Lumos Secures US$1.5M Deal to Develop FDA-Designated PKU Diagnostic Tool

• US$1.5 million follow-on contract with Aptatek starting September 2025
• Focus on advancing PheCheck™ device design and formal verification testing
• PKU affects 1 in 12,000 newborns, requiring ongoing phenylalanine monitoring
• Previous phase generated US$0.5 million revenue for Lumos
• FDA Breakthrough Device designation expected to accelerate regulatory review

Lumos and Aptatek Deepen Collaboration

Lumos Diagnostics Holdings Ltd (ASX, LDX) has announced a follow-on contract valued at approximately US$1.5 million with Aptatek Biosciences, Inc., a New Jersey-based mobile health company. This agreement marks the next critical step in developing the PheCheck™ in-home monitoring device designed for patients with Phenylketonuria (PKU), a rare inherited disorder that demands constant management to prevent severe neurological damage.

The contract, commencing in September 2025 and spanning roughly 10 months, will see Lumos focus on refining the device’s test design, blood processing unit, and reader technology. Formal verification and validation testing will be conducted to ensure the device meets stringent product requirements ahead of clinical trials and submission to the U.S. Food and Drug Administration (FDA).

Addressing a Rare but Critical Need

PKU affects about one in every 12,000 newborns and leads to a dangerous accumulation of phenylalanine in the body if untreated. This can cause intellectual disabilities, seizures, and behavioral problems. The PheCheck™ device, developed jointly by Aptatek and Lumos, offers a real-time, at-home solution for monitoring phenylalanine levels, potentially transforming disease management by enabling faster detection and more effective ongoing care.

Importantly, the device has received FDA Breakthrough Device designation, a status that could accelerate its regulatory review and eventual market entry. This designation underscores the device’s potential to address an unmet medical need with innovative technology.

Building on Early Success

This follow-on contract builds on an initial phase that began in mid-2022, which generated US$0.5 million in revenue for Lumos. That phase supported Aptatek’s pre-clinical studies, demonstrating the device’s performance and usability. With this new funding, the partnership will advance to formal verification and validation, critical steps before clinical trials can begin.

Both companies have expressed optimism about the collaboration. Aptatek’s CEO Michael Boyce-Jacino highlighted the transformative potential of a reliable at-home monitoring tool for PKU patients and their families. Lumos CEO Doug Ward emphasized that the contract extension reflects the trust Aptatek places in Lumos’ expertise and the quality of their work to date.

Looking Ahead

Beyond this contract, additional revenue opportunities are anticipated as Lumos supports clinical trials and potentially scales up instrument manufacturing. The partnership’s progress will be closely watched by investors and healthcare professionals alike, given the device’s promise to improve patient outcomes in a challenging therapeutic area.

Bottom Line?

Lumos’ expanded role in developing the PheCheck™ device signals growing momentum toward a potentially game-changing PKU monitoring solution.

Questions in the middle?

• What are the anticipated timelines for clinical trial commencement and completion?
• How will the time-and-materials contract structure impact Lumos’ revenue recognition?
• What competitive advantages does PheCheck™ hold against existing PKU monitoring methods?