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New saliva-based coronavirus testing approach wins FDA emergency use authorization

April 16, 2020

iSpecimen advisor Dr. Andy Brooks from Rutgers’ RUCDR Infinite Biologics


Testing for COVID-19 needs to be pervasive, but if you had a choice in methods, would you prefer a swab deep into your nasal cavity or the option to spit in a cup?

The latter is now a potential alternative testing approach thanks to the work of  Rutgers’ RUCDR Infinite Biologics and its collaborators, who just won FDA emergency use authorization for the collection method.

“The impact of this approval is significant,” said Andrew Brooks, chief operating officer and director of technology development at RUCDR. Dr. Brooks is also a Rutgers professor and advisor to iSpecimen.

The Rutgers test raises the possibility of a massive increase in much-needed testing for the disease. “I call it innovation under pressure,” said President Trump, mentioning the test in a Rose Garden briefing on Tuesday.

Ways it could help

The new approach “means we no longer have to put health care professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections,” said Dr. Brooks. “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.”

Saliva testing could also be important in helping people confirm they are not infectious so they can end quarantines.

Positive results are indicative of the presence of SARS-CoV-2 RNA, according to the FDA. According to Rutgers, the tests are available now to the RWJBarnabas Health network, New Jersey’s most comprehensive health care system. Starting Wednesday, tests were expected to become available to county residents at a drive-thru testing facility in Edison, New Jersey. Turnaround time for results is 24 to 48 hours, NBC reported.

This is an exciting development. Congratulations and thank you, Dr. Brooks.