The Russian Ministry of Health Recommends the Genetic Tests of TestGen from the Ulyanovsk Nanocenter for the Diagnosis of the Coronavirus

04 June 2020

On June 3, 2020, the Russian Ministry of Health approved and sent to the regions for use in clinical practice the 7th version of the Temporary Guidelines for the Prevention, Diagnosis, and Treatment of the New Coronavirus Infection (COVID-19). The list of recommended diagnostic tools includes the high-precision genetic CoV-2-Test tests of TestGen from the ULNANOTECH Ulyanovsk nanocenter, part of the investment network of the RUSNANO’s Fund for Infrastructure and Educational Programs.

The document of the Ministry of Health has been developed by an interdisciplinary working group of leading experts based on Russian and foreign clinical experience. The new version of the guidelines significantly redesigned and expanded all sections and presented new treatment regimens with the use of the latest drugs. The guidelines are intended for doctors of medical and preventive institutions of the infectious profile, as well as doctors-resuscitators of intensive care departments of the infectious hospital, and primary care physicians.

The TestGen’s CоV-2-Test test kits allow determining the presence of the coronavirus in a sample taken from the mucosa lining of the naso- or oropharynx, with the accuracy of more than 96% in the early stages of infection. The test is based on the real-time polymerase chain reaction method with reverse transcription (RT-PCR), which is recommended by the World Health Organization as the most accurate and reliable way to diagnose the viral infection. Testing can be carried out in standard PCR laboratories.

The Roszdravnadzor’s registration certificate for the new test was received on May 15, 2020, followed by the immediate launch of mass production thereof. At present, TestGen has also obtained a European CE Compliance Certificate and a registration certificate of the Ministry of Health of the Republic of Kazakhstan for the COV-2-Test test kit.

“The timely detection of SARS-CoV-2 RNA using nucleic acid amplification techniques is of key importance for the COVID-19 etiological laboratory diagnosis. The inclusion of our test in the methodical recommendations of the Russian Ministry of Health underlines the importance of our development for the practical public health of the Russian Federation,” said Andrey Toropovsky, CEO of TestGen, LLC.

In May, the first 10,000 sets of the CoV-2-Test were handed over to the Ulyanovsk region. On May 28, Anatoly Chubais, Chairman of the RUSNANO’s Executive Board, together with a member of the Central Staff of the ONF, the author of the Region of Care project Nyuta Federmesser, brought a lot of 20,000 tests to Dagestan. In total, it is planned to deliver to the country 50,000 tests, purchased both at the expense of the employees of the RUSNANO Group and with funds allocated by the company for charitable assistance.

Reference

The Fund for Infrastructure and Educational Programs was established in 2010 in accordance with Federal Law No. 211-FZ “On reorganization of the Russian Corporation of Nanotechnologies.” The Fund aims to develop the innovative infrastructure in the sphere of nanotechnology and implement the educational and infrastructure programs already started by RUSNANO.

The supreme collegial management body of the Fund is the Supervisory Board. Under the Fund’s Charter, the competence of the Supervisory Council, in particular, includes the issues of determining the priority directions of the Fund’s activity, as well as its strategy and budget. The Chairman of the Fund’s Executive Board, the collegial management body, is the Chairman of the Board of Management Company RUSNANO LLC Sergey Kulikov.

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TestGene LLC is a developer and manufacturer of genetic test systems for molecular diagnostics. The main direction of developments is non-invasive diagnostics of fetal condition during pregnancy and diagnostics in oncology. Since 2013, it has been a resident of the Ulyanovsk nanocenter.

For more information about the company, please visit www.testgen.ru

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#rusnanoVSvirus

The epidemic of the coronavirus infection has affected all areas. Technological solutions of the RUSNANO portfolio companies and start-ups of nanocenters of the Fund for Infrastructure and Educational Programs (FIEP) help to effectively fight the disease and to preserve the comfort and safety of habitual life in the new conditions.

All materials and news on how the RUSNANO Group of Companies helps fight the coronavirus are posted at fiop.site/rosnanovsvirus

  • TestGen company from the Ulyanovsk Nanocenter has launched mass production of its own genetic test for the COVID-19 coronavirus infection. The new test kit shows the presence or absence of SARS-CoV-2 RNA at the earliest stages with the accuracy of more than 96%.
  • GemaCor, the RUSNANO’s portfolio company, provides equipment and test kits for the Thrombodynamics test as part of a clinical study of blood clotting disorders aimed at developing a scheme to prevent severe effects of the coronavirus infection.
  • The Pharmsintez company together with the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry of the RAS is developing a new vaccine against the coronavirus. It should be created before the end of the year, and clinical trials will start at the beginning of 2021. Unlike other developments, it is based on the original technology of creating synthetic pseudo-virtual nanoparticles containing fragments of one of the coronavirus proteins together with genetic sequences encoding them.
  • Mitotech (RUSNANO Portfolio Company) is developing a drug with the code name “Mitotech-19” that will allow patients with apparent respiratory failure requiring oxygen therapy to prevent further development of acute respiratory distress syndrome (ARDS) and reduce the need for artificial lung ventilation.
  • The FIEP nanocenters have manufactured and donated more than 5,000 protective visors to medical facilities working with COVID-19 patients. The small-weight easy-to-use visors are made by 3D printing from durable plastic, are easily disinfected, and can be used repeatedly.
  • The Promobot portfolio company of the Far Eastern Fund of High Technology has developed robots capable of measuring a person’s temperature with great accuracy, recognizing a person’s face and checking it with a database, transmitting visitor information to a responsible employee, issuing access cards, opening turngates, and disinfecting industrial facilities, shopping malls, and educational institutions.
  • ELVIS-NeoTek has created Rubezh-T, the system for automatic temperature measurement and control over the movement of citizens. The system is designed for automated continuous monitoring of the temperature of people in crowded places in real time and controlling the movement of persons with potentially dangerous symptoms.