Lumos Diagnostics secures US$2,984,571 BARDA funding for FebriDx CLIA waiver study

Lumos Diagnostics (ASX:LDX) has been awarded US$2,984,571 in non-dilutive funding from the Biomedical Advanced Research and Development Authority (BARDA) to support the planned Clinical Laboratory Improvement Amendments (CLIA)-waiver clinical study and regulatory submission for Lumos' FebriDx® bacterial/non-bacterial test. The total contract value, if all options are exercised, is US$8,258,774.

Lumos CEO and Managing Director, Doug Ward, on BARDA partnership

Since early clinical practice, doctors have relied primarily on clinical observation to determine whether patients require antibiotics for acute respiratory conditions. FebriDx® is a powerful diagnostic which can provide a quick and clear clinical evaluation, and in doing so, can reduce over-prescription of antibiotics. We are honored to have the opportunity to partner with BARDA on the CLIA waiver study and regulatory submission for FebriDx®. BARDA's expertise and the associated funding will support our objective of expanding the test's utility - from its current use case in moderate/high complexity labs - to US CLIA-waived point-of-care settings, including physician offices, urgent care clinics, or other outpatient clinics. Should this goal be achieved, FebriDx's ability to improve antibiotic stewardship will be vastly expanded.

Lumos Diagnostics BARDA partnership and FebriDx outlook

Lumos Diagnostics (ASX:LDX) has secured US$2,984,571 BARDA funding to support the planned Clinical Laboratory Improvement Amendments (CLIA)-waiver clinical study and regulatory submission for its FebriDx® bacterial/non-bacterial test. The partnership aims to expand authorized testing to CLIA-waived, point-of-care settings, including U.S. physician offices, urgent care clinics, or other outpatient clinics, where empiric antibiotic prescription is common practice. This funding will complement those raised under the recent entitlement offer to Lumos shareholders. FebriDx's ability to improve antibiotic stewardship is expected to be vastly expanded, potentially impacting patient care by providing faster results for bacterial or non-bacterial infections, aiding providers in making more informed treatment decisions.