September 23, 2025- Lumos Diagnostics has announced that the Biomedical Advanced Research and Development Authority (BARDA) has awarded US$6.2 million in non-dilutive funding to support a new U.S. paediatric study of its flagship FebriDx® test. This study will evaluate the use of FebriDx® in children aged 2–12 years across CLIA-waived settings. Commencing in Q3 CY2025, it will form the basis of a dual 510(k)/CLIA waiver submission.
If granted, CLIA waiver expansion could increase Lumos Diagnostic’s U.S. total addressable market more than fifteen-fold to over US$1 billion, providing access to 270,000 clinical sites and covering 80 million annual acute respiratory consultations.
“We greatly appreciate BARDA’s continued support—both in the recently completed CLIA waiver study and now in advancing this important paediatric study. We look forward to working closely with BARDA once again to deliver this study and further expand the accessibility of FebriDx® to paediatric patients across the United States,” said Lumos Diagnostics CEO Doug Ward.
For additional details, please contact MedPro Associates at https://www.mproassociates.com/, manufacturer partner of Lumos Diagnostics.