Lumos Diagnostics Advances Two Key Clinical Programs with $1.1M in Milestone Funding
Key Insights
Lumos Diagnostics secured a $400,000 follow-on contract with Aptatek to manage clinical studies for the PheCheck™ (search) PKU (search) monitoring device toward FDA clearance.
The company achieved a $720,000 BARDA (search) milestone payment for its pediatric FebriDx® (search) clinical study, bringing total milestone payments to $1.92 million.
Both programs target significant market expansions: PheCheck™ (search) addresses PKU (search) management affecting 1 in 12,000 newborns, while pediatric FebriDx® (search) could extend the device's age range from 2-64 years.
Lumos Diagnostics Holdings Ltd (search) has secured significant progress across two key clinical programs, receiving over $1.1 million in combined funding to advance both its PheCheck™ (search) phenylketonuria (search) monitoring device and pediatric expansion of its FebriDx® (search) respiratory infection test.
PheCheck™ Advances Toward FDA Clearance
The Australian diagnostics company has signed a $400,000 follow-on contract with US partner Aptatek Biosciences Inc. (search) to manage a multi-center clinical study supporting FDA clearance for the PheCheck™ (search) in-home PKU (search) monitoring device. The six-month contract, expected to commence in the first half of 2026, will be delivered on a time-and-materials basis.
Under the agreement, Lumos will provide comprehensive clinical study management services, including study start-up, oversight through close-out, statistical analysis of results, and preparation of the clinical study report for FDA submission. The work builds on a previous $1.5 million development services contract announced last year as the PheCheck™ (search) device has progressed from concept to clinical readiness.
The PheCheck™ (search) system addresses phenylketonuria (search), a rare inherited metabolic disorder affecting approximately one in 12,000 newborns. PKU (search) leads to a build-up of the amino acid phenylalanine in the body that, if left unmanaged, can cause severe neurological complications including intellectual disability, seizures, and behavioral issues. The device has already received FDA Breakthrough Device designation, intended to expedite regulatory review of technologies offering potential for more effective treatment or diagnosis of serious conditions.
"We look forward to progressing PheCheck™ (search) through to commercialization and supporting Aptatek at every stage of the journey," said Lumos CEO Doug Ward.
BARDA Milestone Unlocks $720,000 for Pediatric FebriDx® Study
Simultaneously, Lumos achieved its sixth milestone under a partnership with the US Biomedical Advanced Research and Development Authority (BARDA (search)), unlocking $720,000 in non-dilutive funding for its ongoing pediatric clinical study of FebriDx® (search). This brings total milestone payments received under the BARDA contract to $1.92 million.
The milestone relates to patient enrollment targets in the BARDA (search)-funded study evaluating FebriDx® (search) use in children aged 2 to 12 years in CLIA-waived settings. Under the full agreement, BARDA has committed up to $6.2 million across 12 milestones covering clinical trial setup, patient recruitment, FDA submission, and potential FDA 510(k) clearance and CLIA-waiver categorization for pediatric use.
FebriDx® (search) is currently FDA 510(k)-cleared in the US for patients aged 12 to 64 years presenting to urgent care or emergency settings with symptoms of acute respiratory infection (search) for less than seven days and within three days of fever onset. A successful pediatric study outcome would support broadening the device's US label to include patients aged 2 to 64 years, significantly extending its clinical reach.
Market Expansion Potential
The pediatric trial runs alongside Lumos' broader regulatory push to secure CLIA-waiver status for FebriDx® (search) in the US. In August 2025, the company submitted an application to the FDA seeking to expand FebriDx® use from moderately complex laboratory settings into CLIA-waived settings, which would allow the test to be used in physician offices and community clinics.
According to Lumos, a CLIA waiver could increase its US total addressable market approximately 15-fold to more than $1 billion, expanding access from about 18,000 sites to around 270,000 clinical locations and covering an estimated 80 million annual acute respiratory consultations.
"Completing this enrollment milestone in our pediatric study is an important operational milestone on the path to lodging a formal submission," Ward said. "The team has mobilized quickly and has delivered strong enrollment momentum. We look forward to the day that we can better support clinicians in the assessment of acute respiratory infections in children through the use of FebriDx® (search)."
Both programs demonstrate Lumos' strategy of leveraging its diagnostic, regulatory, and clinical expertise to support partners through development and into commercial markets while positioning for potential downstream manufacturing revenue upon regulatory approval.