Digital diagnostics company Ellume announced its first US manufacturing facility in Frederick, Maryland to support the domestic response to COVID-19 and other infectious diseases. Once fully operational, the facility will have the capacity to produce 19 million COVID-19 Home Tests per month.
Earlier this year, the facility was funded by a $231.8 million agreement with the US Department of Defence (DOD) and Department of Health and Human Services (HHS) to accelerate production of the Home Tests. The goal is to establish a sustainable diagnostic supply chain for future pandemics.
The Ellume COVID-19 Home Test was the first rapid COVID-19 self-test to be granted Emergency Use Authorisation by the U.S. Food and Drug Administration (FDA) for asymptomatic and symptomatic use without a prescription.
Ellume will provide 8.5 million COVID-19 home tests to the US government by the end of 2021, with production commencing in the second half of the year.
Developed by Matan Progress Labs, the new facilities build on Ellume’s manufacturing facility in Brisbane, Australia, which has already been supplying the home tests for use in the U.S. In partnership with U.S. National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative, Ellume continues to increase production capacity to meet demands.
Ellume founder and CEO Dr Sean Parsons said as the vaccination rate rises in the US, COVID-19 testing remains a vital tool in response to the pandemic.
“Routine testing is essential for monitoring hotspots and emerging variants and is the key to protecting vulnerable communities by empowering individuals with insight into their COVID-19 status,” he said.
“This new facility will help to ensure our COVID-19 home tests are mobilised quickly at scale and establishes an ongoing domestic source of diagnostics for potential future outbreaks.”
Located near Washington D.C. and internationally recognised academic teaching hospitals and leading experts in healthcare and public health, the new facility will create 1,500 new jobs in the region including technical roles in engineering and science.
Leading the team is Ellume’s U.S. president Jeff Boyle: “I’m thrilled to lead the development and growth of Ellume’s U.S. team and to recruit the highly skilled talent needed to fuel our flagship U.S. facility. This facility will serve as a foundation for Ellume’s vision to both support the domestic response to the current COVID-19 pandemic and better prepare the US for future public health crises.”
Ellume’s vice president for business development and alliance management Dan Mallon said Ellume is bringing its digital diagnostics technology to the US consumer to support the nation’s COVID-19 recovery.
“We will continue to work closely with the U.S. government, as well as retailers and corporate institutions, to mobilise Ellume COVID-19 Home Tests quickly and identify opportunities for long-term diagnostic partnerships,” Mallon said.
The company has also developed a range of diagnostic products for other common infectious diseases including influenza and latent tuberculosis. In the long term the facility will be used to ensure a rapid, scalable response to any future large-scale public health crises.