BioCentury
ARTICLE | Product Development

FDA authorizes first COVID-19 test using at-home saliva samples, begins unveiling serological test validation data

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May 9, 2020 2:41 AM UTC

FDA’s authorization of a COVID-19 diagnostic from Rutgers University marks the first time the agency has signed off on detecting SARS-CoV-2 from saliva samples collected at home, which avoids the inconvenience of both in-office visits and invasive swabs.

The May 7 Emergency Use Authorization (EUA) comes on the heels of the first authorization for a CRISPR-based diagnostic, and the publication of the first data from an independent test validation initiative led by NCI...