First At-Home Rapid Test For COVID-19 Approved By FDA
BOSTON (CBS/AP) - The Food and Drug Administration has approved the first at-home rapid test for COVID-19 that doesn't require a prescription.
Users can swab their nose, run the test and get results in about 20 minutes, FDA Commissioner Stephen Hahn said in a statement.
The kit includes a nasal swab, a chemical solution and a testing strip. The test connects digitally to a smart phone app that displays the results and then helps interpret them. Users can also connect with a health professional via the app.
Initial supplies of the over-the-counter test will be limited. Australian manufacturer Ellume said it expects to produce 3 million tests next month before ramping up production over the first half of 2021.
A company spokesperson said the test will cost about $30 and be available at pharmacies and online.
Dr. Michael Mina of Harvard called the new test "a great addition," to existing options, though he cautioned that its price could limit access.
"This is a milestone, with reservations," Mina told the Associated Press. "I just hope it doesn't drive more of a wedge between haves and have nots."
For people with insurance, federal law requires that plans cover the cost of COVID-19 testing.
(© Copyright 2020 CBS Broadcasting Inc. All Rights Reserved. The Associated Press contributed to this report.)