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Bioneer announced on the 3rd that it will release the product after completing the Class 1 medical device for in vitro diagnosis of the Ministry of Food and Drug Safety of the Saliva Collection Kit, which is a sample transport medium.
Bioneer’s new saliva collection kit is used to transport and preserve saliva samples for disease diagnosis. Since the preservation solution contained in the tube stabilizes nucleic acids by inactivating enzymes in saliva (Saliva), it can be used for molecular diagnostic tests using a highly sensitive gene amplification (PCR) method.
Overseas governments are recognizing the need to perform large-scale tests by lowering the threshold of diagnostic tests in order to detect latent corona19 infections outside the quarantine network.
Bioneer solved the inconvenience of Corona 19 diagnostic test and made great efforts to develop a product suitable for mass testing. It is known that it has been applied as possible.
The saliva collection kit released this time is simple because the test subject directly puts saliva into the kit. It is expected that the discomfort of collecting nasopharyngeal smears using cotton swabs and concerns about secondary infections that may occur in the process of collecting medical staff can be resolved, and it is expected to help in the problem of shortage of medical staff. It can be stored at room temperature for a week, making it convenient to transport, and there is no hassle such as refrigerated storage.
“The saliva collection kit is easy to use and is optimized for mass testing,” said Park Han-oh, CEO of Bioneer. It will become a global molecular diagnostic company that supplies turnkey.”
As the saliva collection kit is expected to be used in various fields, such as the diagnosis of diseases using saliva and genetic testing services, including Corona 19, Bioneer is in a hurry to obtain European CE certification of the saliva collection kit, It is also known to spur the preparation for operation. The company is the only company in Korea to supply a total solution for COVID-19 molecular diagnosis, and it is exporting related products to more than 80 countries.
According to a report by Grand View Research, the size of the Corona 19 specimen collection kit market is estimated to be 14 trillion won in 2020, with an annual average growth of 3.5% until 2027.