CELLTRION
29.4.2021 06:24:11 CEST | 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/
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210428006242/en/
Link:
About Business Wire
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
Fi Expands International Footprint to 38 Countries Worldwide2.6.2026 19:25:00 CEST | Press release
Series 3+ and Mini are now available to pet owners across new European markets Fi, the leader in smart pet technology, today announced a major international expansion, bringing its AI-powered GPS pet wearables and connectivity network to 38 countries across North America and Europe. Fi devices are now available for purchase in 29 markets, including newly added countries such as Finland, Sweden, Denmark, Austria, Belgium, the Netherlands, Romania, Slovakia, and Latvia. Through Fi's international connectivity network, customers can also use Fi in Switzerland, Norway, Liechtenstein, Iceland, and Turkey, bringing Fi's total coverage footprint to 38 countries. The expansion reflects growing demand from pet owners who want reliable connectivity and health insights, whether they're at home or traveling abroad. "Wherever your pet roams, Fi should work," said Jonathan Bensamoun, Founder and CEO of Fi. "As more pet owners travel internationally and expect seamless connectivity, we're expanding F
XFolio AI Acquires Absolute Payment Solutions to Unify Treasury and Payments for UK Corporates2.6.2026 19:16:00 CEST | Press release
XFolio AI (xfolio.ai), a Paris-based treasury and cash management technology group, has acquired Absolute Payment Solutions (APS) (https://www.absolutepayments.com/), one of a select number of Pay.UK-accredited Bacs service providers in the UK. This acquisition creates an integrated platform spanning Bacs and all payment types, open banking, risk management, and treasury—giving UK corporates of all sizes the tools to manage cash and execute payments in one place. APS’s Bacs accreditation underpins payment services relied upon daily by organisations across both the public and private sectors, from SMEs running payroll and direct debit collections to large corporates processing high-volume payment flows. While enterprise payment platforms often demand significant scale and budget, and lighter solutions trade capability for speed of setup, APS and XFolio together deliver accredited Bacs infrastructure combined with advanced treasury intelligence across SWIFT, API, H2H, and EBICS rails—wit
Amazfit Introduces a New Era of Hybrid Training with Balance 3 and Balance Ultra2.6.2026 19:00:00 CEST | Press release
The new Balance series powers Amazfit’s Hybrid Training System, combining advanced smartwatch hardware with Zepp App intelligence to help athletes train with structure across strength, endurance, recovery, and daily life Amazfit, a leading global smart wearable brand owned by Zepp Health, today unveiled the Amazfit Balance 3 and Amazfit Balance Ultra, the newest additions to the Balance series and the hero watches for Amazfit’s new Hybrid Training System, connecting performance tracking with intelligent training guidance through the Zepp App. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260602329170/en/ Built around how modern athletes train today, Balance 3 and Balance Ultra are designed for people balancing strength, endurance, recovery, work, stress, and daily life. The devices serve as the engine layer of the connected Hybrid Training ecosystem, capturing how users train, recover, and respond over time. The products we
Mouser's Rise of the Robots Program Explores Humanoid Design Considerations2.6.2026 17:19:00 CEST | Press release
Mouser Electronics, Inc., the authorized global distributor with the newest electronic components and industrial automation products, today announced the latest installment of its Empowering Innovation Together (EIT) technology series, Rise of the Robots, which explores key technologies behind humanoid robots and their potential for transformation. The series shares how these robots have progressed from simple machinery to critical tools used in caregiving, industrial automation, education, and even in the harshest environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260602293561/en/ The latest EIT installment explores the engineering design process, system integration challenges, and the role of legacy infrastructure, safety, and ROI in shaping scalable humanoid robot deployment. While science fiction has long envisioned robots resembling humans, recent advances in sensing, actuation, AI, embedded computing, and pow
Blue Cloud Ventures Announces Final Close of Blue Cloud Ventures V2.6.2026 16:35:00 CEST | Press release
With over $1B in assets under management, Blue Cloud Ventures strengthens its commitment to the next generation of AI-driven enterprise software companies Blue Cloud Ventures (BCV), a venture growth firm focused on investing in enterprise software companies, announced the final close of its fifth fund, Blue Cloud Ventures V (BCV V). This milestone reinforces the firm’s continued mission to back category-defining companies that are poised to thrive in the age of AI. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260602186634/en/ At the core of BCV’s strategy is building deep conviction in and backing companies that possess the potential to define or reshape entire industries. With BCV V, the firm is doubling down on its AI-first investment thesis, aiming to back and support visionary teams on their long-term growth journey as they build the systems that will serve as the backbone of the modern enterprise. Blue Cloud typically
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