Seasun Biomaterials to launch COVID-19 assay

2020 04 29 16 39 2873 Seasun Biomat Product Image 400

Seasun Biomaterials plans to release its second COVID-19 assay following emergency use authorization (EUA) from the U.S. Food Drug Administration (FDA).

Seasun Biomaterials' AQ-Top COVID-19 rapid detection kit is designed to target the ORF1ab gene of SARS-CoV-2 with an endogenous control human RNase P gene. The company also currently is distributing its real-time polymerase chain reaction (qPCR)-based U-Top COVID-19 detection kit to countries in Europe and the Middle East.

Both kits have received Europe's CE Mark of approval as IVD devices. The AQ-Top COVID-19 kit is pending clearance from Korea's Ministry of Food and Drug Safety (MFDS). The U-Top COVID-19 detection kit has received approval from the MFDS and the FDA through the EUA pathway.

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