A saliva-based COVID-19 laboratory diagnostic test developed by researchers at the Yale School of Public Health has been granted an emergency use authorization by the U.S. Food and Drug Administration (FDA). SalivaDirect, which is currently being used on a research basis for testing asymptomatic players and staff from the National Basketball Association (NBA), is designed to be simpler, less expensive, and less invasive than the traditional method for SARS-CoV-2 testing using nasal-based swabbing.
The Jackson Laboratory for Genomic Medicine (JAX) is partnering with Yale to explore how to implement the test more broadly. JAX’s licensed CLIA (Clinical Laboratory Improvement Amendments) and CAP-accredited laboratory already analyzes nasal and oral swabs from patients for an RNA signature unique to SARS-CoV-2, the virus that causes COVID-19 as part of its commitment to fighting the pandemic.
“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. This method is an important next step toward this goal,” said Charles Lee, Ph.D., FACMG, director and professor, The Jackson Laboratory for Genomic Medicine. “We’re honored to be collaborating with Yale to help stand up these tests in short order and overcome some of the significant testing obstacles that we have faced in our fight against COVID-19.”
Development of SalivaDirect as a means of rapidly expanding SARS-CoV-2 testing was spearheaded this spring by Nathan Grubaugh and Anne Wyllie, assistant professor and associate research scientist, respectively, at the Yale School of Public Health. After finding saliva to be a promising sample type for SARS-CoV-2 detection, they wanted to improve the method further.
Grubaugh and Wyllie said that they are not seeking to commercialize the method. Rather, they want the simplified testing method to help those most in need. Broad availability of testing for SARS-CoV-2 has been a major stumbling block in the fight against the pandemic, with long delays of test results by some testing centers and some of the difficulties around collection of nasal-based samples. Some experts have said that up to 4 million tests are needed per day, with turn-around-times for results being less than 24 hours for effective contact tracing efforts. SalivaDirect provides one potential pathway toward that goal, the researchers said.
“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.”