Rutgers’ saliva test approved by FDA for at-home use

Mass testing? At home? That idea is now a reality.

The COVID-19 salvia test created by Rutgers University scientists at RUCDR Infinite Biologics that Gov. Phil Murphy hopes will be a key to increased testing in the state took another step toward doing just that when the Food & Drug Administration approved it to be the first test that will allow people to collect their own saliva at home and send to a lab for results.

Andrew Brooks, chief operating officer and director of technology development at RUCDR, said the approval not only will help more people get tested, but allow more people to get tested without having to use the personal protection equipment that is in short supply.

“The impact of this approval means that, not only do we no longer have to put health care professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections, we can now preserve precious PPE for use in patient care instead of testing and can significantly increase the number of people collected each and every day in places other than a health care setting,” he said.

“Protecting both patients and health care professionals from any unnecessary exposure is of paramount importance, and saliva home collection addresses almost all issues around testing quality, safety and availability.”

Increasing access, Brooks said, is key.

“This will enable testing for people that do not have the means to get to a collection center and/or are at home because they are sick, quarantined, at increased risk for infection or simply concerned about exposing themselves by traveling to a collection site,” he said. “This approach will have a significant impact on helping people in New Jersey and across the United States get back to work as we will be able to monitor large numbers of people in a variety of locations.”

The decision follows the FDA’s recent emergency approval to RUCDR Infinite Biologics for the first saliva-based test, which involves health care workers collecting saliva from individuals at testing sites.

The new at-home saliva self-collection assay, developed by RUCDR in partnership with Spectrum Solutions and Accurate Diagnostic Labs, allows for broader screening than through the standard method using nose and throat swabs at a health care facility or testing location that requires a physical interaction with a health care professional.

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