Macrogen, a genomics biotech company, announced Thursday that its AxenTM Covid-19 RT test kit has gained the Drug Ministry’s approval for export.
“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,” said Macrogen CEO Lee Su-kang.
“We will not only improve our test kit’s performance to detect numerous mutations of coronavirus, which will continue to appear in the future, but also promptly respond to prolonged COVID-19 and any new emerging virus,” said Lee.
AxenTM Covid-19 RT is a real-time polymerase chain reaction test kit that can confirm a person’s COVID-19 infection in under two hours. This allows for quick and efficient tests in large volumes.
The kit detects ORF1ab and E genes, two genes related to COVID-19, and boasts a high level of accuracy and target detection, Macrogen said.
The company has enough raw materials to manufacture at least 100,000 tests per week, in accordance with good manufacturing practice regulations.
Macrogen has 24 years of expertise in genome analysis and diagnostic reagent development.
The global demand for Macrogen’s COVID-19 test kits has been strong prior to the approval, with inquiries especially coming from the South American region, according to the company.
Macrogen plans to apply for Emergency Use Authorization from the US Food and Drug Administration and CE In-Vitro Diagnostics (CE-IVD) from the European Medicines Agency, for expanded export routes of its kits.
Macrogen’s business portfolio includes joint research with universities and governmental organizations upon novel virus outbreaks such as the Middle East respiratory syndrome and severe acute respiratory syndrome. The company manufactures oligo, the key material in diagnostic reagent, and also produces model mice therapeutics and vaccine development.
By Lim Jeong-yeo (email@example.com)