Ukraine’s scientists make COVID-19 tests. Why isn’t the government buying?

It was February, less than two months ago. The novel coronavirus had started spreading around the world, but had not yet reached Ukraine.

While COVID-19 was far from most Ukrainians’ minds, two private genetics laboratories in Kyiv created their own versions of the most reliable test for diagnosing the disease, the polymerase chain reaction test or PCR. A third state laboratory started work on the same test and finished it by mid-March.

The state lab was acting at the government’s behest. The other two decided to do it independently. Regardless, all three labs’ work attracted little attention at the time.

On March 3, the first case of coronavirus infection was identified in Ukraine. And the country did not have enough tests required to protect the nation’s health. Since then, the virus has infected over 804 people and killed 20 in Ukraine as of April 2. 

As the virus spreads, Ukraine has failed to build up testing capacity — despite the health ministry saying it wants 2 million PCR tests.

All three Ukrainian labs say they are happy to supply as many tests as they can. Two labs told the Kyiv Post that, combined, they can produce over 100,000 tests in less than a month. The third company would not reveal its capacity, but said it can make “enough” PCR tests.

But there’s a problem. The government is in no hurry to make a deal and give funding to the labs.

On March 23, Ukraine’s chief sanitary doctor, Viktor Lyashko, announced that domestic test manufacturers will soon begin mass production, but did not go into details. He repeated this on April 2 saying the mass production will start from the next week. 

So far, two out of three test producers have not heard any specifics from the Ministry.  

Building capacity

Lyashko has made it clear that Ukraine wants to make 2 million PCR tests. But the country has only met 0.19% of that goal. It has tested 3,834 people as of April 2.

In contrast, Lithuania — which has roughly the same number of active coronavirus cases — has tested 15,635 people.

To meet the goal set by Lyashko, Ukraine needs to get roughly 13 times as many tests as it has now.

So far, the vast majority of Ukraine’s tests have been provided by donors — 100,000 from a Ukrainian politician who bought them in South Korea, 50,000 from Chinese tycoon Jack Ma and 2,550 from the World Health Organization.

Ukraine has the knowledge and technical skill to make its own COVID-19 test.

Coronaviruses are common in animals and can sometimes evolve into forms that infect humans. That’s exactly how COVID-19 originated in Wuhan, China in late 2019, scientists say. 

Chinese researchers then began studying SARS-CoV-2, the technical name for the virus that causes COVID-19. In mid-January, they made the genetic sequence of the virus public. That was a key step for countries to develop diagnostic kits like PCR tests.

The PCR test is the only reliable way to diagnose COVID-19. It looks deep into the person’s DNA and searches for SARS-Cov-2. It can even detect the disease in the early stages, before symptoms are apparent. The PCR method was such a breakthrough that its invention won the 1993 Nobel Prize in Chemistry.

A laboratory technician analyses samples looking into patients’ DNA to see whether they are infected with COVID-19 novel coronavirus in the Institute of Molecular Biology and Genetics in Kyiv on April 2, 2020. (Oleg Petrasiuk)

As soon as Chinese scientists decoded the virus, their colleagues around the globe started to work on diagnostic tests for the disease. 

In Ukraine, the state Institute of Molecular Biology and Genetics (IMBG) and two private laboratories, Ukrainian Genetic Technologies (Ukrgentech) and Diagen, separately created their PCR tests in February and March.

Testing Ukrainian style

The Ukrainian-made tests are all very similar. They only differ from one another in a few ways: the raw materials they are made of, the country where the laboratory that checked their effectiveness is based, and which identifiers of the virus and its genome the tests look for in the DNA.

“Our test is designed to look for one of these viruses’ genes. Other producers’ tests can look for other genes. This target can match or vary. We, producers, are now so busy with work that we have not yet talked to figure that out,” Oleksandr Kolyada, co-founder of Diagen told the Kyiv Post.

All three labs’ tests use imported raw materials and reagents needed for the chemical reaction. They are not produced in Ukraine.

“Normally, we buy these reagents where they are cheaper, in Poland, but we also buy them from Germany, France or the United States,” said Serhiy Komisarenko, chairman of the coronavirus working group put together at the National Academy of Science of Ukraine. 

Diagen told the Kyiv Post that they do not buy reagents from Russia. Ukrgentech said the countries they buy reagents from are the company’s confidential information.

But many countries in the world are now producing PCR tests, which creates enormous demand on the reagents market, according to scientists. That means Ukrainians have to compete with everyone else for the best deal.

After the labs made their tests in Ukraine, they had to get them approved by a reference laboratory, an independent team of researchers who confirm that the tests actually work.

IMBG verified its tests in Kyiv and in British labs. Diagen verified its version in Kyiv and Germany. Ukrgentech only verified it in Kyiv.

A laboratory technician analyses samples looking into patients’ DNA to see whether they are infected with COVID-19 novel coronavirus in the Institute of Molecular Biology and Genetics in Kyiv on April 2, 2020. (Oleg Petrasiuk)

These differences do not have a substantial impact on the quality or price of the test, researchers say. Testing one person will cost roughly Hr 200-250 ($7-10) depending on the producer.

“Our tests are even cheaper than this,” said Bijan Sharopov, chief biologist at Ukrgentech.

Regardless of the lab, Ukrainian-made tests still cost half the price of foreigner ones, according to scientists.

In principle, they all work the same way. First, healthcare workers take a sample, a swab from the patient’s nose and throat, and deliver it to the lab. There the researchers extract the nucleic acid from the patient’s samples, enlarge it until it is suitable for further analysis and search for SARS-CoV-2.

The lab analysis takes around 5-6 hours.

Tests first, then money

Currently, all three test producers are holding their breath, expecting the Ministry of Health to place huge orders of test supplies. 

Diagen told the Kyiv Post that it is ready to produce at least 50,000 tests in a month. IMBG said it can do another 40-80,000 tests. Ukrgentech did not reveal its capacity. Both Ukrgentech and Diagen are now selling their PCR tests to private and state hospitals across the country.

On March 23, Lyashko announced the imminent launch of domestic test manufacturing. A few days later, Ukrgentech confirmed that its negotiations with the ministry are ongoing and the lab expects to sign a contract soon. 

However, the situation with the other two producers, state IMBG and private Diagen, is more complicated. Both have faced difficulties negotiating with state authorities. 

IMBG’s problem was money. On Feb. 21, Ukraine’s National Security and Defense Council asked the institute to start creating PCR tests for diagnosing coronavirus — but offered no money. IMBG still obeyed.

In mid-March, IMBG made 600 PCR tests and gave them to the health ministry and a regional lab in Zhytomyr, a city about 140 kilometers to the west of Kyiv. Only then did the government give IMBG a “little funding” for producing tests, the institute said in a statement.

On April 1, the Ministry of Finance told the Kyiv Post that it had transferred Hr 385,000 ($13,000) to IMBG to produce 1,000 tests. 

However, the latest order IMBG received from the security council was to produce 200,000 tests. That will cost $2 million, chairman Komisarenko told the Kyiv Post. And the money the institute received from the ministry was actually reimbursement for the expenses IMBG incurred while producing the first 600 tests, he said.

Mykhaylo Tukalo, a director at the Institute of Molecular Biology and Genetics, on April 2, 2020, demonstrates PCR tests for COVID-19 diagnostics the Institute has produced. (Oleg Petrasiuk)

For IMBG, $2 million is a huge amount of money that it doesn’t have. In March, it had to force its employees to take unpaid leave because it could not pay salaries.

“We have massive and chronic underfunding for all institutions of the National Academy of Science,” Mykhailo Tukalo, a director at IMBG, said in a statement.

Financial problems at IMBG coincided with the national quarantine that was imposed in Ukraine on March 13 to reduce the spread of coronavirus. This means a total lockdown. 

The small number of scientists who still go to work are those involved in the PCR test production ordered by the state. 

Russian fingerprints?

Diagen has also faced problems trying to cooperate with the state. 

It was the first company in Ukraine to register its PCR tests with the Ministry of Health on Feb. 14. 

A few days later, on Feb. 20, a plane with evacuees from Wuhan, China, then the epicenter of the coronavirus outbreak, landed in Ukraine with 48 Ukrainians and 27 foreigners on board. These people were immediately locked in a sanatorium in the town of Novi Sanzhary for a 14-day quarantine. 

The next day, the National Security and Defense Council asked IMBG to start producing tests. But that would take a month, and the evacuees needed to get tested urgently. So Diagen gave its newly-made PCR tests to the government for free, Kolyada said.

“We donated our very first batch of tests to the Ministry of Health so they can test these people evacuated from China,” said Kolyada. He added that he does not know whether the ministry used these tests, but the batch was “enough for testing hundreds of people.”

Then, on Feb. 27, the scandal broke. Lawmaker Oleksandra Ustinova accused Diagen of being owned by a Russian company.

Redwood Ltd., a company registered in Kyiv in 2017, owns 55% of Diagen’s shares. Redwood’s owner, Tetyana Zvezdohlyad, previously worked for the Kyiv office of Euroset, a Russian mobile phone retailer.

Kolyada denied that Diagen has any connection to Russia.

Ustinova also accused Diagen of using Russian reagents for its PCR tests. However, the company says it considered using them at first, but ultimately did not.

Diagen now hopes the Ministry of Health will buy its tests. But for all the urgency of the coronavirus crisis, no one knows when — and whether — that will happen.