Yuhan Corporation Begins Supplying Yuhan COVID-19 Diagnostic Kits

Partnering with Osang Healthcare to Supply Diagnostic Kits to Pharmacies

[Asia Economy Reporter Lee Gwan-joo] Yuhan Corporation announced on the 10th that it has partnered with the in vitro diagnostics specialist Osang Healthcare to start selling Yuhan's own brand, the 'Yuhan COVID-19 Antigen Self-Test Kit,' at pharmacies.

The self-test kit supplied by Yuhan uses immunochromatography to determine the presence of the COVID-19 virus from a nasal swab sample within 15 minutes.

It received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) in February this year, and in a prospective clinical trial conducted in Europe, it showed a sensitivity of 96.67% and specificity of 100%.

It has obtained the European Conformity Certification (CE COC), which applies strict standards, and has completed the application for Emergency Use Authorization from the World Health Organization (WHO). It also demonstrates high performance against recently prevalent Omicron subvariants (BA 5, BA 2.75, etc.).

Manufacturer Osang Healthcare, leveraging its technology accumulated through exporting diagnostic products to over 110 countries, was the first domestic company to receive the U.S. FDA Emergency Use Authorization (EUA) for a COVID-19 PCR diagnostic kit in 2020. It was also the only Korean company selected as one of the final four among 85 global applicants in the international organization 'FIND Dx' project to supply COVID-19 self-test kits to underdeveloped countries.

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