The Ellume COVID-19 Home test will be available in American pharmacies without a doctor’s prescription.
The Food and Drug Administration (FDA) issued an emergency use permit for the Ellume COVID-19 Home Test, the first home diagnostic test for COVID – 19 that does not require a prescription to be purchased. This was announced on Tuesday afternoon by the Minister of Health and Human Services Alex Azar.
“Today’s approval is an important milestone in the diagnostic testing of COVID-19,” said FDA chief Dr. Stephen Hahn.
Last month, the FDA approved the use of a home test for the coronavirus, which is sold by prescription. In total, since the beginning of the pandemic, the FDA has approved the use of more than 225 tests for COVID-19.
The test is performed using a nasal swab and correctly detects the virus’s presence in 96% of cases in patients with symptoms of coronavirus.
According to the FDA statement, the test “uses an analyzer that connects to a software application on a smartphone to help users perform the test and interpret its results,” which can be obtained in just 20 minutes.
The new rapid test was developed with the support of the RADx Tech program established by the National Institutes of Health, under which $ 30 million was allocated for this task.
“The FDA has approved the first test for COVID-19, which can be purchased without a prescription, made at home and quickly get a result,” the head of the Ministry of Health said in a statement.
Azar said that a new opportunity for diagnosis appeared thanks to the RADx Tech initiative, which was established as part of “Operation Supersonic Speed.”
“With the new home testing capability and with the tens of millions of rapid tests that have already been distributed by the Ministry of Health this fall across the country, we have been able to… create the world’s best testing system for [COVID-19],” said Alex Azar.