U.S. inks $232 million deal with Ellume for at-home rapid COVID-19 tests

The Ellume COVID-19 Home Test was the first rapid self-test authorized by the FDA for the detection of COVID-19 in individuals with or without symptoms.
By Mallory Hackett
11:47 am
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The Biden administration has cut a deal with Australian digital diagnostics company Ellume to increase the availability of its at-home rapid response COVID-19 test kit in the U.S.

The Department of Defense, with the Department of Health and Human Services, will pay $231.8 million for Ellume to deliver 8.5 million tests across the U.S. in accordance with the National Strategy for the COVID-19 Response and Pandemic Preparedness policy.

Ellume will also build a U.S. manufacturing facility with the financial support. Until the new facility is built, Ellume will send 100,000 tests per month from its Australian facility. Once it’s built, the company will be able to produce up to 19 million tests per month.

WHY THIS MATTERS

Testing is a key component of the federal government’s strategy to minimize the spread of COVID-19. It is especially important to identify and quickly quarantine individuals because of the potential for asymptomatic and pre-symptomatic transmission, according to the Centers for Disease Control and Prevention.

The Ellume COVID-19 Home Test was the first rapid self-test given emergency use authorization by the Food and Drug Administration for the detection of COVID-19 in individuals with or without symptoms.

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. It comes with an accompanying app that guides users through the testing process and automatically reports its results for disease monitoring. The test gives results in 15 to 20 minutes.

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. Its performance dropped to 91% of positive samples and 96% of negative samples from asymptomatic individuals.

Despite the influx of tests that this deal with the DOD will create, the Ellume kit has an expected cost of $30 and requires a smartphone to get the results. For a virus that has had worse outcomes in poorer and more diverse areas, barriers like cost and access to technology could prevent widespread testing in places that need it most.

THE LARGER TREND

While Ellume’s test offers at-home testing without a prescription, the FDA has doled out a number of EUAs for other testing options.

Labcorp has a prescription test that is authorized for at-home sample collection and in-lab molecular testing. Lucira’s COVID-19 All-in-One Test Kit allows for in-home sample collection and gives the results within 30 minutes, but it requires a prescription for suspected infection and costs $50. Abbott released a $5 rapid test, but it is designated for use by healthcare professionals at approved point-of-care facilities.

As of January 30, the U.S. has completed nearly 297 million COVID-19 tests, according to the CDC. The seven-day moving average of positive tests decreased to 8% at the end of January, compared to an average of 12.3% at the beginning of the month, according to Johns Hopkins University.

ON THE RECORD

“Our focus is enabling the U.S. to minimize community transmission and reopen as quickly as possible. The Ellume COVID-19 Home Test is the only authorized test of its kind and is an essential tool for the broader pandemic response in the U.S,” said Dr. Sean Parsons, the founder and CEO of Ellume.

“We are prioritizing our partnership with the U.S. government to mobilize tests quickly and in the most impactful way. 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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