Celltrion's 'COVID-19 Antigen Rapid Test Kit' Receives US FDA Emergency Use Authorization

Dual Antigen Method Detects Both N and S Antigens
Continuous Testing Also Allowed... Rapid Patient Isolation

Celltrion Submits Clinical Trial Results of Self-Diagnostic Kit to FDA

[Asia Economy Reporter Kim Ji-hee] Celltrion announced on the 19th that its COVID-19 point-of-care antigen rapid diagnostic kit 'DiaTrust,' jointly developed with in-vitro diagnostics specialist Humasis, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

DiaTrust utilizes antibodies developed by Celltrion that strongly bind to COVID-19, enabling the detection of viral antigens. It can diagnose infection status within 15 minutes. Unlike competitors' rapid diagnostic kits that typically detect only one antigen, either N antigen or S antigen, DiaTrust employs a 'dual antigen' method detecting both antigens, maximizing sensitivity. Clinical trials on early symptomatic COVID-19 patients showed sensitivity and specificity of 93.3% and 99.1%, respectively.

Following this FDA approval, DiaTrust will be supplied immediately within the United States. In December last year, Celltrion signed a supply contract worth 240 billion KRW for COVID-19 antigen diagnostic kits with Prime Healthcare Distributors, a diagnostic kit and personal protective equipment wholesale distributor based in New York, through its U.S. subsidiary CelltrionUSA.

Additionally, this approval allows for serial testing, enabling COVID-19 tests twice a week at intervals of every three days or every 24 to 36 hours. This facilitates follow-up monitoring of initially asymptomatic patients, allowing rapid on-site isolation of infected individuals from the early stages of infection.

Celltrion, together with Humasis, confirmed detection capabilities against various variants through in-vitro tests, including those originating from the UK, South Africa, Brazil, California, and New York. Clinical trials conducted in the U.S. during periods of active UK variant spread and trials in Brazil showed detection rates exceeding 90%, confirming detection performance comparable to the original virus.

Celltrion anticipates increased market demand for self-diagnostic kits in Korea as well and has submitted clinical trial results conducted on over 450 subjects in the U.S. during February and March to the FDA. This product has the same analytical performance as the approved DiaTrust, and since regulatory authorities only need to review the clinical results additionally, a swift review process is expected.

A Celltrion official stated, "DiaTrust is an antigen diagnostic kit that rapidly diagnoses infection with COVID-19 and most currently threatening variants such as those from the UK and South Africa in a single test without expensive diagnostic equipment." They added, "As the global spread of variant viruses intensifies, we plan to expand exports to overseas countries based on this FDA approval."