It is not possible to test them all on COVID-19, says co-founder Diana Biotechnologies

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Your company Diana Biotechnologies produces approximately a quarter of all currently used coronavirus tests in the Czech Republic. At the same time, until recently, you did not pay attention to this area at all. Was it difficult to persuade hospitals to bet on an unproven product in a crisis situation?

Coronavirus has been tested practically since the beginning of the epidemic, we started quite late. Until then, we were primarily concerned with the development of new drugs and new diagnostic methods, but we did not produce diagnostic tests ourselves. We started developing tests for COVID-19 about a month after the epidemic began. Within the Czech Republic, possibly worldwide, however, we have unique expertise in, among other things, laboratory automation. Thanks to this, we were able to develop and launch these tests in a very short time.

What’s going on?

This is not a new technology, but we produce tests in a format that is suitable for automation. We supply hospitals with a ready-made solution – they receive from us both kits with the necessary chemistry and a device that allows the evaluation of up to thousands of samples per day. We came to the market relatively late, at the turn of July and August, but about that time we perform a new installation in the diagnostic laboratory almost every week. Now, about 7,000 tests a day are being evaluated on our devices in the Czech Republic, and more will be added. Our advantage is that we are a Czech company, which means stability of supply. Many laboratories turn to us not because their previous technologies did not work, but because their foreign supplier stopped supplying the Czech Republic.

Have you noticed interest in your goods abroad?

We are registering a large demand. After all, our very first installation was not in the Czech Republic, it was in a Polish laboratory. But then we stopped abroad, because the demand on the Czech market is such that we did not manage to satisfy it. So far, we are increasing our production and personnel capacities. And once we are in a position to serve foreign markets, we will focus in this direction.

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How many people have you hired since the beginning of the year?

At the beginning of the year there were 13 of us and now there are 20 of us and we also hire part-time workers. But given the number of tests we do, it’s not much. We say that for every human being we also have a robot that will do the next job. We have a great deal of automation here. In addition, we have now rented new premises, are moving production there and the degree of automation there should be even greater. We now have a capacity of 300,000 tests per month, the new line should at least double that.

What can a patient find out about a PCR test to see if he or she is infected with coronavirus?

For the time being, the tests are used only qualitatively, ie positive / negative. The PCR method is in principle quantitative. This means that it also provides you with information about the amount of virus in the sample taken. It is certainly not an absolute number from which unambiguous conclusions can be drawn, moreover, the viral load changes during the infection, but it is other supporting information that could be used. Interestingly with coronavirus, individual patients can vary dramatically in the amount of virus. You have patients who have dozens of copies of the virus in the sample, and you have patients who have billions. In a situation such as this now, when hygiene and tracing systems are overloaded, it is important to consider giving preference to patients with a higher viral load when tracing.

So if a patient has more virus in their body, are they more likely to infect their surroundings? Or that he has a more severe course of the disease?

So far, the parameter of the amount of virus in the sample has not been worked on much. This means that solid data linking the severity of the course and possibly infectivity to the amount of virus is still lacking. But I think that at least in terms of infectivity, the correlation with the viral load detected in the test will be relatively large. There is also a consensus in the professional community that it depends on how much virus you get infected at the beginning. And this tends to have an effect on the severity of the course. But using tests to predict the course of the disease can still be difficult, and we would need more clinical data for that.

There is talk that a PCR test can be false positive…

The false positivity of the PCR test is really small. It almost never happens that the test shows the presence of viral RNA and it was not in the sample. But it happens that patients who have already had the disease are still positive for PCR tests, but when they tried to multiply the virus from their samples in the laboratory, they did not succeed. There is a hypothesis that these people still have some remnants of viral genetic information in them, but the virus is no longer present in a form in which it would be able to infect someone else. For example, in the Czech Republic, a policy has been adopted that ten days after infection, a person is released from quarantine on the grounds that he is no longer infectious. But I would be careful here, even though we know that infectivity decreases as the disease progresses.

So do you consider the ten-day quarantine too short?

It is a pragmatically chosen time based on the data available. We are talking about medicine here, which is never 100%, so there will definitely be some exceptions. But somehow you have to set up the system.

During the spring wave of coronavirus spread, some countries, where the situation deteriorated sharply, stopped testing populations who came in contact with those infected. Does testing still make sense in the Czech Republic?

It definitely makes sense to test. But perhaps the question is who should be tested in this situation. If the epidemic is very severe and you have patients with clear symptoms who are isolated, then testing them may be unnecessary to some extent. But it is still very important to test people in key positions. This means, for example, doctors, staff in retirement homes or employees in companies key to the economy. The argument not to test would apply when we closed the whole country and people did not meet at all. We are still not close to the population being wasted, and that is really not the way we should go. Although the situation is undoubtedly dramatic, we are certainly not close to the fact that everyone in the population is infected. This means that it still makes sense to identify infected individuals and isolate them in time. Along with wearing veils and respirators and restricting large actions, it is the most effective tool for preventing the virus from spreading.

In the summer, you announced that you were developing a PCR test for COVID-19 from saliva. How far are you?

Technically, the test is developed, we use it in our laboratories, we test our employees and measure validation samples. We have a large clinical study ahead of us, which we will start in one of Prague’s major hospitals. For thousands of patients, we perform a standard PCR test from smears and, at the same time, our test from saliva. We hope that what we see in the laboratories will be confirmed, ie that the results correlate well and that it is possible to detect even a very small amount of the virus from saliva and detect infected at the earliest stage of infection. We then submit these results to the regulator and request approval of the test for clinical diagnosis.

How long can this process take?

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