NEW HAVEN, Conn. - A new saliva-based laboratory diagnostic test for the novel coronavirus developed by researchers at Yale University's School of Public Health has been granted an emergency use authorization by the Food and Drug Administration.
SalivaDirect is a simple, affordable, and less invasive testing method that has been found to yield similar outcomes to the traditional nasal swab test.
“This is a huge step forward to make testing more accessible,” said Chantal Vogels, a Yale postdoctoral fellow, who led the laboratory development and validation along with Doug Brackney, an adjunct assistant clinical professor. “This started off as an idea in our lab soon after we found saliva to be a promising sample type of the detection of SARS-CoV-2, and now it has the potential to be used on a large scale to help protect public health. We are delighted to make this contribution to the fight against coronavirus.”
A file image shows a medical staff member taking a saliva swab from a patient for coronavirus testing during the COVID-19 pandemic. Yegor Aleyev/TASS (Photo by Yegor AleyevTASS via Getty Images)
The development of the test was spearheaded by Yale School of Public Health assistant professor Nathan Grubaugh and associate research scientist Anne Wyllie, who were looking to increase the availability of saliva-based testing and decrease overall testing times and costs.
“Wide-spread testing is critical for our control efforts. 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. "If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic, even before a vaccine.”
The Jackson Laboratory for Genomic Medicine in Farmington, Connecticut, will partner with Yale to explore how 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,” said Charles Lee, the laboratory’s director. “This method is an important next step toward this goal.”
The Yale School of Public Health will also continue to partner with the Ivy League university's pathology department.
“Using SalivaDirect, our lab can double our testing capacity,” said Professor Chen Liu, chair of Yale Pathology, who oversaw the clinical validation of the study.
Liu added that the department's CLIA-certified clinical laboratory will start offering SalivaDirect as a testing option in the coming days.
Related research was funded by the National Basketball Players Association and a Fast Grant from the Emergent Ventures at George Mason University's Mercatus Center. SalivaDirect is also being offered to NBA players and staff as part of a program to help test for asymptomatic individuals.
According to Johns Hopkins University, there are more than 5.3 million confirmed coronavirus cases in the United States and more than 169,000 deaths related to the pandemic.