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‘At the peak, we could be talking about millions of tests’ An interview with the CEO of Russia’s largest medical equipment company on the country’s coronavirus prospects and his own struggle to get a test approved

Source: Meduza

On March 16, Deputy Prime Minister Tatyana Golikova announced plans to multiply the number of coronavirus tests available in Russia and start free testing throughout the country. So far, however, the only test system in use in Russia is a kit developed by the Novosibirsk state-owned research center “Vektor.” Conducted in two stages, these tests are not highly sensitive, making them prone to false negatives. The Russian company “DNA Technologies,” which specializes in medical equipment and producing reagents for analytical tests, has designed its own coronavirus test, but regulations imposed by the Federal Service for Consumer Rights Protection and Human Welfare (Rospotrebnadzor) have made trial studies impossible. Meduza spoke to DNA Technologies CEO Vladimir Kolin to find out more about testing in Russia, its accuracy, and what to expect as COVID-19 spreads further.

Meduza: How do coronavirus tests in Russia work right now?

Vladimir Kolin: The main testing method for coronavirus is PCR [polymerase chain reaction, a method of amplifying certain pieces of DNA from a sample to detect their presence]. They take a swab from the upper respiratory tract [the nose and throat] or they collect phlegm from the lower respiratory tract after coughing.

I can explain this mechanism in very rough terms — it’s based on the mechanism of cell division and reproduction. The virus is basically encased RNA. We need to destroy the membrane, isolate the RNA, and convert it into cDNA. We get a kind of soup that contains a lot of different DNA: bacteria, viruses, human DNA. Then we need to determine if coronavirus is present among all this variety. The RNA of coronavirus SARS-CoV-2 has certain characteristic segments. We synthesize a small piece of its DNA — the target — and look for this same DNA in the soup. If we find it, then we can multiply it using a natural mechanism and thereby see the virus. This process requires reagents [a number of chemical and biological substances that are combined with genetic samples to perform tests] and equipment. Many are now criticizing Russian medicine, but not for our PCR technology, which is highly advanced. We have PCR tests for HIV, hepatitis, chlamydia, and genetic diseases. Roche’s real-time PCR [RT-PCR] patent limits the use of this method in Japan, Europe, and the U.S., but not in Russia, Asia, and Africa. For that reason, the use of PCR research in Russia and some Asian countries is greater than in Europe, Japan, and the United States. We have a large number of laboratories with well-trained specialists, and high competition means the cost of research [in Russia] is the lowest in the world. There are reagent manufacturers and equipment producers. What’s key is utilizing all these resources.

Why have tests been so unavailable across Russia? You can’t find them in hospitals.

At first, the state opted for centralization. There’s Rospotrebnadzor, which is responsible for countering the epidemic nationwide. Because the risk of infection is so high, they instituted strict requirements for laboratories that conduct this research, and they’ve limited access to samples of the virus, even for test developers.

To demonstrate that a test is effective, you have to get a sample of the virus somehow. If you don’t get it, you can’t test the accuracy of your kit. This [getting permission from Rospotrebnadzor’s leadership] has become a problem. Maybe it’s because of the high pathogenicity level [the virus’s ability to harm the host] — maybe there were fears that the situation would get out of control. There might be other considerations as well, including political ones. In any case, we were unable to test our tests quickly within Russia. We started looking into possibilities for getting a sample of the strain from China and held negotiations with our European partners. Some private companies were willing to help us; they said, “Send it over — we can check how well your test works.” We even sent our kits to an infectious disease hospital in Belarus. They checked them and said the tests worked correctly, that they did detect the coronavirus.

How much time did you spend on that process?

Two or three weeks. Collaborating with the Ministry of Industry and Trade really helped us — the Ministry’s portfolio includes the development of the medical industry. All of those steps taken together did change the situation for the better: We were given access, and we were able to get permission to test our kit in Moscow. If the results are positive, then we’ll be able to register and go to market. Right now, the only registered tests belong to the Vektor state scientific center and the Center for Strategic Planning and Biomedical Health Risk Management (TsSP), which is a federal state budget institution under the Health Ministry. The more registered kits there are, the better for the government. There’ll be competition, and we’ll get enough experience to show which choices are best. The fact that we didn’t make that move right from the beginning was not optimal given the fact that Russia has good, high-quality manufacturers. The government should be taking advantage of that, but instead, the decision was made to centralize everything.

When will you be able to test the test in Russia?

We have an agreement, but for various reasons, we still haven’t been able to test it. We hope that will happen very soon.

If there are more tests, will there be more testing, too?

Right now, the number of laboratories that are allowed to conduct tests is quite small. These are labs that have permits to work with particularly dangerous infections, and most of them are under Rospotrebnadzor’s umbrella. But as the scale of the disaster grows, the demands on these labs will probably start to decrease. Today, it was announced that “Invitro” will start conducting coronavirus tests — as far as I know, they’ll be using tests from TsSP in the Health Ministry. How to increase the number of labs that can perform tests is exactly what’s under discussion right now. There’s an example to look to with labs that test for HIV and hepatitis, which are also quite infectious and high-risk, but the protection requirements for laboratories are lower. As of now, they’re looking into the possibility of using more state-owned labs for these trials, but there are private labs as well.

In theory, there are a lot of laboratory resources throughout the country, and we just need organizational decisions about where information about sick patients should go and how and how it should be regulated. In France, for example, only the Pasteur Institute was allowed to test at first, but then they started bringing in private labs. On March 9, some of their websites posted a notification saying they had permission to conduct tests.

Another concern is the sensitivity of the tests Vektor is making. Vektor says the sensitivity of their test system is 10⁵. In tests for other viruses, sensitivity is higher — 10³.

I wouldn’t want to criticize anybody. Vektor was one of the first to make a test at all, and they released that initial tension in the market, which is not bad. When they were developing their tests, there still weren’t any recommendations on how to do the diagnostics or which sections of DNA to sample. We developed our test later on and looked more into what people were doing abroad. We’re announcing a sensitivity of 10³, but now our test is going to be tested, and we have to check that number using real samples. There is some likelihood that the precision will be higher. The new tests from TsSP at the Health Ministry also have a sensitivity of 10³.

Is it possible to compare the Russian tests to the foreign tests in any way?

I don’t know. Of course, 10³ is a more anticipated number than 10⁵. The higher the sensitivity, the better. But abroad, there are various kinds of kits as well, and not everything is really so rosy. Russian companies are developing kits on a solid, world-class level. Not only that, but all the [Russian] companies, including ours, are exporting reagents. They [other countries] are buying our tests.

A lot of people are frustrated with the fact that we’ve performed more than 100,000 tests and only found 114 patients. How do you feel about those numbers?

You know, they have me worried, too, but on the other hand, there is a certain percentage of severe cases in the world. It’s a known proportion. I don’t understand how someone could hide the fact that any given severe case stems from a coronavirus infection — there should be some investigation of the causes behind any lethal case. And if a lethal outcome does take place, then the viral count is sufficient [for a positive test result]; it’s impossible not to find it. And in Russia, not a single lethal outcome or severe case stemming from the coronavirus has yet been found. That’s an indication that our infection rate is still not very high. I think it’s unrealistic to think that somebody has been hiding [severe cases]: The doctors understand the risk themselves, and they don’t want to get infected. Even in China, which is authoritarian and closed off, they couldn’t hide this.

That said, 100 cases out of 140 million people is really quite small relative to other countries. There are several possible reasons [for that disparity]. First of all, we have fewer tourists than Italy. Fewer people go abroad. The country is more widely distributed — the population density is lower. All of these factors are working. Based on the percentage of severe cases and lethal outcomes, I believe the official statistics here are closer to the truth. On top of that, the speed at which the number of confirmed cases is growing shows that the stats are trustworthy to some degree.

How many coronavirus tests would we need to cover the entire country?

That’s a good question, but I don’t have an answer to it yet. We could be talking about millions of tests, especially at the peak of the epidemic. This crisis has also become a litmus test for the situation surrounding import phase-outs in Russia. Even though both journalists and doctors reacted negatively to import substitution in Russia, and people always said imported products are better than Russian ones. What do we have now? It’s no secret that some governments are starting to ban exports of medical products. And in Russia, the question will arise of how we can provide our population with the necessary personal protection equipment, masks, single-use clothing, testing equipment, reagents, and so on.

I’m not saying one option is better or worse. That’s another question. But we could end up in a situation where nobody is sending us medical products or equipment. We have to understand that it’s not simple at all to ramp up production and that the production cycle itself is long. Our equipment has a half-year production cycle — inertia is high. To increase production by 10 times on short notice is impossible.

Right now, the demand for equipment in Russia is very high, but meeting it quickly is difficult. It’s easier [to rapidly increase production of] reagents.

[Our company] can produce research kits for about 100,000 patients per day. That number could be doubled if, say, we work in two shifts. There are other major companies that could produce at least as much: the Central Scientific Research Center and Vektor-Best in Novosibirsk. The situation with equipment is tougher. There’s only one major equipment manufacturer, and that’s us.

If the government had just told manufacturers in time that it needed a coronavirus test, then the situation would be less constrained.

What’s the percentage of imported components in your tests?

About 15 or 20 percent. There are concerns about single-use test tubes because those basically aren’t produced in Russia. But some amount has been accumulated, China is recovering, and we haven’t felt a deficit so far. Now is when we’re going to see how well we’ve substituted for our imports in these past few years.