Rutgers Secures US FDA Emergency Use Authorization for New Coronavirus Saliva Test

A new collection approach that utilizes saliva as the primary test biomaterial for the SARS-CoV-2 coronavirus has become the first such method to be granted Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA). The new saliva collection method, which has been developed by Rutgers University’s (New Brunswick, NJ, USA) RUCDR Infinite Biologics in partnership with Spectrum Solutions (Salt Lake City, UT, USA) and Accurate Diagnostic Labs (South Plainfield, NJ, USA), will allow for broader population screening than the current method of nose and throat swabs.

The FDA’s approval of the new saliva testing approach is the second major announcement in recent days from RUCDR, which launched a genetic testing service for the coronavirus that can test thousands of samples daily. With the new saliva test, that number may increase to tens of thousands of samples daily.

“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.”

Related Links:
Rutgers University
Spectrum Solutions
Accurate Diagnostic Labs