Lumos Diagnostics Holdings Ltd executive chair Sam Lanyon talked with Proactive about two significant developments across the company’s diagnostics pipeline — a new contract with Aptatek Biosciences Inc. for its PheCheck™ PKU device, and a new paediatric study for FebriDx® backed by BARDA.
The Aptatek agreement, valued at approximately US$1.5 million, covers a 10-month development phase beginning in September 2025. Lumos will refine the design of the PheCheck™ device, including blood processing and reader systems, and carry out formal verification testing. These steps are intended to prepare the device for clinical trials and FDA regulatory submission.
“This follow-on contract reflects both the quality of our work to date and the trust Aptatek places in Lumos’ expertise,” Lanyon said.
The PheCheck™ device is designed for in-home monitoring of phenylketonuria (PKU), a rare genetic disorder. It has been granted FDA Breakthrough Device designation.
Separately, Lumos has secured nearly US$6.2 million in new non-dilutive funding from the US Biomedical Advanced Research and Development Authority (BARDA) to support a paediatric clinical study of FebriDx®. The study will evaluate the rapid test in children aged 2–12 years and is expected to begin during the US 2025/26 respiratory season. A successful trial could lead to a dual FDA 510(k) and CLIA waiver application, potentially expanding FebriDx’s reach into an additional 60,000 clinical sites.
Lanyon highlighted BARDA’s ongoing support, saying: “We greatly appreciate BARDA’s continued support — both in the recently completed CLIA waiver study and now in advancing this important paediatric study.”
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