Fda Director Steven Hahn After the Fda Granted Emergency Use Authorization for the First at-Home Covid-19 Diagnostic Test Available without a Prescription.

December 15, 2020

By authorizing a test for over- the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes.

  • The nasal swab test by Australian manufacturer Ellume delivers results via an app on your phone and is expected to cost $30.
  • Unlike the other 225+ COVID-19 diagnostic tests approved this year by the FDA, Ellume’s is available over-the-counter.
  • Last week, Ellume requested emergency use authorization from the FDA and submitted the results of a study conducted in five states involving nearly 200 participants ages 2 to 82.
  • According to the FDA, the Ellume test “correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms. In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples. Ellume, the test correctly.”
  • Ellume says it plans to ship more than 100,000 tests per day over the next month, and deliver 20 million within the U.S. during the first half of 2021.

by Jenna Lee,