Yale launches SalivaDirect test for COVID-19

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By Natalie Missakian

Yale University has begun rolling out its much-anticipated SalivaDirect test for COVID-19, identifying on Friday the first labs that have begun offering the test in four states.

Developed by researchers at the School of Public Health, the test is now available to people in Connecticut, Florida, Minnesota and New York, according to the university.

In addition to its own Yale Pathology Labs, Yale said three independent laboratories have begun offering the test.

They are: Access Medical Laboratories in Juniper, Fla., Hennepin County Medical Center (HCMC) in Minneapolis, Minn., and Mirimus Inc. in Brooklyn, N.Y.

“We are working with labs to get others also up and running," Anne Wyllie, one of the research scientists who developed the test, said via email Friday. "We have initiated the designation process with an additional 47 labs and will start another 30 today."

Saliva testing has been described as a game-changer for curbing COVID-19 because the samples are so quick and easy to collect.

SalivaDirect is billed as less expensive and less invasive than current testing methods, which typically require insertion of a swab into the back of the naval cavity.

It is also unique in that saliva can be collected in any sterile container, eliminating the need for a special type of swab or collection device, its developers say. The test also eliminates a separate nucleic acid extraction step. Kits used for that step have been prone to shortages, according to the researchers.

The test was successfully used this past spring in a pilot program to test asymptomatic people within the NBA. It received emergency use authorization from the U.S. Food & Drug Administration on Aug. 15.

Only specially certified high-complexity labs in the United States, known as CLIA labs, may offer the test. SalivaDirect is accepting applications on its website.

Nathan Grubaugh, an assistant professor of epidemiology at Yale who led the research team with Wyllie, said he is hoping many more labs will begin performing the test.

“While we are not looking to commercialize the method, we absolutely want it to be widely available,” he said in a statement. “The only way we will see this pandemic in the rearview mirror is to increase testing in every single neighborhood across the country, regardless of economics.”