Ellume establishes flagship U.S. manufacturing facility in Maryland Industry veterans Jeff Boyle, PhD and Dan Mallon will lead Ellume’s U.S. team to support the company’s rapid growth. Learn more Ellume COVID-19 Home Test now available at selected CVS Pharmacies The first rapid, fully at-home test to receive Emergency Use Authorization by the FDA for at-home use without a prescription, is now available in CVS Pharmacies in select locations across the United States. Learn more US-Government-Agreement US-Government-Agreement Ellume Announces
US$231.8 Million Agreement
with the U.S. Government
Biden Administration makes major investment to increase availability and scale-up U.S. production of Ellume COVID-19 Home Tests.
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FDA authorizes* Ellume COVID-19 Home Test for over-the-counter use Proven performance in adults and children, with and without symptoms, with results in 15 minutes. Learn more Responding to the COVID-19 global pandemic Ellume is developing next generation diagnostic products to address the current COVID-19 healthcare burden on our global community. Learn more Global partnership with QIAGEN for COVID-19 diagnosis Ellume has partnered with global diagnostics company QIAGEN to bring fast, reliable COVID-19 tests to market, addressing the global demand for rapid diagnostic tests. Learn more

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*The Ellume COVID-19 Home Test has not been FDA cleared or approved; but has been authorized by the FDA under an emergency use authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and 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 Cosmetics Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.


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