ACCEL ELISA COVID-19, South Korea’s first antibody test kit developed by a local platform developer, has has moved a step closer to getting Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), a move that will enable its immediate sale in the U.S. and exports to other markets.

“We received confirmation e-mail of Emergency Use Authorization registration from the FDA on Wednesday,” said Kim Ki-beom, chief executive of Plexense Inc. that developed ACCEL ELISA COVID-19. “[The antibody test kit] will launch sales in the U.S. market under ‘EUA201904’ granted by the FDA.”

The FDA listing comes after Plexense submitted documents for EUA approval in the U.S. on April 16.

“The FDA handled review and feedback procedure [relatively] swiftly,” Kim said.

The BioNano Health Guard Research Center under the Ministry of Science and ICT, Korea Research Institute of Bioscience and Biotechnology, and Korea Cancer Center Hospital have given support to make it happen, he added.

According to Kim, five U.S. states, Canada, Russia, Indonesia, the Philippines, and Vietnam are showing active intension to buy the kit after its listing on the FDA website. The CEO said that the company will launch the kit’s sale in mid-July in the U.S. and begin shipments to each country.

Plexense is capable of producing up to 1 million test kits per day, Kim said. The company plans to gradually increase production capacity to expand overseas shipments. It is also in preparation for contract manufacturing organization in North America and South America.

“We are already in touch with candidates,” Kim said.

ACCEL ELISA COVID-19 is an antibody test kit developed based on immunodiagnosis technology completed by Plexense in 2015 and nucleic acid protein antigen produced at state-run BioNano Health Guard Research Center.

The kit can detect not only COVID-19 infection but also determine whether or not the patient has formed antibody against the virus and check whether he or she is free from it within 30 minutes. The existing molecular diagnosis method takes four to six hours to check infection.

According to Kim, ACCEL ELISA COVID-19 amplifies detectability by more than 50 times compared to other rapid test kits, enhancing diagnosis accuracy and saving per test cost. It is also able to test 94 patients at the same time within 40 minutes.

“We expect ACCEL ELISA COVID-19 to be widely used at hospitals, health centers, and clinics in the U.S. and Europe where coronavirus situation is grave,” Kim said.

By Kim Si-gyun and Lee Eun-joo

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