SugenTech Receives FDA Approval for On-Site COVID-19 Rapid Test Kit

[Asia Economy Reporter Yoo Hyun-seok] SuzenTech announced on the 26th that it has succeeded in obtaining the 'CLIA-waived FDA Emergency Use Authorization (EUA)' for the 'COVID-19 Antibody Rapid Test Kit Using Fingertip Blood,' which is applicable for point-of-care diagnostics.

CLIA-waived products can be used for diagnosis in small hospitals and pharmacies, allowing the product to be supplied through a wide range of distribution channels.

Because CLIA-waived antibody diagnostic EUA products using fingertip blood must pass the very stringent clinical requirements demanded by the US FDA, only five companies worldwide have been approved so far. SuzenTech explained that it is the first domestic company and the sixth globally to receive CLIA-waived FDA approval.

The product that received this EUA has enhanced sensitivity to blood reactions, enabling 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 at the point of care.

A SuzenTech official stated, “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 point-of-care 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, confirm asymptomatic infections, and verify infection history according to each country's health policies, expanding sales channels from large medical institutions to retail pharmacies is expected to generate significant demand and contribute greatly to sales.”

SuzenTech had already proven its technological capabilities externally by successfully obtaining the US FDA EUA last September for a venous blood antibody test 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 introduced immediately not only in the US, regarded as the world's largest market, but also in countries recognizing US FDA approval.

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

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