FDA approves first saliva-based coronavirus test

April 15, 2020 Pharma

The Food and Drug Administration (FDA) approved the first saliva-based coronavirus test under its emergency powers, Rutgers University announced.
The FDA deployed its emergency-use authorization to approve of the test from the Rutgers lab RUCDR Infinite Biologics, informing the university of its approval. The new saliva-based test aims to allow for increased testing and safety for health professionals conducting screening.
The test, which was developed in partnership with Spectrum Solutions and Accurate Diagnostic Labs, will be available through hospitals and clinics associated with the university. Spectrum Solutions is a Utah-based company that produces similar saliva devices for DNA-based ancestry testing services.
Current testing requires health professionals to take samples from a patient’s nose or throat. Hospitals and clinics have instructed these professionals to get rid of gloves and masks after being in contact with a patient who may have the virus, further straining already stretched medical supplies.
But with this test, patients will spit in a tube several times and give it to the health professional for testing, making it less likely they will get infected, Andrew Brooks, the chief operating officer and director of technology development at the Rutgers lab, said in the university’s release.
“Saliva testing will help with the global shortage of swabs for sampling and increase testing of patients, and it will not require health care professionals to be put at risk to collect samples,” Brooks said. “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.”
The White House task force called Brooks to congratulate him and to offer support for increasing the testing capabilities, according to the university’s release.
The Rutgers lab can process 10,000 patient samples per day, according to The Associated Press.
The FDA instructed the lab that the test should be conducted only “in a health care setting under the supervision of a trained health care provider,” according to the AP. It also directed that all patients who receive negative results from the saliva test must receive confirmation with another testing method.

Source : thehill

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