Seegene Announces Submission to U.S. FDA for Emergency Use Authorization of Its AllplexTM SARS-CoV-2/FluA/FluB/RSV Assay
March 01, 2021 at 09:30 am EST
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Seegene Inc. has submitted its Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay to the U.S. 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. The Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay is currently available in Europe and elsewhere around the world.
Seegene Inc is a Korea-based company engaged in the development, manufacturing and distribution of molecular diagnostic reagents. The Company mainly provides infectious pathogens inspection products, including allergic respiratory pathogens, sexually transmitted diseases pathogens, human papilloma virus (HPV) and other inspection products, drug resistance inspection products, single nucleotide polymorphisms (SNP) inspection products, as well as somatic mutation cancer inspection products. In addition, it is involved in the provision of automatic real-time detection instruments. The Company provides its products under the brand names of Seeplex, Anyplex and Magicplex. The Company distributes its products within domestic market and to overseas markets.
SEEGENE, INC. 
