FDA approves first saliva-based coronavirus test

Tuesday, April 14, 2020

Source: MassDevice

The FDA granted emergency use authorization (EUA) to Rutgers University’s RUCDR Infinite Biologics and its collaborators for an approach using saliva as test biomaterial for COVID-19.

In tandem with Spectrum Solutions and Accurate Diagnostics Labs, RUCDR developed the saliva collection methods as an alternative to nose and throat swabs when testing for SARS-CoV-2, the virus that causes coronavirus. It is the first authorization given to a saliva-based test amid the COVID-19 pandemic.

Saliva testing is seen as a testing option because of the global shortage of swabs for sampling combined with the increase in testing, along with offering information on how infectious people are during and after quarantine, according to a news release.

RUCDR already launched a genetic testing service for the coronavirus designed to test thousands of samples daily, and it believes that the new saliva test could increase that number to tens of thousands of samples daily. The tests are available to the RWJBarnabas Health network.

“The impact of this approval is significant,” RUCDR COO & director of technology development Andrew Brooks said in the release. “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. All of this combined will have a tremendous impact on testing in New Jersey and across the United States.”

The testing can be performed exclusively using collaborator Spectrum Solutions’ Spectrum SDNA-1000 saliva collection device, designed to protect and preserve RNA used for detecting infection, according to that company.

“Using saliva to test for COVID-19 overcomes many of the challenges the nation faces that are inherent to current testing methods including supply shortages and risks to exposure for healthcare professionals,” Spectrum Solutions CEO Stephen Fanning said in a news release. “Now, under a medical professional’s direction, the saliva collection can be self-administered by individuals who may be in quarantine or self-isolation, removing the need to be in close contact with medical staff.”

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