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Celltrion Receives FDA Emergency Use Authorization for Point of Care Antigen Rapid Test Kit – DiaTrust™ COVID-19 Ag Rapid Test | Business

INCHEON, South Korea–(BUSINESS WIRE)–Apr 29, 2021–

Celltrion (KRX:068270) announced on April 29 that DiaTrust™ (Celltrion DiaTrust™ COVID-19 Ag Rapid Test) is now launched and available for immediate supply.

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, DiaTrust TM is available for immediate supply and distribution.

DiaTrust TM 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 DiaTrust TM 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.

DiaTrust TM 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, “DiaTrust TM 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.”

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.

Eunyoung Lee, +82 32 850 4384

Tae-Gyun Kim, +82 32 850 5136

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INDUSTRY KEYWORD: OTHER PROFESSIONAL SERVICES BIOTECHNOLOGY PHARMACEUTICAL MEDICAL SUPPLIES HEALTH INFECTIOUS DISEASES HOSPITALS PROFESSIONAL SERVICES

Copyright Business Wire 2021.

PUB: 04/29/2021 12:22 AM/DISC: 04/29/2021 12:22 AM

Copyright Business Wire 2021.


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