Seegene's Allplex(TM) 2019-nCoV Assay receives FDA Emergency Use Authorization
SEOUL, South Korea, April 21, 2020 /PRNewswire/ -- Seegene, Inc. announced that U.S. Food and Drug Administration (FDA) granted 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's Allplex 2019-nCoV Assay, already sold over 10 million tests globally in over 60 countries and being used as a standard SARS-CoV-2 assay, has a unique feature that identifies 3 different target genes (E, RdRP and N genes) in a single reaction tube, which allows for highly accurate results and maximizes the throughput for high volume testing.
Using its exclusive AI-based assay design platform, Seegene was able to rapidly develop the assay shortly after the COVID-19 outbreak started in China. Seegene's proprietary high multiplex chemistry, technology combined with its unique automated solution, has played a pivotal role in South Korea's rapid response to the COVID 19 outbreak.
"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. Jong-Yoon Chun, CEO of Seegene.
Seegene anticipates that the FDA EUA approval will now enable laboratories in the United States to run the Seegene's test immediately for high-volume testing.
"We feel that it is our duty to help the society with our technologies in this time of need. We are incredibly proud to be providing the Seegene Assay which represents the leading edge of testing technologies. We will continue to stay prepared for any modifications required to ensure the most accurate detection of the mutative SARS-CoV-2," said Dr. Jong-Yoon Chun, CEO of 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.