Macrogen Obtains Europe's CE-IVD Certificate for its COVID-19 Test Kit

August 4,2020

The Korean biotech company Macrogen (CEO Sukang Lee), announced on the 3rd that it had obtained the CE marking for Europe's In-Vitro Diagnostic (CE-IVD) devices for its coronavirus disease 2019 (COVID-19) test kit 'Axen™ COVID-19 RT'.

Europe's CE-IVD is an essential certification for the distribution of in-vitro diagnostic reagents, as it is considered as a 'passport' that allows entry into the European market, and the products with this certification are subject to distribution in the markets throughout Europe without any restriction.

Macrogen plans to make major inroads into the European market following this acquisition of CE-IVD, and supply test kits to government agencies and medical institutions through its local corporations and branches as well as diagnostic agent distributors. Since the test kit has now become available for export to entire Europe and many countries that recognize the certification as well as Latin America with which agreements will soon be signed, Macrogen is projected to dramatically increase its export across the globe.

Macrogen's COVID-19 test kit is a product that uses RT-PCR, and can confirm whether the person is infected with COVID-19 in just two hours, which allows for conducting a large number of tests quickly and efficiently. As the kit detects ORF1ab and E genes, two genes related to COVID-19, it has a high level of accuracy and target detection. Hence, the test kit is evaluated as more appropriate to screen patients with trace amounts of COVID-19. Earlier, Macrogen conducted a clinical trial with its test kit, confirmed 100% consistency in 20 samples each in the positive and negative groups.

Macrogen CEO Sukang Lee said, "While the confirmed cases of COVID-19 continue to soar across the world, we have secured active pharmaceutical ingredients and drastically expanded our production and logistics systems to produce to meet their demand. We are currently discussing signing agreements with major European countries, and a number of countries in Latin America and Southeast Asia as well as the Middle East, and we will rapidly respond to the continued global demand."

Meanwhile, Macrogen has obtained an export approval from the Korean Ministry of Food and Drug Safety in May and is currently awaiting for EUA approval by the U.S. Food and Drug Administration (FDA).