Rutgers gains emergency use authorization for new saliva test to detect SARS-CoV-2

Rutgers University gained emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) this week for a new test utilizing saliva to detect SARS-CoV-2, the virus that causes COVID-19.

The test comes from Rutgers’ RUCDR Infinite Biologics, the world’s largest university-based cell and DNA repository. The new saliva collection method — the first to gain an EUA from the FDA — was developed in partnership with Spectrum Solutions and Accurate Diagnostic Labs. It also should help expand population screening capabilities, according to its developers.

“The impact of this approval is significant,” said Andrew Brooks, COO and director of technology development at RUCDR, and a professor in the School of Arts and Sciences Department of Genetics at Rutgers University-New Brunswick. “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.”

Brooks added that this type of testing will help with the global shortage of swabs. He also hailed it as a significant forward step for those currently in quarantine, with no clear idea of how long it will be until their infectious period has passed. With this test, infected health care workers could release themselves from quarantine and return safely to work as soon as they know the results.

Further, the information potential contained within the test cannot be understated.

“The test can help hospital-based and private physicians to accurately assess the infection status of more patients, with RUCDR Infinite Biologics doing the analysis,” Jay Tischfield, the founder, CEO and scientific director of RUCDR, said.

The developers have already been in contact with the White House’s COVID-19 testing task force, which pledged support in navigating testing and getting the test to other labs. Companies have also circled, looking to benefit from the innovations yielded by the effort.