FDA Grants Emergency Authorization to First COVID-19 Saliva Test

This is the first diagnostic for SARS-CoV-2 infection which uses a saliva-based collection method to be granted authorization by the FDA.

The US Food and Drug Administration (FDA) has granted emergency use authorization to a saliva-based test for SARS-CoV-2 infection. The device was developed by Rutgers University’s RUCDR Infinite Biologics laboratory.

This is the first diagnostic for SARS-CoV-2 infection which uses a saliva-based collection method to be granted authorization by the FDA.

The new method, which RUCDR developed in partnership with Spectrum Solutions and Accurate Diagnostic Labs, may allow for broader testing rollout than the current methods of nasal and throat swabs.

“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,” said Andrew Brooks, PhD, chief operating officer and director of technology development at RUCDR, in a press release.

Brooks was contacted by the White House’s Coronavirus Task Force to voice its support and to ask about any barriers to expanding testing which would prevent other laboratories from replicating the test.The RUCDR team was also contacted by several life sciences companies that are involved in COVID-19 testing.

In recent days, RUCDR also launched a genetic testing service for coronavirus disease 2019 that can test thousands of samples daily. With the new saliva test, testing capacity could rise even higher.

“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.