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Seegene Received Emergency Use Authorization (EUA) by USFDA For COVID-19 Test Kit

  • Wednesday, April 22, 2020, 2:56 pm
  • ACROFAN=Seunghee Shin
  • seunghee.shin@acrofan.com
 

Seegene, a Korean company specialized in molecular diagnostics, announced on the 22nd that it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for Allplex™ 2019-nCoV Assay.

Seegene's coronavirus test kit, Allplex™ 2019-nCoV Assay is used worldwide for COVID-19 screening. Since Allplex™ 2019-nCoV Assay can detect all three target genes (E, RdRp, N), it is not only highly accurate, but also can test with only one tube, so it can efficiently perform a large number of tests.

Immediately after the occurrence of COVID-19 in China, Seegene quickly began to develop COVID-19 diagnostic reagents using its own AI reagent development system. Seegene's diagnostic reagent technology and automated testing systems have played a pivotal role in effectively controlling the COVID-19 situation in Korea.

Seegene Medical Foundation, the affiliated company of Seegene and the largest inspection agency in Korea, can test up to 15,000 COVID-19 tests a day based on the automated testing system.

Seegene's testing system has become a global standard for COVID-19 diagnosis and is currently used in more than 60 countries, mainly Italy, Spain, France, and Germany.

Having secured an extensive global network and established an excellent reputation through a variety of reagent products, Seegene has been able to quickly apply COVID-19 tests through dedicated testing equipment installed in various places, and it is still generating a great demand from all over the world.