SugenTech's 'Omicron Diagnostic COVID-19 Test Kit' Approved in Saudi Arabia

[Asia Economy Reporter Hyunseok Yoo] SuzenTech announced on the 14th that its COVID-19 antigen rapid diagnostic kit ‘SGTi-flex COVID-19 Ag’ has received product approval from the Saudi Food and Drug Authority (SFDA).

The product approved by the SFDA has been internally evaluated for performance against the Omicron variant and was confirmed to be capable of diagnosing the Omicron variant, enabling effective response to the spread of variants.

The evaluation confirmed that SuzenTech’s antigen rapid diagnostic kit’s efficacy is not affected regardless of the Omicron variant. The efficacy evaluation was conducted through an in-silico analysis. The analysis revealed that the mutated regions of Omicron and the target regions used by SuzenTech’s COVID-19 diagnostic product for detection are different.

This means that even if mutations occur, the part of the virus that the diagnostic kit checks to determine infection status is not affected, allowing diagnosis even when the Omicron variant emerges.

Saudi Arabia has some of the world’s most stringent regulations and certification systems related to pharmaceuticals. To enter the Saudi market, registration with both the Saudi Food and Drug Authority (SFDA) and the Saudi Ministry of Health (MOH) is required.

A SuzenTech official stated, “The COVID-19 antigen rapid diagnostic kit approved this time is a product that detects whether COVID-19 virus antigens are present in nasopharyngeal swab specimens (nasal mucus) and diagnoses infection status visually within 15 minutes without expensive testing equipment,” adding, “With concerns about variant viruses rising due to the emergence of the Omicron variant following the Delta variant, demand for COVID-19 diagnostic kits is steadily increasing. We expect that this Saudi approval will serve as a turning point to expand entry into the Middle Eastern market.”

SuzenTech recently also obtained SFDA approval for the ‘SGTi-flex COVID-19 & Flu A/B Ag DUO’ diagnostic product, which can simultaneously diagnose COVID-19 and influenza (Influenza A/B). As the first domestic company to receive the European official personal use approval conformity certification (CoC) for a COVID-19 personal antigen product, SuzenTech continues to have its product technology recognized overseas.