FDA Approves Use of Rutgers University Saliva Test for COVID-19

April 14, 2020

In collaboration with Spectrum Solutions and Accurate Diagnostic Labs, RUCDR Infinite Biologics developed the new collection approach, which utilizes saliva as the primary test biomaterial for COVID-19. 

Officials with the FDA granted emergency use authorization (EAU) to Rutgers University’s new test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that utilizes saliva, according to Rutgers University.  

In collaboration with Spectrum Solutions and Accurate Diagnostic Labs, RUCDR Infinite Biologics developed the new collection approach, which utilizes saliva as the primary test biomaterial for the virus, making it the first of its kind to be approved. The new method will allow or broader population screening. Currently, tests for the novel coronavirus disease 2019 (COVID-19) utilize nose and throat swabs.

Moreover, the new testing method will not require health care professionals be put at risk to collect samples, and will help with the global shortage of swabs for sampling.

“The impact of this approval is significant,” Andrew Brooks, chief operating officer and director of technology development at RUCDR, who is also a professor in the School of Arts and Sciences Department of genetics at Rutgers University-New Brunswick, said in a statement. “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 day 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.”

The tests are available to the RWJBarnabas Health network, which has partnered with Rutgers University and is New Jersey’s most comprehensive health care system. Starting Wednesday, Rutgers, in partnership with the Middlesex County government and RWJ Barnabas Health, will make the test available to county residents at a drive-thru testing facility in Edison, New Jersey.

References:

1. New Rutgers Saliva Test for Coronavirus Gets FDA Approval. News Release. Rutgers Today; April 13, 2020. Accessed April 14, 2020. https://www.rutgers.edu/news/new-rutgers-saliva-test-coronavirus-gets-fda-approval.