There are two approaches that can be taken (and we have done both here in the US) you can get a “test” authorized for COVID-19 testing which breaks down all the different contributing elements like our device, the lab doing the processing, specific assays, extraction chemistries, etc… and there is no deviation from that protocol. Meaning no other lab can copy the protocol without obtaining their own unique authorization using their own proof-points.
Since this is a long and complicated process the other option is obtaining authorization for our individual saliva collection device outside of any specific testing protocol. This provides the widest path of user accessibility offering any and all EUA authorized labs the opportunity to integrate saliva-based COVID-19 testing immediately into their current protocols without a new submission for FDA authorization.