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History

Development of SmartAmp

The SmartAmp technology was developed by Professor Yoshihide Hayashizaki (98th on the h-index) and his team in 2007 at Riken (Japan) – a major scientific research institute. In 2009 the technology was successfully used implemented in dealing with the H1N1 swine flu pandemic (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3266250/pdf/pone.0030236.pdf).

That same year, SmartAmp was patented in Japan (patent No. JP4370385B2) and the ownership rights for its manufacture were transferred to К.К.DNAForm, a Japanese company. Subsequently, patent applications were both reviewed and approved by the U.S. Patent and Trademark in 2012 (US8206902B2) and the European Patent Office in 2014 (EP1712618B1).

Development of Japanese-Russian partnership

Meanwhile, when SmartAmp was developing in Japan, Eidos – a company specializing in the development and production of medical equipment, emerged in the city of Kazan. Its product range includes medical simulators to train healthcare professionals and practice medical assistance techniques across a wide range of specialties (first aid, resuscitation, laparoscopy, etc.). The company started cooperating with K.K.DNAForm in 2014 thus facilitating the introduction of medical simulators to the international market. Eidos strives to continuously improve its products and the high quality of its medical simulators, which by now have been recognized by the Russian and international medical community.

In 2017, in Moscow, a new company was set up – Genetic Technologies. The company’s mission is to bring scientific research in genetics into medical and healthcare practice to increase the availability of the latest technology for the public, and to improve the quality of life in Russia. The company stimulates the development and facilitates the implementation of research in the clinical diagnostic genetic testing field for medical purposes. This includes non-invasive prenatal testing (NIPT), oncogenic gene panels (79 genes), and whole genome sequencing including a full report and consultation by specialists.

The company has been successfully cooperating with a number of international and Russian companies. In 2019, talks with K.K.Mirai Genomics were initiated on implementing the new SmartAmp molecular genetic technology and localizing it in the Russian healthcare sector to diagnose infectious diseases in a fundamentally new format: rapidly, accurately, and right at the “patient’s bedside”. Subsequent events have demonstrated that in the near future these technologies would be in extremely high demand both in Russia and globally to combat the new adversary and to save lives.

The purpose of SmartAmp

It soon became clear that the SmartAmp technology was a new step forward in the diagnosis of infectious diseases and could meet the demand for a safe, rapid and accurate diagnostic procedure for patients at their hospital beds, in an operating theatre, in organizations where no fully equipped PCR laboratory is available. And so to joint efforts, a Russian-Japanese company has been created – Mirai Genomics. LifeRing and LifePad were developed – high-tech devices to instantly diagnose infectious diseases with unprecedented accuracy, sensitivity and high speed. The time required from sampling to generating results is just 30 minutes, and the entire process does not require an equipped laboratory.

At present, the LifePad device is undergoing technical testing and clinical trials, as well as the registration process in Japan. It is also subject to approval by the FDA (the Food and Drug Administration) in the US, while the results of the first clinical trials in Russia have already been received.

A new challenge to humanity: the COVID-19 (SARS-CoV-2) coronavirus pandemic

In December 2019, first cases of the new COVID-19 virus have been identified in China. In January 2020, the Diamond Princess cruise liner approached Japan’s coastline, and among its passengers clinically ill and infected people were detected. The Japanese government, together with the Riken research institute, reacted swiftly to the situation. Professor Yoshihide Hayashizaki and his team synthesized new SmartAmp components to diagnose the COVID-19 virus as quickly as possible. This enabled the Japanese authorities to evacuate the cruise liner and obtain the first highly valuable epidemiological data on a number of the virus’ characteristics: its ability to spread quickly, cases of both asymptomatic progression of the disease and its mild forms, etc.

On February 20th, 2020, the Japanese authorities began to evacuate passengers from the cruise liner using the results obtained from the testing systems: https://www.niid.go.jp/niid/en/2019-ncov-e/9417-covid-dp-fe-02.html

On February 27th, 2020 an official press conference was held which announced the successful use of the technology for the diagnosis of the coronavirus infection, which had made it possible to evacuate the cruise liner in such a short time and stop the spread of the virus among its passengers (https://www.japantimes.co.jp/news/2020/02/27/national/riken-coronavirus-test/#.Xpdkty17GuU ).

Russia joins the common fight against the invisible enemy

Events unfolded rapidly in both China and worldwide. It became clear that Russia would very soon require reliable, fast testing systems to fight the oncoming infection as effectively as possible. In the shortest possible time, a Russian-Japanese company, Evotech Mirai Genomics (EMG, taxpayer ID number 7728364310, tax registration reason classification code 772801001, main state registration code 1177746213512), specializing in new-generation rapid testing kits was established. The co-founders of the company were K.K.Mirai Genomics and LLC Genetic Technologies. The company’s mission is to improve diagnostic methods for infectious diseases, and to implement diagnostic systems at the earliest possible stages of contagion to mitigate the course of the disease in people and to improve the epidemiological situation in places with higher population density.

Understandably, scaling up the production of the systems across the entire country required significant investment. At this stage, seeing the potential of this technology, and how vital it would be not only for Russia but also for other countries, the Russian Direct Investment Fund (RDIF) made an invaluable contribution (https://rdif.ru/fullNews/4943/) investing in its development.

This meant that the scientific expertise, technology, strategic vision, and investment were all concentrated in one company. This enabled a fast development and implementation of this unique new molecular genetic diagnostic technology in record time – along with an innovative technological solution.

Testing the new SmartAmp technology in Russia

First and foremost it was crucial to conduct all the required preclinical trials in Russia. In a short period of time, world-class experts at the Federal Budgetary Scientific Institution State Scientific Centre of Virology and Biotechnology “Vector”, part of Rospotrebnadzor (Federal Service for Oversight Over Protecting Consumer Rights and Human Well-Being), carried out all the necessary procedures, according to the strictest protocols, and assigned the EMG diagnostic system the heist ratings: as research results showed, the system performed brilliantly on 100% of all samples tested, with a 99.98% level of sensitivity. After Roszdravnadzor registering the reagents (Federal Service for Healthcare Oversight; RZN 2020/9845 dated March 20th, 2020), the EMG testing system was approved for use in Russia, and became available to the general public to diagnose the new coronavirus infection.

Parallely, the United Arab Emirates, Saudi Arabia, and Austria expressed their willingness to conduct preclinical trials. The EMG testing system passed all their testing procedures with flying colours, and was admitted for use in those countries.

At the same time, the testing system was included in Japan’s national health insurance programme: https://www.mhlw.go.jp/content/12404000/000612063.pdf

http://japan.kantei.go.jp/ongoingtopics/_00013.html

New pandemics requires a new production scale

It did not take long to resolve the issue of production expansion. Both domestic and foreign organizations quickly responded to calls for cooperation. It was calculated that in order to swiftly produce the required amount of a key enzyme, one ton of high-tech raw material, in the form of bacterial biomass, would be required. LLC “Kombiotech” made its production facility’s capacity available, and within a tight deadline produced one ton of the needed material to deliver to Japan.

Because certain key component reagents are manufactured by Japanese partner organizations, the need exists to combine the reagents into one testing kit in Russia and produce ready-made kits that are convenient to use by the end consumer. This capability was provided by LLC Sigma Lab (Moscow, Skolkovo, ISO certificate of conformity 13485-2017 No. РСК.RU.0001.P.394529), which has the necessary production capacity to manufacture up to 2.5 million testing kits per week.

An innovative solution for an “innovative” pandemic

Taking a cue from China, South Korea, and other countries, during the pandemic’s early stages it became evident that testing and early identification of infected people constituted a key mechanism to help keep the virus in check, and to mitigate the consequences of the new coronavirus infection. However, a potential shortage of equipped PCR laboratories in the country was also evident, since the pandemic’s projected scale and the necessary scope of testing was many times greater than the demand for those laboratories’ services in the absence of such a wide-scale pandemic (in “times of peace”, if you will).

EMG decided to urgently create a fundamentally new type of laboratory – one that is completely mobile. Learning from the LifePad development experience, a new device called LifeCase was quickly designed, implemented, registered and put into production. This enabled professionals to conduct full-fledged PCR diagnostics outside the bounds of a PCR laboratory. To produce the mobile laboratories on a large scale two companies, Joint-Stock Production Association Serov Plant (AO POZiS) and LLC Eidos-Medicine, made their production facilities available.

Achievements and prospects

As at the beginning of May, 2020 more than two million diagnostic testing kits have already been produced, and more than one million people have been successfully tested. Mass production of LifeCase was launched, with the expectation of more than 1,000 units per month.

EMG is in the process of developing a new-generation robot, the LifeBot, which will be able to conduct mass testing – 96 samples at once – and with the advantages of SmartAmp. With its unprecedented speed and accuracy, the LifeBot promises to be a unique and unparalleled solution in the world of PCR testing.