US government agency backs accelerated development of Ellume diagnostic

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Brisbane-based rapid digital diagnostics company Ellume has announced it has been awarded US$30million from the US National Institutes of Health (NIH) to support the accelerated clinical testing and manufacturing scale-up of the company’s COVID-19 antigen tests.

The funding has been awarded under the NIH Rapid Acceleration of Diagnostics (RADx) initiative.

Ellume said its 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.

It said this funding for the at-home test is the result of early feasibility studies conducted by the NIH RADx initiative.

“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 of Ellume. “We are working intensely to expand access to fast, accurate and affordable testing for use in communities across the US, and this funding enables significant acceleration of our efforts.”

Ellume’s at-home COVID-19 test enables the average and untrained consumer to rapidly detect the virus 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 said it has made this digitisation inexpensive and practical, opening many avenues for treatment and disease control.

The company said it has adapted the same technology to create 'ellume·lab'. It is a digital diagnostic device for healthcare professionals. It was designed for point-of-care testing in medical clinics, pharmacies and in-field use.

Is said that once authorised by the FDA, ellume·lab will launch in the US as one of the first point-of-care, rapid, immunoassay-based testing platforms offering both a COVID serology test (for recent or past infections) and a COVID antigen test (for active infections) on the same device.

Ellume said a high-throughput version of the ellume·lab antigen test is also in development. It will come to the US 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.