Celltrion Obtains Conditional Approval from MFDS for COVID-19 Self-Test Kit

'Diatrust COVID-19 Antigen Home Test'
Celltrion's Independently Developed Antibody Applied
"Maximizing Sensitivity with 'Dual Antigen' Method"

[Asia Economy Reporter Kim Ji-hee] Celltrion announced on the 3rd that it had obtained conditional approval from the Ministry of Food and Drug Safety on the 30th of last month for the self-test kit 'Diatrust COVID-19 Antigen Home Test,' which allows individuals to check their COVID-19 infection status by themselves.

The Diatrust Home Test is an antigen-based kit that applies Celltrion's independently developed antibody, which strongly binds to COVID-19, to detect specific viral components in specimens from symptomatic COVID-19 patients to confirm infection. Individuals can collect nasal specimens themselves using the swab included in the kit without expert assistance and check the results within approximately 15 minutes.

Celltrion jointly developed this product with Humasis, a company specializing in in vitro diagnostics. In South Korea, it plans to supply the product through various distribution channels, including Celltrion Pharm, which is responsible for domestic distribution of Celltrion products.

Notably, unlike the typical method that detects only one antigen, the Diatrust Home Test uses a 'dual antigen' method that detects both the N antigen and the S antigen. Celltrion explains that this maximizes sensitivity, resulting in excellent accuracy.

Celltrion expects global demand for this self-test kit to increase. It submitted clinical trial results conducted on about 450 children and adults in the United States in February and March to the U.S. Food and Drug Administration (FDA) and is currently awaiting review results. Additionally, in April, it obtained FDA emergency use authorization for the on-site COVID-19 antigen rapid diagnostic kit 'Diatrust' and began supplying it to the U.S. market.

A Celltrion official stated, "Since the Diatrust Home Test, developed based on Celltrion's antibody technology, has received conditional approval, we will expedite supply so that the general public can purchase and use the product for testing as soon as possible." He added, "According to this conditional approval, we plan to submit additional clinical performance test data for the self-test kit to the Ministry of Food and Drug Safety within three months."

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