AndyForce Obtains Export Approval for Rapid Diagnostic Kits... "Pursuing FDA Emergency Use Authorization with US Professor Roger Kornberg"

[Asia Economy Reporter Jang Hyowon] AndyForce's rapid antibody diagnostic kit for the novel coronavirus infection (COVID-19) has received export item approval from the Ministry of Food and Drug Safety, accelerating its entry into overseas markets.

AndyForce announced on the 21st that it obtained export approval from the Ministry of Food and Drug Safety for the COVID-19 antibody rapid diagnostic kit ‘ND COVID-19 IgG/IgM Rapid Test’. AndyForce plans to pursue emergency use authorization from the US FDA in the future.

The newly approved rapid diagnostic kit is a diagnostic kit that uses immunoassay methods to test for the presence of COVID-19 specific antibodies in the blood.

AndyForce applied COVID-19 antigens, the main raw material of this diagnostic kit, isolated and purified from insect cells, which are higher organisms than the previously used Escherichia coli, to secure higher accuracy. Clinical trial results conducted during the export approval process showed an accuracy rate of over 95%.

Unlike molecular diagnostics that require large-scale equipment, antibody testing has no restrictions related to location or skill level and can confirm infection status within 10 minutes, leading to increased demand especially in countries with relatively underdeveloped quarantine infrastructure.

An AndyForce official stated, “AndyForce’s antibody rapid diagnostic kit has superior accuracy and convenience compared to other products, and pre-orders are continuously coming in from countries in Latin America, the Middle East, and Asia,” adding, “We are already negotiating supply with numerous domestic and international companies.”

He continued, “Especially after receiving European CE certification on the 3rd, test order volumes are flooding in from Europe, including Italy and France,” and added, “We plan to collaborate with Roger Kornberg, an internal director and professor at Stanford University, to pursue US FDA emergency use authorization and expand exports to the US market.”

Meanwhile, AndyForce not only holds export approval for the existing COVID-19 molecular diagnostic kit and antibody rapid diagnostic kit but has also completed development of an antigen rapid diagnostic kit, possessing all technological capabilities related to COVID-19 diagnostic kits.

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