FDA Granted EUA to Rutgers University for New COVID-19 Saliva Test

April 14, 2020

The first COVID-19 test to receive approval that does not use invasive cotton swabs to collect patient samples will be available in New Jersey starting Wednesday.

The US Food and Drug Administration (FDA) granted emergency use authorization (EUA) for a new collection method that utilizes saliva as the primary test biomaterial for coronavirus disease 2019 (COVID-19), the first such approval by the agency.

The new test, developed by Rutgers University’s RUCDR Infinite Biologics and Spectrum Solutions and Accurate Diagnostic Labs, will allow for broader population screening vs the current nose and throat swabs used at COVID-19 testing facilitates.

“The impact of this approval is significant,” said Andrew Brooks, PhD, chief operating officer and director of technology development at RUCDR in a Rutgers press release. “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.”

The test can be self-administered and, because saliva collection is quicker and more scalable than the swab method, COVID-19 testing facilities can hopefully significantly increase the number of patients tested daily, said Brooks.

Brooks noted that saliva testing will be important for people in quarantine who otherwise would not know when they are no longer infectious and will allow healthcare workers to “release themselves from quarantine and safely come back to work.”

“All of this combined will have a tremendous impact on testing in New Jersey and across the United States,” said Brooks.

Researchers also shared their information with chief executive officers of large life sciences companies involved with COVID-19 testing.

“I have spoken with these companies’ leadership to not only share knowledge but to create opportunities for continuing to help innovate during this crisis,” said Brooks. “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.”

Starting Wednesday, the new saliva test will be available to New Jersey residents at a drive-thru testing facility in Edison, New Jersey. 

For more COVID-19 coverage for primary care, visit our COVID-19 Resource Page.

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