Oxford Immunotec Signs Exclusive Distributor Agreement with RIKEN Genesis, a Subsidiary of Sysmex, to Market the T-SPOT® Discovery SARS-CoV-2 Kit for the Measurement of the T cell Immune Response to SARS-CoV-2 Infection in Japan

Rhea-AI Summary

Oxford Immunotec Global PLC (Nasdaq: OXFD) has signed an exclusive distribution agreement with RIKEN Genesis Co., Ltd in Japan for its T-SPOT Discovery SARS-CoV-2 kit, designed to detect SARS-CoV-2 specific T cells. This kit, already available in Europe and the USA, aims to enhance understanding of immunity against COVID-19. The collaboration seeks to broaden the usage of this research-use-only kit in Japan, contributing to the ongoing pandemic management. Oxford Immunotec emphasizes the potential for new insights into T cell immunity to COVID-19 through this partnership.

Positive

• Exclusive agreement with RIKEN Genesis in Japan for T-SPOT Discovery SARS-CoV-2 kit.
• Potential to broaden usage of T-SPOT technology in COVID-19 research.
• Previous trial success in Japan with the T-SPOT Discovery SARS-CoV-2 kit.
• Collaboration expected to significantly inform COVID-19 management strategies.

Negative

• None.

OXFORD, United Kingdom and MARLBOROUGH, Mass., Dec. 02, 2020 (GLOBE NEWSWIRE) -- Oxford Immunotec Global PLC (Nasdaq: OXFD) (the “Company”), a global, high-growth diagnostics company today announces it has entered into an exclusive distribution agreement with RIKEN Genesis Co., Ltd, a subsidiary of The Sysmex Corporation (Sysmex), in Japan.

Under the agreement, RIKEN Genesis will exclusively distribute the T-SPOT Discovery SARS-CoV-2 kit (Research Use Only), developed by Oxford Immunotec for the detection and measurement of SARS-CoV-2 specific T cells, which may offer new insight into immunity to SARS-CoV-2 infection.

Based on the company’s T-SPOT technology, the only globally approved ELISPOT currently used clinically for the diagnosis of Tuberculosis infection; the T-SPOT Discovery SARS-CoV-2 kit is already available for research use across Europe and the USA. Trial data recently released by Public Health England¹ using the T-SPOT Discovery SARS-CoV-2 kit suggests that individuals with SARS-CoV-2 specific T cells but without detectible antibodies (serology) may be protected from infection.

Sysmex are committed to the establishment of diagnosis/treatment methods for COVID-19 and already offer PCR tests, antigen tests, and antibody tests. Following a successful trial of the T-SPOT Discovery SARS-CoV-2 kit in Japan, Sysmex believe offering a T cell response kit will form an important adjunct to their current range of tests for COVID-19.

Dr. Peter Wrighton-Smith, CEO of Oxford Immunotec, said “We’ve been working with RIKEN Genesis for almost ten years now in Japan and we are delighted to deepen our partnership with this distribution arrangement for our research use SARS-CoV-2 T cell test. RIKEN’s strong channel to research customers in Japan will help broaden usage of our T-SPOT Discovery SARS-CoV-2 kit, which we believe will be able to make a significant contribution in informing how we can better manage the ongoing pandemic.”

Dr. Naoto Kondo, President and CEO of RIKEN Genesis, said “We are excited to start handling T-SPOT Discovery SARS-CoV-2 kit in Japan. We have provided the T-SPOT technology to Japan market in strong collaboration with Oxford Immunotec. We hope this kit will contribute to research support and drug development for COVID19, especially vaccine development.”

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 on T-SPOT Discovery SARS-CoV-2 visit: https://www.tspotdiscovery.com.

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 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 RIKEN Genesis

Established in October 2007, RIKEN Genesis (a subsidiary of The Sysmex Corporation) provides products for genetic testing based on cutting-edge gene analysis technology and laboratory assay services with the mission of realizing precision medicine using genomic science and molecular diagnostic technology joined the Sysmex Group in June 2016 for the practical application of genomic medicine. RIKEN Genesis provides highly reliable tests based on international quality standards in laboratories that have obtained CAP certification / CLIA certification and ISO 15189 certification, and has a track record in clinical sequence, drug discovery research support, and clinical research support. Additional information can be found at the RIKEN Genesis website www.rikengenesis.jp or at The Sysmex Corporation site https://www.sysmex.co.jp/en/.

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 Companies 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 h room temperature (RT) sample stability) or T-Cell Select™ reagent (54 h 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.

T-SPOT, the Oxford Immunotec logo, T-Cell Xtend, 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 distribution arrangement with RIKEN Genesis to market the T-SPOT^® Discovery SARS-CoV-2 kit for the measurement of the T cell immune response to SARS-CoV-2 infection in Japan will provide data that provides new insights into immunity to COVID-19, including 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 distribution arrangement 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 distribution arrangement 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.com

1 To view the PHE publication visit: https://www.medrxiv.org/content/10.1101/2020.11.02.20222778v1

FAQ

What is the latest news from Oxford Immunotec (OXFD) regarding COVID-19 diagnostics?

Oxford Immunotec has entered into an exclusive distribution agreement with RIKEN Genesis to distribute the T-SPOT Discovery SARS-CoV-2 kit in Japan.

How does the T-SPOT Discovery SARS-CoV-2 kit work?

The T-SPOT Discovery SARS-CoV-2 kit detects and measures SARS-CoV-2 specific T cells to provide insights into immunity against COVID-19.

When was the distribution agreement between OXFD and RIKEN Genesis announced?

The distribution agreement was announced on December 2, 2020.

What market does the T-SPOT Discovery SARS-CoV-2 kit target?

The kit is targeted for research use only and is distributed exclusively in Japan under the agreement.

What are the potential benefits of the T-SPOT Discovery SARS-CoV-2 kit?

The kit may provide important insights into T cell immunity and support efforts in managing COVID-19.