Breast cancer diagnosis by DNA: the beginning of a success story
How to turn science into moneyVladislav Mileyko, Slon.ru
How to get a grant in a country where science is not very supported? What needs to be done to turn fundamental research into a technology that works in real life? Is it possible to turn science into a business? Slon begins a series of materials about young Russian scientists who have embarked on the path of entrepreneurship.
The first heroes are Genomix, a team of scientists from Novosibirsk who came up with a simpler and more economical technology for diagnosing breast cancer than existing ones. All research and development related to technology, until recently, was carried out on grants. Recently, the creators have attracted initial investments in order to turn the project into a commercial channel and achieve practical application of their developments. The head of the company Vladislav Mileyko is a 24–year-old employee of the Institute of Chemical Biology and Fundamental Medicine of the Siberian Branch of the Russian Academy of Sciences, winner of the Zvorykin Prize in the category "Best Innovative Project". The story is told in the first person.
(Here it is, this face, in a photo from the website of the Faculty of Journalism of NSU – VM.)
I received my first investment in my project with a monetary "cutlet" at the Zvorykin Prize. Exactly one million rubles in cash – a bundle of bills, 20 cm thick. I remember stuffing money into my pockets, walking through Moscow at night and, of course, very nervous. This money, which, thanks to fate, I managed to bring home, was needed by my team to develop our technology for early diagnosis of breast cancer.
The Primzvorykin Prize is the National Innovation Award for Young Scientists and Specialists – an annual project competition held by the Federal Agency for Youth Affairs within the framework of the Zvorykin Project program. Young citizens of the Russian Federation aged from 14 to 30 years can become participants.
It all started a few years ago in Novosibirsk Akademgorodok, where I worked. The Cell Biology Group at the Institute of the Russian Academy of Sciences (about 10 people in total) has been doing its research here for many years. One day it dawned on the head of the laboratory: he figured out how to diagnose cancer at an early stage, significantly (100 times) saving on technology. He caught fire with the idea, infected his colleagues with it, found a way to get grants and began research. We studied the phenomenon of extracellular DNA, which at that time had just begun to be discussed in scientific circles. Having dealt with the fundamental aspects of the issue, we took up the development of diagnostic application technology.
The main direction of using our technology today is the diagnosis of breast cancer. At the first stage, this disease is treated in 98% of cases, but it is very difficult to recognize it in time (according to statistics, it is found only in 15% of sick women). There are several basic diagnostic methods, but all of them either do not detect a tumor in the early stages (cancer markers CA15-3, REA), or require the most complex expensive equipment and exceptional specialist qualifications. There are also so-called minimally invasive methods, when a person is literally pierced with a needle to penetrate the alleged tumor and take a sample. This is a fairly accurate method, but it is even more painful. In addition, physical penetration into the tumor can provoke malignant activity in it.
The key advantage of our technology is the price. Accurate diagnostic methods cost about $400. The cost of our test is $3. At the same time, it can be done by a minimally trained laboratory assistant in the conditions of the simplest clinical diagnostic laboratory. The patient simply donates blood during a routine medical examination: a standard sample of venous blood is taken for examination, then it is sent to the laboratory, where circulating DNA is isolated and analyzed using PCR.
It would seem that a blood test is the most convenient and easiest way to detect the presence of a tumor in the body. But not everything is so simple! Those markers that are being analyzed in the blood today are extremely non-specific. Their appearance may indicate an inflammatory process, trauma, and simply about individual characteristics. It is much more accurate to identify tumor cells by analyzing circulating DNA, which carry virtually all the information not only about the presence of cancer, but also about its features, histotype, prognosis of the course and much more. But there are problems here too: DNA from tumor cells is only a small fraction of the entire circulating DNA, this is not enough to make a diagnosis. The solution to this fundamental problem was found within the walls of our laboratory: we began to get from the sample not only DNA fragments floating freely in the blood, but also those molecules that are firmly connected to the surface of blood cells. And their area, by the way, is up to several square meters per milliliter of blood – there is where to collect material from!
All other existing technologies, in our opinion, are simply frightening. Women are forced to undergo an X-ray examination. This is a painful procedure, and women are afraid of these devices and avoid preventive examinations. The global market for such X–ray procedures is slightly less than $23 billion. And we want to "eat" a serious share of this market.
In 2004, our laboratory received several grants and began research. A team of 10 people in the Cell Biology Group of the Institute of Chemical Biology and Fundamental Medicine of the Russian Academy of Sciences. Grants from the American Foundation for Civic Research and Development, RFBR grants, grants from the President of the Russian Federation. In total, about 4.5 million rubles, In 2006 they made a technology that already had to be tested on people.
We advertised in the local newspaper Navigator. Usually the ads in it look something like this: "I'll give the kittens to someone", "Tomorrow the water will be turned off for 2 hours" - but we suggested that women take the test. They did not promise money, they called for participation for the sake of Science. 70 people came: in Akademgorodok, participation in research is a form of leisure, along with a cinema and shopping. We found a tumor in two women – they didn't believe it, they went to double-check on an X-ray. "No tumors," they said. And only after 2 months, an X-ray revealed these tumors. After the results obtained, we immediately sent them to be observed at the regional oncological dispensary, where the tumors were found during the examination (with the help of an X-ray).
In 2007, the grants ended, and the work stopped. At the end of 2010, I sold my DNA kinship company and came to the laboratory with the words: "Let's defrost the project." I started looking for investors, writing letters to funds, went to Boston – it was useless. In the States, they did not believe that such a technology was possible in Russia, and in Russia they wanted to invest only in IT. I decided to give up everything, when suddenly a million rubles "fell" on me in the form of that very bundle of bills – young scientists were encouraged. Recently, we have attracted another 5 million rubles – in the form of a grant from the Ministry of Health and Social Development.
It so happened that at some point at the "highest" level, a recommendation was given to pay attention to our project. We started receiving emails and answering a lot of phone calls – people from different authorities and organizations praised the technology and asked to send a presentation. I promptly sent it. This was the end of communication with potential investors: the recommendation "from above" was formally implemented, attention was paid to us. At the same time. And only Nikolay Semenov, the head of the innovation department from the Ministry of Health and Social Development, who had just joined the civil service from business, called to Moscow to talk. I remember all the details of the meeting well.
First I talked about the technology. Semenov nodded and really listened. He liked what I was saying. He began to tell me that the technology would be included in a long-term program... With the words "long-term program..." I realized that I would have to wait at least five years for money.
"Money is needed urgently. And either we are getting them in Russia now, or we are being sold to foreigners. Then in 5 years you will buy our products 10 times more expensive," I said. The words worked. Of course, I had to prepare a little more than 800 documents with a total weight of 3 kilograms to receive a grant. But we received the money within a year. This is a very good result for state investments.
In October of this year, we passed the Skolkovo examination and became its residents. On the one hand, it would be possible to start selling technology right now. On the other hand, it's early. If you finish R&D, develop a little and "pack" the technology, the company's value will soar by an order of magnitude. 27 million rubles are needed for this – and we will look for them.
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25.11.2011