Wells Bio, a subsidiary of Access Bio, said it aims to contribute to the global fight against the Mycoplasma pneumonia outbreak in Asia and Europe by exporting its careGENE Pneumonia Detection Kit, a molecular diagnostic reagent for pneumonia.

Mycoplasma pneumonia shares symptoms with epidemic influenza, including headache, fever, runny nose, and sore throat. Unlike the flu, its manifestations typically persist for three to four weeks, and in certain cases, it may advance to severe stages, underscoring the crucial significance of early diagnosis and treatment.

Compounding the challenge, the absence of a vaccine for the virus makes halting an outbreak difficult.

Wells Bio's careGENE Pneumonia Detection Kit, granted export approval by the Ministry of Food and Drug Safety in July 2022, is designed for the detection of Mycoplasma pneumonia.

The kit can concurrently confirm the presence of antibiotic resistance mutations in Mycoplasma pneumoniae, adding clinical significance and ensuring more comprehensive diagnostic outcomes.

Utilizing real-time polymerase chain reaction (PCR), this kit diagnoses pneumonia infection by detecting the nucleic acids of bacteria causing pneumonia in sputum and nasopharyngeal swab samples from suspected patients. The company underscores that the analysis time for this product is under 110 minutes, ensuring both efficiency and high accuracy.

In terms of performance, it is capable of detecting low concentrations of as few as 25 DNA copies per test and can simultaneously detect 12 types of pneumonia-causing bacteria, enhancing user convenience and diagnostic efficiency.

Wells Bio stressed it is planning to expand its export business to various countries in Europe and Asia based on already completed export licenses and CE certification.

Locally, the company intends to assist quarantine authorities by seeking domestic approval from the Ministry of Food and Drug Safety in the near future.