Research & Development
Macrogen receives Korean Ministry of Food and Drug Safety export approval for 'AxenTM COVID-19 RT'
21 May 2020 -

Macrogen (KOSDAQ: 038290), a Korea-based biotech company, has received export approval from the nation's Ministry of Food and Drug Safety for the company's COVID-19 test kit 'AxenTM COVID-19 RT', it was reported on Wednesday.

The test kit uses RT-PCR, and can confirm if a person is infected with COVID-19 in two hours, which enables a large number of tests to be completed quickly and efficiently. The kit detects ORF1ab and E genes, two genes related to COVID-19.

Presently, the company is preparing to receive Emergency Use Authorization from the United States FDA and Europe's CE In-Vitro Diagnostics. These authorisations are expected to increase Macrogen's exports across the US and Europe, as well as Brazil and Uruguay, where the test kit is currently under negotiation.