Celltrion Receives FDA Emergency Use Authorization for Point of Care Antigen Rapid Test Kit – DiaTrust™ COVID-19 Ag Rapid Test
29.4.2021 07:22:00 EEST | Business Wire | Press release
Celltrion (KRX:068270) announced on April 29 that DiaTrust™ (Celltrion DiaTrust™ COVID-19 Ag Rapid Test) is now launched and available for immediate supply.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210428006242/en/
Celltrion DiaTrust™ COVID-19 Ag Rapid Test (Photo: Business Wire)
DiaTrust™ received the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) approval for their COVID-19 Point of Care (POC) antigen rapid test kit, DiaTrust™ (Celltrion DiaTrust™ COVID-19 Ag Rapid Test). With the recent EUA approval, DiaTrustTM is available for immediate supply and distribution.
DiaTrustTM uses Celltrion’s proprietary antibody, which specifically binds to the COVID-19 virus and detects the infection within 15 minutes. Most rapid test kits in the market generally detect only one of the N or S antigens, but DiaTrustTM is characterized by maximizing the sensitivity with a dual antigen method that detects both antigens. Clinical trials with patients within the first seven days of symptom onset showed sensitivity and specificity levels at 93.3% and 99.0%, respectively, showing a high level of accuracy.
DiaTrustTM is also authorized for screening with Serial Testing under an EUA. Serial Testing is intended to be used on individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection. Serial Testing allows the same individual to be tested twice over two (or three) days with at least 24 hours (and no more than 48 hours) between tests, increasing the chances to detect asymptomatic individuals that may not show up with a single test.
Celltrion confirmed the equivalent level of sensitivity of detecting variants from the UK, South Africa, Brazil, California, and New York with clinical studies or in-vitro studies. Clinical trials were conducted in the U.S. when the UK variant was the most prevalent, and clinical trials in Brazil also showed more than 90% sensitivity.
A Celltrion representative stated, "DiaTrustTM is an antigen test kit that quickly detects the most recent COVID-19 variants from the UK, Brazil, etc., through one test, without the need for expensive detection equipment. As the continued rise of the variants continues to threaten the world, Celltrion plans to expand supplying these testing kits globally.”
About Celltrion, Inc
Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacturing of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA and EC’s approval for Inflectra® and Remsima®, respectively, which is the world’s first mAb biosimilar to receive approval from a regulatory agency in a developed country. Also Celltrion received FDA and EC’s approval for Truxima® and Herzuma®. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210428006242/en/
Contact information
Celltrion, Inc.
Eunyoung Lee, +82 32 850 4384
Eunyoung.lee1@celltrion.com
Or
Tae-Gyun Kim, +82 32 850 5136
Taegyun.kim@celltrion.com
For business inquires, please contact
Diaturst@celltrion.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Bridger Photonics Posts Record Year as Operators Turn to Trusted Emissions Intelligence4.2.2026 14:20:00 EET | Press release
Bridger Photonics (“Bridger”) closed its strongest year in company history last year, marked by record asset coverage, record revenue, and global adoption of its methane emissions data and intelligence across multiple continents and the entire oil and natural gas value chain. Bridger’s momentum reflects a clear shift in how operators choose to manage emissions: away from legacy and weather-limited approaches and toward entire asset coverage with data they can trust. Bridger continues to lead the methane detection space—growing existing customers and attracting new ones. Bridger has competitively displaced 32 customers from other aerial technologies, driven by deep industry expertise, proven data reliability and actionability, the ability to operate across challenging conditions and seasons, close coordination with ground crews, and a white-glove service model designed around operator needs. Customers across onshore production, midstream, LNG, and offshore operations are increasingly re
Macrobond Launches Macrobond Amplify, A New Standard for Interactive Financial Research4.2.2026 14:00:00 EET | Press release
Macrobond, the global platform for macroeconomic and financial data, announced the launch of Macrobond Amplify, a browser-based research distribution tool that enables economists and analysts to deliver rich, interactive content to their consumers at scale. Amplify empowers analysts and research teams to move beyond static charts and PDFs, delivering interactive, explorable insights that build trust, foster collaboration, and drive better decision-making. With Amplify, research teams can publish interactive, auditable research models that clients can explore directly through charts and dynamic visualizations. By sharing a simple link, Amplify users can distribute their research at scale with both internal partners and clients. “As the research industry evolves, analysts and economists face growing pressure to ensure their work reaches the right audiences, shows transparency, and demonstrates the rigour behind their thinking,” says Dan Seal, Chief Product Officer at Macrobond. “Amplify
Registrar Corp Acquires TechniCAL and Becomes the Global Compliance Leader in Shelf-stable Packaged Foods Safety4.2.2026 14:00:00 EET | Press release
Registrar Corp, the world’s largest food and beverage regulatory compliance provider, today announced its acquisition of TechniCAL, the world’s leading independent Process Authority for low-acid and acidified foods. Registrar Corp is a Paine Schwartz Partners portfolio company. Consumer demand for convenience and longer product life without refrigeration has driven rapid growth in shelf-stable foods and beverages, with packaging innovations extending beyond cans and glass jars to formats such as retort pouches and cartons. Ensuring products in these various packaging formats are safe from harmful microorganisms is critical to public health and required by the U.S. FDA. Together, Registrar Corp and TechniCAL provide the industry’s most complete solution, combining proven scientific expertise, regulatory knowledge, training, and advanced thermal testing. “TechniCAL is world renowned for its Process Authority expertise and advanced testing technologies assuring compliant thermal processin
Kinaxis Announces Intention to Maximize Size of Normal Course Issuer Bid4.2.2026 14:00:00 EET | Press release
Kinaxis® Inc. (“Kinaxis” or the “Company”) (TSX: KXS) today announces that it intends to amend its current normal course issuer bid (the “NCIB”) to increase the number of its common shares (the “Shares”) that may be repurchased from 1,403,042, representing 5% of the Company’s issued and outstanding Shares as at October 31, 2025, to approximately 2,799,843, representing 10% of the Company’s “public float” as at October 31, 2025, which is the maximum allowable under the rules of the Toronto Stock Exchange (the “TSX”). The Company has already invested US$54 million under its current NCIB. At the average price paid to date for the Shares under the current NCIB, repurchasing 10% of the Shares would represent an additional investment of approximately US$284 million. “There is a fundamental misunderstanding of the opportunities and threats from generative and agentic AI to mission-critical enterprise software, like ours, that solves deeply complex problems and enables highly consequential dec
Morgan Stanley Inclusive & Sustainable Ventures Hosts Global Demo Day, Opens Applications for Next Cohort4.2.2026 14:00:00 EET | Press release
Morgan Stanley (NYSE: MS) today is hosting its annual global Inclusive & Sustainable Ventures (MSISV) Demo Day, with startups and nonprofits participating from across the Americas, Europe, the Middle East and Africa (EMEA). The organizations will pitch over 300 investors, as well as potential business partners and customers. Over the past five months, MSISV has supported 29 startups and four nonprofits through an intensive accelerator program, providing them with capital, a tailored curriculum, mentorship opportunities and business-growth resources from Morgan Stanley’s ecosystem of internal and external partners. “With founders spanning 10 countries and 13 industries, our Morgan Stanley Inclusive & Sustainable Ventures cohort underscores the potential of innovators globally to bring disruptive solutions for business and society to market,” said Jessica Alsford, Morgan Stanley Chief Sustainability Officer. “We are eager to watch as these founders continue to scale with the backing of o
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom