Macrogen, a biotech company specializing in precision medicine, said Thursday that its fast-test kit, Axen™ COVID-19 IgM/IgG RAPID, has received the CE-IVD (European Community In-Vitro Diagnostic device) certification.

In February, Macrogen secured the overseas business rights for the kit developed by ImmuneMed. With the CE-IVD certification, the company will export the kits as its brand.

The fast test kit can quickly detect Covid-19 infections with a tiny amount of blood in less than 15 minutes. The test kit showed higher than 97 percent accuracy in Seoul National University Hospital clinical test, which also confirmed its sensitivity and specificity, the company said.

Macrogen established its European headquarter in Amsterdam in 2017, following a branch in Madrid in 2016 to secure a regional network in the European market. The company has also completed registering as a supplier to the U.K. government. It plans to supply diagnostic kits in the European market by utilizing a wide range of global infrastructure and brand value.

“Although Covid-19 vaccination administration started worldwide, Covid-19 screening test is still considered a prime issue due to the time taken for antibody formation after vaccination,” said Hwang Sang-joon, general manager of health and disease genome business department at Macrogen.  

Macrogen plans to secure business rights for all of ImmuneMed’s Covid-19 rapid test kits and export them to foreign markets on the occasion of winning the European certification, he added.