Seegene Allplex(TM) 2019-nCoV Assay (SARS-CoV-2) Gets Expanded FDA Emergency Use Authorization
SEOUL, South Korea, July 30, 2020 /PRNewswire/ -- Seegene, Inc. announced that U.S. Food and Drug Administration (FDA) has further expanded the emergency use authorization (EUA) 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 initially received EUA on April 21, 2020 and this 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.
Seegene's Allplex 2019-nCoV Assay has a unique feature that identifies 3 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. Allplex 2019-nCoV Assay has been independently validated by the Foundation for Innovative New Diagnostics, a global non-profit organization that is a WHO Collaborating Centre for Laboratory Strengthening and Diagnostic Technology Evaluation. Using its exclusive AI-based assay design platform and proprietary high multiplex chemistry technologies, and combining that with its high throughput, automated instrument and software solutions, Seegene offers unparalleled capacity at the most competitive pricing available on the market.
Leveraging its 20 years of experience in molecular diagnostics and infectious disease, Seegene is now focused on delivering its Flu A/B, RSV A/B, SARS-CoV-2 combo test to the US market in time for the upcoming flu season.
About Seegene
Seegene (KQ: 096530) is a global pioneer in symptom-based in vitro molecular diagnostics focusing on advancing science to develop multiplex molecular technologies and to manufacture multiplex in vitro diagnostic devices and reagents. Seegene's core enabling power is the passion for wide spreading of multiplex molecular diagnostics to improve the quality of life and health of people. Using its innovative proprietary technologies, Seegene has been making considerable contributions to giving the most economic and clinic-friendly molecular diagnostic solutions for infectious diseases, genetics, pharmacogenetics, and oncology. For more information, please visit www.seegene.com or contact [email protected].
SOURCE Seegene
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