FDA Approves Saliva-Based Coronavirus Test For Emergency Use

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

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

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

In the release, Assistant Professor Nathan Grubaugh said the test is less expensive and less invasive than the traditional form of diagnostic testing, nasopharyngeal swabbing. They expect laboratories to charge about $10 per test.

“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 COVID Tracking Project found that U.S.’s testing has fallen in recent weeks, reaching on average 733,000 people tested each day in August, compared to 750,000 in July.

With recent test shortages, the delay in reporting and the overall declining rate of testing may inhibit the goal of widespread testing that is needed to help control the pandemic and identify asymptomatic carriers


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