Corporate Announcement Archives

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 establishes state-of-the-art diagnostic manufacturing facility in Frederick, Maryland, which is on track to begin limited operation in second half 2021; The facility was funded by a $231.8 million agreement with the U.S. Department of Defense […]

Over-the-counter COVID-19 testing now available at CVS Pharmacy

Retailer expands access to convenient, at-home testing options with new-to-market, home tests available in stores and online. WOONSOCKET, R.I., Monday, April 19, 2021 — CVS Pharmacy, the retail division of CVS Health (NYSE: CVS), today announced the availability of three over-the-counter COVID-19 testing options in stores and online. The tests include the Ellume COVID-19 Home Test, […]

Ellume and Cambridge Consultants Collaborate on Core Technology Behind Ellume’s Rapid Antigen COVID-19 Test

Cambridge Consultants developed the ground-breaking optics technology powering Ellume’s FDA authorized COVID-19 Home Test CAMBRIDGE, United Kingdom and BRISBANE, Australia, March 10, 2021 Today, digital diagnostics company Ellume highlights the revolutionary technology created in partnership with global product development and technology consultancy firm, Cambridge Consultants, part of the Capgemini Group. Together, the two companies have […]

Ellume Announces $231.8 Million Agreement with the U.S. Government

The contract includes the delivery of 8.5 million Ellume COVID-19 Home Tests to support the U.S. Government’s pandemic response The investment will support the establishment of Ellume’s first U.S. manufacturing facility, increasing Ellume’s global production capacity by 500,000+ tests per day once completed; The investment extends Ellume’s engagement with the U.S. government following the NIH […]

FDA authorizes Ellume COVID-19 Home Test as First Over-the-Counter Fully At-Home Diagnostic Test

Proven performance in adults and children, with and without symptoms Highlights FDA grants Emergency Use Authorization for Ellume COVID-19 Home Test for non-prescription home use in symptomatic and asymptomatic individuals The test demonstrated 96% accuracy in a multi-site US clinical study of both adults and children 2 years and above Ellume is ramping up manufacture, […]

Ellume’s COVID-19 Home Test shows 96% accuracy in multi-site US clinical study

Highlights Ellume submits Emergency Use Authorization to the U.S. Food and Drug Administration for the Ellume COVID-19 home test Clinical study demonstrated overall sensitivity of 95% and specificity of 97% Clinically validated for use in symptomatic and asymptomatic users ages 2 years and above Independently run, simulated home-use clinical study of 198 subjects Ellume is […]

Ellume awarded US$30M from US National Institutes of Health RADx initiative to accelerate development of rapid COVID-19 diagnostics

Brisbane, Australia — 7 October 2020 Ellume, a leader in rapid digital diagnostics, today announced it was successfully awarded US$30million from the U.S. National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative to accelerate the clinical testing and manufacturing scale-up of the company’s COVID-19 antigen tests. Ellume’s core fluorescent immunoassay platform has been […]

Ellume announces high-performance test for active COVID-19 infection

Highlights New high-performance antigen test for active COVID-19 infection, developed by Ellume, provides accurate results in less than 15 minutes Builds on existing QIAGEN partnership to bring another test to market to join the rapid, reliable COVID antibody test as announced last month Easy to use; each device can process over 30 samples per hour, […]

Ellume announces global partnership with QIAGEN for COVID-19 diagnosis

Highlights Ellume builds on existing partnership with global diagnostics company QIAGEN, to bring a rapid, reliable COVID antibody test to market QIAreach™ Anti-SARS-CoV-2 Total serology test has been submitted for US FDA Emergency Use Authorization 900,000 tests pre-ordered Brisbane, Australia – 25 August 2020 Digital diagnostics firm Ellume Ltd (Ellume or “the Company”) has extended […]

Ellume appoints Joanne Moss to its Board as Non-executive Director

Brisbane, Australia – 12 November 2019 Ellume Limited (Ellume) is pleased to announce the appointment of Ms Joanne Moss to its Board as an Independent Non-Executive Director and Chair of Audit and Risk, effective immediately. This appointment supports Ellume’s commitment to good governance and strengthens management resources in preparation for US commercialisation and potential upcoming […]

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