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FDA Grants EUA to First Saliva-Based Coronavirus Test

TAGS: IVD
FDA Grants EUA to First Saliva-Based Coronavirus Test
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The test was developed by Rutgers’ RUCDR Infinite Biologics and collaborators. The diagnostic uses saliva as the primary biomaterial to detect the SARS-CoV-2 coronavirus.

FDA has granted out a ton of emergency use authorizations for tests to detect the novel coronavirus. However, the federal agency’s latest EUA designation could be a first.

On Tuesday, Rutger’s RUCDR Infinite Biologics along with Spectrum Solutions and Accurate Diagnostics Labs (ADL) have developed an application that uses saliva as the primary test biomaterial for the SARS-CoV-2 coronavirus.

The feeling is that the test will allow for broader population screening than the current method of nose and throat swabs.

In release, Andrew Brooks, COO and director of technology development at RUCDR said, “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.”

Rutgers said the tests are available to the RWJBarnabas Health network, including Robert Wood Johnson University Hospital, University Hospital in Newark and many other facilities, including several county health departments.

MD+DI has been tracking FDA’s response to the deadly disease since late January. The federal agency began its efforts by laying out a complex strategy to tackle the virus. FDA then granted EUA to the Centers for Disease Control and Prevention for a 2019-nCoV Real-Time RT-PCR Diagnostic Panel. Since then FDA has granted numerous EUA's and in some cases approvals for novel coronavirus tests. 

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