Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF)'s Sam Lanyon earlier this week discussed with Proactive two material developments in its diagnostics pipeline. The company has signed a US$1.5 million contract with Aptatek Biosciences Inc. to progress development of the PheCheck™ PKU monitoring device, and separately secured new BARDA funding to support a paediatric trial of its FebriDx® rapid test.
- Lumos signed a US$1.5 million development contract with Aptatek for the PheCheck™ PKU device.
- The contract runs for 10 months from September 2025.
- Lumos will mature test design, blood processing, and conduct verification testing.
- The device aims to support in-home PKU monitoring and has FDA Breakthrough Device designation.
- FebriDx® will be studied in children aged 2–12 with nearly US$6.2 million in BARDA funding.
- The paediatric trial begins in Q3 2025 and aims to support a dual FDA 510(k) and CLIA waiver submission.
- If approved, FebriDx’s addressable US market could grow to 270,000+ clinical sites.
- Sam Lanyon emphasised continued collaboration with Aptatek and BARDA’s ongoing support.
Aptatek contract
The Aptatek contract begins in September 2025 and will run for around 10 months. Lumos said it will use this phase to refine the design of the blood processing and reader systems for the device and to carry out formal verification testing. The company said these steps are aimed at supporting FDA submission and future clinical trials.
The PheCheck™ platform, designed for real-time at-home phenylalanine monitoring, has been granted Breakthrough Device designation by the US FDA. Lumos initially partnered with Aptatek in 2022 following a competitive bidding process.
BARDA funding
A second key milestone came in the form of additional non-dilutive funding from the US Biomedical Advanced Research and Development Authority (BARDA). The company said BARDA has committed nearly US$6.2 million to fund a paediatric clinical study of FebriDx® in children aged 2–12 years.
The trial is scheduled to begin in the third quarter of 2025 and will run over a single respiratory season. Lumos said the data could support a dual 510(k) and CLIA waiver application for this age group.
If approved, FebriDx® could expand into 270,000 CLIA-waived clinics across the United States, with the paediatric extension opening further access to 60,000 clinicians treating children under 12.
The company said BARDA’s continued funding increases the total value of its contract with the agency to over US$9.1 million.