TestGene Receives European CE Certificate for COVID-19 Detection Tests

21 May 2020

On May 20, 2020 TestGene received the European CE Certificate for a genetic test designed to detect the SARS-CoV-2 RNA of COVID-19 at the earliest stages. TestGene operates at the ULNANOTECH Ulyanovsk nanocenter included in the investment network of the RUSNANO Group Fund for Infrastructure and Educational Programs.

СЕ_ТестГена

The certificate confirms that the company’s medical device meets the requirements of the European Union. The document is valid throughout the European Union and allows for the unrestricted distribution of products. According to Andrey Toropovsky, CEO of TestGene, the CE Certificate is another confirmation of the high quality of medical products manufactured by the company. “The new test system has a good export potential. To date, we have already requests from Ireland, Sweden, Germany, the Czech Republic, and the Netherlands,” the CEO believes.

On May 15 this year, TestGene received a registration certificate of the Federal Service for Surveillance in Healthcare (Roszdravnadzor) for its COVID-19 test systems and immediately started its mass production. “Our production capacities allow us to produce up to 50,000 tests per day, and up to two million per month in the future. I’m sure that the company will make a worthy contribution to the fight against the pandemic by offering the world community, along with existing analogues, a high-quality and high-precision diagnostic kit,” Andrey Toropovsky stressed.

The test allows for determining the presence of coronavirus in a sample taken from the nasal or oropharyngeal mucosa with an accuracy of more than 96% at the early stages of infection. The CoV-2 Test is based on the real-time reverse transcription polymerase chain reaction (RT-PCR) method, which the World Health Organization recommends as the most accurate and reliable way to diagnose viral infection. Testing can be performed in standard PCR laboratories.

“TestGene has one of the strongest teams in the country in the field of molecular genetics,” said Anatoly Chubais, Chairman of the Executive Board of RUSNANO Management Company. “Their new test will help fulfill the instruction of the Russian President Vladimir Putin to increase the scale of testing for coronavirus infection as the restrictions are gradually being removed. Mass testing will long remain a common practice for all large production facilities, a part of our daily life.”

To recap, TestGene already has European CE Certificates for test systems for diagnosing the gender of a child from the blood of a pregnant woman and for early diagnosis of prostate cancer. These and other diagnostic kits have been supplied to countries of the near and far abroad for several years.

Additional information

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 Anatoly Chubais; the Chief Executive Officer of the Fund is Andrey Svinarenko.

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The Ulyanovsk nanocenter ULNANOTECH was established in accordance with the program for the creation of nanotechnological centers of JSC RUSNANO. The total investment in the nanocenter will amount to 2.1 bln rubles. The official launch was in August 2013.

The nanocenter specializes in automotive components (composite metal materials, composite polymer materials based on glass and carbon fiber, glass coating, engineering, and prototyping), aviation and space (tooling for metal casting), composite non-ferrous metal castings, prototyping and small-scale production of metal products), and construction (composite materials based on non-metallic minerals, modified concretes, liquid building mixtures and paintwork materials, architectural coated glass, and structural building materials). Andrey Redkin is Director General.

More about the nanocenter — www.ulnanotech.com

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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