Diagnostics

FDA authorizes first at-home saliva test kit for Covid-19

The agency gave an emergency use authorization to the testing assay, developed by Rutgers University, Spectrum Solutions and Accurate Diagnostic Labs, for collection of samples at home. The saliva-based test was originally authorized last month.

The Food and Drug Administration has given what the agency calls its first emergency use authorization to a test for Covid-19 that permits collection of samples at home using saliva, the agency said Friday.

Rutgers University said Friday that the FDA had given the EUA to the Rutgers Clinical Genomics Laboratory’s TaqPath SARS-CoV-2 Assay, developed by the university’s RUCDR Infinite Biologics under a partnership with Salt Lake City-based Spectrum Solutions and Accurate Diagnostic Labs. Rutgers said it would allow for broader screening than the standard method of using nose and throat swabs at sites that require people to interact physically with healthcare professionals. A letter granting the EUA was sent on Thursday.

“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 [personal protective equipment] 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,” RUCDR COO Andrew Brooks said in a statement. “This will enable testing for people who 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.”

The FDA had already granted an EUA last month for the use of Rutgers’ test, though not for use at home. The university initially made the test available at a drive-through testing facility in Edison, New Jersey.

The FDA noted that Thursday’s EUA also follows last month’s reissue of the EUA for LabCorp’s Covid-19 RT-PCR Test to permit testing of samples collected by patients at home using the company’s home collection kit, thereby marking the first authorization of a home collection kit.

The Covid-19 pandemic has seen additional firsts in the arena of diagnostic testing as well. Last week, the FDA gave its first-ever authorization of any kind to a product that uses CRISPR technology, when it granted an EUA to Sherlock Biosciences for its SARS-CoV-2 test.

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Photo: Centers for Disease Control and Prevention