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GENERIUM registered an EXPRESS test for SARS-CoV-2 (COVID-19)

04/06/2020
Novosibirsk, Moscow, 6 April. An innovative express test for coronavirus infection of GENERIUM, a leading Russian biopharmaceutical company, developed by Medical Biological Union Group, was registered by the Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor). This is the first national express test that allows determining the presence of coronavirus with an accuracy of more than 94% within 40 minutes, including sample preparation, using the standard equipment.
GENERIUM registered an EXPRESS test for SARS-CoV-2 (COVID-19) фото

Detection of coronavirus RNA is carried out using isothermal loop amplification as a technological platform. The use of this screening kit will significantly increase the productivity of laboratories, as well as the likelihood of viral infection detection in patients due to its high sensitivity.

Sergey Tsyb, First Deputy Minister of Industry and Trade of the Russian Federation, said,

'Using the example of this development, we can see that scientific and industrial resources are being marshalled to solve the issues of state importance. The implementation of the best laboratory diagnostic standards in pandemic conditions, the synergy of departments and teams helps to bring projects to life and ensures an unprecedented evolution in the technical characteristics of coronavirus diagnostic agents, from the simple to the most advanced'.

Andrey Ivanov, prof., Dr. Sci. (Med), Corresponding Member of the Russian Academy of Sciences, Board Chairman of the All-Russian Public Organisation Scientific and Practical Society of Specialists, Laboratory Medicine, Head of the Department of Clinical Biochemistry and Laboratory Diagnostics of the Military Medical Academy named after S.M. Kirov, chief laboratory assistant of the Ministry of Defence of the Russian Federation, St. Petersburg,

'In the current epidemic situation, the capacities of existing laboratories are crucial for a complete and objective diagnosis of coronavirus infection. As opposed to the systems based on the principle of reverse transcription PCR (polymerase chain reaction), Isotherm SARS-CoV-2 RNA-screen test uses a loop-mediated isothermal amplification (LAMP) method, which is now successfully used in many countries worldwide. Due to the simplified sample preparation procedure and the reduction in the number of analysis steps, the pathogen detection time is less than an hour. It will increase the throughput capacity of laboratory equipment and the number of studies performed by more than 3 times, compared with the existing methods'.

Dmitry Kudlay, prof., General Director, GENERIUM JSC, 'As a graduate of Novosibirsk Medical University, I am proud that the Siberian scientific school is at the forefront of solving vital challenges that concern every Russian citizen! Today I can say that GENERIUM and the Medical Biological Union will soon provide the Russian healthcare system with a number of modern technological solutions in the field of molecular diagnostics'.


Detailed information about companies:

GENERIUM

GENERIUM is a biotechnology company, the leader in the Russian pharmaceutical market for orphan diseases. The Company possesses its own R&D park, which is capable of developing any biotech product, from molecule design to commercial production. GENERIUM's manufacturing facilities are organised in strict compliance with international GMP standards. The Company's plants produce a unique variety of biotech products and are capable of manufacturing any kind of biomedical cell products.

www.generium.ru

Medical Biological Union Group

The main activity of the Medical Biological Union Group is the development and production of reagent kits for the diagnosis of infectious diseases, including socially dangerous infections (HIV, etc.). Reagent kits have been used in clinical diagnostic laboratories, medical institutions, Blood Supply Service laboratories and Centres for AIDS Control and Prevention for over 25 years. Medical Biological Union LLC is the third largest manufacturer of reagent kits for infectious diseases in the Russian Federation.

www.mbu.ru

Contacts

M&A and Licensing:
bd@generium.ru

Media inquiries :
pr@generium.ru

tel.: +7 (495) 988-47-94