Rutgers Coronavirus Saliva Test Receives FDA Approval

The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Rutgers’ RUCDR Infinite Biologics and its collaborators for a new collection approach that utilizes saliva as the primary test biomaterial for the SARS-CoV-2 coronavirus.

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.

"The impact of this approval is significant," said Andrew Brooks, chief operating officer and director of technology development at RUCDR, who also is 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."

"I have spoken with these companies’ leadership to not only share knowledge but to create opportunities for continuing to help innovate during this crisis," Brooks said. "We will work closely with these new partners, the FDA and the White House task force to leverage everything Rutgers has to offer to not only help our community but also make a global impact."

"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," said Jay A. Tischfield, the founder, chief executive officer and scientific director of RUCDR and a Distinguished Professor also in the Department of Genetics at Rutgers–New Brunswick and at Rutgers Robert Wood Johnson Medical School.

"Rutgers is proud to be on the cutting edge of the fight against the COVID-19 pandemic," said Rutgers Biomedical and Health Sciences Chancellor Brian Strom. "We have long said our researchers and health care employees are working to help make the world well, but never has it been more true than now."
 

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