[Special Stock] Suzentec's COVID-19 Kit CLIA Exempted... "Securing Distribution Channels from Major US Medical Institutions to Pharmacies"

[Asia Economy Reporter Hyungsoo Park] SuzenTech's stock price has been strong for two consecutive days. The news that it succeeded in obtaining 'CLIA-waived FDA Emergency Use Authorization (EUA)' for the 'COVID-19 antibody rapid test kit using fingertip blood,' applicable for on-site diagnosis, appears to have influenced the stock price. Since CLIA-waived products can be used for diagnosis in small hospitals and pharmacies, the product can be supplied through a wide range of distribution channels.

As of 9:09 a.m. on the 27th, SuzenTech is trading at 34,000 KRW, up 17.85% from the previous day.

A SuzenTech official stated, "The CLIA-waived antibody diagnostic emergency use authorization product using fingertip blood for on-site testing must pass the very stringent clinical requirements demanded by the U.S. FDA," adding, "Only five companies worldwide have received approval."

He continued, "SuzenTech is the first domestic company and the sixth globally to achieve CLIA-waived FDA approval."

The product that received emergency use authorization has increased sensitivity to blood reactions, allowing the detection of IgG antibody formation against the vaccine target 'S protein RBD' of the coronavirus within 10 minutes using a very small amount of fingertip blood on-site.

A SuzenTech official said, "Previously FDA-approved products use venous blood and are used in large hospitals or comprehensive health screening centers, whereas the newly approved product is a fingertip blood-based on-site CLIA-waived product that can be sold in pharmacies and small hospitals."

He added, "Since antibody tests can be widely applied to immediately assess immune formation after vaccination, asymptomatic infection confirmation, and infection history verification according to each country's health policies, expanding sales channels from large medical institutions to local pharmacies is expected to generate significant demand and contribute greatly to sales."

SuzenTech had already proven its technological capability externally by successfully obtaining the U.S. FDA emergency use authorization last September for the venous blood antibody testing method used in large hospitals and screening centers, becoming the first domestic company to do so. The newly approved COVID-19 rapid antibody test kit is expected to be immediately introduced not only in the U.S., regarded as the world's largest market, but also in countries recognizing U.S. FDA approval.

Following the antibody rapid diagnostic kit, SuzenTech is currently pursuing U.S. FDA emergency use authorization for its antigen diagnostic kit. The antigen rapid diagnostic kit has been verified by major countries including the European CE certification, Germany, Brazil, Russia, and Austria, and is being sold worldwide, in addition to export approval from the Korean Ministry of Food and Drug Safety.