Lumos Diagnostics Reaches 50% Recruitment Milestone in FebriDx CLIA Waiver Clinical Study
2 June 2025
Lumos Diagnostics has announced that the Company has now successfully achieved 61 bacterial positive patients, representing 50% of the target of 120 bacterial positive patient results required for the study.
With 439 total patients recruited to date, Lumos progressing well toward its next milestone of 500 patients, which will trigger a US$298,457 payment from its partner, the Biomedical Advanced Research and Development Authority (BARDA).
This clinical study is a critical step towards securing a CLIA Waiver from the U.S. Food and Drug Administration (FDA), enabling FebriDx to be used in a broader range of healthcare settings, including U.S. physician offices, urgent care clinics, or other outpatient clinics that do not operate under high-complexity laboratory certification.
At the current accrual rate the study is anticipated to conclude in Q4 CY2025. Subject to successful data outcomes, Lumos expects to submit its CLIA waiver application to the FDA in Q4 CY2025.
Lumos Diagnostics Managing Director, Doug Ward, commented:
"Reaching the halfway mark in bacterial positive patient recruitment for our CLIA waiver clinical study is an important achievement for Lumos. We are encouraged by the progress of the study with the support of BARDA and remain focused on delivering a successful outcome that expands the availability of FebriDx to clinicians and patients across the U.S.”
Click to read the ASX release.
With 439 total patients recruited to date, Lumos progressing well toward its next milestone of 500 patients, which will trigger a US$298,457 payment from its partner, the Biomedical Advanced Research and Development Authority (BARDA).
This clinical study is a critical step towards securing a CLIA Waiver from the U.S. Food and Drug Administration (FDA), enabling FebriDx to be used in a broader range of healthcare settings, including U.S. physician offices, urgent care clinics, or other outpatient clinics that do not operate under high-complexity laboratory certification.
At the current accrual rate the study is anticipated to conclude in Q4 CY2025. Subject to successful data outcomes, Lumos expects to submit its CLIA waiver application to the FDA in Q4 CY2025.
Lumos Diagnostics Managing Director, Doug Ward, commented:
"Reaching the halfway mark in bacterial positive patient recruitment for our CLIA waiver clinical study is an important achievement for Lumos. We are encouraged by the progress of the study with the support of BARDA and remain focused on delivering a successful outcome that expands the availability of FebriDx to clinicians and patients across the U.S.”
Click to read the ASX release.
