Dive Brief:

• The Department of Defense, in coordination with HHS, awarded $231.8 million to Australia's Ellume to expand U.S. production of a rapid at-home test for COVID-19.
• The contract, awarded Monday, includes the purchase of 8.5 million antigen tests for nationwide distribution as part of President Joe Biden's pandemic response effort.
• Ellume's product, the first over-the-counter self-test for COVID-19 to receive FDA emergency use authorization, was developed with a $30 million contract from the National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) initiative.

Dive Insight:

Biden is following through on a campaign pledge to scale up testing capacity and invest in advanced technologies such as at-home and rapid tests as part of a unified national strategy to reduce the spread of COVID-19. The president has also issued an executive order to establish a national pandemic testing board to coordinate federal efforts to expand test availability and use.

FDA in December issued an EUA for Abbott's antigen-based BinaxNOW COVID-19 Ag Card Home Test, but it requires a prescription. However, the Ellume home test will be available without a prescription. Some public health experts are questioning why prescriptions are being required for some tests, potentially limiting their availability.   

Ellume's antigen test, which can be performed in about 15 minutes using a nasal swab specimen from adults and children as young as 2 years old, is authorized for people with or without coronavirus symptoms. A smartphone application walks users through instructions to perform the test and receive a result.

Abbott's BinaxNOW home test, which delivers results in about 20 minutes with the use of an app, is authorized for those 15 years or older suspected by their healthcare provider of infection within the first 7 days of symptom onset, as well as adult-collected nasal swab samples from individuals ages 4 years or older who are likewise suspected of COVID-19 by their healthcare provider within the first 7 days of symptom onset.

The DoD funding announced on Monday will support Ellume's establishment of a U.S.-based manufacturing facility. Until the plant is built, however, the company's Australian operation will deliver 100,000 tests per month, Ellume said. Once built, the U.S. plant will enable the company to increase production capacity by 640,000 tests per day by December, to support domestic COVID-19 testing efforts, the Defense Department said.

The Ellume product is an antigen test, and FDA has acknowledged that this type of test is less sensitive and less specific than molecular tests run in a lab and therefore can yield more false positive or false negative results. In November, the agency issued an alert to clinical labs and healthcare providers warning of the potential for COVID-19 antigen tests to deliver false positives.

When it authorized the Ellume ​test in December, FDA said the company's data, from a study of 198 people, showed the test correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms. In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples.

Ellume said its rollout strategy for the COVID-19 home test includes retail commercialization and partnerships with other public and private institutions.