SugenTech's 'COVID-19 and Influenza Simultaneous Rapid Diagnostic Kit' Approved for Export by MFDS

[Asia Economy Reporter Hyunseok Yoo] SuzenTech announced on the 30th that it has received export approval from the Ministry of Food and Drug Safety (MFDS) for the 'Novel Coronavirus Infection (COVID-19) - Influenza A/B Antigen Simultaneous Rapid Diagnostic Kit.'

SuzenTech has been developing and marketing influenza antigen rapid diagnostic kits for several years and recently succeeded in developing a COVID-19 antigen rapid diagnostic kit, which was combined with the existing product to create a simultaneous diagnostic kit. Since the influenza and COVID-19 antigen diagnostic kits have each been validated as separate products, it is expected that overseas certification will proceed smoothly following domestic approval.

The 'Antigen Rapid Diagnostic Kit' received approval from the German Federal Institute for Drugs and Medical Devices and has begun supply to Germany. The 'COVID-19 - Influenza Antigen Rapid Diagnostic Kit' is expected to smoothly supply products after receiving approval from major European countries centered on Germany, following the 'Antigen Rapid Diagnostic Kit.'

SuzenTech's COVID-19 - Influenza A/B Antigen Rapid Diagnostic Kit, 'SGTi-flex COVID-19 & Flu A/B Ag DUO,' diagnoses infection by testing for the presence of COVID-19 and influenza A/B virus antigens in nasopharyngeal swab specimens (nasal mucus).

As it is a rapid diagnostic kit method, it allows visual analysis on-site within 20 to 30 minutes using only the diagnostic kit without expensive testing equipment or facilities, thus potentially replacing molecular diagnostics.

In the 'double pandemic' situation where influenza and COVID-19 spread simultaneously, there is a limit to increasing testing capacity solely through molecular diagnostics in response to the surge in test subjects, making the global adoption of 'simultaneous rapid diagnostic kits' inevitable.

A SuzenTech official stated, "Although many molecular diagnostic reagents capable of simultaneous COVID-19 and influenza diagnosis have been developed, molecular diagnostics require expensive infrastructure such as testing equipment and facilities, making it difficult to rapidly increase testing capacity. Without utilizing antigen rapid diagnostic kits, it is highly likely that the current testing capacity will be insufficient to cope."

He added, "As winter approaches, related demand increases, but the number of companies able to supply is limited. The 'COVID-19 - Influenza' simultaneous diagnostic kit cannot be developed without a COVID-19 antigen rapid diagnostic kit, and so far, only 3 to 4 companies in Korea have succeeded in developing 'antigen rapid diagnostic kits.'"