September 10, 2025- Lumos Diagnostics 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.
For additional details, please contact MedPro Associates at https://www.mproassociates.com/, manufacturer partner of Lumos Diagnostics.