An Australian company that recently began selling a rapid at-home COVID-19 test plans to open its first U.S. production plant in Maryland later this year.
Ellume plans to announce today that it will make the test kits in Ballenger Creek, just south of Frederick, and eventually employ 1,500 people to make up to 19 million test kits a month.
The facility is part of the federal government’s effort to boost infrastructure and supplies during this pandemic and prepare for future pandemics. To that end, the U.S. Departments of Defense and Health and Human Services said they would provide Ellume with $231.8 million to accelerate production of the tests, which also could be adapted in future outbreaks.
Company officials believe demand will be ongoing for COVID-19 tests and consumers will look for convenience of a home test rather than going to a public testing site or a doctor’s office.
They expect demand will remain, though the level of testing has been declining somewhat as more people are vaccinated and infections drop. There have been around a million or fewer tests daily nationwide in May, compared with close to 2 million during the winter surge, but there are still tens of thousands of cases being reported daily.
“There will be a need for continuous testing to identify cases in the community, before you travel or go back to work or school,” said Dan Mallon, Ellume’s vice president of business development.
“We’re thrilled to see vaccination rates going up, but we won’t reach herd immunity anytime soon,” he said. “Our feeling is that we want a product that is easy to use, one test with one result, and accessible to consumers for the long haul.”
Testing for COVID-19 ramped up slowly at the start of the pandemic last year after the U.S. Centers for Disease Control and Prevention introduced a flawed test. Only people with symptoms in hospitals were tested initially for the disease caused by the coronavirus.
Since then testing has expanded widely with availability of standard PCR tests used at the Maryland testing sites and rapid antigen tests like Ellume’s that could give results in 15-30 minutes.
Ellume was given emergency authorization to sell its tests in December and now produces about 100,000 a month in Australia. Mallon said some businesses and schools are already using the tests and consumers are beginning to buy them. The retail giant CVS said recently that it would sell them online and in limited stores in the Northeast to start.
As part of the federal investment, the U.S. government will receive about 8.5 million of the tests this year.
“The ability to quickly test, to contact trace and quarantine is the linchpin of our national strategy and will be a vital part of containing the virus and stopping community spread,” said Andy Slavitt, senior adviser to the White House COVID-19 Response Team, at the Feb. 1 announcement of the federal funding.
As testing continues, officials look to see that the so-called testing positivity rate, which gauges how well a community is identifying infections, is below 5%. The national rate is now below that threshold, though it exceeded 13% at the mid-January case peak, according to data collected by the Johns Hopkins University.
Maryland has been reporting between 10,000 and 40,000 tests a day in recent weeks, and the positivity rate has been below 5% for two weeks.
Dr. Jinlene Chan, the state’s deputy secretary of public health services, said the public will continue to need testing. She cited CDC guidance that directs anyone with symptoms, whether vaccinated or not, to get tested.
“As we’ve vaccinated more people, of course, they might not be tested as frequently as people who are unvaccinated,” Chan said. “However, people who have symptoms absolutely should get tested. Period.”
The most accurate tests had been considered the PCR tests, which are conducted in a lab and typically take a day or so. The U.S. Food and Drug Administration initially authorized a battery of rapid antigen tests that were fast but had high rates of false positives and negatives.
Data shows the Ellume test’s accuracy exceeds 90% even when people don’t have symptoms. It was the first at-home rapid test that didn’t need a doctor’s order given emergency authorization, and the company plans to submit further data to be fully approved soon.
Officials said they don’t have data yet on the accuracy of the tests with prevalent coronavirus variants.
Having the capacity to make appropriate tests will be key to identifying and containing outbreaks during this pandemic and the next, officials said.
“We will continue to have hotspots of transmission as well as cases imported from other countries,” said Dr. William Moss, an infectious disease expert and executive director of the Johns Hopkins Bloomberg School of Public Health’s International Vaccine Access Center. “Our best strategy to identify these focal areas of transmission and stop them is through testing, followed by isolation and quarantine of close contacts.”
With Ellume’s tests only recently available to consumers, the level of demand is unclear. The test requires users to download an app on a smartphone that wirelessly analyzes a sample taken from a nose swab, mixed with a liquid medium and dropped on a stick.
It costs about $30, while tests conducted at public testing sites are currently free. Abbott also offers a rapid at-home COVID test that costs somewhat less but requires two tests over a few days.
The facility where the tests will be made, in a development called Progress Labs at Center 85, will not be far from federal health and defense agencies that for now are the biggest customers, as well as other life sciences companies. Mallon also noted the large pool of biotech workers in the region.
Karen Glenn Hood, a spokeswoman for the Maryland Department of Commerce, said the agency still is working on what incentives the state will provide, but she said Ellume is eligible for assistance that could include a loan contingent on job creation and capital investment.
“It is outstanding news that Ellume has chosen Maryland for this significant expansion and will create more than 1,500 new life sciences jobs in our state at a time when they are needed the most,” Maryland Gov. Larry Hogan said in a statement.
Frederick County also approved the project for fast-track permitting and could provide tax credits.
“This is great news for Frederick County,” Frederick County Executive Jan Gardner said in a statement. “Ellume is on the cutting edge, making products that will help the world to overcome this health pandemic. We are excited to welcome Ellume to our thriving life science and biopharma family.”