Seegene’s COVID-19 test kits get FDA emergency approval

Seegene said Wednesday it real-time PCR test kits were granted the US Food and Drug Administration’s emergency use authorization for COVID-19 testing.

The company’s Allplex 2019-nCoV Assay has already sold over 10 million tests globally in over 60 countries. Allplex can identify three different target genes -- E, RdRP and N genes -- in a single reaction tube, which maximizes throughput for high volume testing.

Seegene is now exporting 3 million test kits every week, and plans to expand the export volume to weekly 5 million starting May.

“Our automated system, with its advanced analysis software, has proven to be extremely useful due to its convenience and scalability, especially in such a pandemic situation where thousands of tests may be required to be performed in a day at every location,” said Dr. Chun Jong-yoon, CEO of Seegene.

Seegene anticipates that the FDA approval will now enable laboratories in the US to run Seegene’s test immediately for high-volume testing.

Seegene is also providing support to countries lacking infrastructure for RT-PCR test analyzation. If the company receives samples from overseas, results can be derived in 24 hours upon collection. The company can process up to 15,000 COVID-19 tests a day.

It has received global attention for being one of the very first South Korean test kit companies to develop an RT-PCR kit for COVID-19.

Before the virus hit Korea late January, Seegene had begun research for viable test kits using its artificial intelligence system and the genetic information of the SARS-CoV-2 virus shared globally by the Chinese scientists.

Prior to Seegene, Korea’s Osang Healthcare also received an emergency use authorization from the FDA for its RT-qPCR test kit GeneFinder COVID-19 Plus RealAmp Kit.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)