TIDMOBD
RNS Number : 1034T
Oxford BioDynamics PLC
23 March 2021
Oxford BioDynamics announces US launch of
its EpiSwitch(R) COVID-19 Severity Test (CST)
-- EpiSwitch(R) CST is a highly accurate prognostic test that
predicts personalized risk of severe illness due to SARS-CoV-2
virus
-- Precision medicine blood test with strong performance
metrics: Accuracy: 92%, Sensitivity: 96%, Specificity: 86%, PPV:
92%, NPV: 93%
-- Important tool to manage the uncertainty of daily life during
the pandemic by identifying high-risk individuals and for those
that cannot be vaccinated,
-- Easy-to-interpret EpiSwitch(R) CST Risk Score helps to assess
risk, to develop personal healthcare plans and guide patient
care
-- Next test to launch will be a predictive immune response
profile for immuno-oncology (IO) checkpoint inhibitor treatments in
2021
Oxford, UK - 23 March 2021 - Oxford BioDynamics Plc (AIM: OBD,
the Company), a biotechnology company developing precision medicine
tests for personalized healthcare based on the EpiSwitch (R) 3D
genomics platform, has launched its EpiSwitch(R) COVID-19 Severity
Test (CST), in line with the expanded strategy announced on 15
December 2020.
Requiring only a routine blood draw, this important prognostic
test is able to identify high-risk individuals who, if exposed to
the SARS-CoV-2 virus, are likely to experience the most severe
COVID-19 complications and will potentially require hospitalization
and intensive care unit (ICU) support. This test is also relevant
to manage care for those individuals who because they are
immunocompromised / immunosuppressed or for other medical reasons
cannot be vaccinated.
Standard available COVID-19 tests can only detect current or
previous infection. They cannot predict immune response.
EpiSwitch(R) CST is a prognostic test which uses specific 3D
genomic biomarkers to assess immune health and therefore can
predict the likely severity of an individual's COVID-19 response
ahead of infection.
People known to have a high risk of severe or critical disease
may be able to benefit from increased infection mitigation, early
aggressive medication, or early intervention in the event of
infection. The score provided by the EpiSwitch(R) CST will better
enable physicians and at-risk individuals to form effective
healthcare management plans, including making informed clinical
decisions, lifestyle choices and workplace strategies.
The EpiSwitch(R) CST is based on the findings of OBD's recently
published, genome-wide study of Covid-positive patients, which
identified key 3D genomic biomarkers that determine severity of
Covid response [1]. This precision medicine qPCR test was validated
using international cohorts of COVID-19 patients (n=116) from North
America, South America and the United Kingdom, with the full
spectrum of severities of response [2]. It was shown to be robust
for predicting critical (ICU) illness due to COVID-19, with high
accuracy (92%), sensitivity (96%), specificity (86%), PPV (92%) and
NPV (93%).
Dr Jon Burrows, CEO of Oxford BioDynamics, said:
"As COVID-19 continues to have a major impact on us all,
smarter, not just more, testing is required, to enable us to make
informed decisions and manage our lives and livelihoods. We are
delighted today to be launching our EpiSwitch(R) CST. I commend the
entire OBD team on its outstanding execution of the strategic plan
that was put forth in December 2020.
"Even with advanced national vaccination programs underway,
millions of people (10 million in the US alone [3]) remain exposed
to the risk of severe Covid disease because they are
immunocompromised / immunosuppressed or for other medical reasons
cannot be vaccinated. Understanding their individual risk will
enable them and their physicians to formulate a proactive
healthcare plan, and ensure they take appropriate infection
mitigation measures."
Further information about OBD's EpiSwitch(R) CST is available at
www.covidseveritytest.com.
OBD is also continuing work on other products and indications,
including rheumatoid arthritis, ALS, lymphoma and prostate cancer
[4-7]. OBD will launch its predictive immune response profile for
immuno-oncology (IO) checkpoint inhibitor treatments [8,9] in 2021.
This EpiSwitch(R) IO response test aims to help physicians stratify
complete and partial responders to targeted medicines, enabling
improved treatment options and outcomes.
-Ends-
FOR MORE INFORMATION:
Oxford BioDynamics Plc Tel: +44 (0)1865 518910
Jon Burrows, CEO
Paul Stockdale, CFO
Shore Capital - Nominated Adviser and Tel: +44 (0)20 7408 4090
Broker
Edward Mansfield / John More
Instinctif Partners Tel: +44 (0)20 7457 2020
Melanie Toyne-Sewell / Agnes Stephens OxfordBioDynamics@instinctif.com
/ Katie Duffell
/ Nathan Billis
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.
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 team in the US 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.
References:
1. Hunter, E., Koutsothanasi, C., Wilson, A., Santos, F. C.,
Salter, M., Powell, R., Dring, A., Brajer, P., Egan, B., Westra, J.
W., Ramadass, A. , Messer, W., Brunton, A., Lyski, Z.,
Vancheeswaran, R., Barlow, A., Pchejetski, D., Robbins, P. A.,
Mellor, J., & Akoulitchev, A. (2021). 3D genomic capture of
regulatory immuno-genetic profiles in COVID-19 patients for
prognosis of severe COVID disease outcome. BioRxiv,
2021.03.14.435295. https://doi.org/10.1101/2021.03.14.435295 (prognosis of severe COVID outcomes)
2. NIH Spectrum COVID-19 Treatment Guidelines: https://www.covid19treatmentguidelines.nih.gov/overview/clinical-spectrum/
3. Johns Hopkins University Bloomberg School of Public Health. COVID-19 outcomes for patients on immunosuppressive drugs on par with non-immunosuppressed patients, study finds.
ScienceDaily, 7 January 2021.
https://www.sciencedaily.com/releases/2021/01/210107135651.htm
4. Carini, C., Hunter, E. , Scottish Early Rheumatoid Arthritis
Inception cohort Investigators., Ramadass, A. S., Green, J.,
Akoulitchev, A., McInnes, I. B., & Goodyear, C.S. (2018).
Chromosome conformation signatures define predictive markers of
inadequate response to methotrexate in early rheumatoid arthritis.
J Trans. Med, 16(18). https://doi.org/10.1186/s12976-018-1387-19
(predictive for inadequate response to MTX in rheumatoid
arthritis)
5. Salter, M., Corfield, E., Ramadass, A., Grand, F., Green, J.,
Westra, J., Lim, C. R., Farrimond, L., Feneberg, E., Scaber, J.,
Thompson, A., Ossher, L., Turner, M., Talbot, K., Cudkowicz, M.,
Berry, J., Hunter, E., & Akoulitchev, A. (2018). Initial
Identification of a Blood-Based Chromosome Conformation Signature
for Aiding in the Diagnosis of Amyotrophic Lateral Sclerosis.
EBioMedicine, 33. https://doi.org/10.1016/j.ebiom.2018.06.015
(diagnosis of ALS)
6. Hunter, E. , McCord, R., Ramadass, A. S., Green, J., Westra,
J. W., Mundt, K., & Akoulitchev, A. (2020). Comparative
molecular cell-of-origin classification of diffuse large B-cell
lymphoma based on liquid and tissue biopsies. Translational
Medicine Communications, 5(1).
https://doi.org/10.1186/s41231-020-00054-1 (prognostic for B cell
lymphoma)
7. Alshaker, H., Mills, R., Hunter, E., Salter, M., Ramadass,
A., Skinner, B. M., Westra, W., Green, J., Akoulitchev, A.,
Winkler, M., & Pchejetski, D. (2021). Chromatin conformation
changes in peripheral blood can detect prostate cancer and stratify
disease risk groups. Journal of Translational Medicine, 19(1).
https://doi.org/10.1186/s12967-021-02710-y (prognostic for
high-risk prostate cancer)
8. Hunter, E., Potluri, S., Zhang, S. Dezfouli, M., Back, J.,
James, L., Jandor, N., Powell, R., Salter, M., Ramadass, A., Green,
J., Westra, W., Dong, H., Dronca, R., Markovic, S. N., Robbins, P.
B., Cai, T., Akoulitchev, A., & Shah, P. K. (2019). Development
and validation of baseline predictive biomarkers for response to
avelumab in second-line (2L) non-small cell lung cancer (NSCLC)
using EpiSwitch (TM) epigenetic profiling. SITC, J. Immunotherapy
Cancer 7(282) P142.
https://www.oxfordbiodynamics.com/wp-content/uploads/2020/06/SITC2019_P142_avelumab.pdf
(IO for Avelumab with Pfizer and EMD Serono)
9. Hunter, E., Potluri, S., Zhang, S. Dezfouli, M., Back, J.,
James, L., Jandor, N., Powell, R., Salter, M., Ramadass, A., Green,
J., Westra, W., Dong, H., Dronca, R., Markovic, S. N., Robbins, P.
B., Cai, T., Akoulitchev, A., & Shah, P. K. (2019). Development
and validation of baseline predictive biomarkers for response to
immuno-checkpoint treatments in the context of multi-line and
multi-therapy cohorts using EpiSwitch (TM) epigenetic profiling.
SITC, J. Immunotherapy Cancer 7(282) P143.
https://www.oxfordbiodynamics.com/wp-content/uploads/2020/06/SITC2019_P143_multitherapy.pdf
(IO for Avelumab with Pfizer and EMD Serono)
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