Ellume establishes flagship U.S. manufacturing facility in Maryland
Digital diagnostics company Ellume today announced it has established its first U.S. 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 Ellume COVID-19 Home Tests per month.
The Ellume COVID-19 Home Test was the first rapid COVID-19 self-test to be granted Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) for both asymptomatic and symptomatic use without a prescription. In February, Ellume announced a $231.8 million agreement with the U.S. Department of Defense (DOD) and Department of Health and Human Services (HHS) to accelerate production of its COVID-19 home tests. The agreement provided funding to support the establishment of Ellume’s first U.S. manufacturing facility, with the goal of building a sustainable domestic supply chain to better respond to future pandemics. As part of this agreement, Ellume will provide 8.5 million COVID-19 home tests to the U.S. Government by end-of-year.
Ellume’s U.S. operation will include two state-of-the-art manufacturing facilities totaling more than 180,000 square feet, developed by Matan Progress Labs. The facilities will begin limited production of Ellume’s COVID-19 Home Tests in the second half of 2021, and scale-up production capacity through the remainder of the year.
The new U.S.-based facilities build upon Ellume’s existing state-of-the-art manufacturing facility in Brisbane, Australia, which is already supplying COVID-19 Home Tests for use throughout the U.S. In partnership with U.S. National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative, Ellume continues to increase its production capacity to meet demands of its consumer retail partners like CVS, as well as additional corporate employers and educational institutions.
“As the vaccination rate rises in the U.S., COVID-19 testing remains a vital tool in our 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,” said Dr. Sean Parsons, Ellume founder and CEO. “This new facility will help to ensure our COVID-19 home tests are mobilized quickly at scale and also establishes an ongoing domestic source of diagnostics for potential future outbreaks.”
The Frederick, Maryland campus was chosen for its proximity to Washington, D.C., and supports the company’s continued engagement with the DOD, HHS, FDA, NIH and other departments of the U.S. Government. The location is ideally situated close to internationally recognized academic teaching hospitals and leading experts in healthcare and public health and boasts a strong talent pool to support Ellume’s growth. The company is actively recruiting for 1,500 new positions in the region, including highly skilled technical roles in engineering and science, and is working in close partnership with the Frederick County Office of Economic Development and the Maryland Department of Commerce.
To support Ellume’s long-term growth and partnerships in the U.S., two industry veterans have joined the company’s Maryland-based team:
Jeff Boyle, PhD, will serve as the company’s first U.S. President, overseeing all domestic business operations. Boyle brings more than 25 years of senior research, development, and technical expertise, including more than a decade in Senior Director and Global Franchise Lead roles at leading global infectious disease diagnostics company QIAGEN.
“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 U.S. for future public health crises,” said Boyle.
Dan Mallon has joined Ellume as the company’s Vice President of Business Development and Alliance Management. Mallon brings more than 20 years of corporate development experience, including senior positions at Emergent BioSolutions and Gene Logic. Most recently, he served as Vice President of Business Development for biopharmaceutical product development company, RRD International.
“Ellume is embarking on a transformation to its business in support of the U.S. response to COVID-19 by bringing its digital diagnostics technology to the U.S. consumer. We will continue to work closely with the U.S. Government, as well as retailers and corporate institutions, to mobilize Ellume COVID-19 home tests quickly and identify opportunities for long-term diagnostic partnerships,” said Mallon.
In addition to the Ellume COVID-19 Home Test, the company has developed a range of diagnostic products for use by healthcare professionals and consumers, for other common infectious diseases including influenza and latent tuberculosis. In the longer term, the facility will be used to enable a rapid, scalable response to the next public health crisis, supporting the U.S. to prepare for future large-scale outbreaks and pandemics.
Ellume is a digital diagnostics company that develops, manufactures, and commercializes high-performance, connected products for healthcare professionals and consumers. It is at the forefront of accurate, rapid and accessible testing that is integral to today’s COVID-19 response and will help ensure the world is prepared for the next infectious disease pandemic. Ellume’s key focus is on the detection of common infectious diseases which affect the global population across all diagnostic settings; at-home, point-of-care and in-laboratory. Ellume has a global consumer health partnership with GlaxoSmithKline, a global COVID-19 and latent TB partnership with QIAGEN, and a range of professional products under its ellume·lab brand. Ellume is committed to developing high-quality digital diagnostics that the world can rely on in a health crisis.
Further information can be found at ellumehealth.com.
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