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.


Pentagon and Anthropic Clash Over AI Safeguards in National Security Use
Indonesia Stocks Face Fragile Sentiment After MSCI Warning and Market Rout
CSPC Pharma and AstraZeneca Forge Multibillion-Dollar Partnership to Develop Long-Acting Peptide Drugs
Samsung Electronics Posts Record Q4 2025 Profit as AI Chip Demand Soars
Elon Musk’s SpaceX Explores Merger Options With Tesla or xAI, Reports Say
Wall Street Slips as Tech Stocks Slide on AI Spending Fears and Earnings Concerns
Meta Stock Surges After Q4 2025 Earnings Beat and Strong Q1 2026 Revenue Outlook Despite Higher Capex
Thailand Moves to Regulate Gold Trading to Curb Baht Strength and Support Economic Growth
NVIDIA, Microsoft, and Amazon Eye Massive OpenAI Investment Amid $100B Funding Push
Gold Prices Pull Back After Record Highs as January Rally Remains Strong
Apple Earnings Beat Expectations as iPhone Sales Surge to Four-Year High
Gold Prices Hit Record High Above $5,500 as Iran Strike Fears Fuel Safe-Haven Demand
Panama Supreme Court Voids CK Hutchison Port Concessions, Raising Geopolitical and Trade Concerns
Philippine Economy Slows in Late 2025, Raising Expectations of Further Rate Cuts
UK Vehicle Production Falls Sharply in 2025 Amid Cyberattack, Tariffs, and Industry Restructuring
Indonesian Stocks Plunge as MSCI Downgrade Risk Sparks Investor Exodus 



