Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has signed a new development contract with Aptatek Biosciences Inc. to progress the PheCheck™ aptamer-based in-home monitoring device for phenylketonuria (PKU). The agreement is valued at approximately US$1.5 million (AU$2.29M) and will begin in September 2025 and run for around 10 months.
Revenue will be recognised on a time-and-materials basis. Under the arrangement, Lumos will mature the design of the tests, blood processing unit and readers, while also conducting formal verification testing.
These steps are intended to ensure that the device meets product requirements for clinical trials and regulatory submission to the US Food and Drug Administration (FDA). Future revenue opportunities are expected to arise from Lumos’ support of clinical trials and potential instrument manufacturing as the partnership moves into later phases.
“We are pleased to extend our collaboration with Aptatek on this important program. Securing this follow-on contract reflects both the quality of our work to date and the trust Aptatek places in Lumos’ expertise,” Lumos Diagnostics chief executive officer Doug Ward said.
“We look forward to supporting Aptatek through the next critical stages of development and towards commercialisation.”
Both parties emphasised that the collaboration builds on a strong track record and shared commitment to innovation in point-of-care diagnostics.
Addressing an unmet medical need
PKU is a rare genetic condition that affects approximately 1 in 12,000 newborns. It causes a dangerous build-up of the amino acid phenylalanine, which can lead to intellectual disability, seizures, behavioural issues, and other health complications if not properly managed.
The Aptatek device, developed in partnership with Lumos, enables patients to measure phenylalanine levels in real time from home or point-of-care settings.
By providing rapid results, the tool is designed to improve disease monitoring and management. The device has been granted FDA Breakthrough Device designation, which is expected to expedite the regulatory review process and shorten the pathway to market. Such developments could significantly improve outcomes for patients and families affected by PKU.
Background and development progress
Lumos was initially engaged by Aptatek in June 2022 after a competitive bidding process.
The first phase of the collaboration generated US$0.5 million in revenue for Lumos and supported Aptatek’s pre-clinical studies, which demonstrated the device’s usability and performance with end users.
With new funding secured, Aptatek is now positioned to move into the next stage of formal verification and validation studies. Both companies view this as a crucial step towards commercial readiness. Aptatek chief executive officer Michael Boyce-Jacino said: “We are delighted to have selected Lumos once again as our partner in bringing the PheCheck™ aptamer-based in-home monitoring platform to market”.