Lumos scores BARDA funding for paediatric study, secures follow-on contract with Aptatek

• BARDA to support Lumos paediatric study evaluating FebriDx on children aged 2-12
• A US$6.198m non-dilutive funding package will underpin that support
• Lumos inks follow-on US$1.5 million deal with Apatek Biosciences for development of PKU in-home monitoring device

Special Report: Lumos Diagnostics has announced two significant milestones that highlight its growing role in the US healthcare market and its focus on making fast, reliable diagnostic tools more widely available for doctors and patients.

Lumos Diagnostics (ASX:LDX) has launched a US government-backed clinical study to extend the use of its rapid point-of-care test to differentiate between bacterial and non-bacterial acute respiratory infections FebriDx to children aged 2–12.

And, in another major milestone, the company has signed a new contract with Aptatek Biosciences to further develop an at-home device that helps monitor the rare genetic disorder phenylketonuria (PKU).

BARDA partnership expands FebriDx into paediatric settings

 The Biomedical Advanced Research and Development Authority (BARDA) has exercised its option to support Lumos in conducting a clinical study and regulatory submission aimed at expanding eligibility for FebriDx use on 2-12-year-olds in Clinical Laboratory Improvement Amendments (CLIA)-waived settings.

Currently, FebriDx has US Food and Drug Administration (FDA) 510(k) clearance for use in patients aged 12–64 years presenting to urgent care or emergency care settings for evaluation of acute respiratory infection who have had symptoms for less than seven days and within three days of fever onset.

Upon completion of the CLIA-waiver study on patients aged 12–64 years, Lumos in August 2025 – supported by BARDA – applied to the FDA seeking to expand FebriDx use from moderately complex settings into CLIA-waived settings.

Approval would enable FebriDx to be used in a broader range of healthcare settings, including physician offices, urgent care clinics or other outpatient clinics that do not operate under high-complexity laboratory certification.

If a CLIA waiver is granted, this expansion would increase Lumos’ US total addressable market 15-fold to more than US$1 billion, providing access to 270,000 clinical sites (currently 18,000), and covering around 80 million annual acute respiratory consultations.

Lumos said the proposed age eligibility extension would enable clinicians, including the 60,000 clinicians treating children 2–12 years of age, to access an additional diagnostic aid for differentiating bacterial acute respiratory infections from non-bacterial causes.

Exercise of option to start paediatric study

With the CLIA-waiver study for 12–64 complete, BARDA has exercised its option to start a paediatric study and evaluate FebriDx on children from 2-12.

The study is anticipated to enrol the first patient in the US fall (Q3 CY25), with the target to complete enrolment within a single 12-month respiratory season, followed by dual 510(k)/CLIA waiver submission.

Extension to the paediatric study expands the overall total value of the BARDA contract to Lumos to ~US$9.18m, upon completion of all milestones.

BARDA will support the latest study with a US$6.198m non-dilutive funding package.

Milestone payments from BARDA to Lumos will be triggered upon achievement of 12 key events.

These include clinical trial set-up, patient recruitment, FDA application submission, and FDA granting of 510(k) clearance and CLIA-waiver categorisation for children 2–12 years of age.

This project has been funded in whole or in part with federal funds from the US Department of Health and Human Services; the Administration for Strategic Preparedness and Response; and BARDA.

“We greatly appreciate BARDA’s continued support – both in the recently completed CLIA waiver study and now in advancing this important pediatric study,” CEO and MD Doug 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.”

Watch: LDX on track for US approval 

Follow-on Aptatek contract to advance PKU in-home monitoring device

In parallel with its work on FebriDx, Lumos has secured a follow-on development contract worth ~US$1.5m with New Jersey-based Aptatek Biosciences.

The study is to advance the proprietary PheCheck aptamer-based, in-home monitoring tool for the screening and management of phenylketonuria (PKU).

PKU is a rare inherited disorder affecting ~1 in 12,000 newborns. It causes a build-up of the amino acid phenylalanine in the body, which, if untreated, can lead to intellectual disabilities, seizures, behavioural issues and mental health disorders.

The Aptatek device, developed in collaboration with Lumos, is designed to enable the measurement of phenylalanine levels in real time from home or at the point of care, enabling faster detection and improved ongoing management.

The product has been granted FDA breakthrough device designation, which is expected to expedite its regulatory review.

Lumos was first engaged by Aptatek in June 2022 following a competitive bidding process.

The initial phase of the collaboration generated US$500,000 in revenue for Lumos and supported Aptatek’s pre-clinical studies designed to demonstrate the device’s performance and usability in the hands of end users.

With additional funding secured, Aptatek will now progress to the next stage to complete development and conduct formal verification and validation studies.

Under the new contract, Lumos will focus on maturing the design of the tests, blood processing unit, and readers along with conducting formal verification testing to ensure the device meets product requirements for clinical trials and FDA submission.

The contract is expected to start this month and run for around 10 months and will be charged on a time-and-materials basis.

Additional revenue opportunities are anticipated through Lumos’ support of clinical trials and ongoing instrument manufacturing in subsequent phases of the partnership.

Potential to transform PKU management

Aptatek Biosciences CEO Michael Boyce-Jacino said the company was delighted to have selected Lumos once again as its partner in bringing the PheCheck aptamer-based, in-home monitoring platform to market.

“PKU is a challenging condition for patients and families, and a reliable at-home monitoring tool has the potential to transform how it is managed,” he said.

Ward said Lumos was also pleased to extend its collaboration with Aptatek on the important program.

“Securing this follow-on contract reflects both the quality of our work to date and the trust Aptatek places in Lumos’ expertise,” he said.

“We look forward to supporting Aptatek through the next critical stages of development and towards commercialisation.”

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.