FDA Authorizes First At-Home OTC COVID-19 Test

The FDA has granted Emergency Use Authorization (EUA) to the first at-home, rapid, OTC coronavirus disease 2019 (COVID-19) antigen test.

The test, which was developed by Ellume, is authorized for use in adults and children aged 2 years and over, with or without symptoms. It is the first test of its kind to be granted an EUA by the FDA.

The COVID-19 pandemic as caused over 1.62 million deaths and there have been more than 71.9 million confirmed cases worldwide, according to the World Health Organization.

The test includes a nasal swab, a dropper, and processing fluid. The kit utilizes a Bluetooth connection to pair the analyzer with an app on the user’s smartphone. Using the app, patients are able to set up their kit, take their sample, and receive results in 15 minutes or less. Through a secure cloud, the results can also be sent to health authorities, employers, and educators for efficient COVID-19 mapping.

The test has demonstrated a 96% accuracy, an overall sensitivity of 95%, and has a specificity of 97%. The FDA granted the EUA based on a simulated home-setting clinical study comprised of 198 subjects ranging in age from 2 years to 82 years.

“As COVID-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing,” said Sean Parsons, MBBS, founder and CEO of Ellume, in a press release. “Ellume’s COVID-19 Home Test delivers this important first line of defense — it can be widely available without the need for a prescription, enabling the U.S. to respond to the pandemic in its most urgent stage.”

From the next month, Ellume will be shipping more than 100,000 tests a day. Within the first half of 2021, Ellume said it hopes to manufacture and deliver 20 million tests to the United States.

REFERENCE:

FDA Authorizes Ellume COVID-19 Home Test As First Over-The-Counter Fully At-Home Diagnostic Test [News Release] December 15, 2020; Valencia, CA. Accessed December 16, 2020. https://www.ellumehealth.com/2020/12/15/fda-authorizes-ellume-covid-19-home-test-as-first-over-the-counter-fully-at-home-diagnostic-test/.