Celltrion Inc. recently received FDA emergency use authorization (EUA) for its Diatrust COVID-19 Ag home test. “With the FDA approval, we will now prioritize getting the test kits to the U.S. and into users’ hands as soon as possible,” a spokesperson for the Incheon, South Korea-based Celltrion told BioWorld. The test kits will be distributed through Celltrion’s U.S. arm, Celltrion USA Inc. Celltrion is currently in the final stage of negotiations with the U.S. government, as well as online and offline distributors.

HONG KONG – Celltrion Inc. continues its quest to take its Diatrust COVID-19 Ag Rapid Test overseas, after receiving the FDA’s emergency use authorization (EUA). The Incheon, South Korea-based company also submitted results of clinical trials in which 450 people throughout the U.S. were tested between February and March 2021 to the regulator, with the trial results currently under review.