Research & Development
Macrogen achieves CE-IVD certificate for export of COVID-19 test kit into Europe and several other countries
5 August 2020 -

Korean biotech company Macrogen reported on Tuesday the receipt of the CE Mark for in-vitro diagnostic devices (CE-IVD) in Europe for the distribution of the Axen COVID-19 RT test kits into the European market, as well as several other countries that recognize the CE-IVD .

Macrogen said its COVID-19 test kit uses RT-PCR which confirms whether a person is infected with COVID-19 in just two hours, allowing a large number of tests to be performed quickly and effective. As the kit detects the ORF1ab and E genes, two genes related to COVID-19, it has a high level of precision and target detection. Thus, the test kit is more appropriately evaluated for COVID-19 trace-controlled patients.

Earlier, the company has successfully launched a clinical trial with its test kit, confirming 100% consistency in 20 samples, each with positive and negative groups.

In addition, Macrogen stated that it has received the export approval from the Korean Ministry of Food and Drug Safety as well as is currently awaiting US approval through the United States Food and Drug Administration (FDA).