The U.S. FDA announced today an Emergency Use Authorization for the first over-the-counter COVID-19 diagnostic test for home use.

Developed by Australian digital diagnostics company Ellume Health, the single-use kit is accompanied by a Bluetooth-connected app that guides users through the testing process and automatically reports its results for disease monitoring.

The test returns its results in 15 to 20 minutes. It's intended for use with self-collected nasal swab samples from individuals aged 16 years or older, or adult-collected samples from children aged two years or older.

The Ellume COVID-19 Home Test kit comes with a sterile nasal swab with a child adapter, processing fluid, a dropper and a Bluetooth-connected sample analyzer. Users are instructed to download the accompanying Ellume COVID-19 Home Test App for iOS or Android, which includes a quick start guide on how to connect the app to the analyzer as well as an instructional video on how to collect a sample and conduct the diagnostic test.

Of note, the app requires users to log their ZIP code and date of birth so the results can automatically be reported to relevant public health authorities in accordance to local, state and federal requirements. Results can also be shared with healthcare providers, employers and educators, according to Ellume.

Because it is a rapid, lateral flow antigen test, the agency warned that a small portion of its results may be incorrect. In a simulated home setting conducted among 198 subjects, the test was shown to correctly identify 96% of positive samples and 100% of negative samples from those with COVID-19 symptoms, the agency wrote, but its performance dropped to 91% of positive samples and 96% of negative samples from asymptomatic individuals.

With this in mind, users with COVID-like symptoms but negative results should still follow up with a healthcare provider, the agency advised, while positive results without symptoms should still be treated as presumptively positive until confirmed by a second test.

WHAT'S THE IMPACT

As an over-the-counter product, the test does not require users to have a prescription, symptoms or other epidemiological reasons to believe they've been infected. This would increase the availability of testing and potentially help catch more asymptomatic, unsuspected cases – while rapid in-home testing reduces the chance of further community transmission.

“As COVID-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing,” Dr. Sean Parsons, Ellume founder and CEO, 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 U.S. to respond to the pandemic in its most urgent stage.”

Thanks in part to a $30 million grant from the U.S. National Institutes of Health, Ellume said it was able to streamline development of the test and is already expanding its manufacturing capabilities. The company said it's on track to ship more than 100,000 tests per day starting in January and a total of 20 million tests to the U.S. in the first half of 2021.

“As COVID-19 case numbers hit record highs, the world needs access to fast, affordable, easy-to-use home testing,” Parsons said. “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.”

THE LARGER TREND

Ellume's green light is the latest in a flurry of diagnostic testing authorizations out of the regulator. So far, the agency has already authorized hundreds since the pandemic's start, 25 of which involve home collection of samples. Among the more noteworthy of these in the home space were last month's authorization of Lucira's at-home prescription kit and LabCorp's RT-PCR test for home collection and lab processing that was authorized in April. And after a rocky start in March, a substantial number of consumer health testing and telehealth startups have also rolled out varying forms of mail-order COVID-19 testing services over the last several months.