@instinctif.com
Adam Loudon
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 product is EpiSwitch(R) CiRT (Checkpoint Inhibitor
Response Test) for cancer, a predictive immune response profile for
immuno-oncology (IO) checkpoint inhibitor treatments, launched in
February 2022.
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 .
The Company has developed a proprietary 3D genomic biomarker
platform, EpiSwitch(R), which can build molecular diagnostic
classifiers for 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 10,000 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, MD, USA and a reference laboratory in Penang,
Malaysia.
For more information, please visit the Company's website,
www.oxfordbiodynamics.com , or follow on Twitter or 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 10,000 samples in 30 disease areas, and reduced to
practice.
In addition to stratifying patients with respect to anticipated
clinical outcome, 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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