Australian diagnostics test maker Ellume will lease two buildings in Frederick, Maryland, for its first U.S.-based manufacturing operations, and will create 1,500 jobs by the end of 2022.
Ellume’s at-home COVID-19 test was the first rapid self-test approved by the U.S. Food and Drug Administration.
Ellume signed a $231.8 million agreement in February with the U.S. Department of Defense in coordination with the U.S. Department of Health and Human Services to accelerate production of its COVID-19 home tests and to support ongoing pandemic preparation and response.
“We look forward to building the foundation for Ellume’s long-term vision in the U.S. and recruiting the highly skilled talent in Maryland’s Biotech Corridor needed to fuel our flagship U.S. facility,” said Ellume U.S. president Jeff Boyle.
“The facility will serve as a foundation for Ellume to support the domestic response to the COVID-19 pandemic and better prepare the U.S. for future public health crises.”
Ellume makes a number of digital diagnostic tests for infectious diseases. It has a consumer health partnership with GlaxoSmithKline and a COVID-19 and tuberculosis partnership with QIAGEN.
The company’s at-home rapid COVID-19 test transmits sample results to an app, which returns the results.
Ellume expects its Frederick manufacturing operations, in two buildings totaling almost 200,000 square feet, will be operational in the second half of 2021.
It is actively recruiting for the jobs available, including highly-skilled engineering and science positions. Once fully operational, it will have the capacity to produce 19 million COVID-10 home tests per month.
Ellume’s existing production facility in Brisbane, Australia, is currently supplying COVD-19 home tests through a partnership with the U.S. National Institutes of Health. Its kits also are sold at retailers, including CVS Health.
Even with more Americans being vaccinated against COVID-19, Ellume said testing will remain important.
“As the vaccination rate rise in the U.S., COVID-19 testing remains a vital tool in our response to the pandemic. Routine testing is essential for monitoring hot spots and emerging variants and is the key to protecting vulnerable communities,” said Ellume founder and CEO Sean Parsons.