The Russian biotechnological company “Generium”, “Oxford Immunotec” and “PharmLine” agreed on the local production of the laboratory IGRA-test (Interferon gamma release assay) T-SPOT®.TB that is used for detection of tuberculosis (TB) infection. This agreement signifies a long-term cooperation in the field of high-precision diagnostic test systems for socially significant infectious diseases.
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 and has seen expanding uptake of the T-SPOT®.TB test. In collaboration with PharmLine, Oxford Immunotec will now also be working with 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.
Being a high-tech production company, which operates according to the GMP standards, Generium will fully meet the needs of the healthcare systems of Russia for IGRA-tests.
“Generium” currently produces another product for the early detection of tuberculosis infection — Diaskintest®, which is recommended by the Russian Ministry of Health for mass screening of TB infection in children aged over 8 years.
“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,” 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.”
The T-SPOT®.TB test is a unique, single-visit blood test for tuberculosis screening, also known as an interferon gamma release assay (IGRA). The T-SPOT®.TB test has demonstrated in a pivotal clinical study both sensitivity and specificity exceeding 95% and reliability in all at-risk groups.¹ The T-SPOT®.TB blood test does not cross react with the BCG vaccine and there is no association between T-SPOT®.TB blood test results and immunocompromised status.¹ IGRAs, such as the T-SPOT®.TB test have been recommended for use in clinical guidelines for TB testing in over 30 countries worldwide, including the World Health Organization’s List of Essential In Vitro Diagnostics.
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.
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.
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.
¹Oxford Immunotec. T-SPOT®.TB Package Insert PI-TB-US-V6. Abingdon, UK. May 2017
T-SPOT is a registered trademark of Oxford Immunotec Ltd.
Diaskintest is a registered trademark of JSC ”Generium”