‘Big Deal’: FDA OKs First At-Home, No-Prescription Test For COVID
In a potential game-changer, Americans will soon be able to buy Ellume's over-the-counter COVID-19 test for $30 or less, that they can take at home and get results in under 20 minutes.
The New York Times:
New At-Home Covid Test Gets Green Light From F.D.A.
The Food and Drug Administration on Tuesday issued an emergency authorization for the country’s first coronavirus test that can run from start to finish at home without the need for a prescription. People as young as 2 years old are cleared to use the test, which takes just 15 to 20 minutes to deliver a result. Unlike many similar products, which are only supposed to be used by people with symptoms of Covid-19, this test is authorized for people with or without symptoms. (Wu, 12/15)
The Washington Post:
FDA Authorizes First Rapid, Over-The-Counter Home Coronavirus Test
The FDA allowed the test under an emergency use authorization. The newly approved home test will cost about $30, and the first batches will be shipped out the first week of January, according to Ellume. “It’s a big deal, and a huge step for efforts to take back control from the virus,” said Mara G. Aspinall, a biomedical diagnostics professor at Arizona State University. (Wan, 12/15)
NPR:
FDA Authorizes Coronavirus Test You Can Take At Home Without Prescription
The test kit includes a special swab that enables users to collect a sample from just inside their nose. Because it can be used on adults and children as young as 2 years old, the swab comes with a special adapter that shortens the length when swabbing youngsters. Users add a few drops of liquid to the sample and place it into a small plastic device that looks like a home pregnancy test. Results are wirelessly transmitted to a smartphone app within about 15 minutes. (Stein, 12/15)
The Hill:
FDA Approves First Over-The-Counter COVID-19 Test That Delivers Near-Instant Results
Clinical data revealed that Ellume’s tests identified 96 percent of positive samples as infected, and 100 percent of corresponding negative samples among symptomatic patients, and correctly identified 91 percent of positive samples and 96 percent of negative samples among asymptomatic patients. The test is fast, with an estimated wait time of 20 minutes, and sends results via a proprietary smartphone app.
The company anticipates three million tests will be produced by January. (Kelley, 12/15)
