Coronavirus saliva test gets FDA emergency use approval, Rutgers University says
Medical Technology

Coronavirus saliva test gets FDA emergency use approval, Rutgers University says

By Tommy Fradenburg

Contributing Writer for Telegraph Local | See @tommyfradenburg

In an effort to increase the available testing for COVID-19, the Food and Drug administration has granted emergency authorization for use of a saliva test developed at Rutgers University.

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The test, devolved by the Rutgers RUCDR Infinite Biologics team along with Spectrum Solutions and Accurate Diagnostic Labs, is the first of its kind approved by the FDA; and is conducted by subjects spitting into a cup rather than medical personnel collecting data with nose or throat swabs.

“The impact of this approval is significant,” said RUCDR chief operating officer and director of technology development Andrew Brooks.

“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.”

The approval could increase the number of available tests by about 10,000 per day according to Rutgers, something infectious disease expert Dr. Tom Moore described as “enormous.”

“The release of any reliable test, expanded capacity of tests or introduction of new tests … will go a really long way toward curbing the pandemic,” he said.

Another advantage of the test is the increased amount of biological material that the tests can collect for analysis compared to swabs; leading to greater accuracy. It also allows for quick diagnosis with results becoming available in just 24-48 hours after arrival.

The increase in available tests won’t just help future patients, but those currently infected as well said Brooks.

“Saliva testing will also be important for people who are in quarantine because they don’t know how long it will be until they are no longer infectious. This will allow health care workers to release themselves from quarantine and safely come back to work.”

For now the tests are available to the RWJBarnabas Health Network; a partner of Rutgers University and the most complete health care system in New Jersey. People can also access the tests at a drive through testing site in Edison, New Jersey.

The approval is the second headline RUCDR has made this week; as it launched a genetic testing service that also increased the amount of people that can be tested.

Under current guidelines the FDA requires the supervision of a “trained health professional,” but the professional doesn’t need to administer the test itself.

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The White House called Rutgers to congratulate the team on the approval, but the FDA has yet to comment.

RUCDR Infinite Biologics, part of the Rutgers Human Genetics Institute of New Jersey, is the world’s largest university-based cell and DNA repository.

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