Rutgers’ RUCDR Infinite Biologics received an amended emergency use authorization from the FDA late Thursday for the first SARS-CoV-2 coronavirus test that will allow people to collect their own saliva at home and send to a lab for results.
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 healthcare facility or testing location that requires a physical interaction with a healthcare professional.
“The impact of this approval means that not only do we no longer have to put healthcare 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 healthcare setting,” said Andrew Brooks, chief operating officer and director of technology development at RUCDR, who also is a professor in the School of Arts and Sciences Department of Genetics at Rutgers University–New Brunswick.
“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. 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.
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