Swedish medical technology company QLife Holding AB (STO:QLIFE) on Thursday announced positive results from a clinical study conducted with Birmingham Women's and Children's NHS Foundation Trust on its Egoo PHE self-test for phenylketonuria (PKU).

The study focused on children and young people under 18, comparing at-home self-testing with the standard dried blood spot method.

Results showed high concordance between the Egoo PHE test and the reference method, with consistent classification of clinically significant values and strong repeatability across the measurement range. Caregivers favoured the self-test for faster results, reduced blood volume, and ease of use at home.

The data will be presented at the European Society for PKU annual meeting in September. The Egoo PHE system is now in its final phase before submission for self-testing approval in the UK and under EU IVDR regulations, with filing expected in Q4 2025.

Qlife estimates the immediate addressable market for PKU self-testing in the UK, EU, and Middle East at more than SEK1bn, representing 75,000 patients across these regions.

(EUR1=SEK11.17)