The Korean regulator is likely to authorize PCL’s saliva-based Covid-19 test device soon, industry sources said.
On Friday, sources from the medical community and the medical device industry said that PCL, a Korean in vitro diagnostic device manufacturer, was expected to win the Ministry of Food and Drug Safety’s (MFDS) approval for a saliva sample-based Covid-19 rapid antigen test kit. Herpes 2 Rapid Screen Test
All the MFDS-authorized Covid-19 diagnostic kits in Korea require a sample collection by inserting a cotton swab into the nostril (nasal cavity) or deep inside the nose (nasopharynx).
If PCL’s saliva test kit gets approval, it will be the nation’s first saliva-based Covid-19 test device.
PCL previously applied for the local license based on a clinical trial overseas. However, it conducted a local study again this year and submitted data to the MFDS.
Medical device developers continue working on saliva-based diagnostic kits because they would be much more convenient than nasal or nasopharyngeal smear tests where users feel pain.
Korean saliva-based Covid-19 test kits developers include PCL, SD Biosensor, Boditech Med, PHC, Rapigen, and Phylosis.
PCL recently said its saliva-based Covid-19 rapid antigen test device, PCL COVID 19 Ag Gold, won Health Canada’s authorization.
Boditech Med is conducting a clinical trial at a local medical institute. PHC, Rapigen, and Phylosis are soon to begin clinical trials after getting the nod from the independent review board (IRB).
Hepatitis Virus Test An official at the MFDS said the ministry was reviewing one saliva-based Covid-19 test kit.