100 Percent Reliability

Text: Artur Toporkov
Photo: Yevgeniy Dugin

At the beginning of April in Moscow, the first in Russia joint Russian-German Centre for genetic studies U-Genios was launched, it was founded by UNIDENT Group and the Berlin Institute of Medical Molecular Diagnostics IMMD.

Elena Baranova, a physician-geneticist, headed the company. She is a Candidate of Medical Sciences, curriculum director of the Department of Medical Genetics of the Russian Medical Academy of Postgraduate Education, as well as a multiple winner of national and international competitions for students and young scientists.

Our center will be engaged in laboratory studies that help specialized medical professionals to diagnose the condition of their patient and to detect possible medical abnormalities associated in particular with the genetics. Such key – obstetrics and gynecology,

Head of the center U-Genios physician-geneticist Elena Baranova

— The German colleagues, including Professor Richard Grosse, who heads one of the largest genetic laboratories in Germany, have been dealing with these issues for more than twenty years and have gained huge experience. And now we can use this experience in our country. In fact, together with the creation of U-Genios representing the leading European genetic centers in Russia, we can safely say that the studies which were previously practically inaccessible will finally occur in our country. They were not carried out by a whole range of reasons. Firstly, it is the lack of own development in the field of applied genetics. Which naturally leads to a deficit of professionals capable of conducting such studies. It would be possible to use ready-made foreign technologies… a sufficient number of specialists makes the world's largest manufacturers wary of the Russian market – simply because due to the lack of experience their technologies can be applied improperly.

Quality assurance

Professor Richard Gross managed to break the vicious circle. A graduate of Department of Chemistry of Moscow State University, who speaks Russian perfectly and dreamt for a long time to open a medical center in the country where he started his professional career, he became one of the main ideologists of creation of U-Genios. And his name has become the guarantor of the new project quality for professional geneticists all over the world. – Our strategic partner became one of the world's leading manufacturers of reagents required for genetic studies, a Belgian company Multiplicom, – Elena Evgenyevna continues. – To date, we have opened a laboratory of incomplete cycle in the clinic on Chistye Prudy where we obtain biomaterial and prepare it for further genetic analysis. However, at this stage, the samples are sent to our German and Belgian colleagues for direct research.

Doctor of Medical Science Rachik Grigoryants

According to the general director of U-Genios, the Center of genetic studies could have opened the first such full cycle laboratory in Russia right away. But while it was impossible to do so because the reagents necessary for testing are not legalized in the country yet – no marketing authorisations have been issued for them by the Federal Service on Surveillance in Health Care and Social Development of the Russian Federation. First technical and then clinical studies of the reagents Multiplicom will be carried out, which are necessary for its certification – it is a common procedure provided for by the Russian legislation.

— For UNIDENT it is not a problem to open another medical center. Everything is restricted only by the speed of the certification procedure, — says Rachik Grigoryants, Doctor of Medical Science and consultant of U-Genios on interaction with partners and key customers. – We have a team. And there is understanding what equipment we are operating. Also we have the project and the territory. Once it will be obvious that, notionally, in four months all the necessary documents are ready, — we will begin to build the laboratory. And by the time of obtaining them we will have an enterprise unique for Russia, working on the certificated equipment and supplies, staffed by the best specialists.

The Candidate of chemical sciences Maxim Belenikin will head the laboratory, who is a specialist in the field of molecular genetics and bioinformatics, who attended in April a special training in the laboratory of Richard Grosse in Berlin. In the future, according to the heads of the Center, he will assist the group conducting in Russia the clinical studies of reagents required for their certification, and then to train a group of laboratory geneticists with the help of German professors and Belgian specialists.

Approximate launch date of the laboratory conducting a full cycle of all necessary genetic studies is the beginning of the following spring. Moreover, along with it, there is a plan to open a separate Genetic clinical center where specialized medical specialists will work ready to interpret the results obtained and to help their patients to understand them.

Availability and operational efficiency

Despite the fact that the need for clinical genetic studies exists nowadays in Russia, the demand for them can not be called global. Mainly because the companies that promise to carry out them, in fact, do it abroad, often at semi-legal and informal level. And the lack of practical application of modern technologies still made genetic analysis in the eyes of a common person something from science fiction or another episode of “House, M. D.”.

Therefore, the significance of opening of the first Center of genetic research in Russia for the whole community of Russian medical professionals and their patients can hardly be overestimated. Modern diagnostic techniques turn for them from a dream into reality. Which is tangible and accessible.

— Cost of genetic studies is quite high, and under conditions of a small market and limited offer their availability in Russia, of course, leaves much to be desired, – says Rachik Grigoryants. – Today, one test may cost about 35 thousand rubles on average. The possibility to perform a complete analysis cycle on the site will allow us to lower this bar by at least 20 percent. In the future, along with the popularization of new technologies both among medical professionals and the patients, it will be possible to talk about further reduction of the final cost of such service.
In addition, opening of the laboratory in Moscow will allow, from the viewpoint of a final consumer, to cut the objective terms of genetic analyzes almost by half. Even with the present level of development of logistics it takes nowadays about fifteen days to send the biomaterial abroad, to conduct complex tests and obtain the data back. The timing of these studies in the Center U-Genios with regard to possible cross-checking of the results obtained will be not more than a week..

Samples of biomaterial are prepared to be sent to the German and Belgian institutions for direct studies

Safety

The benefits in cost and time can be estimated in rubles, hours, minutes. It is impossible to measure only one advantage that will bring availability of new technologies to mass Russian consumer – safety. Because human life is priceless.
A simple example. One of the specialized spheres of the new U-Genios laboratory will be conducting noninvasive prenatal tests. In simple language, it is a study that enables to know whether the development of a baby is normal in an expectant mother or the fetus has any abnormalities.

– In Russia, there are two million expectant mothers annually. We can not say that each of them is our potential client. But there are women who are in risk group, – explains Elena Baranova. – As a rule, it is connected either with the age of the patient, or with her history, such as cases of birth of children with pathology earlier. Today in our country, only invasive methods of testing are available for them, which are risky themselves. This is a complex procedure, sometimes leading to serious consequences. If of the uterus has been punctured during collection of material for research there is a likelihood that the side effect will be the termination of pregnancy.

The probability of this is about two percent … And now imagine a thousand of women, each of which is sent for the invasive test. According to statistics, at least half of them simply would refuse the tests. The second half would agree and, notionally, in one in five of these women, their tests will show a positive result, the rest 400 women would undergo the invasive uterine puncture procedure in vain. But the most terrible thing is that about ten women who would bear a perfectly healthy baby would lose it simply due to imperfection of the research methodology.

– The same thousand women will undergo the non-invasive testing quietly, without any risk for themselves and the unborn baby, – continues Elena Evgenyevna. – Thanks to the latest technologies nowadays we can detect the presence of the same spectrum of markers, by subjecting to genetic analysis a simple blood sample of the expectant mother. This completely eliminates any risk. And no those two percent any more.

Candidate of Chemical Sciences Maxim Belenikin, a specialist in the field of molecular genetics and bioinformatics

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