Data Showing SARS-CoV-2 Reactive T Cells are Associated with Protection from COVID-19 and Can Be Both Detected and Measured Using Oxford Immunotecs T-SPOT® Technology is Published by Public Health England and Oxford Immunotec
OXFORD, United Kingdom and MARLBOROUGH, Mass., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq: OXFD) (the “Company”), a global, high-growth diagnostics company, today announced the release of data from a prospective cohort study in keyworkers in the UK – a collaboration between the Company and Public Health England (PHE). The data demonstrates that SARS-CoV-2 reactive T cells may be sufficient to give protection from COVID-19 and that serology alone may underestimate those at lower risk of clinical SARS-CoV-2 infection. The paper published on MedRxiv ‘SARS-CoV-2 responsive T cell numbers are associated with protection from COVID-19: A prospective cohort study in keyworkers’, presents data generated as part of the EDSAB-HOME study which investigated both antibody (serology) and T cell responses in a cohort of police, fire and healthcare workers.In the study, T cell tests were conducted at enrolment in almost 3,000 participants using the Company’s standardised research use only T-SPOT® Discovery SARS-CoV-2 assay. These individuals were then followed up for subsequent development of symptomatic, PCR confirmed SARS-CoV-2 infection. None of the participants with a high T cell response developed symptomatic SARS-CoV-2 infection in the follow-up period, whereas amongst those with low T cell responses there were 20 confirmed infections. Further follow-up is planned allowing for updated analyses as case numbers rise which may help yield additional insights into disease risk.These, and additional results from the data, suggest that: * Serology alone may underestimate the working age population at lower risk of clinical SARS-CoV-2 infection * Individual level risk stratification may be possible using T cell assays * Numbers of individuals with high levels of SARS-CoV-2 responsive T cells declines with increasing age, specifically in the absence of antibodies (serology), and this may explain higher illness incidence and severity in this group * The T-SPOT Discovery SARS-CoV-2 test detected PCR confirmed SARS-CoV-2 infections that were not positive in antibody (serology) testing.Dr. David Wyllie, Consultant Microbiologist at Public Health England and the lead author of the study, said, “We conducted a prospective cohort study in almost three thousand volunteers working in hospitals, and in the fire and police services in England. Four months into the study, 20 participants with lower T cell responses had developed COVID-19, compared with none among individuals with higher T cell responses. This suggests individuals with higher numbers of T-cells recognising SARS-CoV-2 may have some level of protection from COVID-19, although more research is required to confirm this.”Oxford Immunotec CEO, Dr Peter Wrighton-Smith said, “Our T-SPOT technology platform is the only globally regulated ELISPOT platform currently available and we are pleased that we may be able to use it to support efforts to combat COVID-19. Our collaboration with Public Health England is a great example of the public and private sector working together. The successful outcomes of this study would not have been possible without the specialist skills and resource available within Public Health England.”T-SPOT Discovery SARS-CoV-2 is for research use only, not for use in diagnostic proceduresNot all products are available in all regions, please contact us for information on availability in any specific countryFor further information visit: https://www.tspotdiscovery.com To view the publication visit: https://www.medrxiv.org/content/10.1101/2020.11.02.20222778v1About Oxford ImmunotecOxford Immunotec Global PLC is a global, high-growth diagnostics company. We bring energy and invention to a world in need of diagnostic truth. We are uniquely placed as the only company in the world offering regulated ELISPOT assays for T cell measurement, with approval around the globe. Our leading product, the T-SPOT®.TB test, is used for diagnosing infection with Tuberculosis, the world’s largest cause of death from infectious disease. The Company is an experienced manufacturer of IVD tests, operating under a fully audited Quality Management System, ensuring rigorous batch control. The company has manufactured in excess of 20 million clinical T cell tests for TB infection. The T-SPOT.TB test has been approved for sale in over 50 countries, including the United States, where it has received pre-market approval from the Food and Drug Administration, Europe, where it has obtained a CE mark, as well as Japan and China. The Company is headquartered near Oxford, U.K. and in Marlborough, MA. Additional information can be found at www.oxfordimmunotec.com.About T-SPOT Discovery SARS-CoV-2Oxford Immunotec has been developing and strengthening its expertise in T cell measurement for over 15 years since the introduction of its T-SPOT technology in the field of TB diagnostics. In that time, we have taken the classic ELISPOT technique and developed it into the world leading proprietary T-SPOT technology platform we now use to measure T cell immune responses, improving performance, standardising results, and streamlining the workflow. This high performance is ensured by our regularly audited manufacturing facility operating to our rigorous quality management system. The T-SPOT.TB test, an in vitro diagnostic (IVD) test using the T-SPOT technology platform, has been granted regulatory approval for clinical diagnostic use in over 50 countries, including US, EU, Japan and China. The research use-only T-SPOT Discovery SARS-CoV-2 assay uses this same T-SPOT technology to allow SARS-CoV-2-specific T cells to be detected and enumerated. The optimized antigen mix used in the test is based on SARS-CoV-2 structural proteins and allows the maximum breadth of the immune response to be measured. The Company’s single antigen-per-well approach allows specific information about the immune response to different SARS-CoV-2 antigens to be gathered in parallel. Sample processing can be centralised whilst still enabling testing on fresh (rather than frozen) blood, using the Company’s T-Cell Xtend® reagent (32 hr room temperature (RT) sample stability) or T-Cell Select™ reagent (54 hr RT sample stability - automated processing). The T-Cell Select reagent kit also allows for automation and therefore accommodates variations in scale - automation solutions are available for low, medium and high throughput settings.About the EDSAB-HOME trialThe EDSAB-HOME trial is designed to address uncertainties around delivery of community-based mass antibody testing for previous SARS-CoV-2 infection, to allow rapid program development. The trial will evaluate the “first purchase” home test kits (HTKs) which the national program will be using, while providing a route to rapid validation & verification of alternatives which may be available later in 2020, including validation of industry enzyme immunoassay kits. The aim of the mass testing program will be to provide information to individuals as to whether they have been previously exposed to the virus. The first phase of the program has recruited over 3000 individuals from high risk (healthcare workers) and lower risk groups.T-SPOT, the Oxford Immunotec logo, T-Cell Xtend, T-Cell Select and T-SPOT Discovery are trademarks of Oxford Immunotec Limited.Forward-Looking StatementsCertain statements in this press release constitute forward-looking statements within the meaning of applicable U.S. and U.K. laws and regulations, including under the U.S. Private Securities Litigation Reform Act of 1995. Any statements contained herein which do not describe historical or current facts, including beliefs the Company’s research collaboration with PHE and the EDSAB-HOME trial and data results, including the success of the trial and beliefs about the data and related analyses; the belief that measuring T cells, in conjunction with other tests, may overcome limitations with the measurement of antibody-mediated immunity as well as other expected benefits of the T-SPOT Discovery SARS-CoV-2 test kit, including that the T cell assay may support efforts to combat COVID-19 and beliefs that the EDSAB-HOME trial will yield important information constitute forward-looking statements. Any forward-looking statements are based on our management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include the possibility that the collaboration with PHE and the EDSAB-Home trial will not yield the expected benefits in a timely manner or at all, or that the results of the initial data analyses will not contribute to the study or assisting in COVID-19 efforts as expected; the Company’s Discovery line of testing might not be a successful or timely tool in combatting COVID-19, the risk that further research data from the Discovery test kit will not produce results that support its clinical use, the likelihood that the Company will be able to partner with a third party to make a testing device clinically available and the possibility that, even if ultimately made commercially available, the testing kit will not be efficacious in testing for or combatting COVID-19, as well as those other risks and uncertainties described in Oxford Immunotec’s filings with the U.S. Securities and Exchange Commission (the “Commission”), including the Company’s Annual Report on Form 10-K for the year-ended December 31, 2019 and its Quarterly Report on Form 10-Q for the quarters ended March 31, 2020, June 30, 2020, and September 30, 2020 and in any other reports it files with the Commission, including any other Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. Oxford Immunotec’s filings with the Commission are available for free by visiting the investor section of our website, www.oxfordimmunotec.com, or the Commission’s website, www.sec.gov.Investors should give careful consideration to these risks and uncertainties. Forward-looking statements contained herein are based on current expectations and assumptions and currently available data and are neither predictions nor guarantees of future events or performance. Investors should not place undue reliance on forward-looking statements contained herein, which speak only as of the date of this release. Oxford Immunotec does not undertake to update or revise any forward-looking statements after they are made, whether as a result of new information, future events, or otherwise, except as required by applicable law.For Investor Inquiries: Matt McLaughlin Chief Financial Officer Oxford Immunotec Tel: +1 (508) 573-9953 mtmclaughlin@oxfordimmunotec.comFor Media Enquiries Peter Wrighton-Smith Chief Executive Officer Oxford Immunotec +44 1235 442796 info@oxfordimmunotec.com
GlobeNewswire · 11/10 14:00