Oxford Immunotec Submits Emergency Use Authorization Request to the FDA and CE Marks T-SPOT®.COVID, a Test for the Detection of a Cell Mediated (T cell) Immune Response to SARS-CoV-2 Infection

Oxford Immunotec Global PLC., a global, high-growth diagnostics company, announced that today it has released the T-SPOT.COVID test, a CE marked ELISPOT based test intended for qualitative detection of a cell mediated (T cell) immune response to SARS-CoV-2 in human whole blood. The company has filed an EUA request to the FDA for the test.

Serology does not give the full picture of the adaptive immune response to SARS-CoV-2 infection. Antibodies are not always produced in response to SARS-CoV-2 infection, or may be delayed1,2. Antibodies can also wane quickly after infection4 and reports show T cells may be more long lived than the antibody response3. In the absence of an antibody response, the T cell response may be protective from SARS-CoV-2 infection5.

In a clinical study using samples collected in the US, the T-SPOT.COVID test was proven to detect a SARS-CoV-2 cell mediated (T cell) immune response in PCR positive individuals, even with negative serology test results6. The T-SPOT.COVID test therefore complements results obtained by antibody serology to give a more comprehensive view of an individual's adaptive immune response to SARS-CoV-2 infection. The test could also be used, for example, alongside serology tests to support clinical assessment of individuals who present with suspected COVID-19 but are PCR negative.

In the study, the T-SPOT.COVID test had a positive agreement with PCR-results of 96.6% (84/87) in SARS-CoV-2 infected individuals <60 days after first PCR positive result. At >60 days (with the furthest time point after first positive PCR test result being >240 days) positive agreement remained high at 83.3% (40/48). The T-SPOT.COVID test detected substantially more people with previous positive PCR results than serology in the cohort, whose positivity rate was lower and declined faster over time.

In an endemic cohort of US individuals selected to be at a relative lower risk of SARS-CoV-2 infection (based on the absence of self-reported symptoms, negative serology results and no prior history of a positive PCR test result for SARS-CoV-2) the T-SPOT.COVID  test had a negative agreement of 98.0% (96/98)6. We cannot exclude the possibility that a proportion of this group had, or still have, an asymptomatic infection, seronegative at the time of testing, but in whom the T-SPOT.COVID test was able to detect a T cell response.

Phill Keefe, Senior VP, Product Design, Development and Delivery at Oxford Immunotec said, "T cells and antibodies are two arms of the adaptive immune response. The detection and measurement of each can provide different insights about disease activity and an individual's personal immunity."

The Company developed the T-SPOT.COVID test as an evolution of its T-SPOT® Discovery SARS-CoV-2 assay, a research use only test used to gain insights about the immune response to SARS-CoV-2.

Dr. Peter Wrighton-Smith, CEO of Oxford Immunotec, said, "The T-SPOT® Technology platform is a standardised way of measuring T cells. It has been proven in clinical use for over 18 years with another major infectious disease, tuberculosis, which kills around 1.5 million people every year. Our T-SPOT.COVID test is tailored specifically for the detection and measurement of an individual's T cell response to SARS-CoV-2 infection. Having the ability to determine an individual's immune response to SARS-CoV-2 has the potential to support a wide range of needs in our battle against the COVID-19 pandemic."

Oxford Immunotec has entered in an agreement to be acquired by PerkinElmer (NYSE: PKI). The transaction is expected to close shortly.

1. Tan W, Lu Y, Zhang J et al. Viral kinetics and antibody responses in patients with COVID-19. medRxiv. 2020 March 26. Preprint. https://doi.org/10.1101/2020.03.24.20042382

2. Altmann DM, Boyton RJ. SARS-CoV-2 T cell immunity: Specificity, function, durability, and role in protection. Sci Immunol. 2020;5:eabd6160

3. Zuo J, Dowell A, Pearce H et al. Robust SARS-CoV-2-specific T-cell immunity is maintained at 6 months following primary infection. bioRxiv. 2020. doi: 10.1101/2020.11.01.362319

4. Ibarrondo FJ, Fulcher JA, Goodman-Meza D et al. Rapid decay of anti-SARS-CoV-2 antibodies in persons with mild Covid-19. N Engl J Med. 2020; 383: 1085-1087

5. Wyllie D, Mulchandani R, Jones HE et al. SARS-CoV-2 Reactive T cell numbers are associated with protection from COVID-19: A prospective cohort study. medRxiv. doi: 10.11012020.11.02.20222778

6. Package Insert PI-T-SPOT.COVID-IVD-US v3 T-SPOT-COVID-US-PI-v3-1.pdf

T-SPOT, T-Cell Xtend, T-SPOT Discovery SARS-CoV-2 and the Oxford Immunotec logo, are trademarks of Oxford Immunotec Limited. 

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 Company has over 18 years' experience as a 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.

About T-SPOT.COVID

Oxford Immunotec has been developing and strengthening its expertise in T cell measurement for over 18 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, standardizing results, and streamlining the workflow. The ELISPOT technique is exceptionally sensitive since the target cytokine is captured directly around the secreting cell making ELISPOT assays much more sensitive than conventional ELISA assays. The test enumerates effector T cells responding to stimulation using two separate peptide pools measured in parallel in individual wells. T-SPOT.COVID antigen panels are designed as overlapping peptides spanning sequences of the Spike and Nucleocapsid proteins. This design offers maximum epitope coverage for enhanced detection of T cell reactivity and no HLA restrictions. Antigenic formulations of 253 peptides covering the most immunogenic regions of the virus genome allows measurement of the breadth of immunity and ensures the impact of point mutations is minimized. Specificity to SARS-CoV-2 has been enhanced by removing potentially cross-reactive peptide sequences with high homology to other coronaviruses.