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

  • 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.

Published by XIFIN
INDUSTRY NEWS TAGS: Other


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