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. Vitamin D Rapid Test Kit
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).
Vitamin E Elisa Kit An official at the MFDS said the ministry was reviewing one saliva-based Covid-19 test kit.