How high-precision coronavirus test works and what Tatars have to do with it

Russia and Japan: together against the virus

According to numerous publications in the press, the Russian-Japanese company EMG (Evotech-Mirai Genomics) provides Russia with one of the most modern and high-precision systems for determining the presence of the new coronavirus in the blood. The history of this cooperation began several years ago, and in the context of the COVID-19 pandemic, the development of Russian and Japanese biotechnologists has turned out to be in high demand.

Lenar Valeev, the director general of EMG, told Realnoe Vremya:

“The SmartAmp method of isothermal molecular diagnostics used in test systems had to be adapted to diagnose the new virus such as SARS-CoV-2. This is not an easy task, given that the new coronavirus belongs to a completely different family of viruses than the flu. Together with our Japanese partners, we managed to bring the technology to high accuracy (more than 99,9%) and launch it into mass production. In Japan, this technology was first used in Yokohama, with passengers on the Diamond Princess liner.

So, Russian scientists and technologists have been developing test systems for the presence of viral genetic material in the human body together with Japanese ones since 2016. Moreover, since 2017, they have already been working on their “landing” on the mobile platform. Now it was necessary to finalise the system and reconfigure it to the coronavirus RNA.

In Japan, such tests are already working and have been included in the CHI system, in March they were approved by Roszdravnadzor in Russia.

Germany, the UK, France, and Saudi Arabia are actively interested in the tests. But the main focus of our work now is providing Russian citizens with tests

Official approval and investments from RDIF

As a result of Roszdravnadzor's testing, EMG tests have shown high accuracy, after which the company received a registration certificate. On March 20, the rapid test was entered into the state register of medical devices, under the name 'Kit for detecting RNA of SARS-CoV-2 coronavirus in biological material by isothermal amplification in real time'.

Lenar Valeev says:

“We are grateful to the regulatory authorities for their prompt work. As for other countries, negotiations are underway with many states. Our tests are already available in the United States, Austria, and the United Arab Emirates, where they are either already in use or are in the final stages of obtaining the corresponding permits. Germany, the UK, France, and Saudi Arabia are actively interested in the tests. But the main focus of our work now is providing Russian citizens with tests.

In order to provide Russian citizens with tests, RDIF (Russian Direct Investment Fund) has created the Centre of expertise for testing and applying world practices in the fight against coronavirus. The method proposed by EMG has been studied and recognized as the most effective — and remains so to this day.

When it became known about the encouraging characteristics of the new test system, the supervisory board of the RDIF approved investment in the production of new tests. The result of this support was the rapid deployment of EMG test systems, and they are already being used in various regions of Russia. As of April 27, EMG has already been identified as a supplier in several contracts for a total of about 9 million rubles (according to SPARK-Interfax system).

Two suitcases for 40 people

The two main advantages of the new test system are a multiple increase in the speed and accuracy of testing. Thus, the speed of obtaining the result has been reduced to 18-20 minutes (30 at most) — several times faster than for classic laboratory PCR tests. Sensitivity is measured by dozens of copies of the virus per reaction. Thus, the EMG system can detect the virus at the earliest stages of its presence in the body, and the accuracy of the new test is estimated at about 99,9%.

The speed and accuracy of the test system has been achieved at a high level due to that it uses the method of isothermal molecular diagnostics SmartAmp. In contrast to the test method of PCR (polymerase chain reaction), it doesn't require several cycles of heating and cooling of the sample. This significantly saves testing time and gives the opportunity to conduct testing not only in stationary but also in mobile laboratories. Testing can be carried out, in fact, anywhere — the mobile test system is a set of two small suitcases that contain everything you need. At the same time, this set can process results for 40 people per hour.

The EMG CEO pays attention to the sensitivity of the new system:

“Our method is one of the most sensitive in the world. If we compare the isothermal reaction in EMG systems with other similar solutions, we are guaranteed to catch 100 copies of the virus on the swab, while most other systems often give a result of 1,000 copies or higher. Therefore, the accuracy of our test is over 99,9%, while many other isothermal tests show accuracy below 95%. In the current situation, false negative results are unacceptable, since they let an infected person from observation. This is why the most accurate systems get an advantage over the rest.

Speed, accuracy and mobility make the system indispensable, for example, when checking passengers arriving from abroad, when placing a person in a hospital for a non-infectious disease, and in other situations when it is so important to quickly find out whether there is a virus in the human body or not.

Lenar Valeev: “Connection with Tatarstan has never been interrupted for a minute”

EMG, registered in Moscow, has some connection with the Republic of Tatarstan. According to SPARK Interfax system, Lenar Valeev is also the CEO and co-owner of the Tatarstan company Eidos-Medicine and co-owner of another company registered in Kazan — Eidos Robotics. In his native Tatarstan, Eidos Robotics is known for its unique development of robot simulators of patients for medical research. Under the parent company Eidos umbrella (registered in Moscow, one of the co-owners is again Lenar Valeev), Tatarstan's subsidiaries developed high-tech projects and established contacts with colleagues and investors from Japan.

“Eidos-Medicine has experience of cooperation with Japanese companies. For example, the result of cooperation with the Japanese K.K.DNAFORM was a new line of patient simulators and surgical simulators under the MedVision brand. In 2020, Mirai Genomics planned to open the production of Lifering systems for automatic diagnostics of influenza viruses near Kazan. As you can see, the cooperation with Japanese colleagues had to be accelerated," says Valeev.

Lenar Nailevich told Realnoe Vremya about how closely Eidos-Medicine is connected with the EMG project — in particular, it provides its facilities for the production of tests and reagents. For example, portable diagnostic systems EMG — the same suitcases — are produced in Kazan, among others. And another Tatarstan company is being involved in working on a new generation of tests: POZIS , part of Rostec, is involved in their production.

“The connection with Tatarstan has never been interrupted for a minute. A significant part of the production of portable devices is located on the territory of the republic. The production of test systems is underway at the Kazan Expo medical industrial park. The software and hardware part of the project is being developed there. Rostec's POZIS is also located in Tatarstan — in Zelenodolsk. EMG has become a resident of Innopolis special economic zone, which will give an additional impetus to the development of high-tech developments in the field of fighting viral infections," Lenar Valeev told Realnoe Vremya.

But the project is not limited to Kazan alone: it can be fully called global. Most of the raw materials for reagents are supplied by the Institute of Bioorganic Chemistry of the Russian Academy of Sciences (IBC RAS). Skolkovo has launched a line for bottling final reagents for laboratories.

“We are constantly expanding production, as you can see, different companies act as partners in this project," says Valeev.

Near-term plans: one million tests a week and provision for the entire country

On the question of how localized the production of tests is and whether there are concerns that it may suffer from a reduction in supplies from abroad, Valeev reassures us:

“There is no fear. Most of the components are produced in Russia with RDIF support. Only a small amount of raw materials are imported from Japan and plastic parts are imported from China. The isothermal amplifier, sample processing kits, reagents, reagent filling and reaction kits are all produced in Russia. The key Russian research centre of IBC RAS and partners from Kombiotech design bureau produce the biomass of the producer of DNA polymerase, an enzyme that is a key component of EMG tests. Finally, all commercial rights to the system belong to Russia.

Just recently, doctors have told Vladimir Putin about the three waves of testing: the first — search of the virus (what the aim of EMG tests), the second — antibodies search (enabling the identification of the already affected, with the presence of immunity to coronavirus), and the third — genetic test of immune response. We asked the head of EMG if there are plans to expand the line of tests and what to expect from the company in the near future.

“At the moment, our goal is to increase the mass production of tests for the presence of coronavirus. Our immediate plans are to reach a production capacity of several thousand portable laboratories and more than 1 million tests a week. As for antibody tests and genetic testing, these are completely different technologies. The goal of our tests is to detect infection at an early stage, including those that are asymptomatic. Antibody tests determine mainly the late stage of the disease and those who have already had coronavirus. Unfortunately, the accuracy of such tests is still in the range of 40-60 per cent. What we most need is an early and accurate diagnosis.

Valeev told Realnoe Vremya that EMG tests are already used in different regions of Russia — primarily at the production facilities of major Russian corporations, where it is critical to ensure the safety of all employees and the continuity of the production cycle. Thanks to a joint project of RDIF and Yandex, EMG tests are available for free to residents of Moscow and Moscow Oblast.

“We are certainly considering expanding the range, but in the coming weeks, we are planning to increase production of already approved tests so that they are available throughout the country," concluded the EMG CEO.