Lumos commences FebriDx® CLIA waived pediatric study
22 October 2025
Lumos has commenced its FebriDx® CLIA-waiver pediatric study in the United States, with the first patient successfully enrolled.
The study will assess the use of the FebriDx device in children aged 2 to 12 years within CLIA-waived settings. It will be conducted across 20 clinical sites in the US. Between 500 and 800 patients are expected to be enrolled to achieve the required number of bacterial cases. The study is expected to run for approximately 12 months, following which a formal submission will be prepared for the FDA.
A successful outcome will support the expansion of FebriDx’s use as a diagnostic tool for differentiating bacterial from non-bacterial acute respiratory infections in the US, broadening its patient usage from ages 12 - 64 to 2 - 64 years.
Doug Ward, CEO of Lumos Diagnostics, said:
“The commencement of this study marks an important milestone for FebriDx and our commitment to aiding healthcare professionals in improving infection diagnosis in children. A successful outcome would represent a significant step forward in helping healthcare professionals quickly and confidently differentiate bacterial and non-bacterial acute respiratory infections in children aged 2 to 12 years, supporting better treatment decisions and antibiotic stewardship.”
Click to read the ASX release.
The study will assess the use of the FebriDx device in children aged 2 to 12 years within CLIA-waived settings. It will be conducted across 20 clinical sites in the US. Between 500 and 800 patients are expected to be enrolled to achieve the required number of bacterial cases. The study is expected to run for approximately 12 months, following which a formal submission will be prepared for the FDA.
A successful outcome will support the expansion of FebriDx’s use as a diagnostic tool for differentiating bacterial from non-bacterial acute respiratory infections in the US, broadening its patient usage from ages 12 - 64 to 2 - 64 years.
Doug Ward, CEO of Lumos Diagnostics, said:
“The commencement of this study marks an important milestone for FebriDx and our commitment to aiding healthcare professionals in improving infection diagnosis in children. A successful outcome would represent a significant step forward in helping healthcare professionals quickly and confidently differentiate bacterial and non-bacterial acute respiratory infections in children aged 2 to 12 years, supporting better treatment decisions and antibiotic stewardship.”
Click to read the ASX release.
