On the 16th, GenBody, a specialized company in diagnostic kits, announced that its rapid diagnostic product for Human Metapneumovirus (hMPV), which causes respiratory infections, is the first to obtain medical device approval from the Ministry of Food and Drug Safety in Korea.
The main symptoms of hMPV infection include cough, nasal congestion, fever, and difficulty breathing, which are similar to the common cold, but it can cause severe complications such as pneumonia and bronchitis in infants, the elderly, and those with underlying conditions. It rapidly spread in countries like China, India, and the United States at the end of last year and the beginning of this year.
GenBody's hMPV Ag can quickly and accurately determine the presence of hMPV infection through clinical specimens. A representative of the company noted that "only three products have received CE certification (CE IVD) globally, making this approval significant."
The company explained, "We prepared for product launch, considering that the possibility of a resurgence of hMPV is high," adding, "Quick diagnosis is important as hMPV can lead to severe outcomes when co-infected with other respiratory viruses."
Existing polymerase chain reaction (PCR) tests determine the presence of viral genomes by replicating specific parts of DNA, which are more accurate than rapid diagnostic devices but are not conducive to quick diagnosis and response during pandemics.
A representative from GenBody stated, "With this approval, we have become the only corporation in Korea capable of diagnosing all five major respiratory infections: type A influenza, type B influenza, COVID-19, respiratory syncytial virus (RSV), and hMPV," and added, "We plan to develop a kit that can simultaneously diagnose these five respiratory infections and launch it as a first in Korea."