FDA Clears Saliva Test for COVID-19, Opening Door to Wider Testing

STAT News is reporting that the Food and Drug Administration (FDA) over the weekend granted emergency use authorization to Yale School of Public Health for its COVID-19 saliva test, called SalivaDirect. The inexpensive test has the capacity to run roughly 90 samples in fewer than three hours in a lab. That number will likely be higher in larger, automated labs. Yale intends to offer its "open source" testing protocol to laboratories nationwide to enable them to implement the method using commercially available testing components. The reagents needed for the test cost less than $5, so the Yale researchers estimate that labs should charge about $10 per sample. The testing method is available immediately, but the researchers added it can be rapidly scaled up for use in the coming weeks. Yale researcher Nathan Grubaugh says: "If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic even before a vaccine." To validate the test, researchers relied in part on NBA players, coaches, and staff. Yale says the test is now being studied in asymptomatic people through its program with the NBA and its players union.