Reality Check - timeline of EUA granted for Saliva
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Posted On: 08/18/2020 1:56:48 AM
Reality Check - timeline of EUA granted for SalivaDirect
Not a biologic so I am not implying the timeline will be the same however Yale submitted as a laboratory-developed test for approval under Emergency Use Authorization to the US FDA on July 14, 2020 and received approved August 15 2020. Given this we may need to relax expectations.
https://www.fda.gov/media/141194/download
From the FDA Press Announcement on August 17:
The FDA issued Yale School of Public Health an emergency use authorization (EUA) for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19. This molecular test is for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider. SalivaDirect does not require any special type of swab or collection device – a saliva sample can be collected in any sterile container. It is also unique because it does not require a separate nucleic acid extraction step. This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past.
Not a biologic so I am not implying the timeline will be the same however Yale submitted as a laboratory-developed test for approval under Emergency Use Authorization to the US FDA on July 14, 2020 and received approved August 15 2020. Given this we may need to relax expectations.
https://www.fda.gov/media/141194/download
From the FDA Press Announcement on August 17:
The FDA issued Yale School of Public Health an emergency use authorization (EUA) for its SalivaDirect COVID-19 diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19. This molecular test is for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider. SalivaDirect does not require any special type of swab or collection device – a saliva sample can be collected in any sterile container. It is also unique because it does not require a separate nucleic acid extraction step. This is significant because the extraction kits used for this step in other tests have been prone to shortages in the past.
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