FDA grants emergency use authorization to Yale’s SalivaDirect COVID-19 test

A COVID-19 diagnostic created by Yale School of Public Health — the SalivaDirect test — became the first of its kind to gain a United States Food and Drug Administration (FDA) emergency use authorization (EUA) last week.

SalivaDirect approaches the processing of saliva samples in an entirely new, rapid way, requiring no special swabs or collection devices, just a sterile container of any kind. Neither does it require a separate step for nucleic acid extraction, cutting out a potential bottleneck, as the kits used for that extraction have previously faced shortages.

“Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” FDA Commissioner Stephen Hahn said. “Today’s authorization is another example of the FDA working with test developers to bring the most innovative technology to market in an effort to ensure access to testing for all people in America.”

Adm. Brett Giroir, M.D. and Assistant Secretary for Health, called the test an “innovation game changer.” The test has also been authorized for use with various combinations of commonly used reagents and instruments, granting it broad capability of use in high-complexity labs. Even collection of the samples is simple, being self-undertaken merely under the observation of a healthcare professional.

Yale will offer SalivaDirect to interested labs as an open source service, meaning they could follow Yale’s established protocols to obtain required components and perform the test. No proprietary equipment is necessary so that it can be widely utilized. This marks the fifth COVID-19 saliva test the FDA has authorized.

“Our current national expansion of COVID-19 testing is only possible because of FDA’s technical expertise and reduction of regulatory barriers, coupled with the private sector’s ability to innovate and their high motivation to answer complex challenges posed by this pandemic,” Giroir said.