Business Wire

Celltrion Receives FDA Emergency Use Authorization for Point of Care Antigen Rapid Test Kit – DiaTrust™ COVID-19 Ag Rapid Test

Share

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/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

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.

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

Year-old European startup Maisa named alongside Google and Amazon in elite list of leading AI agent vendors in top global US research reports by Gartner3.7.2025 02:01:00 EEST | Press release

Maisa, a rising star of enterprise AI, has been named by leading global research and advisory firm Gartner in its list of leading vendors for developing reliable AI agents. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702640749/en/ Maisa founders David Villalón and Manuel Romero Inclusion in Gartner’s 2025 Hype Cycle for AI and Hype Cycle for the Future of Work marks the first time a Spanish startup has been mentioned in these influential reports. The company, which is barely a year old and made its first raise of $5m+ from leading US investors last year, now finds itself named alongside global giants Amazon Web Services, Google, Salesforce and LangChain. The Gartner Hype Cycle for AI Agents provides an overview of emerging technologies in AI, helping organizations navigate the evolving landscape of autonomous software agents. The Hype Cycle for the Future of Work provides CIOs with a crucial human-first lens on the tra

Hoffmann Green Announces a Historic Increase in Production Over the First Half of 2025, Already Outperforming the Annual Volumes Realized in 20242.7.2025 20:05:00 EEST | Press release

Hoffmann Green Cement Technologies (ISIN: FR0013451044, Ticker: ALHGR) (“Hoffmann Green Cement” or the “Company”), an industrial player committed to the decarbonation of the construction sector that designs and markets innovative clinker-free cements, today announces a strong acceleration of production over the first half of 2025, validating the relevance of its industrial and commercial business model. Production volumes reached 19,640 tonnes over the first half of 2025, compared with 7,833 tonnes in the first half of 2024, representing a 2.5-fold increase. This very strong level of activity enabled the Company to outperform its total 2024 volumes (16,269 tonnes) over the first half of 2025. This dynamic is illustrated by the supply of more than 130 construction sites across the country during the half-year, exceeding 60,000 m³ of concrete formulated with 0% clinker cement delivered by more than 10,000 truck mixers. Julien BLANCHARD and David HOFFMANN, Co-founders of Hoffmann Green Ce

Institutional Real Estate, Inc. Announces Acquisition of U.K.-based Lyndon Publishing 2 Limited2.7.2025 19:44:00 EEST | Press release

Institutional Real Estate, Inc. (“IREI”) has completed its acquisition of the assets of London-based Lyndon Publishing 2 Ltd (“Lyndon Publishing”), which include The Property ChronicleandThe Green Chronicle.The former Lyndon Publishing 2 will now operate as a division of IREI. The Property Chronicle reaches a global audience of real estate investment professionals, researchers, and academics. Its sister publication, The Green Chronicle, is edited to address the interests and concerns of emerging young talent in these real estate professions. Both publications are produced as weekly news briefings filled with original content and contributed feature articles from industry thought and opinion leaders. In addition, The Property Chronicle is also published as a quarterly, illustrated full-color magazine available in both digital and print formats, while The Green Chronicleis published exclusively in digital format. Together, the two publications reach approximately 50,000 professionals acr

Sinopec Wins Technological Innovation Award at 2 nd Sino-European Corporate ESG Best Practice Conference2.7.2025 19:21:00 EEST | Press release

China Petroleum & Chemical Corporation ("Sinopec", HKG: 0386) has won the "Best Scientific and Technological Innovation Practice" award at the 2nd Sino-European Corporate ESG Best Practice Conference (the "Conference") on June 26 in Stuttgart. Sinopec’s case submission of Breakthrough in Depth, Climb to New Heights — Empowering the Energy and Chemical Industry with Technological Innovation stood out among numerous entries. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702387465/en/ Wang Tao, Sinopec representative, delivered a speech at the conference. The Conference reviews and awards the best ESG application cases in six areas of environmental protection, social responsibility, corporate management, scientific and technological innovation, education, and training to further enhance mutual understanding between Chinese and European businesses, facilitate bilateral economic and trade exchanges, and showcase China’s open,

Xsolla Releases Their Q2 2025 The State of Play Report: Mobile Gaming Is Projected to Hit $126B in 2025 Amid Global App Boom With In-Depth Analysis of Trends, Genres, and Monetization Strategies2.7.2025 19:00:00 EEST | Press release

Xsolla, a leading global video game commerce company, proudly announces the release of the Q2 2025 Edition of “The Xsolla Report: The State of Play.” This detailed report provides crucial insights, trends, and opportunities shaping the gaming landscape, empowering industry professionals to adapt and thrive in today’s rapidly changing market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702208715/en/ Graphic: Xsolla In 2024, global mobile app usage soared to an astonishing 4.2 trillion hours, an all-time high that powered a massive $150 billion consumer spending across mobile platforms. Mobile gaming is leading this charge, which accounted for more than half of that total. Despite a 6% dip in overall game downloads, falling to 49.6 billion, in-app purchase (IAP) revenue surged, indicating deeper user engagement and a more valuable player base. And the momentum is far from over: mobile gaming revenue is projected to grow

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye