Ellume’s test is important because it will be available over the counter, can be completed entirely at home, and delivers results very quickly. It’s a so-called antigen test, a different technology from the PCR tests that have been more common, which generally involve processing samples in a laboratory. Ellume’s test is entirely self-contained and gives results in 15 minutes.

Since the beginning of the coronavirus pandemic, health experts have said expanded testing would be critical to controlling the spread of the virus and helping get the economy back to something resembling normal. And even with vaccines rolling out, testing will likely be an important part of health protocols, both for businesses and individuals, for years to come.

When can I buy Ellume’s tests in stores?

Though 8.5 million tests are earmarked for the U.S. government as part of the DoD contract, the funds are also intended to help the company expand its production to 19 million tests per month by the end of 2021. Many of those tests will be sold directly through retail outlets such as CVS and other pharmacies: Ellume’s will be the first rapid home COVID test sold without a prescription. Ellume CEO Sean Parsons says that test manufacturing in Australia will reach peak capacity by the end of March, and the tests will be “closer to meeting retail demand” at around that time.

The catalyzing role of the government deal is notable here. “This deal certainly increases our ability to supply at scale into that retail channel,” says Parsons. In addition to ramping up production at Ellume’s facilities in Australia, that will include building entirely new production facilities in the United States. Ellume is still considering locations for those U.S. plants.

Though Ellume’s tests were first approved for emergency use in the U.S. on Dec. 15, 2020, they have not yet become widely available. That’s in part because of challenges sourcing raw materials. Parsons says that testing swabs have been a “bottleneck,” but that Ellume’s swab supplier, Maine-based Puritan Medical, is nearing the end of an effort to expand its own production pipeline.

How much will Ellume’s COVID test cost?

“We certainly would like to see this priced in the $30 range,” says Parsons. But, he admits, “it will definitely start at more than that” for retail purchase early in the test’s availability, as Ellume works to increase capacity.

Parsons didn’t offer a likely price range in the near term, though, and the company is still finalizing its retail sales plans.

How accurate will the tests be?

Ellume’s self-administered home test detects a coronavirus infection by looking for antigens, which are proteins produced by the virus. Antigen tests are broadly less accurate than tests that look for genetic material shed by the virus, known as PCR tests.

But Ellume’s test is nonetheless quite accurate: 96% accurate in symptomatic COVID patients and 90% accurate in those showing no symptoms. This means 4% of symptomatic and 10% of asymptomatic test takers could get inaccurate results.

That’s accurate enough to be useful, but neither Ellume nor the FDA consider the test a stand-alone solution.

“We definitely will have some false negatives,” says Parsons, which are more common with antigen-based tests. “We won’t get every case. And then there will be the odd false positive, so we do recommend that people who get positive results get confirmatory testing.”

False negatives are possible with any COVID test, though, with one study finding false negative rates of 20% early in an infection, even when using more accurate PCR tests. That’s why health authorities recommend frequent testing, which Ellume’s test will make easier.

Who should use an at-home COVID test?

Anyone who is regularly in situations where they might be exposed or expose others should consider getting regular COVID-19 tests. But testing is often a hassle, particularly for the very same frontline workers who need it the most. Even 11 months after the start of the pandemic, testing at clinics and hospitals can involve long waits and other logistical barriers. And though other at-home COVID tests are already available, they are generally delivered by mail and must be returned to a central facility for results, which can take up to 24 hours.

Ellume’s is the first test approved for sale in U.S. stores that provides results nearly immediately—within 15 minutes. The wider availability will make it more convenient, while the rapid results mean users can self-isolate more quickly. The Ellume test is approved for patients as young as 2 years old.

The test’s convenience is particularly important because recent research has shown that a majority of COVID cases are spread by those showing no symptoms at all. In a best-case scenario, easily accessible rapid home testing will make it easier for teachers, service workers, and others to protect themselves and the public, potentially slowing the overall spread of the virus.

Will we still need COVID testing after most Americans are vaccinated?

Ellume’s ramp-up to full production, including its new American facilities, will take at least several months, though Parsons says the complexity of the project means the timeline can’t be predicted precisely.

That presents an apparent quandary: President Biden has said vaccines may be available to all Americans by this spring. It’s tempting to think that widespread vaccination will make testing a moot point.

But that would be a mistake. Even the highly protective Pfizer/BioNTech and Moderna vaccines are not a guarantee against COVID-19, and it’s still unknown whether vaccine recipients can transmit the virus to others. An even greater risk may come from the one-fourth of Americans still hesitant to get the vaccine at all. Though that number will likely go down over time, it suggests many Americans will not be protected against the coronavirus even after shots are easily available.

“There is still going to be COVID circulating in the community for some time,” says Parsons. “So there will still be a need for testing. Self-testing will play a role in that.”

How big is this deal for Ellume?

A $230 million contract would be big for nearly any company, but for Ellume, it will be transformational. Ellume’s production capacity for its COVID test will ultimately triple. The company, which currently has 320 employees, expects to add 300 new jobs in Australia and more than 1,000 in the U.S.

Why aren’t an Australian company’s tests going to Australia?

Parsons said his company’s tests will be available in its home country “eventually,” but all of the tests now being produced in its Australian facilities are bound for the U.S., and tests produced in new U.S. facilities will also remain in the U.S., at least for some time.

While Parsons says Ellume has always been focused on the U.S. market, its tests are explicitly limited to being sold in the U.S. in the near term because they were developed with funding from the U.S. National Institutes of Health’s RADx program. Ellume was awarded $30 million in development funds by the program in October.

Parson, who is himself Australian, heaped praise on the NIH research program.

“As always, America is leading the world when it comes to new technologies. It tends to fall to America to lead the way and invest in companies to develop products.”