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
Hitachi Joins Anthropic’s Critical Infrastructure Defense Program9.10.2026 02:32:00 CEST | Press release
Hitachi, Ltd. (TSE:6501, "Hitachi"), today announced that it has joined Anthropic, PBC’s (“Anthropic”) “Critical Infrastructure Defense Program,” launched on October 8, 2026, as a founding partner. The program is aimed at strengthening cyber defense for critical infrastructure, including control systems supporting power, water, manufacturing, and transportation services. Infrastructure systems that underpin society and the economy cannot tolerate prolonged downtime, making it difficult to implement certain security measures, such as system shutdowns for patch deployment. At the same time, advances in AI are significantly shortening the time between vulnerability disclosure and exploitation, creating an urgent need to redesign systems based on the assumption that cyberattacks will occur. The program seeks to strengthen cybersecurity through rapid vulnerability detection and remediation by integrating Anthropic’s advanced AI models, Claude, into the products and services of trusted syste
Lapmaster Wolters and Precision Surfacing Solutions Secures Strategic Minority Investment from The Cynosure Group and Fernweh Group to Accelerate Growth8.10.2026 22:49:00 CEST | Press release
Investment strengthens the balance sheet and brings long-term strategic partners to support continued growth and expansion across semiconductors, advanced materials, advanced packaging, and precision optics end markets. Lapmaster Wolters and Precision Surfacing Solutions (“Lapmaster Wolters”), a leading global supplier of high-precision machine systems and consumables to the semiconductor, advanced materials, precision optics, and advanced packaging industries, today announced the completion of a minority equity investment by affiliates of The Cynosure Group (“Cynosure”) and Fernweh Group (“Fernweh”). The investment strengthens the balance sheet and adds long-term, engaged partners to support the company’s next phase of growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261008141876/en/ Positioned for growth Demand for ultra-high-precision surface finishing continues to grow as customers in semiconductors, advanced mater
Dubai Launches Global Create AI Agents Championship with Prize Pool Exceeding AED 2.5 Million8.10.2026 19:05:00 CEST | Press release
Dubai has launched the Create AI Agents Championship, a global competition inviting innovators to develop practical and scalable AI-agent solutions that address real-world challenges, with a total prize pool exceeding AED 2.5 million. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261008883373/en/ Dubai has launched the Create AI Agents Championship as part of its efforts to accelerate the adoption and development of Agentic AI (Photo: AETOSWire) The launch of the championship was announced by H.H. Sheikh Hamdan bin Mohammed bin Rashid Al Maktoum, Crown Prince of Dubai, Deputy Prime Minister and Minister of Defence of the UAE, and Chairman of The Executive Council of Dubai, who encouraged innovators from around the world to participate. Led by Dubai Chamber of Digital Economy, the championship aims to accelerate the adoption of Agentic AI and support the development of innovative AI-agent solutions with strong potential for
Seiden Law LLP issues statement: Prosecuted by Press Conference: Declared Guilty Without a Charge, Yim Leak Family Asks UN Human Rights Experts to Hold Thailand to Its Own Treaty Commitments8.10.2026 18:26:00 CEST | Press release
Urgent appeal to UN Special Rapporteurs cites the presumption of innocence, due process and protection of a child. The key facts are the Thai government's own words and files. Seiden Law LLP, chief global counsel to Cambodian businessman Yim Leak, announced today that Jared Genser, international counsel to Mr. Yim and his wife, has asked two UN Special Rapporteurs to send an urgent appeal to the Thai government. The request is made on behalf of the couple and their seven-year-old son. It says Thailand violated its international human rights commitments by announcing the family’s guilt before any court had tried them, and by freezing their assets, including their minor son’s savings, without a hearing. Six Official Statements in Nine Months. No Charge Filed in Any Court. Between December 2025 and September 2026, Thai officials described Mr. Yim as the center of a criminal network on six occasions: at two press conferences chaired by the head of the Thai government, in the House of Repre
Sam Altman-Backed Meanwhile Raises $37.5M as Families Across Asia, Europe and the Middle East Turn to Bitcoin Life Insurance8.10.2026 18:12:00 CEST | Press release
Existing investors, led by Bain Capital Crypto, back the first licensed Bitcoin life insurer after its single-premium policy for international clients drives a record year Meanwhile, the first life insurer licensed to operate entirely in Bitcoin, today announced $37.5 million in new funding from its existing investors. Bain Capital Crypto led the round, alongside Haun Ventures, Framework Ventures, Pantera Capital, Apollo, Northwestern Mutual Future Ventures, and Morgan Creek Digital. Meanwhile, whose backers also include Sam Altman, has now raised more than $180 million. The round follows a surge in international demand for Meanwhile’s Bitcoin life insurance policies, particularly in Asia, Europe and the Middle East amid broader macro instability. In early 2026, Meanwhile launched BTC Life 1-Pay, a single-premium whole life policy built for high-net-worth clients outside the United States. It is the company's second product line after BTC 10-Pay, which is purposely designed for US taxp
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