A high-throughput multiplex assay for SARS-CoV-2 has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA). The Seegene Allplex™ 2019-nCoV Assay contains all reagents necessary to test for COVID-19 in one tube, allowing users to maximize 96-well plate runs. 

Within this single reaction tube, the assay targets three SARS-Cov-2 genes; E, RdRP and N genes, thus providing greater specificity.

Before receiving FDA-EUA, Seegene had already sold 10 million tests globally and now has the capacity to produce one million tests per week. The assay has also been approved for import by Health Canada, where the majority of tests approved have been developed in-house.

The test runs on CFX96™ and CFX96 Touch™ Real-Time PCR Detection Systems (Bio-Rad) with a limit of detection (LoD) of 1250 copies/ml and 4167 copies/ml respectively.  

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.

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.