Rutgers University Cell and DNA Repository's Infinite Biologics laboratory received an amended emergency use authorization from the FDA late Thursday for the first coronavirus test that will allow people to collect their own saliva at home and send to a lab for results.
The new at-home saliva self-collection test was developed by RUCDR in partnership with Spectrum Solutions and Accurate Diagnostic Labs.
"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 RUCDR's chief operation officer Andrew Brooks said.
It's the lab's second such authorization in recent weeks. RUCDR Infinite Biologics was also the first to receive FDA approval for a saliva-based test in which samples were collected by health care workers at testing sites.
RUCDR was already set up to test thousands of the samples daily, but with the authorization the lab says they'll now be able to handle tens of thousands of test samples every day.
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