Macrogen receives export approval for COVID-19 test kit

By William Girling
South Korean biotech company Macrogen has announced that its COVID-19 test has been approved by the Ministry of Food and Drug Safety (MFDS). Dubbed &ls...

South Korean biotech company Macrogen has announced that its COVID-19 test has been approved by the Ministry of Food and Drug Safety (MFDS). 

Dubbed ‘Axen COVID-19 RT’, the test is able to detect the presence of the COVID-19 virus in two hours, making it a valuable asset in the struggle to regain control during the pandemic. Its clearance for export will also make it useful for other countries. 

Capable of detecting two genes found in the virus (ORF1ab and E), the Axem test has a high detection and accuracy rate - clinical trials of 20 different samples resulted in 100% consistency.

Helping the world fight coronavirus

Currently lobbying the US’ Food and Drug Administration (FDA) under the terms of emergency use authorisation (EUA), Macrogen hopes that talks will open up markets for the test in North and South America and Europe.

“We are planning to supply our test kit to major countries, which contacted us even during the test kit development phase and were looking forward to export approval together with us, first and as early as possible,” said Sukang Lee, CEO.

“We will not only improve our test kit’s performance to detect numerous mutations of coronavirus, which continue to appear in the future, but also promptly respond to prolonged COVID-19 and any new emerging virus.”

The company states that it has the capacity, resources and technology to create a minimum 100,000 tests per week. The Axen test is apparently already gaining attention from potential buyers, including the authorities of Brazil and Uruguay. 


Macrogen reasons that the recognition is due to its “all-encompassing business portfolio, which includes Korea’s leading virus research in the face of the outbreak of novel viruses, such as MERS and SARS,” according to the press release.  

Controlling the virus through technology

South Korea itself has been recognised for its impressive containment of the virus; despite its proximity to the epicentre of the pandemic, the country has still sustained relatively few infections and deaths.

Some of that success could be attributed to the deployment of smartphone apps to measure, track and trace the incidence of COVID-19 among the population. An article by Aljiazeera reported that people must download the app immediately upon arriving into the country and record their symptoms daily. 

In a previous article, Business Chief explored Singapore-based company AI Hub’s social distancing app, which utilised edge computing and photo recognition technology to detect when someone is in too close proximity to the user.

China-based mobile transport and food delivery company DiDi Chuxing has also launched an AI-based solution for its drivers, requiring regular updates on their health, in-vehicle sanitising standards and adherence to wearing a mask at all times.

Clearly, technology will play a very important role as Asia works to contain and control the spread of COVID-19.

For more information on business topics in APAC, please take a look at the latest edition of Business Chief APAC

Follow Business Chief on LinkedIn and Twitter


Featured Videos

View all

Schneider Electric - Global Specialist in Energy Management

Digital Strategy

Allianz Malaysia: Closer to customers through digital