Humasis-Celltrion rapid Covid-19 test kit wins FDA nod

Celltrion DiaTrust COVID-19 Rapid Test (DiaTrust), developed jointly by Humasis and Celltrion, won emergency use authorization from the U.S. Food and Drug Administration last Friday.

Celltrion DiaTrustTM COVID-19 Rapid Test (DiaTrust), developed jointly by Humasis and Celltrion, has won emergency use approval from the U.S. Food and Drug Administration.

Humasis said it would exclusively supply the products to Celltrion's U.S. branch for distribution. DiaTrust has received approval for professional users.

In the clinical trials with early infections in the U.S., the sensitivity was 93.3 percent, and the specificity for identifying healthy people was 99.1 percent. The diagnostic kit's high sensitivity allows serial testing twice a week, either once every day days or with intervals of 24 to 36 hours.

Humasis also requested Korean universities to verify screening ability for the U.K. and South African variants and confirmed the same accuracy to the existing virus testing performance.

"We could win the FDA's nod through close collaboration with Celltrion, and we have confirmed the high accuracy of antigen diagnostic kit. It was the first time for a Korean company to meet the U.S. clinical standards," Humasis CEO Cha Jeong-hak said.

Humasis expects the EUA will provide an opportunity to prove Korea's technological prowess in the U.S., where the world's best products fiercely compete in the market, and also a turning point in increasing exports to European and South American countries, Cha added.

The company's self-diagnostic kit received approvals in Sweden also on Friday, following nods from the Czech Republic, Austria, and Denmark, according to Humasis.