The Biden administration awarded $231.8 million to Australia-based Ellume to boost production of the company's over-the-counter at-home COVID-19 diagnostics test. The test can develop results within 15 minutes of receiving a swab-based sample and guides users through the testing process via a smartphone app.
The Food and Drug Administration had granted Ellume's request for an emergency use authorization back in December, after the test delivered results with 96% accuracy in a U.S. clinical study. The test is authorized for use in individuals age 2 years and older without a prescription from a healthcare provider.
"Our focus is enabling the U.S. to minimize community transmission and reopen as quickly as possible," said Dr. Sean Parsons, Ellume founder and CEO, in a statement. "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 to output across our production facilities, creating more possibilities for retail and private institution use in the future."
Under the agreement, Ellume will supply the government with 8.5 million COVID-19 home tests to be distributed in the country. The company has also agreed to establish a manufacturing facility in the U.S. The company stated that the U.S-based manufacturing capacity will build on Ellume's own Australian production, which is on track to deliver about 200,000 tests per day this quarter.
Ellume has agreed to deliver 100,000 tests per month to the U.S. from Australia until the U.S. facility is built. At full capacity, the U.S. facility will be able to produce up to 19 million test per month, or roughly 600,000 tests per day.
The Biden administration is working to increase testing efforts within the U.S. through President Joe Biden's National Strategy for the COVID-19 Response and Pandemic Preparedness plan, with one of the plans goals being to mitigate the virus's spread through the expansion of public health and safety measures like testing.
The current U.S. average daily testing rate is about 550 per 100,000 people, according to a seven-day moving average calculated by Johns Hopkins University, which is about 1.8 million tests per day.
The Ellume COVID-19 Home Testing kit includes a nasal swab, dropper, processing fluid, and analyzer which is then paired with a Bluetooth-enabled app that guides the users through step-by-step instructions to perform the test and produce results. At an estimated $30 per test, the test is unlikely to be a daily routine screening in the future, but it is a step in the right direction towards an accessible and easy at-home coronavirus test.