Ellume’s at-home coronavirus test receives FDA clearance

Image source: ©tillalucida via canva.com

Ellume’s at-home coronavirus test receives clearance from the U.S. Food and Drug Administration, according to the developer’s CEO.

He said that Ellume’s at-home coronavirus test will be available at drugstores as soon as February.

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“We’ll be shipping first product in the beginning of January. That will be ramping up through the months of January, February and March,” Ellume CEO Dr. Sean Parsons told CNBC’s “Squawk on the Street.”

“We would anticipate that in the second part of February or March, we would like to have that available in the major retailers across the U.S.,” said Parsons, who founded the diagnostic products company based in Queensland, Australia.

The item is the first at-home test for the Covid test that does not require a prescription to get emergency use authorization by the FDA.

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For FDA Commissioner Dr. Stephen Hahn, Ellume’s product is a “major milestone” in 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,” Hahn said in a press release.

Ellume was granted $30 million for test development by the National Institutes of Health. The company announced it can produce 20 million of the at-home tests in the first six months of 2021. Parsons was optimistic about the manufacturing process. “We we’re pretty confident we can exceed that 20 million number in the first half of next year,” he told CNBC.

Parsons explained everything that is needed for the test is already inside the box. Ellume’s test uses a nasal swab that is less invasive than some other coronavirus tests, he said.

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“And then you put that sample onto a digital analyzer,” he said. “Inside this digital analyzer is a Bluetooth-connected instrument which talks to your phone. All of the analysis happens inside of here, and the result is communicated to your phone, positive or negative.”

Ellume’s test was 96% accurate in detecting Covid-19 in people who were manifesting symptoms of the disease, according to the FDA. Meanwhile, the test was 91% accurate in spotting infections when the person was asymptomatic.

Like Ellume, Abbott also received authorization for its at-home rapid Covid test from FDA.

Results of the antigen test can be released in about 15 minutes. It had been authorized for use by trained personnel but the new clearance will allow patients to test themselves at home. They can be assisted by a doctor virtually. The antigen test is the third test authorized in the U.S. “that can be used completely at home,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

“FDA continues to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options,” FDA Commissioner Dr. Stephen Hahn said in a statement. “The BinaxNOW COVID-19 Ag Home Test will have a significant manufacturing footprint with the potential to support testing for millions of people.”