Submission of CLIA Waiver Application for FebriDx®
18 August 2025
Lumos Diagnostics has announced the completion of the clinical study and submission of its application to the U.S. Food and Drug Administration (FDA) for Clinical Laboratory Improvement Amendments (CLIA) waiver classification for FebriDx®.
The clinical study - which aimed to demonstrate the simplicity and ease of use of the FebriDx® device in the hands of untrained users - exceeded performance targets, demonstrating a 99.1% concordance between trained and untrained operators testing bacterial positive patients, and a 98.4% concordance for non-bacterial patients.
The study was supported by funding from the Biomedical Advanced Research and Development Authority (BARDA), and Lumos expects to receive combined milestones payments of US$1,253,520 shortly from BARDA. A final milestone payment of $507,377 will be triggered if the FebriDx CLIA waiver is granted.
The CLIA waiver application submission also marks the achievement of a key milestone under the distribution agreement with PHASE Scientific, triggering a US$1,500,000 FebriDx product purchase prepayment to Lumos.
Lumos CEO, Doug Ward, said:
“We are very pleased with the successful results of our CLIA waiver study for FebriDx® and the timely submission of our application to the FDA. This milestone represents the culmination of significant effort from the Lumos team and our partners. I’d like to extend our sincere thanks to BARDA for their substantial support in helping us achieve this outcome.”
“We look forward to receiving the FDA’s findings, which we expect to receive in the first quarter of the 2026 calendar year. The anticipated granting of CLIA waiver will expand our U.S. addressable market by around 15 times to over US$1.0 billion.”
Click to read the ASX release
The clinical study - which aimed to demonstrate the simplicity and ease of use of the FebriDx® device in the hands of untrained users - exceeded performance targets, demonstrating a 99.1% concordance between trained and untrained operators testing bacterial positive patients, and a 98.4% concordance for non-bacterial patients.
The study was supported by funding from the Biomedical Advanced Research and Development Authority (BARDA), and Lumos expects to receive combined milestones payments of US$1,253,520 shortly from BARDA. A final milestone payment of $507,377 will be triggered if the FebriDx CLIA waiver is granted.
The CLIA waiver application submission also marks the achievement of a key milestone under the distribution agreement with PHASE Scientific, triggering a US$1,500,000 FebriDx product purchase prepayment to Lumos.
Lumos CEO, Doug Ward, said:
“We are very pleased with the successful results of our CLIA waiver study for FebriDx® and the timely submission of our application to the FDA. This milestone represents the culmination of significant effort from the Lumos team and our partners. I’d like to extend our sincere thanks to BARDA for their substantial support in helping us achieve this outcome.”
“We look forward to receiving the FDA’s findings, which we expect to receive in the first quarter of the 2026 calendar year. The anticipated granting of CLIA waiver will expand our U.S. addressable market by around 15 times to over US$1.0 billion.”
Click to read the ASX release
