Swedish medical technology company QLife Holding AB (STO:QLIFE) said on Tuesday that it has received approval from UK authorities to begin a clinical trial for the Egoo Phe System, a device designed to measure phenylalanine (Phe) levels for individuals with phenylketonuria (PKU).

The trial, expected to run for six months, is the final step before submitting the product for self-testing approval in the UK and under the IVDR for EU markets.

The Egoo Phe System is intended to become the first self-testing product available for Phe measurement, providing results within 30 minutes. Currently, individuals with PKU rely on laboratory testing to monitor Phe levels, a process that is both time-consuming and inconvenient due to the need for frequent monitoring to manage dietary adjustments.

Qlife plans to submit the dossier for review by a Notified Body after the trial, with market launch anticipated in early Q4 2025. The company estimates that the Total Addressable Market (TAM) for the UK, European Union and Middle East exceeds SEK1bn, with a projected average usage of one test per person per week.

Approximately 5,000 individuals in the UK, 50,000 in the EU and 20,000 in the Middle East are affected by PKU, highlighting significant market potential for the Egoo Phe System.

(EUR1=SEK10.80)