FDA Oks 1st At-Home Collection Kit for Use with Multiple Labs, Coronavirus Tests

June 8, 2020

FDA has for the first time authorized multiple laboratories to test for coronavirus in nasal samples collected by consumers using an at-home kit.
In an emergency use authorization issued Friday to Everlywell, FDA has permitted consumers to self-collect nasal specimens with the kit for analysis at designated, CLIA-certified laboratories, using two COVID-19 diagnostics approved under separate EUAs. Fulgent Therapeutics and Assurance Scientific Laboratories are currently authorized to test the samples.
Friday’s authorization by the agency follows earlier EUAs that allowed LabCorp and Rutgers Clinical Genomics Laboratory to collect at-home specimens for analysis at their own labs.