Ellume officially opens production facility in Frederick, Maryland
Digital diagnostics company Ellume, a producer of at-home COVID-19 test kits, today officially opened its new, 215,000 square foot production facility in Frederick, Maryland. Joined by Maryland Governor Larry Hogan, Ellume Founder and Chief Executive Officer Dr. Sean Parsons inaugurated the new facility, which has the capacity to produce approximately 15 million COVID-19 Home Tests per month and will create hundreds of new jobs.
"From the very onset of the COVID-19 pandemic, Ellume has been committed to supporting the U.S. government's response. With this new facility, we now have the capacity to substantially scale production to meet any future surge in demand for home tests, while also accelerating innovation in developing solutions for the public health needs of today and tomorrow," said Dr. Sean Parsons, Ellume Founder and CEO. "We are grateful for the support of the US Department of Defense, US Department of Health and Human Services, our partnerships with the State of Maryland, the Governor's office and Frederick County, as well as the highly skilled workforce in Maryland's Biotech Corridor who have helped make this facility a reality."
"Maryland truly is open for business, and we are seeing further proof of that here today as Ellume, a respected, global digital diagnostics company opens its very first U.S.-based facility right here in Frederick County," said Governor Larry Hogan. "I want to congratulate the entire team at Ellume, and thank you for investing in the future of our state and helping to build on the already strong mateship between our two great nations."
"The pandemic and the economic disruptions it has caused underscore the need to improve our supply chains and make more in America – especially critical medical equipment," said Senator Chris Van Hollen. "With a federal investment of more than $230 million, Ellume is joining us in our efforts to bring more American manufacturing jobs to our state as they produce the tests we need to stay on top of the ongoing fight against COVID-19. This investment in Western Maryland will strengthen the region and its economy."
"I am delighted to welcome Ellume's flagship facility to Frederick County," said Congressman Jamie Raskin. "Keeping the COVID-19 pandemic at bay requires sustained investment in our public health infrastructure. I am proud that Maryland's Eighth District continues to serve as an economic and public health engine for our nation."
Ellume's COVID-19 Home Test, the first over-the-counter (OTC) rapid antigen test to receive emergency use authorization from the U.S. Food and Drug Administration, is a best-in-class product that Americans count on to keep their families safe. One of the most reliable at-home antigen tests on the market, it is also the only at-home antigen test to use fluorescent detection technology – usually reserved for healthcare professionals and clinical laboratories – and one of the only tests to incorporate sample quality controls to support accurate results. Ellume COVID-19 Home Tests are currently available through a variety of major retailers and in partnership with Federal and local governments.
Test assembly operations were initiated at the Frederick facility in February 2022. The facility will initially bring 200 jobs to the community and up to 1,500 when operating at full capacity.
An innovator in infectious disease digital diagnostics and global health preparedness, Ellume continues to work with the U.S. government to respond to COVID-19 and prepare for and mitigate future pandemics.
About EllumeEllume 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 COVID-19 and 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.
For further information visit ellumehealth.com.
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In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under an EUA. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.