Oxford Immunotec Joins Forces with Public Health England (PHE) in a Large Clinical Trial Utilizing T-SPOT® Discovery™ SARS-CoV-2 Test
Oxford Immunotec Joins Forces with Public Health England (PHE) in a Large Clinical Trial Utilizing T-SPOT® Discovery™ SARS-CoV-2 Test
OXFORD, United Kingdom and MARLBOROUGH, Mass., September 22, 2020 (GLOBE NEWSWIRE) – Oxford Immunotec Global PLC (Nasdaq: OXFD) (the “Company”), a global, high-growth diagnostics company, today announced that it has entered into an extensive research collaboration with Public Health England (PHE), an executive agency of the UK’s Department for Health and Social Care (DHSC). As part of this, PHE has launched the ‘Evaluating Detection of SARS-CoV-2 antibodies using home test kits’ study (EDSAB-HOME), a cohort study of high risk (healthcare workers) and lower risk populations to provide rapid validation of SARS-CoV-2 (“COVID-19”) testing kits. With this collaboration, the Company will be contributing its T-SPOT Discovery SARS-CoV-2 testing kits for use in the trial.
The T-SPOT Discovery SARS-CoV-2 test is unique within the trial as it is the only test that uses the T cell response rather than antibody-mediated immunity to investigate previous exposure to the virus.
Limitations have been reported with the measurement of antibody-mediated immunity, including that: 1) Antibodies may not be present after infection1, 2) Where antibodies are present they may not persist over time2, and 3) There is currently no direct evidence that people who do have detectable antibodies are protected from a second infection3. Measuring T cells in conjunction with other tests may overcome some of these issues.
The T-SPOT Discovery SARS-CoV-2 test will be used to generate data to help understand:
- How widely T cells are produced in confirmed infected patients
- Whether T cells are able to be detected in infected patients who are serology negative
- The strength of the T cell response against SARS-CoV-2 both with and without a concomitant antibody response
- The breadth of, and potentially the longevity of, the T cell response to SARS-CoV-2
Peter Wrighton-Smith, CEO of Oxford Immunotec said “We are very pleased to be partnering with PHE, and to be contributing to the UK’s efforts to find the best testing protocols to fight COVID-19. We have been able to employ our expertise in immunology and particularly the T cell response to add value to these efforts. We believe a successful EDSAB-HOME trial will yield important information about our test, to further our knowledge of how it works and help us to develop the test further.”
T-SPOT Discovery SARS-CoV-2 is for research use only, not for use in diagnostic procedures
Not all products are available in all regions, please contact us for information on availability in any specific country
For further information visit: http://go.oxfordimmunotec.com/t-spot_discovery_SARS_CoV-2
About Oxford Immunotec
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 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, with sequences of high homology to other coronaviruses removed. This allows the maximum breadth of the immune response to be measured, while minimizing cross reactivity. Oxford Immunotec’s single antigen-per-well approach also allows specific information about the immune response to different SARS-CoV-2 antigens to be gathered in parallel.
T-SPOT technology can be automated using the T-Cell Select™ reagent kit to accommodate variations in scale – automation solutions are available for low, medium and high throughput settings. The T-Cell Select reagent kit also enables sample stability of 54 hours to be achieved, significantly simplifying sample logistics.
About the EDSAB-HOME trial
The 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 Select and T-SPOT Discovery are trademarks of Oxford Immunotec Limited.
Forward-Looking Statements
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 the Company’s research collaboration with PHE and the EDSAB-HOME trial, including the benefits and timing of such efforts and the goals of the mass testing program; 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 the identification of an appropriate adaptive immune response to a vaccine in a trial or be able to confirm the previously uninfected status of vaccine trial participants and help with selection bias; expectations for the data generated from the T-SPOT Discovery SARS-CoV-2 test, including regarding the production, detection, strength, breadth and longevity of the T cell response 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 T-SPOT Discovery SARS-CoV-2 test will not generate the data or otherwise contribute to the study as expected; the Company’s Discovery line of testing might not be a successful or timely tool in combatting COVID-19, the risk that 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 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.
CONTACTS:
For Media and Investor Inquiries:
Matt McLaughlin
Chief Financial Officer
Oxford Immunotec
Tel: +1 (508) 573-9953
mtmclaughlin@oxfordimmunotec.com
REFERENCES
1 Wu F, Wang A, Liu M, et al. Neutralizing antibody responses to SARS-CoV-2 in a COVID-19 recovered patient cohort and their implications. medRxiv 2020: 2020.03.30.20047365.
2 World Health Organisation, Scientific Briefs. “Immunity passports” in the context of COVID-19. https://www.who.int/news-room/commentaries/detail/immunity-passports-in-the-context-of-covid-19
3 Thieme CJ, Anft M, Paniskaki K et al The SARS-CoV-2 T-cell immunity is directed against the spike, membrane, and nucleocapsid protein and associated with COVID 19 severity
Immunity Pre-Print: medRxiv https://www.medrxiv.org/content/10.1101/2020.05.13.20100636v1.full.pdf
