On the 23rd, Seasun Biomaterials, a molecular diagnostic reagent for COVID-19 detection,'AQ-TOP COVID-19 Plus' (AQ-TOP COVID-19 Rapid Detection Kit Plus), was launched by the Food and Drug Administration (FDA). Following the approval for use, it announced on the 24th that it has received official approval from the Ministry of Food and Drug Safety.
Prior to this, SeasunBio received official permission from'U-TOP COVID-19 Detection Kit Plus' (U-TOP™ COVID-19 Detection Kit Plus), which was officially approved by the Ministry of Food and Drug Safety. An integrated diagnosis system capable of both precise and rapid diagnosis has been completed.
'Accuracy' is a molecular diagnostic method (PCR) that directly detects the coronavirus gene (SARS-CoV-2) invading the human body, unlike an immune response test that tests with a corona antibody or antigen generated by a human immune response. It is a product that caught both rabbits and quickness.
'U-TOP Plus', which was officially approved by the Ministry of Food and Drug Safety in October, is a PCR product that can more accurately determine the presence of COVID 19 infection by using a quadruple gene index, unlike competitors that use a dual gene index.
For faster and more accurate COVID 19 diagnosis, SightBio has completed the construction of the OneSTOP Platform, which can proceed from sample collection to result analysis, and is focusing on overseas exports.
The one-stop platform consists of all product lines used for corona 19 testing in one package. The package includes'TOP Virus Collection Kit' for sample collection and transportation, and'Top Viral D&A/R&A Extraction Kit' that extracts SARS CoV-2 gene for identification of COVID-19 infection from the sample. It is composed of (TOP™ Viral DNA/RNA Extraction Kit) and a molecular diagnostic kit that helps diagnose infection by checking the presence of SARS CoV-2 gene.
All products of the One-Stop Platform have been approved for manufacturing by the Korean Food and Drug Administration, and the Top Virus Collection Kit is currently being exported to countries around the world after official approval from the US Food and Drug Administration (FDA) in September.
Park Hee-kyung, CEO of Seasun Bio, said, “The'One-Stop Platform' can provide a package of tools and diagnostic reagents necessary for COVID 19 diagnosis.” I will do it.”