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FDA Grants Ellume EUA for First Over-the-Counter At-Home SARS-CoV-2 Test

NEW YORK – Australian diagnostics firm Ellume said Tuesday it has received US Food and Drug Administration Emergency Use Authorization for its over-the-counter at-home rapid antigen test for SARS-CoV-2.

Approved for use in both symptomatic and asymptomatic individuals, and in children as well as adults, the Ellume COVID-19 Home Test is the first OTC at-home test to receive FDA EUA.

According to Ellume, it is ramping up production and will be able to produce around 100,000 tests per day in January.

The test uses a mid-turbinate nasal swab, which must be inserted farther than a typical nasal swab but not as far as a nasopharyngeal swab, and an analyzer that connects with a smartphone app that provides instructions on using the test and interpreting results, which are delivered in around 20 minutes. The app also delivers results, along with patient zip code and date of birth, to public health authorities to help monitor disease prevalence.

In a study of the test in 198 subjects ranging from 2 years to 82 years of age, it correctly identified 96 percent of positive samples and 100 percent of negative samples in symptomatic individuals and 91 percent of positive samples and 96 percent of negative samples in people without symptoms.

"As COVID-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing," Ellume Founder and CEO Sean Parsons said in a statement. "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 US to respond to the pandemic in its most urgent stage."

"Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes," FDA Commissioner Stephen Hahn said in a statement. "As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes."

Last month, Ellume said it is developing three different SARS-CoV-2 tests, including one in collaboration with Qiagen.