WellsBio Obtains MFDS Export Approval for COVID-19 Rapid Test Kit... "Global Export Launch"

[Asia Economy Reporter Park Jihwan] WellsBio's coronavirus disease (COVID-19) antibody diagnostic kit (rapid diagnostic kit) has obtained export approval from the Ministry of Food and Drug Safety. This product is characterized by its ability to determine COVID-19 infection status within 10 to 15 minutes.

WellsBio, an affiliate of Wooridul Pharmaceutical, announced on the 15th that it newly acquired export approval from the Ministry of Food and Drug Safety for the antibody diagnostic kit on the 14th. The product also recently received European certification (CE), enabling the company to actively begin exporting and selling the COVID-19 rapid diagnostic kit.

WellsBio had already obtained export approval and European certification (CE) for its COVID-19 molecular diagnostic kit in March. With this new export approval from the Ministry of Food and Drug Safety, WellsBio now possesses two types of COVID-19 diagnostic kits: molecular diagnostic kits and antibody diagnostic kits.

A WellsBio official stated, "Through collaboration with our overseas joint marketing partner Wooridul Pharmaceutical, we will actively supply customized products to the global COVID-19 diagnostic market, accelerating market expansion and sales growth."

The COVID-19 antibody diagnostic kit (careUS COVID-19 IgM/IgG), which received approval from the Ministry of Food and Drug Safety, demonstrated high sensitivity in comparative tests conducted by a clinical trial specialized institution for export approval. It is characterized by its ability to determine infection status on-site within 10 to 15 minutes using a small blood sample. The demand for COVID-19 antibody diagnostic kits has been increasing recently due to the growing need for herd immunity investigations.

COVID-19 diagnosis is broadly divided into molecular diagnostic methods such as RT-PCR diagnostic kits and immunological antibody diagnostic kits. While molecular diagnostics are useful for early infection detection, antibody diagnostic kits have higher accuracy in the later stages of infection, increasing the necessity for combined use of both diagnostic kits.

Meanwhile, WellsBio is a subsidiary of Access Bio, whose largest stake was acquired by Wooridul Pharmaceutical in July last year.

This content was produced with the assistance of AI translation services.