• Lumos secures follow-on contract to move PKU in-home monitoring device to next stage of clinical development
• US$1.5 million contract commencing September 2025, to be charged on time-and-materials basis
• PKU affects 1 in 12,000 newborns, leading to neurological complications if un-checked

Lumos Diagnostics Holdings Ltd (ASX: LDX) has secured a follow-on development contract with New Jersey-based Aptatek Biosciences, Inc. (Aptatek) to advance the PheCheck™ aptamer-based, in-home monitoring tool for the screening and management of phenylketonuria (PKU). PKU is a rare inherited disorder affecting approximately 1 in 12,000 newborns, causing a build-up of the amino acid phenylalanine in the body, which can lead to intellectual disabilities, seizures, behavioral issues, and mental health disorders if untreated. The Aptatek device, developed in collaboration with Lumos, is designed to enable PKU patients to measure their 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. The new contract, valued at approximately US$1.5 million and charged on a time-and-materials basis, is expected to commence in September 2025 and run for around 10 months. Lumos will focus on maturing the design of the tests, blood processing unit, and readers, as well as conducting formal verification testing to ensure the device meets product requirements for clinical trials and FDA submission. Additional revenue opportunities are anticipated through Lumos support of clinical trials and ongoing instrument manufacturing in subsequent phases of the partnership.