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Celltrion's COVID-19 test kit receives conditional approval in Korea
By Shim Woo-hyunPublished : May 3, 2021 - 17:09
South Korea‘s pharmaceutical giant Celltrion announced Monday that the company has received a conditional approval for its COVID-19 test kit DiaTrust from the country‘s drug safety agency.
DiaTrust, developed jointly by Humasis and Celltrion, is an antigen test kit that can detect the most recent COVID-19 variants from the UK and Brazil. The test kit uses a sterile nasal swab which can identify specific antigens of COVID-19 present in specimens collected from the nasal cavity within 15 minutes.
According to Celltrion, DiaTrust uses a dual antigen method that detects both the N or S antigens, unlike other test kits in the market that could detect only one of the two.
Celltrion expects that global demand for the company’s COVID-19 test kit will increase down the road.
“(Celltrion) will speed up its supply of COVID-19 test kit in the domestic market,” a Celltrion official said. “The company will submit additional clinical data concerning the test kit to the Ministry of Food and Drug Safety within three months,” the official added.
In the US, DiaTrust already received emergency use authorization from the US Food and Drug Administration in April based on the submitted result of clinical trial conducted on over 450 young children and adults between February and March. The US FDA is currently reviewing the clinical data, according to Celltrion.
By Shim Woo-hyun (ws@heraldcorp.com)
DiaTrust, developed jointly by Humasis and Celltrion, is an antigen test kit that can detect the most recent COVID-19 variants from the UK and Brazil. The test kit uses a sterile nasal swab which can identify specific antigens of COVID-19 present in specimens collected from the nasal cavity within 15 minutes.
According to Celltrion, DiaTrust uses a dual antigen method that detects both the N or S antigens, unlike other test kits in the market that could detect only one of the two.
Celltrion expects that global demand for the company’s COVID-19 test kit will increase down the road.
“(Celltrion) will speed up its supply of COVID-19 test kit in the domestic market,” a Celltrion official said. “The company will submit additional clinical data concerning the test kit to the Ministry of Food and Drug Safety within three months,” the official added.
In the US, DiaTrust already received emergency use authorization from the US Food and Drug Administration in April based on the submitted result of clinical trial conducted on over 450 young children and adults between February and March. The US FDA is currently reviewing the clinical data, according to Celltrion.
By Shim Woo-hyun (ws@heraldcorp.com)
