U.S. FDA urgent use approval for three types of COVID-19 molecular diagnostic products

  • 운영자
  • Date 2021.01.26
  • Hit 42
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, SeasunBio 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 Corona 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 Bio 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.

시선바이오 코로나19 분자진단 제품, 미 FDA 긴급사용승인

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