CELLTRION
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
Ant International and HSBC Test New Cross-Border Payments Solution Using Tokenised Deposits on Swift’s Network and Powered by ISO 2002211.12.2025 04:00:00 CET | Press release
ISO 20022-enabled solution allows blockchain interoperability on Swift’s network, using Ant International’s technology and HSBC’s Tokenised Deposit Service Integration with Swift’s network extends AML and anti-fraud capabilities to tokenised deposits transactions Proof of concept (POC) marks a step towards enabling seamless money movement across borders Ant International, HSBC and Swift today have completed a successful Proof of Concept (POC) for the cross-border transfer of tokenised deposits using ISO 20022 standards. The initiative leverages Swift’s global messaging network and HSBC’s recently launched Tokenised Deposit Service, combined with Ant International’s blockchain technology. The POC marks a key milestone in Ant International, HSBC, and Swift’s efforts to help businesses unlock the full benefits of tokenisation for enhanced liquidity, programmable finance, and 24/7 real-time settlement. As part of this initiative, Ant International and HSBC successfully integrated Ant Inter
Andersen Consulting styrker sit udbud af cybersikkerhed med tilføjelsen af S-RM11.12.2025 00:05:00 CET | Pressemeddelelse
Andersen Consulting indgår en samarbejdsaftale med S‑RM, en global efterretnings- og cybersikkerhedsvirksomhed, og styrker dermed sin evne til at understøtte globale kunder med risikostyring, hændelsesrespons og strategisk rådgivning. S-RM har hovedsæde i Storbritannien og leverer integrerede ydelser, der spænder over cyberrådgivning, digital efterforskning, hændelseshåndtering, virksomhedsefterretning og due diligence i forbindelse med transaktioner. Firmaet betjener family offices, kapitalfonde, Fortune 500-virksomheder og mellemstore virksomheder inden for bl.a. finans-, olie- og sundhedssektoren, og tilbyder praktisk cybersikkerhedsstyring samt tilpassede risikoplatforme. Med døgnåben hændelseshåndtering og dybdegående efterforskningsekspertise hjælper S-RM organisationer med at styrke deres modstandsdygtighed og træffe informerede beslutninger i komplekse miljøer. "I en tid, hvor trusler konstant udvikler sig, skal organisationer være proaktive, ikke reaktive," udtaler Heyrick Bon
Canva Unveils 2026 Design Trends: The Year of ‘Imperfect by Design’10.12.2025 23:52:00 CET | Press release
Canva’s third annual Design Trends Report uncovers insights from millions of Canva users and billions of designs to predict the must-know visual trends for creators and brands in 2026.90% surge in DIY-inspired searches, reflecting a shift toward raw, personal, and imperfect design.85% increase in searches for Zine and Substack inspired layouts as creators gravitate toward editorial style storytelling.80% of creators say 2026 is the year to regain creative control, embracing AI as a partner while prioritizing styles that feel human.54% growth in searches for clean layouts and simple branding as audiences gravitate toward pared back styles.527% surge in lo-fi aesthetic searches in favor of nostalgia driven, emotionally expressive visuals.220% jump in searches for “liminal” and “uncanny” content as lines between real and surreal blur. Canva, the world’s leading all-in-one visual communication platform, today unveiled its third annual Design Trends Report with bold predictions for creativi
Audiencerate Achieves Google Customer Match Partner Status, strengthening its role as a Global Data Provider10.12.2025 22:40:00 CET | Press release
Audiencerate, an international technology company specializing in data activation solutions and platforms within the AdTech and MarTech sectors, has been officially awarded by Google as a Customer Match Upload Partner. This certification is granted to a restricted number of global operators (https://support.google.com/google-ads/answer/7361372?hl=en) authorized to manage and onboard first-party data into the Google Ads and DV360 ecosystem. The company strengthen its strategic partnership with Google by adding the Customer Match Upload Partner accreditation to its existing status as a certified Google Data Provider. This new credential enables Audiencerate to seamlessly integrate proprietary audience segments and data into Google’s advertising platforms. The combination of these two accreditations represents an exceptionalsituation in the international landscape and solidifies Audiencerate's position in the digital advertising market, which is increasingly reliant on first-party data. T
Defence, Security and Resilience Bank (DSRB) Development Group – Official Statement10.12.2025 21:06:00 CET | Press release
On 8 September 2025, the Defence, Security and Resilience Bank (DSRB) Development Group convened a high-level meeting in the City of London with representatives from 37 nations, including all G7 members, alongside the European Commission, NATO, European Parliament, Global Banks, and Ratings Agencies to discuss the DSRB. A number of countries have now indicated their intention to begin the formal steps required to bring the DSRB into existence. This phased pattern of engagement is standard in the creation of international financial institutions, which typically begin with a core group of anchor nations and expand as additional members join through charter negotiations and subsequent capital rounds. The DSRB is designed to complement the European Union’s SAFE initiative, offering a broader multilateral platform that brings together NATO and Indo-Pacific nations and mobilises global capital to build the balance-sheet capacity required to finance nations’ defence spending and long-term res
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