SugenTech, COVID-19 Diagnostic Kit Officially Registered with US FDA

[Asia Economy Reporter Hyunseok Yoo] SuzenTech announced on the 6th that its rapid diagnostic kit for COVID-19, ‘SGTi-flex COVID-19 IgM/IgG,’ has completed product registration with the US FDA.

This FDA product registration was introduced as part of a system to enable the use of antibody rapid diagnostic kits in the US, due to the rapid spread of COVID-19 in the country and the inability of molecular diagnostics (PCR) alone to meet the surging demand for testing.

FDA product registration related to COVID-19 diagnostic devices began in earnest with the introduction of the ‘Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.’ This system approves serological antibody diagnostic kits that have completed FDA product registration (listing) to be freely adopted and used by each state. Through this product registration, SuzenTech has officially gained the qualification to immediately supply rapid diagnostic kits to US state governments and others.

A SuzenTech official stated, “There are two ways to supply diagnostic kits to the US by obtaining official FDA certification: Emergency Use Authorization (EUA) or product registration (listing). Since the antibody rapid diagnostic kit developed by SuzenTech can be supplied faster through product registration (listing) than EUA, we prioritized FDA product registration.”

He added, “Since FDA product registration has been completed, we plan to supply rapid diagnostic kits to US state governments currently in supply negotiations,” and “discussions with the FDA regarding EUA are ongoing following the product registration.”

SuzenTech’s ‘SGTi-flex COVID-19 IgG/IgM’ diagnoses two antibodies (IgG, IgM) simultaneously. It was highly recognized during the FDA product registration process for its rapidity and convenience, able to quickly diagnose COVID-19 infection within 10 minutes using a single drop of blood, and for its accuracy comparable to molecular diagnostics, validated by clinical results from two major domestic hospitals. According to the company, US state governments also highly evaluate this and are proceeding with urgent supply requests.

A SuzenTech official said, “We are already negotiating product supply with three major US state governments and are supplying samples to global US companies for testing procedures,” adding, “As supply requests are increasing in Europe and Asia, demand is also flooding in from the US, so we are making every effort to increase supply volume.” He continued, “Starting mid-this month, we will increase production to five times the current volume, and from May, we plan to double it again, making US supply feasible.”

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