Ellume’s at-home antigen test does not require a prescription. Users receive their results in a smartphone app. Photo credit: Ellume
Diagnostics startup Ellume won a $231.8 million contract from the Department of Health and Human Services to manufacture more of its at-home Covid-19 tests in the U.S. The Brisbane, Australia-based company will open its first U.S. manufacturing facility, with plans to deliver 8.5 million tests as part of its contract.
Ellume received an emergency use authorization from the Food and Drug Administration in December for its antigen test, designed to identify certain proteins from SARS-Cov-2, which can indicate an ongoing infection. Users can swab their nose and put it in an analyzer, which is designed to send results to users’ smartphones in 15 minutes. Users also must input their zip code and date of birth, and can send results to public health authorities.
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Notably, the FDA authorized the test to be used over-the-counter, meaning no prescription is required and it can be used in asymptomatic patients. In its fact sheet, Ellume still cautions the test is more likely to give a false negative result when used by people without symptoms.
It correctly identified 96% of positive cases samples 100% of negative samples in people with symptoms, according to the FDA. For people without symptoms, it identified 91% of positive samples and 96% of negative samples. Ellume previously indicated it would price the tests at $30 each.
Until the U.S. facility is built, Ellume will deliver 100,000 tests per month from its facility in Australia. The U.S. facility is expected to be able to produce up to 19 million tests per month.
“We are prioritizing our partnership with the U.S. government to mobilize tests quickly and in the most impactful way,” Ellume’s CEO and founder Dr. Sean Parsons said in a news release. “We will fulfill the order for these tests at the same time as we ramp up the output across our production facilities, creating more possibilities for retail and private institution use in the future.”
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The contract is being led by the Department of Defense’s Joint rogram Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), in coordination with the DOD Defense Assisted Acquisition Cell (DA2) and funded through the Health Care Enhancement Act (HCEA).
Another company, Lucira, has also developed an authorized at-home test that delivers results onsite. But the molecular test is only available by prescription.