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

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.