Osang Healthcare Receives US FDA Approval for COVID-19 Self-Diagnostic Kit

[Asia Economy Reporter Minji Lee] Osang Healthcare, a subsidiary of Osangjaiel and a global in vitro diagnostics specialist, announced on the 7th that its COVID-19 self-test kit (OHC COVID-19 Antigen Self test) has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

In February, Osang Healthcare was the only domestic company selected as a supplier in the global partner recruitment for COVID-19 self-test kits by the international organization FIND. Following the European CE conformity certification and formal approval from the Korean Ministry of Food and Drug Safety, the company has consecutively obtained major certifications including the recent FDA EUA.

An Osang Healthcare official stated, "This FDA EUA is the first approval for a domestic company since the Omicron variant became dominant. The approved product has demonstrated excellent performance against variants, confirming high detection capability even for the globally prevalent Omicron variant. It is also expected to detect the subvariant known as Stealth Omicron."

Currently, among domestic companies, only SD Biosensor and Osang Healthcare have obtained FDA EUA for both molecular diagnostic kits (PCR) and immunodiagnostic kits (antigen). Osang Healthcare is the third company to receive approval for a self-test kit, following Celltrion (Humasis) and SD Biosensor.

The 'OHC COVID-19 Antigen Self test' will be supplied to the U.S. market through Osang Healthcare's U.S. subsidiary. A company representative explained, "Since we have been conducting preliminary sales through the local subsidiary, exports to the U.S. will begin immediately from April. This will also have a positive impact on sales in other overseas countries."

Meanwhile, Osang Healthcare, established in 1996, is a global in vitro diagnostics specialist engaged in molecular diagnostics, immunodiagnostics, and biochemical diagnostics. Leveraging its accumulated technology and global network from exporting diagnostic products to over 110 countries worldwide, the company was the first domestic firm to receive FDA EUA for a COVID-19 PCR diagnostic kit in 2020.