Seegene Receives US FDA Emergency Use Authorization for COVID-19 Diagnostic Kit

Seegene's COVID-19 diagnostic reagent 'Allplex 2019-nCoV Assay'

[Asia Economy Reporter Eunmo Koo] Molecular diagnostics specialist Seegene announced on the 22nd that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization for Seegene's diagnostic reagent, ‘AllplexTM 2019-nCoV Assay,’ for testing the novel coronavirus infection (COVID-19).

This diagnostic reagent features the ability to detect all three target genes, ensuring high accuracy, and allows testing with just one tube, enabling efficient large-scale testing.

Seegene quickly developed the COVID-19 diagnostic reagent using its artificial intelligence reagent development system immediately after the outbreak. Seegene's diagnostic reagent technology and automated testing system have played a pivotal role in effectively controlling the COVID-19 situation in Korea. Seegene's affiliate, Seegene Medical Foundation, has the capacity to conduct up to 15,000 COVID-19 tests per day based on Seegene's automated testing system.

Jong-yoon Chun, CEO of Seegene, stated, “Seegene's automated system, including result analysis software, has proven to be very useful in significantly increasing testing volume during infection spread situations where thousands of tests must be performed in a single day, due to its convenience in test execution and scalability.”

Seegene's COVID-19 testing system is currently being used in more than 60 countries, primarily in Italy, Spain, France, and Germany.

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