HomeHealth Care NewsFDA Approves At-Home Test, with a Catch

FDA Approves At-Home Test, with a Catch

The U.S. Food and Drug Administration (FDA) gave the green light for the first at-home COVID-19 test that can be purchased without a doctor’s prescription, but users will have to go online to get the results.

The Ellume COVID-19 Home Test requires users to take a swab sample deep inside their nose, although not as far back as a typical PCR test. Unlike the PCR, the Ellume test will primarily detect antigens to the SARS-CoV-2 virus. For detailed directions and interpretation of results, users will have to submit their ZIP code and date of birth, using an app on a smartphone.

Ellume told Health Care News the test will cost $30 and the firm is in “advanced discussions” with national retail chains to sell the kit.

Ellume expects to produce more than three million tests in January 2021, the FDA news release states.

—Staff reports


AnneMarie Schieber
AnneMarie Schieber
AnneMarie Schieber is a research fellow at The Heartland Institute and managing editor of Health Care News, Heartland's monthly newspaper for health care reform.


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