Exacte Labs

Accuracy is virtue of laboratories

There is an opinion that technoparks are focused exclusively on industrial production or IT-technologies. However, they can be an ideal place for companies with different profiles. So, the Slava technopark accommodates the Exacte Labs laboratory center performing medicinal product analyses and medical tests. General Director Vasily Kazey told the Investportal about their research subject and unusual name, as well as a little about India.

- Vasily, your company's name is quite unusual...

- Yes, it is. We started in 2011 as a laboratory that provided services to determine the medicinal drugs concentration in the blood plasma. Determining concentrations actually refers to analytical chemistry, where the main quality parameters include reproducibility and accuracy. "Accuracy" is a good word, but it would be strange to use it as a laboratory name. We looked up the word "accuracy" in other languages. It is “exacte” in Latin. We liked it, it sounded very original. As a result, a company was registered under this name.

- And why did you choose this kind of business?

- In 2011, the Government introduced a federal law that obliged all pharmaceutical manufacturers, without exception, to partially carry out research for their drugs in Russia. One can say, that this law made western pharmaceutical companies look for laboratories in Russia.

Of course, it was still possible to conduct laboratory studies in Europe, India and Canada, but the samples shipping costs a lot of money and takes quite a long time. In addition, if you, for example, order a study in Canada, you receive the report in English or in French. You need to spend both money and time for translation. While for big pharmaceutical companies money is not the most important thing, time is extremely important. Imagine that you spend a month for shipping, and then some time for translation. It is almost two months of active drug sales that can cost a fortune, a lot more than translator services.

The new law opened a niche of laboratory research for pharmaceutical companies. I was engaged in similar activities at my previous job, so I felt this niche right in time and decided to try entering it and see what eventually turns out. At the time, this niche was quite new for Russia, because there were practically no separate laboratories. In a sense, our company was one of the first players on this market.

- Could you please tell more about your company’s activity? What exactly are you researching?

- Our key activity is the reproduced medicines research. All the drugs on the market can be divided into two groups: original and reproduced (generic) drugs. The original drug is subject to a set of tests, which takes 7 to 10 years, and has a period of "exclusivity” protected by a patent after entering the market. After the patent expires, you can bring to the market a generic drug, for which you need to carry out one relatively small study, which is called the bioequivalence study. Within its framework, healthy volunteers first take the original drug once, and after a couple of weeks take the generic to be examined. Then the volunteers’ blood plasma samples are collected, to determine the original drug concentration first, and then the reproduced drug concentration. After that, research data are compared. If the concentrations of the active substance in blood for the original and generic drugs are similar, then those drugs are equivalent. We explore samples and provide reports to pharmaceutical companies.

We are also engaged in clinical diagnostics. In this field, we carried out tuberculosis tests for a year using the immunological method. Classical diagnostics include intradermal tests (Mantoux test, Diaskin-test) They are not always convenient, for instance, because you need to visit the doctor twice; first you get an intradermal injection and then the size is measured. There are other aspects as well. if you were previously vaccinated with BCG, the Mantoux test is likely to show a positive result. To date, there is a new generation of tests that can determine the presence of the causative agent of tuberculosis by lymphocyte immunological response. Simply put, if a person's lymphocytes have previously met a bacterium, it will be shown by the study. So, by analyzing the blood sample, we can find out whether the tested person has (or has recently had) tuberculosis. The test is not included in CHI, so it is paid for by the patients themselves. We have a contract with major private network laboratories that send us material for research.

In addition, we perform a rather interesting test showing if a tumor process is present. It allows to diagnose a tumor at an early stage. However, there is a “but” - the test does not show where the tumor is located. Thus, we can say for sure whether there is a tumor, but we do not know where it is. But at the same time, this test is relatively cheap, it only requires a single serum tube. It can serve as an excellent supplement for a standard medical checkup or examination by an oncologist.

In late 2015, we decided to enter a field that was new to us, namely veterinary. We opened the Anytest veterinary laboratory. It differs from other Moscow laboratories, since it only works with "industrial" animals - chickens, pigs, cattle.  In this niche we work with major Russian agro-industrial complexes, as well as Western pharmaceutical companies that produce medicines for animals.

- By now you have grown into a large laboratory center performing several types of research. And where did you start back in 2011?

- To be honest, it is quite scary to start something new. Imagine: you have a job, you receive a regular salary. Suddenly, you have to take a serious step, to become independent, without any support, except that from your relatives and friends. First there was a transitional stage, during which we founded a company together with my former employers. I have a degree in biochemistry and know nothing about accounting and legal matters, so my companions helped me with registration and accounting.

My companions provided me with a couple of operatives and a laboratory room. I provided equipment and research contracts. I managed to find the first funds, which I used to buy a chromatography-mass spectrometer that allows to accurately determine the concentration of drugs in different samples.

Sooner than in a year, it was already clear to me that, on the one hand, the concept is quite viable, and the laboratory can be a success. On the other hand, I realized that my former employers and I had to go different ways, because they had a different focus and were not particularly interested in the company development. Therefore, I decided to separate and leave the hospitable walls of my former company.

At the very beginning, the Exacte Labs staff consisted of only one person that was me. When we moved to the Slava technopark, there were already two of us, me and an analytical chemist. Now, the staff of the two laboratories makes 30 people.

- Did you consider the technopark as your new location at once? Or did you first look for other options?

- I visited various academic institutions. After all, the biochemist's first thought is going to some institute, where they already have ready laboratories, and renting something there. I had several meetings in such institutions, but the offered cooperation terms did not suit me, as they did not envisage any long-term prospects. My friends told me that in Moscow there are technoparks where we can go. At first I wanted to find some premises closer to home, but the Slava conditions were perfect, so I moved here without hesitation. Firstly, I really liked that this is an industrial building, a closed compound, located near a subway station. The whole building is based on columns, with no distinct boundaries inside, a large open  area. You see, the disadvantage of any chemical laboratory is that you need special ventilation, you need exhaust fans to remove the air with all harmful vapors. An ordinary private business center offers good conditions, a nice reception area, and elevators, but when you ask, whether it is possible to install a couple of chemical  exhaust fans, they suddenly get scared, and after you say something about acids and alkalis, they just lose interest immediately. In the Slava technopark, it was told to us: "Do whatever you want, just show us the preliminary project and observe fire regulations". In December 2012, we signed an agreement with the technopark.

Initially, we occupied an area of 110 square meters, and now the laboratory occupies located 510 square meters. We added 40 square meters first, then 160 and later another 200. This reflects the dynamics of our company. An important advantage for us is that the technopark has its infrastructure: for example, twice a year we hold a conference in the lecture hall. In addition, the technopark is an environment where residents closely interact with each other, and many internal links are created. Once, we bought from our neighbors some equipment, which they no longer used, and we are selling our services to the neighbors above.

I knew nothing about preferences for technopark residents and, honestly, I did not even care, it was too important for me to find a suitable place. However, I sincerely welcome any support measures. I hope, that this year we will get our first experience of this kind. We are very interested in and are preparing documents for taking part in a program, which allows you to get a partial compensation for the cost of equipment. I must say, that the technopark itself is already a strong support measure! If we suddenly have to relocate, I will only consider technoparks.

- Do you plan to enter the foreign market?

- Currently, we are almost 100 percent loaded, so there is no free instrument time which would allow to actively search for orders. There are not so many laboratories in Russia, so the competition is not too high. If we expanded the laboratory and increased our equipment pool twice, it would make me think about entering the western market. I think we can be very competitive.

In such market, India has always been the leader. They did everything twice cheaper, but the quality was not very high, they were repeatedly caught in this, including by the US Food and Drug Administration and the World Health Organization. It went so far that the US Administration published on its website a letter, where it advised against conducting research in India. This somewhat revived and cheered the European and Canadian markets, as most pharmaceutical companies there have stopped having their research carried out in India.

There are very large laboratories in Prague and Barcelona. I am sure that we can do no worse than them and much cheaper. But this requires additional equipment. And one device costs about 400 thousand dollars. We are not so big, and for us the purchase of each piece of equipment is an achievement. While, during their best years, Indian laboratories had 100 instruments each, and the European ones had 20, a large laboratory in Russia is one with about 5. At the moment, we have 4 devices.