SugenTech, Antibody Rapid Diagnostic Kit Receives MFDS Manufacturing Approval, 'Domestic Launch in Full Swing'

[Asia Economy Reporter Yoo Hyun-seok] SuzenTech announced on the 21st that it has obtained domestic manufacturing approval from the Ministry of Food and Drug Safety (MFDS) for the 'COVID-19 Antibody Rapid Diagnostic Kit,' and will officially launch the rapid diagnostic kit in the domestic market.

The COVID-19 Antibody Rapid Diagnostic Kit is a product that SuzenTech received emergency use authorization from the U.S. Food and Drug Administration (FDA) last September, becoming the first domestic company to do so, and its accuracy has already been externally validated. With this approval as a turning point, SuzenTech's COVID-19 Antibody Rapid Diagnostic Kit can now be introduced domestically.

Until now, only molecular diagnostic (PCR) methods have been used domestically due to quarantine policies. However, as confirmed COVID-19 cases have rapidly increased recently, especially in the metropolitan area, the need for rapid test kits that can provide on-site, real-time results has become prominent. Antigen rapid diagnostic kits have already begun to be introduced at testing sites.

The antibody rapid diagnostic kit approved this time can confirm the presence or absence of antibody formation, making it effective for COVID-19 quarantine measures because it can verify not only asymptomatic infections, which have recently become an issue, but also the infection history of confirmed patients.

Major countries overseas are already using molecular diagnostics and antibody rapid diagnostics in parallel as confirmed cases surge. In advanced countries such as the United States and Europe, antibody rapid diagnostic kits are widely used for confirming asymptomatic infections, tracking infection history, and determining whether recovered patients can return to daily life.

A SuzenTech official said, "Through this formal approval by the Korean MFDS, we expect that antibody rapid diagnostic kits will soon be utilized in domestic hospitals, clinics, and medical institutions, similar to overseas cases."

SuzenTech possesses not only antibody rapid diagnostic kits but also COVID-19 antigen rapid diagnostic kits. The antigen rapid diagnostic kits have obtained export approval from the MFDS, CE certification in Europe, and approvals from health authorities in Germany, Brazil, and Russia, and are being distributed worldwide. Emergency use authorization from the U.S. FDA is currently underway.