23/06/2024 8:58 PM


Be life confident

Coronavirus saliva test gets FDA use approval, Rutgers University says

Federal health officials have granted an emergency use authorization for a coronavirus test relying on saliva samples that was developed by a Rutgers University-backed entity, the New Jersey college announced Monday.

The newly authorized test, which require a person with coronavirus symptoms to spit into a cup, could increase by up to 10,000 tests per day the number of screenings for Covid-19, according to Rutgers.

The university noted that its coronavirus test does not rely, as others do, on nose and throat swabs.

Rutgers said the test, developed by Rutgers’ RUCDR Infinite Biologics was granted emergency use authorization by the Food and Drug Administration on Saturday.

RUCDR, which says it is the world’s largest university-based biorepository, has collaborated with Spectrum Solutions, PerkinElmer, Thermo Fisher Scientific, and Accurate Diagnostic Labs on the test.

“It’s a game-changer on three levels,” said Rutgers professor Andrew Brooks, the chief operating officer and director of technology development at RUCDR, in an interview with CNBC.

Brooks said the test will alleviate a global shortage of swabs and other related equipment needed for existing coronavirus tests.

It also will reduce the need for a “tremendous amount” of personal protective equipment for sample collectors, and reduce their risk of getting close to a patient, and possibly becoming infected, during collection, he said.

Brooks also said the test is an improvement because it will significantly increase the amount of biological material that can be collected and tested, which will increase accuracy rates, and also because it can be done quickly before sending the sample to a lab for analysis.

The FDA’s authorization requires the tests to be performed under the “supervision” of a trained health professional, but does not require that such a person collect those samples, said Brooks, who is a molecular neuroscientist.

He said “we’re returning results in from 24 to 48 hours” after it arrives in a lab.

The FDA did not immediately respond to a request for comment from CNBC.

Shortly after the FDA authorized the tests, members of the White House’s Covid-19 testing task force called Brooks to congratulate his team and ask how to remove any regulatory or financial hurdles that could prevent the test from being deployed.

“In our lab,” Brooks said, “we have the capacity of 10,000 [test] reactions a day.”

The FDA authorization, he added, “Should allow for many labs to adopt this” kind of testing.

The test developers also have been contacted by the CEOs of some of the world’s biggest life sciences companies that are involved in coronavirus testing.

Brooks, in a starement, 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. This will allow health-care workers to release themselves from quarantine and safely come back to work.”

Rutgers said the tests are available to the RWJBarnabas Health network, a large health-care system in New Jersey.

The university also said that beginning Wednesday, Rutgers, in partnership with the Middlesex County government and RWJBarnabas Health, will make the test available to county residents at a drive-thru testing facility in Edison, New Jersey.  

Read all of CNBC’s coronavirus coverage here.

Source Article