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.

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.

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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.

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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.

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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.

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We develop, manufacture, and commercialize the next generation of digitally enabled diagnostic products for healthcare professionals and consumers.

COVID-19 Response

Rapid diagnostic products in response to the COVID-19 pandemic.

Consumer Products

Self-performed tests that provide accurate, rapid results directly onto the user’s smartphone.

Professional Products

Products designed to support healthcare professionals and laboratories.

Global Public Health Solutions

Pandemic diagnostic products to support the response to global health crises.

Company News

Media

Channel 10’s new Advancing Australia series features Ellume CEO Dr Sean Parsons

Ellume
June 12, 2021

Corporate Announcement

Ellume establishes flagship U.S. manufacturing facility in Maryland

Ellume
May 10, 2021

Media

More at-home COVID tests coming to the market, and made in Maryland

Ellume
May 10, 2021

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A culture of excellence

We are proud of the recognition we have received for our ongoing contributions to the development of innovative emerging technology for the benefit of humanity.

*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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