For the past year, many experts have called for the development of cheap, rapid home tests as a way to catch and stop viral transmission. Because so much of the transmission occurs among people showing no symptoms, giving Americans an inexpensive way to test themselves regularly would be a breakthrough. But even as testing technology improved, the cost and availability of such tests lagged and remained prohibitive.
Ellume’s home coronavirus test was the first over-the-counter, rapid coronavirus home test to be authorized by the Food and Drug Administration. It was approved Dec. 15. But the test was expected to be available only in limited quantities.
“The purpose of today’s announcement is to move to mass production and scale,” said Andy Slavitt, President Biden’s senior adviser for covid-19 response, at a Monday news briefing.
Slavitt acknowledged that the $30 price per Ellume test — while cheaper than many of the $100-$200 tests that need to be processed by a lab — is still too high for it to be used ubiquitously by many people.
“The cost will come down only if we get to that mass production and scale,” Slavitt said, calling the new contract an initial step to solve that problem. “We know there are efforts to create even lower cost and more innovative approaches and we welcome those.”
In an interview with The Post, Ellume founder and CEO Sean Parsons said he believes scaling up production will allow Ellume to reduce the test’s price. By building a manufacturing plant in the U.S., for instance, the company will no longer have to ship tests from Australia.
The tests could be vital tools in the country’s fight against the virus — especially in the months before most Americans are vaccinated. Unlike previous home tests, the Ellume test does not require samples to be sent to a lab and can be taken without doctor’s orders by anyone older than 2. Two other home tests approved by the FDA — Lucira Health’s “All-In-One” test kit and Abbott’s BinaxNOW test — require a doctor’s prescription, making them unhelpful for stopping asymptomatic transmission.
But the U.S. will have few tests before many Americans are vaccinated. Under the new contract, Ellume is expecting to ship 100,000 tests to the United States per month from February to July.
“That’s good but obviously not where we need to be,” Slavitt said.
By the end of the year, the company’s manufacturing is expected to scale up to be able to produce more than 19 million test kits per month. At least 8.5 million tests have been promised to the U.S. government. The rest will remain in the United States but will be sold through retail stores or distributed in large-scale purchases by private companies or institutions.
“We’ve gotten a lot of interest from retailers to logistics companies wanting to protect their staff to universities and health care groups,” Parsons said.
The Biden administration has not said how it will use the 8.5 million tests it bought, but Ellume’s contract was made through the Department of Defense, making it possible at least some of the tests may be allocated to the military.
A spokeswoman for the Department of Defense said Ellume would provide a detailed distribution plan within 15 days of contract being awarded, and that the intended use for the tests includes “In-home, institutions (such as government departments, education providers and businesses), and high-density transport hubs (like airports, train stations) and events (such as sports, performing arts).”
To achieve large-scale production this year, Ellume will first need to build and get a U.S. manufacturing plant up and running, which isn’t expected until the third quarter of this year.
Until then, the contract, which many experts believe is a positive development, won’t make a huge difference in the fight against the pandemic. The test’s availability will remain extremely limited until Ellume’s U.S. manufacturing facility opens later this year. The company has not yet finalized where that factory will be located.
“We want to help the U.S. reopen as safely and as quickly as possible,” Parsons said in a statement. “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.”
The test was developed by the company following a $30 million grant from the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) initiative in June.
The test uses a nasal swab to collect a sample and produces results within minutes using a plastic device similar to a home pregnancy test.
One critical feature of the new home tests: the ability to capture and report test results.
For months, at least two dozen companies have been trying to develop home tests, most of them rapid antigen tests that detect proteins on the surface of the virus. Because labs are not involved in such tests, there was no clear way to report the results. Without that data, experts warned that the country would be flying blind as it navigates the later stages of the pandemic.
Ellume’s test requires users to download an app on their smartphone to learn their test result. That app automatically sends data by Zip code to the cloud — ensuring that regional health officials can learn about positive results while keeping the data confidential, the company said.
In coming weeks, more new tests are expected to be approved. Experts said that with increasing capacity, a growing need exists for state and federal officials to come up with a national strategy for how to deploy the tests more effectively and to provide federal funding for regular, dedicated mass testing in schools, hard-hit nursing homes and among essential workers.