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. 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, 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.”
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.
Under the new contract, the company 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, Slavitt said. Of that 19 million, 8.5 million tests have been promised to the United States government.
That represents a massive growth in the scale of expected manufacturing. But to achieve that the company 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 and begins producing 19 million tests a month.
In a statement Monday, Ellume founder and CEO Sean Parsons said: “We want to help the U.S. reopen as safely and 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.” Parsons said his company is also exploring retail options and partnerships with private institutions as manufacturing increases.
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 2020.
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.
