(Ellume CEO DR. Sean Parsons saying): "...everything they need to perform the test is inside the kit."
The first over-the counter COVID-19 antigen test approved by the FDA that can be used from start to finish at home will be coming to Americans in January.
The test, created by the Australian company Ellume, offers a nasal swab analyzer that connects to a free app on the user's smartphone.
The app walks the user step-by-step on how to use the test and results are given in 20 minutes. It costs about $30 dollars and a doctor’s note is not needed.
Ellume’s CEO Dr. Sean Parsons:
"So it's the first non-prescription self test approved by the FDA for adults and children to diagnose themselves with coronavirus SARS-CoV-2, whether they're symptomatic or asymptomatic... They do take a swab, here's what the swab looks like. It's not a big long swab that goes all the way to tickle the base of your brain. It's a swab of what's called your mid-turbinate region, which is about that far back. You then apply the swab to a small tube which is supplied within the kit, then you put the sample onto this analyzer, which you can see here."
Dr. Parsons said his tests will be going to America first:
"The biggest reason why it's going to America first is because it can make the biggest dent on helping Americans respond to coronavirus. There are tens of thousands, hundreds of thousands a day in the U.S. and these tests are most needed in America to assist the response."
The news follows authorization last month of the first prescription, fully at-home COVID-19 test, and this week, the FDA also blessed another at-home rapid test, this one from Abbott Laboratories.
FDA Commissioner Stephen Hahn praised these developments saying they will help expand Americans access to testing, but the agency, however, cautioned that antigen tests - like the one from Ellume - are less reliable than PCR tests and may have a small percentage of results that are false.
Ellume said it will be shipping over 100,000 tests per day next month, and plans to deliver 20 million COVID-19 tests to the United States within the first half of 2021.