Celltrion-Humasis COVID-19 Self-Test Kit Receives FDA Emergency Use Authorization

Celltrion 'D-Trust COVID-19 Antigen Home Test' (Photo by Celltrion)

[Asia Economy Reporter Lee Chun-hee] Celltrion's COVID-19 antigen rapid self-test kit, co-developed with in vitro diagnostics specialist Humasis, has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

On the 25th, Celltrion announced that its COVID-19 antigen rapid self-test kit, the ‘DiaTrust COVID-19 Antigen Home Test (Celltrion DiaTrust™ COVID-19 Ag Home Test),’ received FDA emergency use approval. Following the FDA’s EUA granted in April for the ‘DiaTrust COVID-19 Professional (POCT) Antigen Rapid Diagnostic Kit,’ the additional EUA for the ‘DiaTrust COVID-19 Antigen Home Test’ is expected to accelerate Celltrion’s penetration into the U.S. COVID-19 diagnostic kit market. The DiaTrust COVID-19 Antigen Home Test is intended for use by individuals aged 14 and older and can be purchased online or offline without a prescription.

Clinical trials conducted in the U.S. from March to July on approximately 490 symptomatic and asymptomatic individuals showed that the DiaTrust COVID-19 Antigen Home Test demonstrated sensitivity (the ability to correctly identify positive RT-PCR results) and specificity (the ability to correctly identify negative RT-PCR results) of 86.7% and 99.8%, respectively.

The strength of the DiaTrust COVID-19 Antigen Home Test lies in its simplicity. Currently, other FDA-approved products in the U.S. require ‘serial testing’?performing two or more tests regardless of symptom presence. While asymptomatic individuals using the DiaTrust test also need to conduct serial testing, symptomatic individuals can confirm infection status with just a single test.

Celltrion plans to supply the ‘DiaTrust COVID-19 Antigen Home Test’ in the U.S. through its subsidiary CelltrionUSA. Production of the product will be handled by co-developer Humasis.

A Celltrion representative stated, “This emergency use authorization is the result of high trust in Celltrion’s diagnostic kit products. We will strive to contribute to preventing the spread of COVID-19 through early product supply.”