TestGene from RUSNANO Fund for Infrastructure and Educational Programs Network Registers Ultra-accurate Test for COVID-19

18 May 2020

TestGene from the ULNANOTECH Ulyanovsk nanocenter (part of the investment network of the Fund for Infrastructure and Educational Programs (FIEP) of RUSNANO Group) received a registration certificate of the Federal Service for Surveillance in Healthcare (Roszdravnadzor) on May 15, 2020 and has launched mass production of its own genetic test for COVID-19. The new test system shows the presence or absence of SARS-CoV-2 RNA at the earliest stages with high accuracy of more than 96%.

The CoV-2-Test

The CoV-2-Test system was developed by TestGene specialists in about a month. The first batches are ready to be sent to the regions of Russia.

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. When developing the test system, recommendations of the Food and Drug Administration were also taken into account.

The sample for analysis is a biomaterial taken from the nasal or oropharyngeal mucosa of the patient, or sputum from the lungs. Due to the use of modern highly productive enzymes, the test detects even a very small amount of genetic material (RNA) of the virus in the human biological material. This helps to detect the disease in the incubation period at the earliest stages. A high-precision test result can be obtained in two hours.

According to Denis Viktorov, Head of the Laboratory for Scientific and Technical Development of TestGene, PhD in Biology, the RT-PCR method is best suited for detecting SARS-CoV-2, since it is highly sensitive and allows detecting even single copies of the virus RNA in a biological sample. In addition, this method allows for making the test highly specific, since the flexibility at the development stage allows for selecting unique nucleotide sequences that occur only in this virus.

The new test system has successfully passed clinical testing at the Federal State Budgetary Healthcare Institution “Head Center of Hygiene and Epidemiology of the Federal Medical-Biological Agency of Russia” (Moscow) and showed the test accuracy of 96-100% in case of the right analysis at all stages. The sensitivity threshold is 500 copies of virus in 1 ml of biomaterial.

“The company’s production capacities and the availability of GOST ISO 13485 certification allow us to produce up to 50,000 tests per day at the initial stage, and up to 2 mln per month in the future. TestGene will provide any assistance in the delivery of test systems to the regions of Russia,” assured Andrey Toropovsky, CEO of TestGene, PhD in Medicine. According to TestGene CEO, all PCR laboratories are equipped with devices for performing such analyses. Therefore, testing can be performed not only in specialized centers. “To enter the foreign market, we are preparing to receive the European CE Certificate for the test system,” added Andrey Toropovsky.

The Governor of the Ulyanovsk Region Sergey Morozov declared readiness to use new TestGene products in this constituent entity of the Russian Federation: “We have significantly increased the laboratory base. We already have agreements on the supply of systems to hospitals in the Ulyanovsk Region,” Head of the Region stated in an address on his Instagram page.

TestGene believes that one of the bottlenecks in mass diagnostics is the low throughput of laboratories, the so-called “human factor” when one laboratory assistant can qualitatively isolate the virus RNA from about 100 samples during a shift. “When developing the test system, we initially laid down the possibility of automating the process with the application of robotic stations, which will increase the productivity of laboratories by eight times, which means that diagnostics will become more accessible and faster,” said Andrey Toropovsky. “The cost of a test system in the test price structure in laboratories is on average no more than 30%,” Dmitry Pak, Development Director of TestGene, said.

CoV-2-Test is the first solution for the reagent diagnosis of the novel coronavirus, but not the only one proposed by RUSNANO Group. Thus, Troitsk Engineering Center from TechnoSpark Group in collaboration with the Federal Scientific and Clinical Center of Physical and Chemical Medicine of the Federal Medical and Biological Agency have developed the Indicator-BIO analyzer device which is capable of detecting dangerous viruses in 15 minutes. TechnoSpark also produces sets of key parts for Evotech-Mirai Genomics coronavirus mobile diagnostics devices created by the Russian company Evogen and the Japanese company K.K. Mirai Genomics.

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.

* * *

The Ulyanovsk Nanoсentre, ULNANOTECH, established by the Fund for Infrastructure and Educational Programs (RUSNANO Group), invests in and supports technological entrepreneurship projects in their early stages of development, and searches for new technologies created by technology startups. It has the status of a high technology technopark.

* * *

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