Molecular diagnostics specialist Seegene said Wednesday that it has won the emergency use approval (EUA) from the U.S. Food and Drug Administration for its Allplex 2019-nCoV Assay.
Seegene’s product is a real-time reverse transcription-polymerase chain reaction test kit for detecting the Covid-19 virus. It detects three different target genes (E, RdRP, and N genes) in a single tube, which allows highly accurate results and effective mass testing.
|Seegene’s diagnostic kit Allplex 2019-nCoV Assay|
Armed with an AI-based platform for developing a diagnostic kit, the company was able to develop the assay rapidly right after the Covid-19 outbreak in China, it said.
“Our automated system with advanced analysis software has proven to be useful in increasing the test volume drastically because of its convenience and scalability, especially in the current pandemic situation where thousands of tests need to be made every day at multiple locations,” Seegene CEO Chun Jong-yoon said. “More than 60 countries, including Italy, Spain, France, and Germany, are using the kit.”
Seegene expects that testing agencies in the U.S. will use the Seegene’s test soon for high-volume testing, now that the company has won the nod from the FDA.
“Seegene is proud to distribute its diagnostics kit in the U.S., as one of the frontrunners in the field of molecular diagnostic technology,” Cho said. “The company will continue to improve its products to detect numerous mutations of the Covid-19 virus, too.”
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