SugenTech Obtains Saudi Approval for COVID-19 and Influenza Rapid Diagnostic Kits

[Asia Economy Reporter Hyunseok Yoo] SuzenTech announced on the 16th that it has received product approval from the Saudi Food and Drug Authority (SFDA) for the antigen multiplex rapid diagnostic kit ‘SGTi-flex COVID-19 & Flu A/B Ag DUO,’ which can simultaneously diagnose COVID-19 and influenza (Influenza A/B).

The approved antigen multiplex rapid diagnostic kit simultaneously tests for the presence of COVID-19 and Influenza A and B virus antigens in specimens (nasal mucus) collected via nasopharyngeal swab to diagnose infection. It enables on-site simultaneous diagnosis without testing equipment or facilities through a single specimen collection, and results can be confirmed visually within 15 to 30 minutes.

SuzenTech expects demand for related products in the Middle East to increase with this product approval, as Saudi Arabia has opened its borders targeting global travelers in the era of ‘With Corona’ (gradual return to normal life). The Saudi Tourism Authority actively started attracting travelers by opening an office in Seoul, Korea, last October.

Although Saudi Arabia is a market dependent on imported pharmaceuticals, its regulations and certification systems are known to be very stringent globally. Compared to other categories, to enter the Saudi market with pharmaceuticals, registration with both the Saudi Food and Drug Authority (SFDA) and the Saudi Ministry of Health (MOH) is required.

A SuzenTech official said, “Although influenza cases decreased last year due to strict compliance with quarantine rules, this year, as countries worldwide declared ‘With Corona’ and eased quarantine measures, there is great concern about the simultaneous outbreak of COVID-19 and influenza, a ‘twindemic,’ caused by ‘revenge travel’ consumption this winter.”

He added, “Without using rapid diagnostic kits, it may become impossible to respond with the current PCR testing capacity, so we are doing our best to be ready to meet related demand at any time.”

SuzenTech received export approval from the Korean Ministry of Food and Drug Safety for the ‘COVID-19-Influenza Rapid Simultaneous Diagnostic Kit’ last year and has obtained certifications such as the European CE mark and approval from the Mexican Food and Drug Authority this year.