Early diagnosis of cancer: only 12 million rubles are needed for revision
New opportunities for cancer diagnosis
Yu. Alexandrova, "Science in Siberia"On December 14, during the closing ceremony of the III All-Russian Innovation Convention, which takes place within the framework of the forum "Russia, forward!", and the annual presentation of the Zvorykin Awards, the winner in the nomination "Best Innovative Project" was named in Skolkovo near Moscow.
This time the winner of the national prize in the amount of one million rubles was our countryman Vladislav Mileyko, a graduate of Novosibirsk State University, now a graduate student of the Institute of Chemical Biology and Fundamental Medicine of the Siberian Branch of the Russian Academy of Sciences.
A day later, the young scientist and his supervisor, head of the laboratory of the cell biology group Pavel Petrovich Laktionov, met with journalists in Novosibirsk Akademgorodok. The press conference was lively, especially since the theme of the winning project is "BrEp test. The high–precision method of early noninvasive breast cancer diagnosis" is more than relevant nowadays, and the developed technology allows detecting the disease at an early stage with an accuracy of up to 95% (which is 30% higher than the methods known in the world) and distinguishing a benign tumor from a cancerous one. At the same time, according to scientists, they continue to develop the technology, looking for new markers in order to bring it to 100%.
The project involves the development and promotion of a new method of high–precision screening, which will be able to solve the most important problem of modern oncology, namely, the early detection of breast cancer.
Effective methods of treating this common disease, fortunately, exist, but there are no equally effective methods of detecting the disease yet. More precisely, they are available, but, according to V. Mileyko, they have "insufficient analytical characteristics to be able to effectively fight cancer, or they are associated with the maintenance of very expensive and complex equipment and require the highest qualification of specialists." In addition, modern methods of breast cancer screening are mainly instrumental – mammography, ultrasound, tomography. Mammography, in particular, has a number of fundamental disadvantages that it will never be able to overcome; the main one is low sensitivity (accuracy is about 70%, that is, the remaining 30% of patients do not know about their diagnosis). And then, despite the fact that mammography allows you to simultaneously determine the localization of the tumor, this is another fundamental drawback – if the tumor is located outside the area of the "mammographic picture", then it will not be possible to identify it. With certain features of the individual structure of the breast, effective detection of a tumor also becomes impossible. And one more nuance – according to American statistics, about 28% of women at risk annually avoid mammographic screening due to the fact that this procedure is quite unpleasant.
"Thus," Vladislav noted, "the problem of mortality in this case is the problem of ineffective diagnosis. It is with her that we are fighting within the framework of our project." These works have been carried out in the IHBFM for quite a long time, a lot of experience has been accumulated, which is confirmed, among other things, by publications. The method itself was developed in 2004 (and V. Mileyko joined the group a few years ago), but only during the last year it took shape as a project aimed at commercialization of the technology. This happened due to the fact that the country has increased interest in practical innovations and the development of venture investment, new opportunities have appeared for the transfer of fundamental research into the applied channel. A new high-precision method of early diagnosis is based on the analysis of extracellular DNA of blood and implemented as a set of reagents for its processing. At the first stage, the laboratory assistant takes an inert venous blood sample, then the blood is analyzed and processed in the laboratory using quantitative polymerase chain reaction (PCR).
"The principle of operation is," explains P. P. Laktionov, "that any tumor, including the mammary gland, releases nucleic acids into the blood, which have certain differences that are characteristic of this tumor. We are talking about aberrant methylation – this is the specific criterion we are focusing on. According to the latest data, aberrantly methylated nucleic acids are the potential and most acceptable diagnostic material due to their high specificity and the ability to detect them well with modern instrumental methods. So disorders in the body can be detected without interfering with the organ itself, where cancer cells are presumably present. In the process of their vital activity, they constantly divide and die very quickly, so the products of their decay inevitably enter the blood. Acids are isolated from the blood and further analyzed using the PCR method. In short, on those platforms that are now available and are available almost everywhere, the implementation of the method is not difficult (based on this platform method, in principle, it is possible to examine not only the mammary gland, but also other tumors)."
"Thus," adds V. Mileyko, "firstly, we do not depend in any way on the localization of the tumor inside the organ, there are no problems with its individual structure. Secondly, sensitivity is ensured due to the fact that a special preparation procedure and high-precision detection methods are used. At the same time, no special equipment is required – it is enough to equip a modern diagnostic laboratory, which is also important for the possibilities of wide application. However, I would like to emphasize that the staff of our laboratory did not invent some new substance for chemical analysis (this is fundamental!). As a matter of fact, we developed a protocol – how to act, how to process this blood sample, which components to add for further analysis, and did not discover specific secret reagents at all. We just learned how to use the experience that has been accumulated in this area, while adding our own unique elements of key technology. Using our method, even without special automation, a laboratory assistant can process up to 50 samples per day. If you connect automated platforms, the number will increase tens to hundreds of times, and at a fairly low cost! That is why our method claims to be widely available as a general screening."
The Institute of Chemical Biology and Fundamental Medicine of the SB RAS cooperates in various areas with numerous medical and scientific organizations, including the Tomsk Research Institute of Oncology, the Center for New Medical Technologies in Akademgorodok, the Novosibirsk Regional Oncological Dispensary. The technique of early non-invasive diagnosis of breast cancer was "tested" on large groups of women, up to 80 people, as a result of which the high analytical characteristics of the method were confirmed, positioning it as a breakthrough. "Naturally, we cannot engage in medical diagnostics without contacts with doctors," said P. P. Laktionov. – As for the technology as such, our institute is able to implement it without outside help. Well, such things as the processing of analysis data, the creation of conclusions, recommendations – all this, of course, is also carried out in cooperation. Science is not done in one laboratory, the process of integrating different specialists is necessary. At the same time, any new method requires long-term testing, and it should be based on a very specific fundamental science that explains the expected result."
According to scientists, the completion of a full cycle of research will take a little more than a year, about another six months will be required for certification: after that, it will be possible to introduce the method into medical practice. By the standards of medical technology, this is a very fast project. In pharmaceuticals, for example, such a process can take from 5 to 10 years, since, if we talk about clinical trials of new pharmaceuticals, it is necessary to coordinate with the committee, several more stages, including preclinical animal trials. With diagnostics, everything is somewhat different, much simpler – one stage of clinical trials on a large sample of people is required. Scientists presenting their method must prove its high efficiency, otherwise, they will be responsible for undetected cases of cancer. This is a matter of honesty and responsibility of the developers of any new method.
As for financing, the topic remains open for now. "We deliberately dragged it out," says V. Mileyko, "until we found out that our project was the winner. Because now new opportunities are opening up – we can talk to those who are able to provide funds on different terms. In particular, we want to apply to a Russian venture company (although we have not yet fully decided on this issue with our partner). To complete a full R&D cycle, 12 million rubles are required – the cost of equipment, reagents, human resources. And if we are provided with more funding, we will be able to start developing diagnostics of other localizations. If the amount is less, we will lay down a smaller amount of work, the information content of the received systems will be lower. Everything is interconnected – how many resources we have at the input and how many results we get at the output. In addition, if we talk about the fundamental part of these studies, we expect that they will be funded by both state funds and those organizations that are currently engaged in supporting innovative projects. And the million rubles received as a bonus will be directed to the development of the development."
Vladislav speaks confidently and enthusiastically about his work – it is clear that he knows the subject matter like the back of his hand, understands the subtleties of not only scientific, but also "innovative and innovative". Answering the question of why they rejected the offer of virtual residency in Skolkovo, which was received after the project was recognized as the winner, he explains: "it is better to implement the R&D required at the first stage within the framework of a scientific institute, since everything necessary for conducting this kind of work is already available here. I think that when the intended effect becomes obvious, we will look for an opportunity to enter innograd. This does not mean that now we doubt the relevance and necessity of such a structure as Skolkovo. We just didn't understand how this could help in our work. So it is difficult to say how the fate of our projects will develop further, on whose site we will implement them."
But about the "details of his personal life", which also interested journalists, he talks about his path to science rather restrainedly. I am from a family of doctors, I always wanted to study biology, even in my school years I participated in Olympiads of different levels, so the predestination here can be traced. Then – study at NSU. And here, says the Zvorykinsky laureate, "I was lucky to get into the laboratory of P. P. Laktionov, where serious research is being conducted at a serious level." The topic of the PhD thesis, which Vladislav is currently working on, is also connected with the development of the method for which the prize was received. "The idea came from the director of the IHBFM, Academician V. V. Vlasov," says V. Mileyko. – At first, he even "forced" us to do this with some effort – the subject did not seem promising. But quite quickly we managed to prove ourselves, to break into the world scientific community, which at first also reacted warily to the new method."
"As for the Zvorykin project," V. Mileyko continues, "my appearance there was to some extent accidental. At one time, when I applied to the Lavrentievsky Breakthrough (there was such a project on a regional scale), I received a number of valuable consultations and forgot about it until it turned out that my project was recognized as the best for participation in the Regional Innovation Convention. And that's where it started: I got to the District Convention, then I was among the finalists, I made it to the semifinals of the Zvorykin Innovation Convention Award... Of course, all this is great – the opportunity to meet top officials of the state "in the corridor", to establish valuable contacts. In addition, we managed to find out what trends await us in the further development, in the process of modernizing our economy and supporting innovation – to find out, so to speak, "first-hand", and not as guesses and forecasts of analysts."
Returning to the main subject of discussion at the press conference - the diagnosis of breast cancer, it is impossible not to mention that the method, which has not yet been launched for widespread use, has already begun to operate. During tests at the Novosibirsk regional oncological dispensary, he helped to identify oncological diseases at the initial stage in two women who did not even suspect it. "So we already have at least two saved lives on our account," the scientists–developers stated. "In this regard, it seems that this project is truly promising, has all the possibilities to be implemented and find its place in modern clinical and diagnostic medicine."
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14.01.2011