Celltrion's COVID-19 test kit DiaTrust gets a conditional nod in South Korea

Celltrion announced that its COVID-19 test kit called DiaTrust has been given conditional approval by South Korea’s drug safety board. The biopharmaceutical company headquartered in Incheon shared the news on Monday, April 3.

The new coronavirus test kit

The Korea Herald reported that DiaTrust was jointly developed by Celltrion and Humasis, an R&D company based in S. Korea as well. The two sides made this antigen test kit that is said to be capable of detecting the newest COVID-19 variants that originated in Brazil and the U.K.

The rapid test kit can show results in as short as 15 minutes. It will identify the particular antigens of coronavirus that are present in the specimen collected from a person through a sterile nasal swab. Celltrion explained that what sets this kit apart from the other of its kind is that it uses a dual antigen method that can spot both N and S antigens.

“Celltrion will speed up its supply of COVID-19 test kit in the domestic market,” a company official stated. “The firm will submit additional clinical data concerning the test kit to the Ministry of Food and Drug Safety within three months.”

The biopharma company is expecting a surge in global demand for the DiaTrust COVID-19 test kit in the near future. In fact, in the U.S., the kit already received emergency use approval from the Food and Drug Administration (FDA). In April, the agency gave its authorization based on the clinical trial results that Celltrion submitted, and it is now reviewing additional clinical data.

Self-test kit to be marketed after gaining FDA nod

Celltrion was granted conditional approval for DiaTrust last week and to get its formal authorization from S. Korea’s Ministry of Food and Drug Safety. It needs to submit more clinical data within three months, as per the Korea Bio Medical Review.

It was added that the company is planning to supply the COVID-19 test kits via its subsidiary firm, Celltrion Pharm. It is also looking at other distribution outlets such as iMarket Korea.

Meanwhile, Celltrion’s new DiaTrust COVID-19 Ag home test kit was said to have shown results with high accuracy. However, it pointed out that suspected coronavirus patients with an obvious epidemiological connection to infection should get PCR tests at authorized screening centers set up by health authorities because the kits are just a supportive tool.