UK Vaccines Taskforce has Selected Oxford Immunotec as the Sole Supplier of T cell Testing for SARS-CoV-2 Specific Responses in New COVID Vaccine Trials
OXFORD, United Kingdom and MARLBOROUGH, Mass., Oct. 22, 2020 (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq: OXFD) (the “Company”), a global, high-growth diagnostics company, today announced that it has been selected to provide T cell testing to the UK Vaccines Taskforce, a body formed by the UK Government to assess the suitability of vaccines for use in the UK population. Oxford Immunotec was chosen in this competitive process for its expertise in T cell measurement and its unique ability to provide T-SPOT® technology, the only globally regulated ELISPOT platform, currently used clinically for identifying T cells made in response to another respiratory pathogen responsible for Tuberculosis. The award includes the measurement of the magnitude of the SARS-CoV-2 protein-specific T cell response using the company’s new T-SPOT® Discovery SARS-CoV-2 assay and is recognition of the company’s ability to deliver clinical grade, consistent and reproducible diagnostic products.
T cells are becoming increasingly recognised for their role in SARS-CoV-2 infection and immunity; measuring the presence and size of any T cell response can give adjunctive information to that available by serology. Consequently, the UK Vaccines Taskforce is including T cell analysis in COVID vaccine trials.
Kate Bingham, Chair of the UK Government’s Vaccines Taskforce said; "The UK Vaccines Taskforce is delighted to be partnering Oxford Immunotec, an experienced team who are responsible for running the Vaccines Taskforce T cell tests to assess the immunogenicity of COVID-19 vaccines. It is important to be able to assess the different vaccines head-to-head and the T cell response is part of our portfolio of accredited assays that we are employing for cross comparisons."
Oxford Immunotec’s T-SPOT technology platform enables the easy centralisation of fresh blood samples from different study locations, and highly standardised measurement of the T cell response. These attributes are essential in later stage large-scale vaccine trials, and will facilitate longitudinal studies and comparisons between trials.
The UK Business Secretary Alok Sharma said; “T cell testing is crucial in our fight against coronavirus, helping us to assess the effectiveness of vaccine candidates undergoing trials by improving our understanding of people’s immune responses. Today we are partnering with Oxford Immunotec and providing up to £3 million investment so that they can provide this critical testing required for vaccine trials, supporting the development and regulatory approval of the most promising candidates.”
Peter Wrighton-Smith, CEO of Oxford Immunotec, said; “We are thrilled that our expertise and proven track record in delivering T cell measurement tools have been recognised by the UK Vaccines Taskforce.” Peter went on to say, “We are excited to assist the UK government’s vaccination effort and to assist in continued discovery of the role that T cells play in the response and immunity to SARS-CoV-2.”
T-SPOT Discovery SARS-CoV-2 is for research use only, not for use in diagnostic procedures
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Oxford 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-2
Oxford 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 UK Vaccines Task Force
The UK Vaccines Task Force has been commissioned to ensure the swift and safe implementation of a COVID vaccination in the UK. It is led by the UK’s Chief Scientific Adviser Sir Patrick Vallance and Deputy Chief Medical Officer Professor Jonathan van Tam. Chaired by Kate Bingham, it brings together the efforts of both large Pharma and academia under one umbrella. Not only does the UK Vaccines Taskforce drive vaccine development, but it will also review regulations and facilitate the rapid scale up of manufacturing, so that when a vaccine becomes available, it can be produced quickly and safely, in mass quantities, to ensure the protection of the UK population and smooth the pathway to the full reopening of the UK economy. A number of large pharmaceutical companies are working with the UK vaccine task force to achieve these goals including, Astra Zeneca, BioNTech, Pfizer, GlaxoSmithKline and Sanofi Pasteur, as well as academic institutions such as Oxford University and Imperial College London.
T-SPOT, the Oxford Immunotec logo, T-Cell Xtend, T-Cell Select and T-SPOT Discovery are trademarks of Oxford Immunotec Limited.
Certain 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 that measuring T cells may be particularly important in several aspects of vaccine research, including before vaccination, during vaccine trials and clinical trial follow-up; the belief that the T cell response plays an important role in control of the virus independently to antibodies; the belief that T cell response might be more long lived than the antibody response; the belief that T cell response may help our understanding of the presence of immunity during clinical trial recruitment; the belief that T cell testing may help our understanding of the efficacy of new vaccines; and beliefs about the Company's expertise and positioning to benefit the UK Vaccines Task Force 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 measuring T cells in any aspect of vaccine research may be not be as important as expected, T cell response might not play as important of a role as expected in control of the virus independently to antibodies, T cell response might not be as long lived as expected, T cell response may not help understanding of the presence of immunity during clinical trial recruitment, T cell testing may not help our understanding of the efficacy of new vaccines, the ability to execute on the development of T cell testing for SARS-CoV-2 infection and the parties' ability to deliver on the expected benefits of the partnership and UK Vaccines Task Force, 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 and June 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.
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