Wells Bio said Thursday that it has obtained an export license for its new pneumonia molecular diagnostic kit, “careGENE Pneumonia detection kit.”

The kit is an in vitro diagnostic medical device that helps diagnose pneumonia infection. It detects the nucleic acid of pneumonia in sputum and nasopharyngeal swab samples of suspected pneumonia patients by the real-time polymerase chain reaction (PCR) method.

The detection analysis can be done in 110 minutes, and its accuracy is very high, according to the company. In addition, it can detect an extremely low concentration of 10 copies/reaction (10 DNA copies per test). Also, for the first time in Korea, it can detect 12 pneumonia-causing bacteria simultaneously, improving user-friendliness and diagnostic capabilities.

Pneumonia is the fourth-largest cause of death in Korea, and 30-40 percent of the causative bacteria are known as pneumococcal. Recently, a study showed that four out of 10 patients admitted to the hospital suffered from pneumonia due to long-term effects after complete recovery from Covid-19. In addition, experts agree that patients infected with respiratory viruses are more likely to have secondary infections of pneumococcus.

Wells Bio has registered its pneumonia diagnostic kits with the Conformitè Europëenne and exported them to various European and Asian countries. After completing FDA registration, it also plans to enter the U.S. market through its parent company Access Bio, the company said.

While preparing for domestic permission, it will work with PharmGen Science, the largest shareholder of Access Bio, to successfully promote the domestic launch and sales synergy.

"As a sense of crisis over respiratory diseases has increased during the Covid-19 pandemic, the importance of diagnosing pneumonia has also increased,” a company official said, “The molecular diagnostic kit that obtained export license recently can accurately detect 12 types of pneumonia-causing bacteria and will draw attention both here and abroad."