Seegene Submits Allplex SARS-CoV-2/FluA/FluB/RSV Assay for US FDA Emergency Use Authorization

Seegene, Inc. (Seoul, Korea) has submitted its Allplex SARS-CoV-2/FluA/FluB/RSV Assay to the US Food and Drug Administration for Emergency Use Authorization (EUA).

Seegene's Allplex SARS-CoV-2/FluA/FluB/RSV Assay is a real-time RT-PCR assay that can simultaneously detect and differentiate eight target genes, including Flu A, Flu B, RSV A/B and three different target genes of COVID-19 (S gene, RdRP gene and N gene). The assay also includes dual targets for internal control (endogenous and exogenous respectively) in the same reaction tube, also Seegene’s unique channel of allowing for verification of the whole test process, as well as proper sampling, without having to compromise the accuracy of test results.

Such technological advancement not only saves time and cost in testing for the novel Coronavirus, but improves overall process efficiency, enabling massive testing, essential in fighting the COVID-19 pandemic. The Allplex SARS-CoV-2/FluA/FluB/RSV Assay is currently available in Europe and elsewhere around the world.

“Demand for accurate and available COVID-19 testing remains high across the United States,” said Dr. Jong-Yoon Chun, CEO of Seegene. “This multiplex assay will provide clinicians with the ability to differentiate diagnosis between the common flu and COVID-19. It is also incredibly efficient for labs because they will only need to run a single test versus four different tests. We’re committed to bringing innovative solutions to the market and doing our part in the fight against this pandemic.”

“COVID-19 testing will continue to play a vital role in reopening and resuming regular operations in businesses and schools,” said Helen Cha Roberts, President at Seegene Technologies, USA. “EUA approval of Seegene’s Allplex SARS-CoV-2/FluA/FluB/RSV Assay will ensure that facilities have the most advanced testing available to help quickly identify those infected with the virus and curb the spread. Seegene is well-positioned with inventory and a support team based in the US to help address the continued demand."