Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has secured a follow-on contract worth about US$400,000 with US partner Aptatek Biosciences Inc. to manage a key clinical study aimed at progressing the PheCheck™ in-home phenylketonuria (PKU) monitoring device towards US regulatory clearance.
The new agreement marks the next phase of a long-running collaboration between the two companies and will see Lumos manage an Institutional Review Board (IRB)-approved, multi-centre clinical study designed to support a submission for clearance by the US Food and Drug Administration (FDA).
Follow-on contract builds on earlier development work
The six-month contract is expected to commence in the first half of calendar 2026 and will be delivered on a time-and-materials basis. Under the agreement, Lumos will provide end-to-end clinical study management services, including study start-up, oversight through to close-out, statistical analysis of results and preparation of the clinical study report for submission to the FDA.
Lumos said the work reflects the breadth of its in-house capabilities, extending beyond product development and manufacturing into clinical and regulatory affairs. Alongside the clinical program, the company will continue product development activities and complete formal verification studies that began in September 2025.
The follow-on agreement builds on earlier contracts between the parties, including a US$1.5 million development services contract announced last year, as the PheCheck™ device has advanced from concept through to clinical readiness.
Read more: Lumos Diagnostics secures US$1.5M contract to advance PKU monitoring device
Targeting FDA clearance and future manufacturing revenue
Subject to a successful clinical study and the achievement of FDA clearance, Lumos expects to pursue additional commercial opportunities with Aptatek. These could include manufacturing of the PheCheck™ tests and digital reader, providing a potential pathway to longer-term revenue beyond the current services contract.
The PheCheck™ device has already been granted FDA Breakthrough Device designation, a status intended to expedite the regulatory review of technologies that offer the potential for more effective treatment or diagnosis of serious conditions.
Addressing an unmet need in PKU management
PKU is a rare inherited metabolic disorder affecting around one in 12,000 newborns. The condition 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 behavioural issues.
The Aptatek-developed PheCheck™ system, created in collaboration with Lumos, is designed to allow patients to measure phenylalanine levels in real time from home or at the point of care. The aim is to enable faster detection of elevated levels and support more consistent, day-to-day management of the condition.
Progressing PheCheck™ into the clinic
Lumos Diagnostics chief executive Doug Ward said the company was pleased to see the project progress into the clinical trial phase.
“We look forward to progressing PheCheck™ through to commercialisation and supporting Aptatek at every stage of the journey,” he said.
For Lumos, the contract reinforces its strategy of leveraging its diagnostic, regulatory and clinical expertise to support partners through development and into commercial markets, while positioning the company for potential downstream manufacturing revenue if PheCheck™ secures regulatory approval.