Seegene Receives Australian and European Certification for 19-Respiratory Virus Simultaneous Testing Product

Seegene's 'Allplex™ RV Master Assay'

[Asia Economy Reporter Chunhee Lee] Seegene announced on the 6th that its ‘Allplex™ RV Master Assay’ for respiratory virus testing has been certified in Australia and Europe.

This product was developed to simultaneously test for 19 types of respiratory viruses, including influenza, in preparation for the ‘With Corona’ era. It received approval from the Australian Therapeutic Goods Administration (TGA) on the 22nd of last month, followed by the European In Vitro Diagnostic Device Certification (CE-IVD) on the 30th.

The ‘Allplex RV Master Assay’ targets most respiratory viruses including COVID-19, influenza (types A and B), and common cold viruses such as metapneumovirus (MPV), respiratory syncytial virus (RSV), parainfluenza virus (PIV), adenovirus (AdV), and rhinovirus (HRV). Specifically, it targets a total of 21 genes: 3 COVID-19 virus genes, influenza A, influenza B, MPV, 2 types of RSV, 4 types of PIV, 6 types of AdV, and 3 types of HRV, enabling the screening of 19 respiratory viruses.

Due to the COVID-19 pandemic, widespread mask-wearing and social distancing have become common worldwide, significantly reducing the prevalence of respiratory viruses such as influenza. However, with the advent of the With Corona phase, these viruses are resurging. In the Southern Hemisphere, Australia is entering winter, and it is reported that 10-15% of surveyed individuals in various cities are exhibiting symptoms such as cough and fever. Additionally, according to a recent clinical study conducted by Seegene using the ‘Allplex RV Master Assay’ on 1,928 people in Europe, 318 individuals (17%) were infected with respiratory viruses other than COVID-19, and among them, 22 people (7%) were co-infected with two or more viruses.

Dr. Tove Frandsen of Southern Jutland Hospital in Denmark, who conducted clinical trials twice last year and earlier this year using the ‘Allplex RV Master Assay,’ stated, "This product can detect almost all respiratory viruses that can occur throughout the year," adding, "It will be useful worldwide, including in Australia and South America where winter is beginning in the With Corona era, as well as in regions where endemicity is progressing."