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Labs around the nation will have access to a new saliva test for COVID-19 in the coming weeks thanks to the work of Yale scientists.
The test, called SalivaDirect, earned emergency use authorization from the U.S. Food and Drug Administration on Saturday.
Anne Wyllie, one of two scientists who developed the test, said the Yale Pathology Lab hopes to begin using SalivaDirect as a testing option soon.
“We are finalizing important points with Yale and the FDA to make sure all requirements are clear and can be fulfilled by the CLIA labs interested in implementing this,” Wyllie told New Haven Biz in an emailed statement Tuesday.
The Jackson Laboratory for Genomic Medicine in Farmington is working with Yale to implement the test for a broader audience.
“We must continue to invent and implement new ways to conduct SARS-CoV-2 testing faster, more economically and with greater accessibility, while maintaining acceptable test accuracy,” Jackson Lab Director Charles Lee said in a statement. “This method is an important next step toward this goal.”
Saliva testing has been described by experts as a game-changer for curbing the COVID-19 pandemic, because it is so quick and easy to collect. It is billed as less expensive and less invasive than the nasal swab method commonly used.
Results have found that SalivaDirect is highly sensitive and yields similar results to the nasal swab test, according to Yale.
SalivaDirect is the brainchild of Wyllie, an associate research scientist, and fellow Yale School of Public Health scientist Nathan Grubaugh, an assistant professor.
After finding saliva to be a promising sample type for SARS-CoV-2, the virus that causes COVID-19, they worked to improve the method to decrease both testing times and cost.
“We simplified the test so that it only costs a couple of dollars for reagents, and we expect that labs will only charge about $10 per sample,” said Grubaugh in a statement.
The team also eliminated the expensive saliva collection tubes other companies use to preserve the virus, finding they were unnecessary since the virus is stable in saliva for long periods at warm temperatures, Yale said.
“If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic, even before a vaccine,” Grubaugh said.
The researchers said they are not looking to commercialize the method, but wanted to help with the need for increased testing that many experts say is crucial to combatting the pandemic.
The research was partially funded by the National Basketball Association and the National Basketball Players Association.
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