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ESET-funded, Slovak-made diagnostic kit for COVID-19 receives regulatory approval in the Slovak Republic, with 100,000 tests ready for delivery

A new COVID-19 diagnostic kit developed by Slovak scientists is registered by Slovakia’s State Institute for Drug Control (ŠUKL). The first 100,000 tests, donated to the Slovak Republic by the ESET Foundation, are ready to be handed over to state diagnostic laboratories.

BRATISLAVA – Slovak scientists from MultiplexDX, the Biomedical Research Center of the Slovak Academy of Sciences (BMC SAS), the Comenius University Science Park in Bratislava, Lambda Life and ProScience Tech joined forces to develop and register the first Slovak-made diagnostic kit for COVID-19. The ESET Foundation supported the development and production of the kit and donated the first 100,000 tests to the government of the Slovak Republic.

On May 14, the State Institute for Drug Control (ŠUKL) approved the kit, which is called vDetect COVID-19 RT-qPCR. The first 100,000 tests will be delivered to state diagnostic laboratories. “The State Institute for Drug Control dealt with the application for registration of the test as a matter of priority, and the final decision was issued within four working days of receiving the application. With the technical dossier and validation tests meeting the necessary criteria, the registration went smoothly. This is the first registration of an IVD test by the State Institute for Drug Control that was designed, manufactured, and registered in Slovakia,” says the director of ŠUKL, PharmDr. Zuzana Baťová, PhD.

During the process of test validation, Slovak researchers from MultiplexDX came up with a way to increase the test’s sensitivity, which slightly delayed the regulatory submission. “When we performed a forensic analysis, we found that the primers used to confirm the test results according to the Charité protocol were not designed optimally. Therefore, we prepared a new version of primers that increased the sensitivity and, consequently, the accuracy of the test. Then it was necessary to repeat testing and, due to this, the original date of the test’s registration was postponed,” explains Pavol Čekan, PhD, founder of MultiplexDX. The tests underwent validation showing a 100% match with the samples already evaluated.”

Blind validation tests, performed at two independent laboratories on 92 clinical samples, showed identical results in comparison with the reference method, as well as with each other. This demonstrates the high reliability of the test directly on clinical samples,” says RNDr. Boris Klempa, DrSc., from BMC SAV.

The ESET Foundation supported the development of the tests, donating the first 100,000 tests to the state. ESET also covered the financing and coordination of activities related to the test’s production and registration.

“The development of the new diagnostic kit confirms that science in the Slovak Republic is being pursued at a high level and, at the same time, demonstrates the ability for science to bring solutions to societal problems. That’s why we have been supporting science for a long time. ESET’s involvement in the development of the coronavirus diagnostic tests has also been an interesting challenge for us because we have been detecting virtual viruses since our founding as a company,” comments Richard Marko, CEO of ESET.

Throughout the test’s development and validation, the team of RNDr. Tomáš Szemes, PhD from the Charles University Science Park in Prague, also participated: “We worked with the team on optimization and validation, and I was surprised at how quickly and smoothly the process went, including registration.” The final documentation for registration at ŠUKL was prepared by Roman Oravec from the non-profit organization CCCT SK.

The Slovak companies Lambda Life and ProScience Tech were also involved during the entire preparation of the diagnostic kit. “With the cooperation of numerous talented scientists and domestic companies, we not only received approval for the first Slovak-made PCR test for COVID-19, but also developed a top product in difficult conditions, one that will help the country when it needs it most. It was by no means an easy task, and I am happy that it succeeded in the end,” concludes Róbert Mistrík from the Slovak government’s permanent crisis team. 

About Version 2 Limited
Version 2 Limited is one of the most dynamic IT companies in Asia. The company develops and distributes IT products for Internet and IP-based networks, including communication systems, Internet software, security, network, and media products. Through an extensive network of channels, point of sales, resellers, and partnership companies, Version 2 Limited offers quality products and services which are highly acclaimed in the market. Its customers cover a wide spectrum which include Global 1000 enterprises, regional listed companies, public utilities, Government, a vast number of successful SMEs, and consumers in various Asian cities.

About ESET
For 30 years, ESET® has been developing industry-leading IT security software and services for businesses and consumers worldwide. With solutions ranging from endpoint security to encryption and two-factor authentication, ESET’s high-performing, easy-to-use products give individuals and businesses the peace of mind to enjoy the full potential of their technology. ESET unobtrusively protects and monitors 24/7, updating defenses in real time to keep users safe and businesses running without interruption. Evolving threats require an evolving IT security company. Backed by R&D facilities worldwide, ESET became the first IT security company to earn 100 Virus Bulletin VB100 awards, identifying every single “in-the-wild” malware without interruption since 2003.

ESET to support EU CERTs with free access to Threat Intelligence during COVID-19

Bratislava – ESET, a global leader in cybersecurity, has implemented measures to assist national Computer Emergency Response Teams within the EU (EU CERTs) in mitigating threats during the COVID-19 crisis. As a fellow EU-based vendor, ESET is dedicated to partnering with organizations across the EU to ensure that its citizens are safe and secure online.

To help protect the general public and infrastructure in their respective countries, ESET is offering public sector EU CERTs free access for six months to the ESET Threat Intelligence Data Feeds. The offering includes access to ESET’s Domain, URL, Malicious files and Botnet feeds.

The COVID-19 crisis has seen an increase in the number of digital threats, and it is vital that EU nations are equipped with the tools and resources needed to protect their citizens and systems against all potential threats. ESET Threat Intelligence is ESET’s threat reputation network. It uses information gathered from over 110 million sensors in order to share actionable threat intelligence with users.

Access to the ETI Data Feeds will enable the CERTs to monitor possible threats in order to mitigate the risk of an attack and strengthen their defenses. Collaboration is an essential part of threat intelligence and response, and ESET has reached out to 46 CERT institutions across the EU for partnership, with initial feedback very positive and several implementations already underway.

Ignacio Sbampato, Chief Business Officer at ESET, commented: “We believe everyone has the right to a safe and secure experience of technology, and this means that the public sector must be equipped with the resources to protect both its citizens and infrastructure. Unfortunately, there are malicious actors seeking to take advantage of the current crisis, and we are dedicated to assisting emergency response teams across the EU in mitigating and responding to these potential threats. As an EU-based organization, we hold the safety of our citizens close to our hearts, and we endeavor to do everything we can to support local CERT teams during this time.”

Learn more about ESET Threat Intelligence here.

 

About Version 2 Limited
Version 2 Limited is one of the most dynamic IT companies in Asia. The company develops and distributes IT products for Internet and IP-based networks, including communication systems, Internet software, security, network, and media products. Through an extensive network of channels, point of sales, resellers, and partnership companies, Version 2 Limited offers quality products and services which are highly acclaimed in the market. Its customers cover a wide spectrum which include Global 1000 enterprises, regional listed companies, public utilities, Government, a vast number of successful SMEs, and consumers in various Asian cities.

About ESET
For 30 years, ESET® has been developing industry-leading IT security software and services for businesses and consumers worldwide. With solutions ranging from endpoint security to encryption and two-factor authentication, ESET’s high-performing, easy-to-use products give individuals and businesses the peace of mind to enjoy the full potential of their technology. ESET unobtrusively protects and monitors 24/7, updating defenses in real time to keep users safe and businesses running without interruption. Evolving threats require an evolving IT security company. Backed by R&D facilities worldwide, ESET became the first IT security company to earn 100 Virus Bulletin VB100 awards, identifying every single “in-the-wild” malware without interruption since 2003.

ESET Foundation has supported development of a diagnostic PCR test to detect the coronavirus SARS-CoV-2, the cause of COVID-19.

BRATISLAVA, April 14, 2020 – Scientists from the Slovak companies MultiplexDX, Lambda Life and ProScience Tech have joined forces with virologists from the Biomedical Center of the Slovak Academy of Sciences (BMC SAV) to develop a reagent kit according to World Health Organization (WHO) protocols for reliable SARS-CoV-2 detection. In the first phase they plan to produce and make available 100,000 PCR tests. The ESET Foundation supported the development of the kit and will finance the first 100,000 tests to be offered as an in-kind gift to the Slovak Republic.

Key components have been brought to the project by MultiplexDX, a company dedicated to developing and manufacturing various innovative molecular diagnostic reagents. The Slovak PCR test is currently being validated in cooperation with a team of scientists from the BMC SAV. Preliminary results of the new test not only show nominal functionality, but also good sensitivity compared to currently used diagnostics. “This means that our test is reliable and accurate and can help diagnose early stage patients. We can produce key components for 100,000 PCR tests within two weeks,” explained Pavol Čekan, founder of MultiplexDX.

“In the process of validation and subsequent registration of the resulting report, we are cooperating with the non-profit organization CCCT SK. This stage is estimated to take about three weeks,” said Adam Andráško of ProScience Tech.

“Virus detection consists of sample collection, RNA isolation and PCR diagnostics, with our joint efforts focused on the last step,” said Ivan Juráš of Lambda Life.

“I believe that the efforts of our scientists will be crowned with success, and that we will have sufficient PCR tests from our own resources for the task at hand, coronavirus detection. This will not only help Slovakia by providing much-needed testing, but will also create a reserve in case there is a shortage of tests globally,” noted Robert Mistrík from the permanent crisis staff.

The ESET Foundation supported the development of the test and provided funding for the first 100,000 units from its fund to support the effective diagnosis and prevention of COVID-19. These tests will be offered as a gift to Slovak state institutions. “When creating the fund, it was important for us to ensure effective mass-scale diagnostics, which can only be achieved through scientific cooperation. Such a critical situation reveals the importance of supporting science in Slovakia, which the ESET Foundation has been dedicated to for a long time,” said Richard Marko, CEO of ESET.

Production capacity, including the first 100,000 tests, will be available primarily to diagnostic laboratories on the Slovak market. “We are ready to cooperate with state laboratories, flexibly responding to their needs and supplying them efficiently. After satisfying the needs of Slovak laboratories, we can then direct our capacities to other countries that may need our products,” explained the authors of the test.

About Version 2 Limited
Version 2 Limited is one of the most dynamic IT companies in Asia. The company develops and distributes IT products for Internet and IP-based networks, including communication systems, Internet software, security, network, and media products. Through an extensive network of channels, point of sales, resellers, and partnership companies, Version 2 Limited offers quality products and services which are highly acclaimed in the market. Its customers cover a wide spectrum which include Global 1000 enterprises, regional listed companies, public utilities, Government, a vast number of successful SMEs, and consumers in various Asian cities.

About ESET
For 30 years, ESET® has been developing industry-leading IT security software and services for businesses and consumers worldwide. With solutions ranging from endpoint security to encryption and two-factor authentication, ESET’s high-performing, easy-to-use products give individuals and businesses the peace of mind to enjoy the full potential of their technology. ESET unobtrusively protects and monitors 24/7, updating defenses in real time to keep users safe and businesses running without interruption. Evolving threats require an evolving IT security company. Backed by R&D facilities worldwide, ESET became the first IT security company to earn 100 Virus Bulletin VB100 awards, identifying every single “in-the-wild” malware without interruption since 2003.