Ellume Secures $30M from National Institutes of Health RADx Initiative to Accelerate Development of Rapid COVID-19 Diagnostics

The company will launch three rapid COVID-19 testing products in the U.S.


VALENCIA, Calif., Oct. 06, 2020 (GLOBE NEWSWIRE) -- Ellume, the company reimagining digital diagnostics, today announced a $30 million Phase 2 award from the U.S. National Institutes of Health (NIH)’s Rapid Acceleration of Diagnostics (RADx) initiative to accelerate the clinical testing and manufacturing of three COVID-19 antigen tests.

The RADx initiative rigorously reviews and selects innovative, highly accurate diagnostic technologies to move quickly through the development pipeline toward commercialization and broad availability.

Ellume’s breakthrough fluorescent immunoassay technology was deployed to create three distinct COVID-19 antigen tests, suited for at-home, point-of-care and high-throughput laboratory settings, each capable of delivering results in less than 15 minutes. This funding underscores Ellume’s successful completion of Phase 1 RADx milestones and feasibility studies, and validates their development of a high sensitivity detection system for COVID-19.

“We are pleased to receive this funding through the NIH RADx initiative to continue the rapid scaling up of our unique technology during this critical time of need,” said Dr. Sean Parsons, founder and CEO, Ellume. “We are working intensely to expand access to fast, accurate and affordable testing for use in communities across the U.S., and this funding enables significant acceleration of our efforts.”

Ellume’s at-home test enables the average consumer to rapidly detect COVID-19 from the comfort and security of their home. The test uses a Bluetooth®-connected analyzer in conjunction with the user’s smartphone to digitally analyze a self-collected nasal sample. By design, the test virtually eliminates false readings from human error and results are transmitted through the user’s smartphone, together with a digital certificate of the results. Through a secure cloud connection, Ellume’s tests can provide real time reporting of positive test results for efficient contact tracing. Ellume has made this digitization inexpensive and practical, opening many avenues for treatment and disease control.

In parallel, Ellume has adapted the same core technology to support health professionals. The ellume·lab product was designed for point-of-care testing in medical clinics, pharmacies, and in-field use. Once authorized by the FDA, ellume·lab will be one of the first immunoassay-based point-of-care platforms offering rapid COVID-19 serology and antigen tests on the same device. Ellume is also bringing a high-throughput version of the ellume·lab test to the U.S. in partnership with QIAGEN, enabling mass rapid testing in settings like airports, stadiums, and church gatherings.

Ellume’s new manufacturing facility in Brisbane, Australia will begin production in the coming weeks, and tests will launch in the U.S. upon receiving FDA Emergency Use Authorization.

This project has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health. The current contract is funded from the Public Health and Social Services Emergency Fund through the Biomedical Advanced Research and Development Authority, HHS Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services.

About Ellume
Ellume is an Australian-based digital diagnostics company that develops, manufactures and commercializes high-performance, connected products for health professionals and consumers. Our focus is on the detection of common illnesses which affect the global population and our products differ from conventional diagnostics through performance, digital connectivity, actionability and simplicity. Ellume has developed novel detection technology powered by our unique quantum dot nanoparticle, which integrates optics, electronics, biologics and software into an intuitive and high-performance digital platform. Ellume has a global partnership in consumer health with GlaxoSmithKline, a global partnership with QIAGEN in latent tuberculosis, and a range of professional products under the ellume·lab brand which are scheduled for U.S. launch in 2020. Further information can be found at www.ellumehealth.com   

About National Institutes of Health
The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services is the nation’s medical research agency. NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.

About the Rapid Acceleration of Diagnostics (RADx) Initiative
The National Institutes of Health (NIH) launched the Rapid Acceleration of Diagnostics (RADx) initiative to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. Accurate, fast, easy-to-use, and widely accessible testing is required before the nation can safely return to normal life. For further information please follow the FAQs link: https://www.nibib.nih.gov/radx-initiative-covid-19-testing/FAQ

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