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
Dompé Doses First Patient in Phase 3 Study of Cenegermin-bkbj in NAION14.7.2026 15:00:00 EEST | Press release
Dompé, a biopharmaceutical company with operations in Italy and the US, announced the first patient has been enrolled in a Phase 3 study of cenegermin-bkbj for the treatment of non-arteritic anterior ischemic neuropathy (NAION). Involving more than 130 centers globally, the Phase 3 trial, “Galassia-NAION-301” is a multicenter, double-blind study comparing cenegermin-bkbj against placebo in improving vision loss caused by NAION. “Our NGF R&D program continues to accelerate with our third clinical study of 2026,” said Marcello Allegretti, Chief Scientific Officer at Dompé. “Dosing the first patient in our NAION trial marks a critical step in our mission to unlock the full potential of NGF. By advancing our proprietary intranasal NGF in clinical investigation, we are taking a bold, non-invasive approach that bypasses the blood-brain barrier and has the potential to redefine the standard of care.” NAION refers to a loss of blood flow to the optic nerve which causes rapid vision loss that u
Esri to Debut the Power of Where Collection at 2026 Esri User Conference14.7.2026 15:00:00 EEST | Press release
Esri, the global leader in location intelligence, will debut the Power of Where Collection at the 2026 Esri User Conference in July. The collection builds on the ideas introduced in The Power of Where: A Geographic Approach to the World's Greatest Challenges, by Esri president Jack Dangermond, published in 2024. The new collection expands these foundational concepts into focused, real-world applications that demonstrate the growing impact of geographic information system (GIS) technology. The first two other books starting the collection are Geowater: A Geographic Approach to Water Data and Forecasting and Parcels: How Property Shapes Geography. Together, these titles illustrate how spatial thinking and GIS are transforming how organizations understand systems, manage resources, and plan for the future. The Power of Where Collection reflects Esri’s ongoing commitment to helping organizations make smarter, more informed decisions across industries—on topics ranging from water sustainabi
Esri Helps Bring Up-to-Date Road Closure Information to Google Maps and Waze14.7.2026 15:00:00 EEST | Press release
Esri has expanded its Community Maps Program, enabling road closure data to be shared with Google Maps and Waze. The Road Closures solution, in Esri's ArcGIS platform, was introduced last year as a way for users to easily share road closure updates directly with popular consumer mapping providers so they can update their maps with this important information. The solution aimed to bridge the gap between government agencies managing timely road updates and the public, who rely on mapping apps for real-time navigation. Over 100 communities around the United States and other countries are actively sharing their road closure information. ArcGIS users can now easily share that same authoritative data with Google Maps and Waze via the Waze for Cities program. "For over a year, we've been working with dozens of our local government users to share their road closure information with our initial consumer mapping partners, Apple Maps and TomTom," said Deane Kensok, chief technology officer for Ar
CE-IVDR Mark for Hologic’s Aptima ® HPV Test Expanded to Include Self-Collected Sample Claim in Cervical Cancer Screening14.7.2026 15:00:00 EEST | Press release
Hologic, Inc. announced today that its Aptima® HPV Assay received an expanded CE-IVDR marking in the European Union and the UK and is now approved for self-collected vaginal samples using the Aptima Multitest Specimen Collection Kit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260714358586/en/ Hologic’s Aptima® HPV Assay and Aptima Multitest Specimen Collection Kit Cervical cancer is the fourth most common cancer in women but is largely preventable through HPV vaccination and regular screening.1 Evidence shows that organized screening and early detection reduces deaths from cervical cancer, with mortality reduction rates in Europe ranging from 41% to 92%.2 However, even in countries with an established cervical screening program, screening participation rates vary widely, from 25% to 80%, with some showing stagnation or decline in recent years.3 “Despite the benefits of cervical cancer screening, there are still barriers
ExaGrid Recognized in the Prestigious 2026 MES Midmarket 100 List14.7.2026 15:00:00 EEST | Press release
ExaGrid®, the industry’s only Tiered Backup Storage solution with AI-Powered Retention Time-Lock (RTL) that includes a non-network-facing tier (creating a tiered air gap), delayed deletes and immutability for ransomware recovery, announced today that MES Computing, a brand of The Channel Company, has highlighted ExaGrid in its 2026 MES Midmarket 100 list. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260714261987/en/ The annual MES Midmarket 100 recognizes technology vendors with deep knowledge of the unique IT needs of midmarket organizations. These vendors are committed to delivering future-focused products and services that support growth, innovation, and success for their midsize customers. MES Computing defines midmarket organizations as those with an annual revenue of $50 million to $2 billion and/or 100 to 2,500 total supported users/seats. Vendors were selected for the MES Midmarket 100 for their go-to-market strate
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