CelltrionUSA Begins Full-Scale Supply of $400 Million COVID-19 Diagnostic Kits in the U.S.

US Department of Defense Procurement Agency and Amazon Continue Expanding Supply Volume
Effectiveness Confirmed in Detecting Dominant Omicron Variant
Negotiations for Additional Supply Contracts... Accelerating Entry into North American Market

[Asia Economy Reporter Lee Gwanju] Celltrion announced on the 3rd that its U.S. subsidiary CelltrionUSA will begin full-scale supply of two products jointly developed with in vitro diagnostics specialist Humasis: the 'Diatrust COVID-19 Professional Antigen Rapid Test Kit' and the 'Diatrust COVID-19 Antigen Home Test,' valued at approximately 400 billion KRW.

This supply is based on contracts recently signed with more than 10 companies and governments, including the U.S. Department of Defense Procurement Agency and Amazon, the world's largest e-commerce company. The volume to be supplied by April this year is worth about 400 billion KRW.

CelltrionUSA, responsible for marketing the Diatrust product line in the U.S., aims to strengthen brand credibility in the U.S. pharmaceutical and medical device market through this supply, while also entering negotiations for additional volumes with key clients in the second quarter.

In September last year, CelltrionUSA was selected as a supplier in the COVID-19 test kit procurement project conducted by the U.S. Department of Defense Procurement Agency, recognizing the product's quality, production, and supply capabilities through product supply. The two test kits under the current supply contract each received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) in April and October of last year, respectively.

Diatrust Kit. [Photo by Celltrion]

Diatrust is a rapid diagnostic test kit product that allows infection status to be confirmed 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.

Unlike other rapid diagnostic kits, it applies two antibodies that bind respectively to the N protein and S protein of the COVID-19 virus, improving sensitivity and specificity, and demonstrating strong detection effects against variants. Additionally, recent research conducted through the U.S. National Institutes of Health (NIH) on the Omicron variant confirmed the effectiveness of Diatrust in detection.

A CelltrionUSA official stated, "With the Biden administration recently announcing the supply of 1 billion test kits within the U.S., demand and inquiries for the product continue to increase, and we expect record test kit sales in the first quarter." He added, "We will focus on supplying the contracted test kits to contribute to preventing the spread of variant viruses, while also doing our best to enhance product and brand value through expanded supply."

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