Obtained Both European In Vitro Diagnostic Reagent Certification and Domestic MFDS Export Approval
[Asia Economy Reporter Kim Ji-hee] Seegene has launched a new diagnostic reagent product capable of detecting major COVID-19 variants, including Delta and Delta Plus.
On the 30th, Seegene announced on the 1st that it had obtained both the European in vitro diagnostic reagent certification (CE-IVD) and export approval from the Korean Ministry of Food and Drug Safety for its COVID-19 diagnostic reagent, ‘Allplex™ SARS-CoV-2 Variants Ⅱ Assay,’ which can detect infections from six major variants including Delta and Delta Plus. This product is particularly notable for its ability to identify not only the Delta variant but also Delta Plus and Kappa. Additionally, it is a multiplex diagnostic product that can detect variants such as Gamma (Brazil), Beta (South Africa), and Epsilon (California).
The Delta variant has a higher transmissibility than the original COVID-19 virus and has spread to over 90 countries worldwide. According to the Global Initiative on Sharing Avian Influenza Data (GISAID), the infection rates of the Delta variant among new cases in the past four weeks are 91% in the UK, 89% in Indonesia, and 88% in Russia.
To more accurately distinguish the Delta variant, Seegene also completed the development of a research-use prototype, ‘Allplex™ SARS-CoV-2/P681R Assay,’ on the 30th. This will be distributed to laboratories worldwide for combined use with the ‘Allplex™ SARS-CoV-2 Variants Ⅱ Assay’ to precisely differentiate Delta from other variants. Seegene plans to continue releasing new products capable of diagnosing emerging COVID-19 variants in the future.
Lee Min-cheol, Vice President of Seegene Life Science Research Institute, stated, “The Delta and Delta Plus variants have alarming characteristics such as rapid transmissibility, vaccine evasion, and a short incubation period, raising growing concerns about a new pandemic. We believe Seegene’s new product can contribute to early detection of new variants and help prevent further spread.”
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