SeaSun Biomaterials announced on the 6th that the COVID-19 molecular diagnostic product 'AQ-Top COVID-19 Rapid Detection Kit Plus' has received emergency approval from the US Food and Drug Administration (FDA).

As a result, SeaSun Biomaterials has received emergency approval from the US FDA for all three types of COVID-19 molecular diagnostic products.

This product examines the COVID-19 gene (SARS-CoV-2) present in samples collected from human nasopharynx and oropharynx to determine whether they are infected with COVID-19.

In particular, in order to cope with COVID-19, where a lot of various mutations occur, N gene with a relatively low gene mutation rate among the COVID-19 gene (SARS-CoV-2) was added, and a total of two judgment indicators were used with ORF1ab.

This allows a more accurate diagnosis by reducing false negative (false-negative) diagnosis that is diagnosed as non-infectious even if a person infected with COVID-19

In addition, it is also possible to detect a small amount of genes in a sample by using an artificial nucleic acid (PNA probe) with a high binding affinity specifically for the COVID-19 gene. In addition, since the results can be quickly known, it can be used in airports, ports with high mobility, or emergency cases requiring emergency screening, and large-scale group infection prevention.

Park Hee-kyung, CEO of SeaSun Biomaterials, said, "AQ-TOP COVID-19 Rapid Plus is designed to enable faster, more precise and accurate diagnosis. Above all, we provide a one-stop diagnostic platform that can proceed from sample collection to diagnosis at once We made it possible to respond more quickly to the prevention of the spread of COVID-19.”

SeaSun Biomaterials has completed the construction of a one-stop diagnostic platform by sequentially launching the 'Top Virus Collection Kit', a sample collection tool, and the 'Top Viral DNA/RNA Extraction Kit', a nucleic acid extraction reagent in Korea.

Currently, the 'Top Virus Collection Kit', which is a sample collection tool, has been officially approved by the US FDA and is on sale. In addition, it has completed the development of a product capable of extracting nucleic acids within 5 minutes and is about to launch.