DNA diagnostics: a success story

Mutations as a businessAlexey Leontiev, "Expert North-West"
Alexey Weather: "The threshold for entering the DNA diagnostics market from the point of view of financial means is minimal.

You need to have the appropriate basic equipment, but the main thing is knowledge" (photo: INGRIA).

Any science-intensive field, developing, constantly opens up new markets. In 90% of cases, a young innovative enterprise will try to catch on to a new trend, so that then the market itself will ensure stable growth. The history of the St. Petersburg company Fractal Bio, which supplies reagents for DNA diagnostics, is an example from a textbook. It was formed on the basis of the Laboratory of physiological Genetics of St. Petersburg State University, received an impetus to development by winning several tenders for the development of research and development (R&D).

At the same time, there are few such examples in Russian conditions – either because there is no established infrastructure to support and stimulate small innovative companies, or because innovations take root slowly. So it's just right to call "Fractal Bio" unique – she was able to create a new product and find customers. Alexey Weather, the founder of Fractal Bio, as well as the Biocode company, a resident of the Ingria business incubator, which spun off from it into a separate project, told Expert S-Z about how difficult it is to find a new market and work on it.

– When we talk about DNA diagnostics, are we talking about a market that is just emerging?

– DNA diagnostics should be divided: different directions have different developments. There is an infectious diagnosis – for chlamydia, hepatitis, etc. It is already quite developed – the market has existed for six or seven years. There is a DNA diagnosis of genetic diseases, that is, an analysis of a person. This niche is just being formed. There are organizations that conduct such research, but only in the simplest version. The method of detecting mutations is the same – polymerase chain reaction (PCR), but the method of detecting the results is different. The simplest option is when we are in jelly, that is, in agarose gel, looking under ultraviolet light, what was synthesized. And you can monitor in real time so that the device shows whether a specific product is accumulating or not. This method is more sensitive, higher quality in terms of purity of work, but requires special equipment – amplifiers for real-time PCR detection. The systems we are developing are for the real–time PCR method, which is just beginning to develop.

With and without the help of the Ministry of Health– How did you find this niche?

Performing research and development on the orders of the state?

– Indeed, we started with the implementation of state research contracts, participated in tenders, won and implemented programs. The first customer was the Federal Agency for Health and Social Development, then – Rosnauka, then – the Federal Medical and Biological Agency, in parallel with it – the Ministry of Health of the Russian Federation. At the same time there were two state contracts for the supply of reagents.

Of these government orders, one research and one order for the supply of reagents concerned solutions for real-time PCR-based research. The rest is from the field of DNA diagnostics, but in a slightly different area. For example, our first research contract is real–time DNA analysis, but using isothermal amplification instead of PCR. This direction is not developing at all in Russia: it is too time-consuming method.

At the same time, everything we did was done with the idea of how we could commercialize our skills and knowledge in the future. We fulfill contracts, get additional ticks for implementing complex projects, and we invest the money we receive in internal development and promotion in a key direction. Because the margin for intellectual activity is quite high, we need equipment and reagents, but the brain gives the main profit.

– What prompted you to switch from the implementation of state contracts to the creation of your own product?

– There are practically no new research programs in 2010, the Ministry of Science and Education does not announce anything, and what the Ministry of Health announced is primitive and simple. There are no serious works. So the need to urgently bring something to the market independently became obvious even before we had a finished product.

The only project that remained with us at the beginning of 2010 was an order from a state institution for reagents for the diagnosis of mutations. He became the starting point: I analyzed the market, went to a conference of medical geneticists, talked with specialists there. And it became clear that this area of human genetic analysis for hereditary diseases is developing and will continue to develop.

– Is our gap in DNA diagnostics great from other countries?

– First of all, there is already a market for DNA diagnostics of genetic diseases in the West. There are more than a thousand genetic diseases themselves, new ones are constantly being found, and, of course, no one tests everything. But in Europe, the diagnosis of 20 main ones is already the norm. There is no such thing in Russia yet.

There are probably several reasons. Firstly, the hardware base is the devices that are necessary for DNA diagnostics. Five or seven years ago, the equipment of laboratories of medical institutions was very scarce, now the situation is changing. In addition, domestic devices have appeared, which are one and a half to two times cheaper than European ones. The second reason is the knowledge of doctors and their understanding of how to apply diagnostics, what conclusions can be drawn based on the data obtained. As far as I remember, the medical education program devoted 42 hours to genetics over six years of study. During this time, it is difficult to tell something about genetic diseases.

The main thing is desire– What investments does what you do require?

Is a small laboratory and relatively inexpensive equipment enough?

– The threshold for entering the DNA diagnostics market is minimal from the point of view of financial resources. You need to have the appropriate basic equipment, but the main thing is knowledge. Multimillion-dollar investments in the development of production are not required. I planted a laboratory assistant, clearly prescribed what in what sequence he should do, what substances to drip in what quantity. He dripped into test tubes, pasted a label – and the product is ready.

But in terms of expanding the line – to sell kits to one medical institution that are capable of testing all 34 major mutations – everything is more difficult. Here we already need the work of specialists and individual studies. This is our main problem and task – the need to expand the product line.

– It is clear why Fractal Bio appeared: research and development orders for reagents are a logical step to start selling reagents for DNA diagnostics on the market. But where did "Biocode" come from – a company offering IT solutions, albeit for the same DNA diagnostics?

– When developing reagents, it is necessary to carry out bioinformatic search, analyze genetic information. You can do it with your hands, you can do it with the help of calculations on a computer, which is obviously faster. And we understood that many people face such problems. So the idea of a "Biocode" appeared, and it was formed. Then, when we started developing reagents, we saw: yes, it's easier to work with real-time PCR.

But with the help of a computer for a laboratory assistant, everything can be simplified even more. The software that develops the "Biocode" is, roughly speaking, a programmed analysis technique. We attach instructions to our reagents: mix this, put it there, analyze the results according to such and such a formula. But all this technique can be "shoved" into a computer. The laboratory assistant selects the disease, the kit, the brand of the device – and the program begins instructing. He executes it, enters the patient's name and receives a standard report two hours later. There is no need to analyze anything, to understand it specifically. At first, we developed this product as a competitive advantage – an addition to our kits. But now we see that this is a separate product with which you can grab a piece of the infectious diagnostics market.

Portal "Eternal youth" http://vechnayamolodost.ru15.11.2010