After months of development, including weeks of gathering data together and competing paperwork, today the SalivaDirect assay was submitted to the US FDA for Emergency Use Authorization (EUA).
The EUA, once issued, will allow certified diagnostic laboratories to use SalivaDirect to diagnose SARS-CoV-2 infection. This test has a lower cost, speed, and risk to healthcare workers and more flexibility in terms of supplies & equipment. The goal for the test, which will not be commercialized, is to allow expanded testing, especially in lower-resource settings.
SalivaDirect development began when, back in March, researchers were repeatedly running into barriers acquiring reagents and tools to test people for SARS-CoV-2. Led by Chantal Vogels, Anne Wyllie, Doug Brackney, and Nathan Grubaugh, it is a flexible, extraction-free, saliva-based diagnostic test for SARS-CoV-2.
Thus far, the ability of SalivaDirect to detect SARS-CoV-2 RNA has been tested analytically on laboratory generated (mock) samples and on samples that are part of the IMPACT biorepository at Yale. Further validation is currently taking place in partnership with the NBA as part of the SWISH study, the results of which will be posted on CovidTrackerCT as soon as it concludes (around late July).