The FDA has granted emergency use authorization (EUA) for the Spectrum DNA SDNA-1000 Whole Saliva Collection Device to use saliva as the primary test biomaterial for the SARS-CoV-2 coronavirus. The authorization is the first for a saliva-based coronavirus test.
The new saliva collection method, which RUCDR developed in partnership with Spectrum Solutions and Accurate Diagnostic Labs (ADL), will allow for broader population screening than the current method of nose and throat swabs, according to the university.
Earlier this month, Rutgers RUCDR validated the use of saliva to test for COVID-19, saying the “the use of saliva to extract viral RNA was in fact a robust source for COVID-19 detection and equal in performance to the approved swab-based collection samples.”
“The impact of this approval is significant,” said Andrew Brooks, chief operating officer and director of technology development at RUCDR. “It means we no longer have to put health care professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections. We can preserve precious personal protective equipment for use in patient care instead of testing. We can significantly increase the number of people tested each and every day as self-collection of saliva is more quick and scalable than swab collections. All of this combined will have a tremendous impact on testing in New Jersey and across the United States.”
Soon after the Rutgers-ADL team received notification from the FDA on Saturday, the White House’s COVID-19 testing task force called Brooks to offer congratulations and support and to ask about any specific hurdles to expanding testing and enabling other laboratories to benefit from the accomplishment.
Shortly after the White House call, the research team was contacted by chief executive officers of some of the world’s largest life sciences companies that are involved in COVID-19 testing.