Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has secured further support from the US Biomedical Advanced Research and Development Authority (BARDA) to launch a new clinical study evaluating its flagship FebriDx® rapid test in children aged 2–12 years.
BARDA has committed nearly US$6.2 million in non-dilutive funding to back the trial, which will assess FebriDx use in US Clinical Laboratory Improvement Amendments (CLIA)-waived settings — paving the way for a potential age expansion of the test beyond its current 12–64-year clearance. The study is expected to begin in the September quarter of 2025 and run through the US 2025/26 respiratory season.
Expanding access for paediatric patients
FebriDx already has US Food and Drug Administration (FDA) clearance for use in patients aged 12–64 presenting to urgent or emergency care settings with suspected acute respiratory infections. In August, Lumos, with BARDA’s support, submitted a CLIA waiver application to the FDA to broaden the test’s use from moderately complex labs into CLIA-waived clinics.
Read more: Lumos Diagnostics submits CLIA waiver application for FebriDx
If approved, the waiver could expand FebriDx’s US addressable market 15-fold — from 18,000 clinical sites to 270,000 — and lift potential coverage to around 80 million annual respiratory consultations. The newly announced paediatric study aims to extend that reach further, opening access to some 60,000 clinicians treating children aged 2–12 years.
Read more: MST Access lifts Lumos Diagnostics valuation as CLIA waiver bid boosts FebriDx opportunity
Lumos CEO Doug Ward said BARDA’s continued involvement underscores FebriDx’s clinical and commercial potential.
“We greatly appreciate BARDA’s continued support — both in the recently completed CLIA waiver study and now in advancing this important paediatric study,” Ward said. “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.”
Read more: Inside Biotech: Why the future of diagnostics lies beyond the laboratory
Study details and funding
The trial is set to enrol its first patient in the third quarter of this calendar year, with a target to complete recruitment within a single 12-month respiratory season. Upon completion, Lumos intends to submit a dual 510(k) and CLIA waiver application for the paediatric population.
BARDA milestone payments — totalling more than US$6.1 million for the new study — will be triggered at 12 key events, including clinical trial setup, patient enrolment, FDA application submission and regulatory clearance. With this addition, the total value of Lumos’ BARDA contract rises to more than US$9.1 million.
About FebriDx
FebriDx is the first and only rapid, instrument-free, all-in-one point-of-care test that uses a fingerstick blood sample to differentiate bacterial from non-bacterial respiratory infections in about 10 minutes. By aiding clinicians in appropriate antibiotic prescribing decisions, the test is designed to support better patient outcomes while helping combat unnecessary antibiotic use.