Seegene Allplex 2019-nCoV Assay (SARS-CoV-2) Granted Expanded FDA Emergency Use Authorization

Seegene, Inc. (Seoul, South Korea) has been granted expanded Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for its Allplex 2019-nCoV Assay, a Real-time RT-PCR test for SARS-CoV-2, the novel coronavirus responsible for the COVID-19 disease.

Seegene's Allplex 2019-nCoV Assay, which had initially received EUA on April 21, 2020, has a unique feature that identifies three different target genes (E, RdRP and N genes) simultaneously in a single reaction tube/well, which allows for highly accurate results and maximizes the throughput for high volume testing. The current expansion greatly increases the number of nucleic acid extraction/isolation systems and extraction kits as well as PCR instruments. Laboratories can now utilize Seegene STARlet, Seegene NIMBUS, Microlab STARlet IVD and Microlab NIMBUS IVD all with Seegene STARMag RNA/DNA extraction kits, AdvanSure E3 System with AdvanSure NA EX Kits, GeneAll Ribospin vRD (Viral RNA/DNA Extraction Kit) (all six available through Seegene Technologies in San Francisco Bay Area), QIAamp DSP Viral RNA Mini kits, MagNA Pure 96 System, KingFisher Flex System with MagMAX Viral/Pathogen Nucleic Acid Isolation Kits. For PCR instruments, laboratories can use Bio-Rad CFX96 and CFX96 Touch systems or Applied Biosystems 7500 and 7500 Fast Dx real-time PCR detection systems.


"As COVID 19 pandemic continues, there is a continuous demand on increasing test capacity. We hope that the EUA expansion with more options will help laboratories choose the best-fit solution for additional test capacity. We continue to put our effort in ramping up the production as well as exploring new partnership to offer more solution to the market. Our goal is to provide a very affordable and scalable testing solution for both large and small laboratories anywhere in the US," said Dr. Jong-Yoon Chun, CEO of Seegene.