FDA approves saliva-based coronavirus test

FDA approves saliva-based coronavirus test
© Getty Images

The Food and Drug Administration approved an emergency-use authorization for a saliva-based coronavirus test developed by Yale University researchers, the university announced Saturday.

The saliva-based diagnostic test, called SalivaDirect, is being further validated through testing of NBA players and staff who are asymptomatic, according to a news release. The project received funding from the NBA and the National Basketball Players Association.

With FDA approval, SalivaDirect can be used in diagnostic laboratories to potentially pick up the nation’s testing rate. 


The researchers touted the test as less expensive and less invasive than the traditional form of diagnostic testing, nasopharyngeal swabbing. They said they expect laboratories to charge about $10 per test, assistant professor Nathan Grubaugh said in the release.

“With saliva being quick and easy to collect, we realized it could be a game-changer in COVID-19 diagnostics,” Anne Wylie, associate research scientist at Yale School of Public Health, said. 

The researchers are not planning to commercialize the test and instead focus to “help those most in need,” according to the release. 

The FDA also issued an emergency use authorization in May for an at-home saliva collection test created by Rutgers University.

The approval comes as the U.S.’s testing has fallen in recent weeks, reaching on average 733,000 people tested each day this month, compared to almost 750,000 in July, the COVID Tracking Project found.

Public health officials have warned that widespread testing is needed to control the pandemic and identify asymptomatic carriers. But test shortages and the overall declining rate of testing may inhibit that goal.