Lumos and BARDA to Partner to Support FebriDx® CLIA Waiver Study and Application
3 October 2024
Lumos has been awarded US$2,984,571 from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response.
The primary purpose of this funding is to support a planned Clinical Laboratory Improvement Amendments (CLIA)-waiver clinical study and regulatory submission for Lumos’ FebriDx® Bacterial/Non-Bacterial test.
Lumos Diagnostics CEO and MD, Doug Ward, commented:
“We are honoured 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.”
Click to read the ASX release.
The primary purpose of this funding is to support a planned Clinical Laboratory Improvement Amendments (CLIA)-waiver clinical study and regulatory submission for Lumos’ FebriDx® Bacterial/Non-Bacterial test.
Lumos Diagnostics CEO and MD, Doug Ward, commented:
“We are honoured 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.”
Click to read the ASX release.
