FDA Authorization 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 COVID-19 Home Test COVID-19 Home Test shows 96% accuracy in US clinical study Our over-the-counter, rapid self-test detects SARS-CoV-2 antigen with results in 15 minutes. The test is suitable for ages 2+ years for symptomatic and asymptomatic use. Learn more QLD Government Investment QLD Government boost for COVID-19 manufacturing Ellume receives strategic investment from Queensland State Government to enable advanced manufacturing scale-up of its rapid diagnostic tests. Learn more COVID-19 Response 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 Global partnership with QIAGEN for COVID-19 diagnosis Ellume has partnered with global diagnostics company QIAGEN to bring fast, reliable COVID tests to market, addressing the global demand for rapid diagnostic tests. Learn more

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COVID-19 Response

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

Self-performed tests that provide accurate, rapid results directly onto the user’s smartphone.
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Products designed to support healthcare professionals and laboratories.
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Global Public Health Solutions

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

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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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