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
Boyd Watterson Global Names John Creswell Global Chief Client Officer to Accelerate Global Growth and Client Engagement23.7.2026 16:00:00 EEST | Press release
Boyd Watterson Global today announced the appointment of John Creswell as Global Chief Client Officer, a newly created senior leadership role that reflects the firm's continued investment in growth and its evolution into a leading global alternatives investment platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722823117/en/ John Creswell has joined Boyd Watterson Global as Global Chief Client Officer, a newly created role overseeing global sales, client engagement and marketing across the U.S., Europe and APAC. In this role, Creswell will oversee global sales, client engagement and marketing efforts across the United States, Europe and APAC, helping investors access the firm's capabilities while strengthening relationships with institutional and private capital partners worldwide. While based in Chicago, John will spend considerable time at the firm’s headquarters in Cleveland as well as in key offices globally. Cr
Trulioo Launches AI Agent to Resolve Beneficial Ownership Where Global Registries Fall Short23.7.2026 16:00:00 EEST | Press release
Trulioo, a global risk intelligence platform, today announced the UBO Discovery Agent, the newest layer in Trulioo's UBO Discovery capability inside its business risk and Know Your Business (KYB) verification workflow. AI is reshaping fraud, making it easier for bad actors to hide, and harder for companies to catch them. This makes the already tough job of verifying who actually owns a business even more difficult. Determining a business's ultimate beneficial owner is an ongoing, acute challenge for companies: registry coverage is inconsistent across countries, and even where registries exist, they typically record shareholders and directors of record (rather than the people actually in control). That data isn't simply outdated, it reflects a structural lag: ownership changes and time passes before the filing is made and processed, so a lookup often shows who owned a business months or years ago, not who owns it today. Further, ownership chains that cross borders can break entirely onc
Humanoid Raises $152 Million at $1.35 Billion Post-Money Valuation, Becoming Europe's First Pure-Play Humanoid Robotics Unicorn23.7.2026 16:00:00 EEST | Press release
Humanoid, a UK-based AI and robotics company building industrial humanoid robots, announced a $152 million Series A financing at a $1.35 billion post-money valuation. This funding brings the total amount raised to date to $270 million. The round was led by Prime Movers Lab, a venture capital firm focused on investments in breakthrough scientific startups working to revolutionize the world's most important industries and transform billions of lives, with participation from Schaeffler, Bosch, Fubon Financial Holding Venture Capital, and Aglaé Ventures. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260723238282/en/ Humanoid's leadership team with representatives from Prime Movers Lab, the lead investor in Humanoid's Series A financing. Now is a defining moment for the European technology ecosystem which positions the region among the global leaders in one of the world's fastest-growing tech sectors. Until now, much of the Phys
Riskified Named to the CNBC World's Top Fintech Companies 2026 List23.7.2026 15:00:00 EEST | Press release
Riskified (NYSE: RSKD), a global leader in ecommerce fraud detection and risk intelligence, has been named to CNBC's World's Top Fintech Companies 2026 list, in the Payments category. The list, now in its fourth edition, is produced by CNBC in partnership with Statista Inc., the global statistics and industry ranking firm. It was announced on July 22, 2026, and is available on CNBC's website. This is Riskified's second time making the list. The company previously earned this recognition in 2024, reinforcing its position in the ecommerce fraud and risk intelligence sector and underscoring its ongoing success in empowering businesses to grow revenue and profitability by mitigating risk through its AI-powered platform. CNBC and Statista's ranking covers the top 500 companies across eight fintech segments — Payments, Neobanking, Alternative Financing, Wealth Technology, Digital Assets, Enterprise Fintech, Insurtech, and Regtech. Companies are scored using an aggregated model that weighs ov
Azafaros Completes Enrollment of Phase 3 (NAVIGATE) Study Evaluating Nizubaglustat for the Treatment of Patients with GM1/GM2 Gangliosidoses23.7.2026 14:00:00 EEST | Press release
Azafaros, a private company building a portfolio of disease-modifying therapeuticsto become a leader in lysosomal storage disorders (LSDs) focused on addressing neurological symptoms, today announced the completion of patient recruitment in its Phase 3 study evaluating nizubaglustat for the treatment of GM1/GM2 gangliosidoses. “Completing enrollment in our Phase 3 GM1/GM2 study is a significant step toward potentially bringing nizubaglustat to patients and families living with these devastating neurodegenerative diseases," said Stefano Portolano, Chief Executive Officer at Azafaros. "We are deeply grateful to the patients, caregivers, investigators and advocacy groups who have made this milestone possible. As we advance the GM1/GM2 study toward data readout and regulatory submission, we continue to enroll in our Phase 3 NPC study and remain focused on our goal of addressing the significant unmet medical needs faced by these rare disease communities." Professor Roberto Giugliani, Princi
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