“By authorising 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,” Hahn said in a statement.
Lamar Alexander, the chair of the Senate health committee, said: “This is a genuine breakthrough in COVID-19 testing.”
Studies showed the Ellume test correctly identified 96 per cent of positive samples and 100 per cent of negative samples in individuals with COVID-19 symptoms.
For those without symptoms, the test correctly identified 91 per cent of positive samples and 96 per cent of negative samples.
Ellume has said it plans to ship over 100,000 tests per day from January, and to deliver 20 million COVID-19 tests to the US within the first half of 2021.
