About Oxford Immunotec Global

Oxford Immunotec Global PLC operates as a diagnostics company that focuses on developing and commercializing proprietary tests for immunology and infectious disease. The company’s primary product is the proprietary T-SPOT.TB test, which utilizes its T-SPOT technology platform to test for tuberculosis (TB), which is the cause of infectious disease death worldwide. The company has developed reagents and methods to purify white blood cells for use in immunology assays. The T-SPOT.TB Test and Supporting Reagent Kits The company uses two TB-specific antigens, ESAT-6 and CFP10, to stimulate T cells that have previously been exposed to mycobacterium TB, which causes them to release a cytokine called interferon-gamma. T-Cell Select is a reagent kit sold in conjunction with T-SPOT.TB. In 2018, the company certified conformity of T-Cell Select with European in vitro diagnostics regulations, enabling it to attach the CE mark for the T-Cell Select kit, and launched the kit in Europe in 2019. In 2018, the company also obtained acceptance of the regulatory notification for the T-Cell Select kit by the National Medical Products Administration (NMPA). T-Cell Select could be used to isolate mononuclear immune cells using a magnetic bead cell separation system. The T-Cell Xtend reagent is an antibody complex that is added to blood samples in the laboratory before running the T-SPOT.TB assay and allows blood samples to be processed up to 32 hours after venepuncture without affecting the accuracy of the test. T-SPOT.TB Regulatory Approvals and Clinical Validation The company’s T-SPOT.TB test is approved for commercial sale in approximately 50 countries. Key geographies where the company has regulatory approval include: The United States (U.S.): The company obtained premarket approval (PMA) for its T-SPOT.TB test from the FDA (the U.S. Food and Drug Administration) in 2008. Europe: The company obtained a CE mark in 2004, which allows it to sell its T-SPOT.TB test in Europe, as well as other countries that accept the CE mark. China: The company obtained initial approval for its T-SPOT.TB test from the NMPA in 2010. The company applied for re-registration in April 2019. Japan: The company obtained approval for its T-SPOT.TB test from the Ministry of Health, Labour and Welfare (MHLW) in 2012. In addition to being validated in multiple clinical studies, the company’s T-SPOT.TB test has also been the subject of approximately 700 peer-reviewed publications in scientific journals, including various meta-analyses. T-SPOT.TB Distribution, Education and Marketing The company offers its T-SPOT.TB test as an in vitro diagnostic kit worldwide, meaning it sells test kits and associated accessories to laboratories that perform the testing themselves. The company has also established a clinical testing laboratory in the United Kingdom (U.K.), where it performs its T-SPOT.TB test on samples sent to it by customers. The company markets its service offering under the name Oxford Diagnostic Laboratories (ODL). The company markets its T-SPOT.TB test directly in the U.S., China, Japan, and other countries in Europe. In these countries, it uses a combination of sales managers, sales representatives, customer service staff, and technical experts to interact with clinicians, nurses, administrative staff, laboratories, and other groups who are involved in the implementation of TB screening programs. Outside of these territories, it has contracted with distributors who market and sell its test. The company’s customer base includes hospitals, commercial testing laboratories, importers, and distributors. In the U.S., the company maintains a strategic collaboration agreement with Quest Diagnostics, Incorporated (Quest) to provide for close coordination between the two entities across functions, such as sales, marketing, medical affairs, customer experience, managed care and product development. Its U.S. organization also markets T-SPOT.TB to end customers not affiliated with Quest. Pipeline The company’s development programs are primarily focused on improving its T-SPOT.TB test offering, including advancing its T-Cell Select platform. The company is developing multiple product improvements that could add additional clinical utility to its test and improve test workflow and automation. The company has also developed an immune monitoring test for cytomegalovirus (CMV) based on its major T-SPOT technology. This T-SPOT.CMV test is designed for the quantification of effector T cells that respond to stimulation by antigens specific for CMV and has applicability for monitoring CMV-seropositive response in transplant recipients at various time-points post-transplantation. Key Customer Relationships The company’s customers include independent laboratories, major hospital systems, and public and private institutions. Its customer relationships also include its distributors outside of the U.S. The company has a supply agreement with Quest, which was made as of the closing of the sale of its U.S. Laboratory service business to Quest. Pursuant to the supply agreement, the company sells T-SPOT.TB kits and certain accessories to Quest. The agreement expires on November 6, 2025. The company sells its T-SPOT.TB test to a Japanese importer Riken Genesis Co., Ltd. (Riken), which also serves as its marketing authorization holder in Japan, a position required by Japanese regulatory authorities. The company entered into a marketing authorization holder agreement with Riken in 2011 and it was amended in 2013, 2016 and 2017. Pursuant to this agreement, Riken provides services for importation into Japan. In 2019, the company entered into a non-exclusive distribution agreement with Shanghai Pharmaceutical Co., Ltd. (Shanghai Pharma). The company sells its T-SPOT.TB test to this Chinese importer and distributor. This is a non-exclusive agreement for Shanghai Pharma to import, warehouse, and distribute its T-SPOT.TB test kits and related accessories to sub-distributors and direct customers in China. The agreement with Shanghai Pharma was signed on December 24, 2019, with a term of three years. Key Supplier Relationships The company purchases all raw materials used in its tests from external suppliers, including Mabtech AB; EMD Millipore Corporation; MicroCoat Biotechnologie GmbH; Life Technologies Corporation; and StemCell Technologies, Inc. Research and Development For the year ended December 31, 2019, the company’s research and development expense were $8.7 million. Intellectual Property The intellectual property relating to the company’s T-SPOT.TB test that it owns or licenses includes 6 issued U.S. patents and 9 issued patents in other jurisdictions, as well as registered trademarks. The patents covering these inventions expire in 2027 (outside of the U.S.) and 2028 (U.S.). The company has acquired a patent family relating to additional TB antigens, which has issued a patent in the U.S. and has applications pending in 3 other jurisdictions. The expected expiration date for the U.S. patent is August 2035. The company also has licensed certain patents related to the detection of antibody-secreting B cells specific for HLA. The last expected expiration date for the licensed patents is April 2036. Additionally, it owns a patent family, with applications pending in 4 jurisdictions, related to monitoring immune status. License and Assignment Agreements TB Related Patents In 2013, the company entered into an assignment agreement with Oxford University Innovation Ltd. (Oxford Innovation) pursuant to which various patents it previously licensed from Oxford Innovation were assigned to it. The company’s license agreement with The State University of New Jersey (Rutgers) grants it an exclusive license to certain patents to manufacture and commercialize kits for in vitro diagnostic assays relating to TB other than in the ELISA format. The license was made in 2006 and has been amended in 2009, 2011, 2012, 2013, 2016 and 2017. The company’s license is royalty-bearing, worldwide, with the right to sublicense. The company’s royalty obligations to Rutgers would cease in July 2020. Trademarks and Other Protection The trademarks the company employs in its business include T-SPOT, T-Cell Xtend, T-Cell Select, ODL, Oxford Diagnostic Laboratories, and the laboratory logo and the Oxford Immunotec logo. The company has obtained registrations in the U.S. for T-SPOT, T-Cell Xtend, Oxford Diagnostic Laboratories, and the Oxford Immunotec logo. It also has obtained registrations for certain of these trademarks in other jurisdictions, including the U.K., the European Community, Japan and China. Government Regulation The company’s T-SPOT.TB test is a Class III device. It has other Class II devices that have received 510(k) clearance from FDA. The company is required to comply with the Federal Food, Drug, and Cosmetic Act’s general controls, including establishment registration, device listing and labeling requirements. The company’s T-SPOT.TB test obtained a CE mark in 2004 and MHLW approval in Japan in 2012. In China, it obtained NMPA approval in 2010, re-registration in 2014 and applied for re-registration in April 2019. Its T-SPOT.CMV test obtained a CE mark in 2015. The company’s laboratory located in the U.K. operates under accreditation by the United Kingdom Accreditation Service for the International Standard: ISO 17025:2017. The company is subject to the U.S. Foreign Corrupt Practices Act (FCPA). The company is also subject to the FCPA’s accounting provisions. Additionally, it is subject to anti-corruption laws of other countries, including the U.K. Bribery Act of 2010, where it does business. Significant Events In September 2020, Oxford Immunotec Global PLC entered into a research collaboration with Public Health England (PHE). As part of this, PHE has launched the Evaluating Detection of SARS-CoV-2 antibodies using home test kits study, 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 would 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. History Oxford Immunotec Global PLC was founded in 2002. The company was incorporated in England and Wales in 2013.