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
Rimini Street to Report Second Quarter 2026 Financial Results on July 30, 20266.7.2026 15:00:00 CEST | Press release
Rimini Street, Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™ and the leading third-party support provider for Oracle, SAP and VMware software, today announced it will report earnings after market close on July 30, 2026. The company will host a conference call and webcast on that date to discuss the second quarter 2026 results and the second half 2026 outlook at 5:00 p.m. Eastern / 2:00 p.m. Pacific time. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260706560476/en/ Rimini Street to Report Second Quarter 2026 Financial Results on July 30, 2026 A live webcast of the event will be available on Rimini Street’s Investor Relations site via the Rimini Street IR events link and directly via the webcast link. Dial-in participants can access the conference by dialing 1-800-836-8184. A replay of the webcast will be available for one year following the event. About Rimini Street, Inc. Rimini Street, Inc. (Nasda
Orion and Shilpa Medicare Expand Partnership to Develop and Supply Nivolumab Biosimilar for Europe6.7.2026 15:00:00 CEST | Press release
Shilpa Medicare Limited announced that its wholly owned subsidiary, Shilpa Biologicals Private Limited, has entered into a co-development and supply agreement with Orion Corporation for intravenous (IV) nivolumab biosimilar referencing one of the world’s most widely used cancer immunotherapies to widen patient access across Europe. Nivolumab helped usher in the era of immuno-oncology, transforming the outlook for patients with cancers such as melanoma and lung cancer. As the originator approaches loss of exclusivity in Europe, this partnership aims to put a high-quality, EU-GMP-manufactured nivolumab biosimilar within reach of more patients, reducing healthcare burden. In 2025, Nivolumab recorded sales of approximately USD4.1 billion (Source: IQVIA/IMS) Europe — underscoring the scale of the opportunity. Under the agreement, Orion will hold the exclusive rights to register, market, distribute and sell the nivolumab biosimilar across Europe. Shilpa Biologicals will lead product developm
No-Loss Trading Platform UpsideOnly Surpasses 100,000 Users Within Weeks of Launch6.7.2026 14:48:00 CEST | Press release
Rapid growth shows strong demand for a new trading model where users can make market predictions without risking their own capital Perpetuals.com Ltd (Nasdaq: PDC), today announced that UpsideOnly, its risk-free trading and market prediction platform, has seen a surge in new user sign-ups, surpassing the important milestone of 100,000 traders within weeks of its launch on May 19. UpsideOnly lets users make predictions about where global equity, commodity, forex, and crypto markets are heading without ever placing a real trade themselves. Perpetuals uses its own capital to trade on the strongest signals identified by its proprietary AI. If those trades win, Perpetuals shares the profits with the users who helped generate the signal. If the trade doesn’t make money, users lose nothing. Reaching 100,000 users so quickly after launching is a reflection of the enormous demand for a platform that flips the traditional retail trading model on its head, with early platform data showing strong
Klarna Submits Application for U.S. Banking License6.7.2026 14:30:00 CEST | Press release
Klarna (NYSE: KLAR), the global digital bank and flexible payments provider, today announced it has submitted applications to the Utah Department of Financial Institutions and the Federal Deposit Insurance Corporation (FDIC) to establish Klarna Bank USA, a proposed Utah-chartered industrial bank. Klarna has operated as a licensed bank in Europe since 2017 and serves U.S. customers through valued partner banks. Since 2019, Klarna has provided Americans with access to over $91.3 billion in responsible credit, saving them more than $5.1 billion in interest compared to revolving credit card debt. Today, 30 million Americans use Klarna each year, and hundreds of thousands of merchants rely on Klarna to grow their businesses. "Banking is built on trust," said Sebastian Siemiatkowski, co-founder and CEO of Klarna. "We've seen firsthand the appetite for a fairer, more transparent approach in the U.S., and our own banking license is the natural next step, giving customers tools to borrow respon
IQM Quantum Computers Acquires Assets of Quantistry GmbH to Bridge the Gap Between Quantum Algorithms and Solutions for Industrial Enterprises6.7.2026 14:00:00 CEST | Press release
This is a strategic asset acquisition comprising proprietary software and intellectual property of Quantistry GmbH, a pioneer in cloud-native, AI-powered chemical and materials simulation By integrating Quantistry’s advanced simulation platform with IQM’s leading quantum computing hardware, IQM will deliver an end-to-end quantum-classical applications development platform and algorithm libraries powered by a user-friendly native-AI computing environment The transaction secures a critical enterprise software layer that accelerates IQM’s application roadmap, enabling industrial enterprises to develop quantum application proof-of-concepts and scale them over time, backed by a reliable, long-term quantum roadmap It also enhances IQM’s ability to deepen domain expertise across specific industry verticals Quantistry’s core quantum chemistry and machine learning engineering team will join IQM, strengthening the company’s ability to deepen relationships with tier-one industrial enterprises acr
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