Lumos starts paediatric CLIA waiver study for point-of-care respiratory test

• Lumos starts FebriDx CLIA-waiver study in US for patients 2-12 years of age
• 500-800 patients expected to be enrolled at 20 sites over next 12 months
• Successful outcome will broaden market in US for FebriDx, which differentiates between non-bacterial and bacterial acute respiratory infections

Special Report: Lumos Diagnostics has kicked off a key paediatric study in the US for its FebriDx rapid diagnostic test, marking a significant step toward expanding the product’s market and patient base.

Developed by Lumos Diagnostics (ASX:LDX), FebriDx is a simple, point-of-care test that can quickly distinguish between bacterial and non-bacterial acute respiratory infections. 

The test helps clinicians make faster, more accurate treatment decisions and supports antibiotic stewardship by reducing unnecessary prescriptions. 

The Clinical Laboratory Improvement Amendments (CLIA) waiver study is being supported by the US Biomedical Advanced Research and Development Authority (BARDA).

It will evaluate FebriDx in children aged two to 12 years in CLIA-waived clinical settings, including physician offices, urgent care clinics or other outpatient clinics that do not operate under high-complexity laboratory certification.

FebriDx is cleared for use in patients aged 12-64 presenting to urgent or emergency care settings with acute respiratory infection who have had symptoms for less than seven days and within three days of fever onset.

A CLIA-waiver if granted by the US Food and Drug Administration (FDA) would significantly expand its market in paediatric settings.

First patient enrolled triggering milestone payment

The first patient has already been enrolled, with between 500 and 800 children expected to be enrolled to achieve enough bacterial cases.

This study will be run at ~20 sites over the next 12 months, following which a formal submission will be prepared for the US Food and Drug Administration (FDA).

BARDA is providing ~US$6.2 million in non-dilutive funding through 12 milestone payments to support the study including clinical trial set-up, patient recruitment, FDA submission and FDA granting 510(k) clearance and CLIA-waiver categorisation for children aged two-12.

Milestones completed and invoiced to date total $1m, with $400,000 received.

Watch: LDX on track for US approval

‘Important milestone’ follows CLIA waiver submitted in August

Lumos, supported by BARDA, submitted an FDA application in August 2025, seeking to expand the device into CLIA-waived settings for patients aged 12-64.

If approved, this would increase Lumos’ total addressable US market 15-fold, from 18,000 clinical sites to 270,000, covering ~80m annual acute respiratory consultations.

Lumos said the proposed aged eligibility extension would enable US clinicians, including 60,000 treating children aged two to 12, to access an additional diagnostic device to help differentiate between acute bacterial infections from non-bacterial.

“The commencement of this study marks an important milestone for FebriDx and our  commitment to aiding healthcare professionals in improving infection diagnosis in children,” CEO Doug Ward said.

“A  successful outcome would represent a significant step forward in helping healthcare professionals quickly and confidently differentiate bacterial and non-bacterial acute respiratory infections in children aged 2 to 12 years, supporting better treatment decisions and antibiotic stewardship.”

This article was developed in collaboration with Lumos Diagnostics, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.