Seoul, South Korea-based Seegene Inchas announced the launch of a new COVID-19 variant diagnostic test capable of screening newly emerging virus variants including the Delta and the Delta Plus that have become the dominant versions of the SARS-CoV-2 virus circulating around the world.
Seegene announced on June 30 that it has received the CE-IVD mark for its Allplex SARS-CoV-2 Variants II Assay, a new lineup of the company’s variant detection kits capable of detecting the key genetic mutations of SARS-CoV-2 variants such as L452R, W152C, K417T, and K417N. In a single reaction, the variants diagnostic kit identifies a total of six COVID-19 variants that are known to have originated from India such as Delta, Delta Plus, and Kappa, and Gamma (Brazil), Beta (South Africa), and Epsilon (California). The assay is not available for use in the United States. While the number of daily new infections is growing exponentially, the launch of the new assay is expected to play an essential role in monitoring the spread of the Delta and Delta Plus variants that have been largely blamed for the bulk of new infections.
Earlier this year, the World Health Organization (WHO) classified the Delta variant as a variant of concern, as it is expected to rapidly outcompete other variants. Also, the emergence of a new mutation on the spike protein of the Delta known as K417N has raised alarm globally, as it is known to be more contagious than the Delta variant and to exhibit vaccine resistance. These super-contagious variants recently have become a global threat.
Due to these circumstances, the introduction of the Allplex SARS-CoV-2 Variants II Assay is receiving much attention from around the world as the assay can screen both Delta and the Delta Plus variant as well as other major COVID-19 variants. Seegene also said that it has successfully developed a research-use-only diagnostic test, the Allplex SARS-CoV-2/P681R Assay, to precisely target the Delta and Delta Plus variants. According to the company, using the two assays in conjunction with each other will allow researchers to accurately distinguish the Delta and Delta Plus variants from other genetic mutations.
Although more people are receiving vaccinations, the global vaccine alliance stresses the importance of surveillance screening, saying that the Delta Plus variant was found during routine screening. According to Seegene, the combination use of its Allplex SARS-CoV-2 Variants II Assay and Allplex SARS-CoV-2 Variants I Assay can screen almost all existing COVID-19 variants. As the two assays can detect multiple variants in a single test, this streamlines the conventional testing process, which requires a secondary test to identify new variants.
“An increased transmissibility, short incubation period, and a potential reduction in vaccine efficacy are the characteristics of the Delta and Delta Plus variants,” says Min-cheol Lee, Seegene’s chief technology officer. “I know that there is currently a lot of concern about the Delta variants. While experts and the WHO are largely cautioning the public and governments to remain watchful, I believe that our latest two diagnostic tests will play a key role in the early detection of different viruses and help prevent the further spread of SARS-CoV-2.”
The Allplex SARS-CoV-2 Variants II Assay and Allplex SARS-CoV-2 Variants I Assay are not available for sale in the United States.
Featured image: Seegene Allplex SARS-CoV-2 Variants II Assay (Credit: Seegene)