Yale’s COVID-19 Rapid Saliva Test Receives Emergency Use Clearance From FDA

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A new saliva-based laboratory diagnostic test for the novel coronavirus developed by researchers at Yale University’s School of Public Health has received emergency use clearance from the Food and Drug Administration.

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SalivaDirect is a simple, affordable and less invasive test method that gives results similar to those of the traditional nasal swab test.

“This is a huge step forward in making testing more accessible,” said Chantal Vogels, a Yale postdoctoral fellow, who led the development and validation of the lab with Doug Brackney, assistant clinical assistant professor . “It started as an idea in our lab shortly after we discovered that saliva was a promising type of sample for the detection of SARS-CoV-2, and now it has the potential to be used extensively. scale to help protect public health. We are delighted to make this contribution to the fight against the coronavirus. “

Development of the test was led by Assistant Professor Nathan Grubaugh of the Yale School of Public Health and Associate Researcher Anne Wyllie, who sought to increase the availability of saliva-based tests and reduce overall testing times and costs. .

“Large-scale testing is essential for our control efforts. We’ve simplified the test so that it costs just a few dollars for reagents, and we expect labs will only charge around $ 10 per sample, ”Grubaugh said. If inexpensive alternatives like SalivaDirect can be implemented across the country, we could finally get this pandemic under control, even before a vaccine.

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The Jackson Laboratory for Genomic Medicine in Farmington, Connecticut, will partner with Yale to explore how to implement the test for a wider audience.

“We must continue to invent and implement new methods to perform SARS-CoV-2 testing faster, more economically and with greater accessibility, while maintaining acceptable test accuracy,” said Charles Lee, director of the laboratory. “This method is an important next step towards that goal. ”

The Yale School of Public Health will also continue to partner with the Ivy League University’s Department of Pathology.

“By using SalivaDirect, our lab can double our testing capacity,” said Professor Chen Liu, president of Yale Pathology, who oversaw the clinical validation of the study.

Liu added that the department’s CLIA-certified clinical lab will begin offering SalivaDirect as a testing option in the coming days.

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Related research was funded by the National Basketball Players Association and a quick grant from Emergent Ventures to the Mercatus Center at George Mason University. SalivaDirect is also available to NBA players and staff as part of a program to help test asymptomatic individuals.

According to Johns Hopkins University, there are more than 5.3 million confirmed cases of coronavirus in the United States and more than 169,000 deaths linked to the pandemic.

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