Wells Bio Co., Ltd. recently obtained export permission for its first independently developed pneumonia molecular diagnostic kit "careGENE™ Pneumonia detection kit."
Wells Bio Co., Ltd. recently obtained export permission for its first independently developed pneumonia molecular diagnostic kit "careGENE™ Pneumonia detection kit."
"careGENE™ Pneumonia detection kit (No. 22-389)" is an in vitro diagnostic device that helps diagnose pneumonia infection by detecting the nucleic acid of pneumonia-causing bacteria in sputum and nasopharyngeal swab samples.
The analysis time of this kit is within 110 minutes and is characterized by high analysis accuracy. In particular, it is possible to detect extremely low concentrations of 10 copies/reactions (detect only 10 DNA per test) and for the first time in Sohth Korea, 12 pneumonia-causing bacteria can be detected simultaneously, improving user convenience and diagnostic test efficiency. Currently, the existing kits approved in south Korea have 5 to 8 types of pneumonia diagnosis capabilities.
Pneumonia is the fourth-largest cause of death in South Korea, and 30-40% of the causative bacteria are known as pneumococcal. Recently, four out of 10 patients admitted to the hospital due to long-term aftereffects after complete recovery from COVID-19 suffered from pneumonia, a study showed. Experts say that patients who have been infected with respiratory viruses are more likely to have secondary infections of pneumococcus.
Wells Bio's pneumonia diagnostic kit has currently been registered with CE and can be exported to various European and Asian countries. After completing FDA registration, it is also planning to enter the U.S. market through its parent company Access Bio. In addition, after obtaining permission while preparing for domestic permission, it will work with PalmGen Science, the largest shareholder of Access Bio, to promote successful domestic launch and sales synergy.
