- Expo of test kit to entire Europe and numerous countries that recognize CE-IVD ga impetus
The Korean biotech company Macrogen (CEO Sukang Lee), announced on the 3rd that it had obtained the CE ing for Europe's In-Vitro Diagnostic (CE-IVD) devices for its coroirus disease 2019 (COVID-19) test kit 'Axen™ COVID-19 '.
Europe's CE-IVD is an essential ceification for the distribution of in-vitro diagnostic reagents, as it is considered as a 'passpo' that allows entry into the European et, and the products with this ceification are ject to distribution in the ets throughout Europe without any restriction.
Macrogen plans to make major inroads into the European et following this acquisition of CE-IVD, and ply test kits to government agencies and medical titutions through its local coorations and branches as well as diagnostic agent distributors. Since the test kit has now become available for expo to entire Europe and many countries that recognize the ceification as well as Latin America with which agreements will soon be signed, Macrogen is projected to dramatically increase its expo across the globe.
Macrogen's COVID-19 test kit is a product that uses -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 uated 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 les 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 Mide East, and we will rapiy respond to the continued global demand."
Meanwhile, Macrogen has obtained an expo 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).