OXFORD, United Kingdom and MARLBOROUGH, Mass., March 28, 2019 (GLOBE NEWSWIRE) — Oxford Immunotec Global PLC (Nasdaq:OXFD) (the “Company”), a global, high-growth diagnostics company, today announced a new local production initiative to bring the benefits of the T-SPOT®.TB test to the Russian Federation.
Since the T-SPOT.TB test received approval in the Russian Federation in 2013, Oxford Immunotec has been working with a local distribution partner, PharmLine LLC (“PharmLine”) and has seen expanding uptake of the T-SPOT.TB test. In collaboration with PharmLine, Oxford Immunotec will now also be working with Generium Joint Stock Company (“Generium”), who will be manufacturing the T-SPOT.TB test locally at their factory in the Vladimir region of the Russian Federation. This is expected to reduce the cost of, and expand access to, the T-SPOT.TB test for patients in the Russian Federation. Additionally, Generium will be working with PharmLine on marketing and distribution of the T-SPOT.TB test, including applying for national TB control tenders.
The Russian Federation is among the 20 countries worldwide with the highest estimated numbers of incident TB cases, with a reported incidence rate of 60 cases per 100,000 population and a high rate of HIV/TB coinfection.¹ The Russian Federation has the 3rd highest rate of multi-drug resistant TB in the world,² which adds urgency to the need to reduce TB rates before drug resistance undermines the ability to successfully treat those diagnosed. With a strong commitment to new actions to end TB, the WHO and the Government of the Russian Federation convened the First WHO Global Ministerial Conference, Ending TB in the Sustainable Development Era: A Multisectoral Response, which was a fundamental milestone towards the United Nations General Assembly (UNGA) High-Level Meeting on TB in 2018. The development and implementation of more ambitious, fully-funded national TB policies and strategic plans is also one of many commitments included in the Moscow Declaration to End TB.³
The WHO and the UN have both recognized that a critical component in the fight to end TB is the rapid scaling up of access to and testing for TB infection in high-burden countries, particularly focusing on those most at risk of falling ill, such as children and those with HIV.4 They have also called on stakeholders to develop new models to increase access to the tools, such as interferon gamma release assays (IGRA) tests,5 which are now included in the WHO’s List of Essential In Vitro Diagnostics.6
“This new development allows Generium to bring into Russia a high-precision laboratory test for the diagnosis of tuberculosis infection, with the economic benefits of local production,” said Dmitriy Kudlay, CEO of Generium. “Together with PharmLine and Oxford Immunotec we are excited to expand the use of the T-SPOT.TB test in Russia in order to support the state’s aims in ending TB in the country.”
“We are very pleased to enter into this exciting new approach with Generium, who as the skin test providers in Russia, have unparalleled reach and relationships within Russia and Kazakhstan,” said Dr. Peter Wrighton-Smith, CEO of Oxford Immunotec. “We believe working with PharmLine and Generium expands the reach of the T-SPOT.TB test and we are proud to take another step forward in helping the clinical community in Russia in their fight against TB.”
¹ Global tuberculosis report 2018 (35). WHO; 2018
² Global tuberculosis report 2018 (49). WHO; 2018
³ Moscow Declaration to End TB; First WHO Global Ministerial Conference on Ending TB in the Sustainable Development Era: A Multisectoral Response, November 2017. WHO and the Ministry of Health of the Russian Federation; 2017
4 Resolution adopted by the General Assembly on 10 October 2018: 73/3 Political declaration of the high-level meeting of the General Assembly on the fight against tuberculosis (5 – 6). United Nations General Assembly; 2018
5 Resolution adopted by the General Assembly on 10 October 2018: 73/3 Political declaration of the high-level meeting of the General Assembly on the fight against tuberculosis (10). United Nations General Assembly; 2018
6 World Health Organization Model List of Essential In Vitro Diagnostics – First Edition (2018). WHO; November 2018
About Oxford Immunotec
Oxford Immunotec Global PLC is a global, high-growth diagnostics company focused on developing and commercializing proprietary assays for immunology and infectious disease. The Company’s 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.
T-SPOT and the Oxford Immunotec logo are trademarks of Oxford Immunotec Ltd.
Generium is the leading Russian biopharmaceutical company, focused on developing and commercializing diagnostic systems and pharmaceutical products for the treatment of orphan diseases, infection diseases, cancer, multiple sclerosis, myocardial infarction and strokes as well as tuberculosis diagnostic test – Diaskintest®. Generium consists of a high-end R&D center and a fully integrated manufacturing plant. Generium has more than 30 innovative products in the pipeline, including enzymes, monoclonal antibodies and ATMPs. Generium is headquartered in Moscow, Russia. Additional information can be found at www.generium.ru/en.
Diaskintest is a trademark of Generium Joint Stock Company.
PharmLine was founded in 1993 and is a leading healthcare product distributor. PharmLine specializes in the marketing and sales of pharmaceuticals, diagnostic products and technologies for hospital and laboratory use in the Russian Federation and the Confederation of Independent States. PharmLine is located in Moscow, Russia.
This release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this release are forward-looking statements. This includes statements about Oxford Immunotec’s anticipated plans and objectives, future performance and revenues, financial condition, prospects for sales of its products, growth, strategies, expectations and objectives of management. Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts. Forward-looking statements contained in this release reflect Oxford Immunotec’s current expectations and are subject to risks and uncertainties. Actual results may differ materially from those projected or implied by forward-looking statements. Other factors that could adversely affect Oxford Immunotec’s business and prospects are described under the “Risk Factors” section in its filings with the Securities and Exchange Commission (“SEC”). Oxford Immunotec’s SEC filings are available for free by visiting the investor section of its website, www.oxfordimmunotec.com, or the SEC’s website, www.sec.gov.
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