Image source: © 2025 Krish Capital Pty. Ltd.

Highlights

  • Lumos signed a follow-on contract with Aptatek Biosciences valued at USD 1.5 million (AUD 2.3 million), commencing September 2025.

  • The collaboration advances development of the PheCheck™ PKU monitoring device toward clinical validation and FDA submission.

  • PKU impacts approximately one in 12,000 newborns, causing neurological complications if not effectively managed.

Lumos Diagnostics Holdings Ltd (ASX:LDX), a developer of rapid point-of-care diagnostic technologies, has signed a follow-on contract with Aptatek Biosciences, Inc. (Aptatek), a New Jersey-based biotechnology company, to advance the PheCheck™ aptamer-based monitoring tool for phenylketonuria (PKU).

The contract, valued at approximately USD 1.5 million (AUD 2.3 million), will commence in September 2025 and is expected to run for a period of 10 months. The agreement will be executed on a time-and-materials basis and builds on earlier work undertaken between Lumos and Aptatek.

Background on PKU

PKU is a rare inherited disorder that affects around one in every 12,000 newborns. It results in the accumulation of the amino acid phenylalanine, which, if not managed, can cause severe health consequences, including intellectual disabilities, seizures, behavioural problems, and mental health complications. Early diagnosis and effective monitoring are critical in mitigating these risks.

The PheCheck™ monitoring device has been developed to allow patients with PKU to measure their phenylalanine levels in real time at home or in point-of-care settings. By enabling immediate readings, the device supports improved monitoring and management of the condition. The product has already been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA), which is expected to streamline its regulatory pathway.

Project Development

Lumos was originally appointed as Aptatek’s partner in June 2022, following a competitive bidding process. During the initial phase, Lumos delivered services valued at approximately USD 0.5 million (AUD 0.8 million), contributing to Aptatek’s pre-clinical studies. These studies were aimed at demonstrating the device’s usability and technical performance.

With the new funding secured by Aptatek, the collaboration now moves into the next stage of development. Lumos’ role will focus on advancing the design of the blood testing unit, refining the test components, and ensuring the reader devices meet performance requirements. Formal verification and validation studies will also be undertaken to support clinical trials and an eventual submission to the FDA.

Partnership Outlook

Michael Boyce-Jacino, Chief Executive Officer of Aptatek Biosciences, commented on the collaboration, highlighting the importance of progressing the PheCheck™ in-home monitoring device towards clinical readiness and eventual market introduction.

The partnership marks a continuation of Lumos’ work in advancing diagnostic tools designed to meet unmet medical needs and aligns both companies toward the goal of delivering new technologies for rare disease management.