Macrogen, a South Korean genomics biotech firm, said on Thursday that its test kit AxenTM COVID-19 RT received export approval from the South Korean Ministry of Food and Drug Safety.
In a statement, CEO Lee Su-kang said that the company plans to supply its test kits to major countries, which contacted Macrogen even before the approval. Lee assured that the company would improve and enhance the test kit’s efficiency to detect new and emerging mutations of coronavirus in the future.
AxenTM Covid-19 RT uses real-time polymerase chain reaction (RT-PCR) that allows for efficient and rapid tests in massive volumes. The test kit could confirm infection in under two hours with a high level of target detection and accuracy.
Macrogen’s test kit could identify two genes related to COVID-19, the E genes, and the ORF1ab genes. This makes the kits more appropriate to screen patients with trace amounts of coronavirus.
The company, recognized as a reliable diagnostic technology firm, completed the development of the AxenTM COVID-19 RT last month. Macrogen completed its kit production system according to good manufacturing practice (GMP) regulations allowing it to produce at least 100,000 kits per week with enough raw materials.
Even during the development phase, Macrogen saw strong global demand for its COVID-19 test kits, with inquiries coming in from countries such as Uruguay and Brazil. This testifies to the company’s 24-year expertise in diagnostic reagent development and genome analysis.
Currently, Macrogen plans to obtain a CE In-Vitro Diagnostics (CE-IVD) from the European Medicines Agency and U.S. FDA‘s Emergency Use Authorization (EUA). With the certifications, the South Korean company hopes to expand its exports across Europe, the U.S., and the South American region.
Boasting an all-encompassing business portfolio and globalization strategies, Macrogen plans to target the global market. The company also manufactures oligo, a key material used in diagnostic reagents, and also produces model mice for vaccine and therapeutics development.