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

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 deployed to create three high-performance COVID-19 antigen tests for at-home, point-of-care and high-throughput diagnostic settings, all capable of delivering results in less than 15 minutes. This funding for the at-home test is the result of early feasibility studies conducted by the NIH RADx initiative, and ultimately, the successful development and verification 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 scale- 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.”

Supported under this program is Ellume’s at-home COVID-19 test, which enables the average, untrained consumer to rapidly detect COVID-19 from the comfort and security of their home. The test uses a Bluetooth®-connected analyser in conjunction with the user’s smartphone to digitally analyse a self-collected sample from the user’s nasal passage. 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 digitisation inexpensive and practical, opening many avenues for treatment and disease control.

Ellume has adapted the same technology to create ellume·lab, a digital diagnostic device for healthcare professionals. ellume·lab was designed for point-of-care testing in medical clinics, pharmacies, and in-field use. Once authorized by the FDA, ellume·lab will launch in the U.S. as one of the first point-of-care, rapid, immunoassay-based testing platform offering both a COVID serology test (for recent or past infections) and a COVID antigen test (for active infections) on the same device. A high-throughput version of the ellume·lab antigen test is also in development, coming to the U.S. market in partnership with QIAGEN. This product will enable high-throughput rapid testing in airports, stadiums, church gatherings, and other mass screening settings.

Ellume’s new manufacturing facility in Richlands, Brisbane, will be producing tests in coming weeks.

Timing of the U.S. launch will depend on the speed of 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, under Contract No. 75N92020C00034. Ellume acknowledges the great assistance of the NIH in making practical COVID-19 rapid testing an effective reality.

ENDS