Celltrion Applies to US FDA to Expand Use of Self-Test Kits for Under 14

Celltrion 'D'Art Trust COVID-19 Antigen Home Test'

[Asia Economy Reporter Chunhee Lee] Celltrion has begun efforts to expand the age range for use of the COVID-19 rapid antigen self-test kit 'DiaTrust Home Test,' jointly developed with Humasis, in the U.S. market.

On the 11th, Celltrion announced that it recently applied to the U.S. Food and Drug Administration (FDA) for a modification approval to allow children under 14 years old to use the DiaTrust Home Test. The DiaTrust Home Test received Emergency Use Authorization (EUA) from the FDA in October last year and is currently expanding its market presence in the U.S. The current authorized age is 14 years and older, and users can purchase it online or offline without a prescription.

Celltrion is challenging the modification approval to provide a pediatric version of the DiaTrust Home Test with a separate pediatric swab, allowing children aged 2 to 13 to use it. Based on usability test results, the modification application was submitted on the 4th, aiming for approval within the second quarter of this year.

Additionally, Celltrion disclosed on the same day that it received purchase orders for DiaTrust products totaling KRW 459.47928 billion yesterday. This order is based on supply contracts signed earlier this month with about ten companies and government agencies, including the U.S. Department of Defense Procurement Office and Amazon. Supply will be handled by Celltrion USA, the U.S. subsidiary, and products will be delivered immediately.

The DiaTrust Home Test can confirm infection status within 15 minutes after testing without additional equipment. Clinical trials conducted last year in the U.S. on approximately 490 symptomatic and asymptomatic COVID-19 patients showed accuracy levels of 99.8% specificity and 86.7% sensitivity. Furthermore, research conducted through the U.S. National Institutes of Health (NIH) on the DiaTrust diagnostic kit for the Omicron variant confirmed its effectiveness in detecting the Omicron variant.

A Celltrion official stated, “Due to the spread of the Omicron COVID-19 variant, demand for diagnostic kits is rapidly increasing domestically and internationally, and we are actively responding to market demand. In particular, once the modification approval to expand the age range for use in the U.S. is completed, the number of users will significantly increase, which is expected to help prevent the spread of the COVID-19 virus.”

This content was produced with the assistance of AI translation services.