More about Ellume.
Below is a summary of Ellume's journey; for a more comprehensive and independent case study, refer to the NIH PubMed Central database.
Ellume was founded in 2010 by Dr Sean Parsons, who recognised during the 2009 H1N1 pandemic the need for faster diagnostic testing outside healthcare facilities. The company developed pioneering fluorescent immunoassay technology combining ultra-sensitive optics, quantum dot nanoparticles, and smartphone connectivity to deliver highly accurate results in 15 minutes.
The company also created design-award winning ellume·lab, a versatile handheld digital platform for healthcare professionals that offered rapid diagnostic tests for multiple infectious diseases including influenza, COVID-19, and Strep Throat. Beyond diagnostics, ellume·lab provided practitioners with a suite of digital tools to support clinical decision-making and enhance patient engagement, including medical calculators, patient education resources, and secure cloud connectivity for sharing results.
Partnerships
Ellume established strategic partnerships with global pharmaceutical and diagnostics leaders to expand its technology reach. In December 2018, the company partnered with GlaxoSmithKline (GSK) to develop and distribute a home flu test for the consumer market.
In January 2019, Ellume partnered with QIAGEN N.V., securing a US$15 million investment to develop the QIAreach QuantiFERON-TB tuberculosis test. The portable, battery-operated device was designed for low-resource countries, delivering results in three minutes without cold chain requirements. It received approval for use in over 100 countries in January 2022.
Rise During COVID-19
Ellume achieved a historic milestone in December 2020 when its COVID-19 Home Test became the first FDA-authorized fully at-home diagnostic test available over-the-counter. Under the leadership of Chief Marketing Officer Mirja Moenninghoff, Ellume prioritised user-centric design throughout all product development. This commitment earned the company the prestigious 2020 Patron's Australian Design Award, with judges praising its "very strong design approach that combines user-centred research with clinical innovation".
The US government provided US$231.8 million to establish domestic manufacturing, enabling Ellume to expand from 100,000 tests daily in Brisbane to a new 215,000 square-foot Maryland facility opened in April 2022.
Collapse of the home diagnostics sector
The commercial market for Home Tests in the US collapsed when the US government announced 500 million free rapid tests in January 2022. This resulted in widespread commercial difficulties and ultimately failures: Cue Health (valued at US$2.3 billion) filed for bankruptcy in May 2024; Lucira Health collapsed in February 2023 and was was acquired by Pfizer for just 6% of its IPO valuation before Pfizer closed the division in March 2025; LumiraDx entered liquidation in June 2024.
Despite its market lead, Ellume also faced insurmountable challenges. The FDA's relaxed EUA framework eliminated costly requirements Ellume had incorporated under its earlier de novo 510(k) pathway—including digital result reporting, non-visual interpretation, laboratory-grade detection limits, and sample integrity controls. This placed Ellume at a substantial cost disadvantage against visually-read competitors using simpler EUA standards.
Ellume entered voluntary administration in August 2022 and was ultimately liquidated in June 2023.
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