Qlife and Birmingham Women’s & Children’s NHS Trust Achieve Positive Results for At-Home PKU Self-Test

Qlife, in collaboration with Birmingham Women’s and Children’s NHS Foundation Trust, has successfully completed a clinical study of its Egoo PHE at-home self-test for children and young people with Phenylketonuria (PKU).

The study, led by Professor Anita MacDonald, showed that Egoo’s results closely matched traditional dried blood spot (DBS) tests, even at clinically important low levels. It also demonstrated high repeatability, and caregivers praised the test for being faster, easier, and requiring less blood than conventional methods.

Egoo PHE is now entering the final phase before submission for self-testing approval in the UK and under the EU IVDR, with approval expected in Q4 2025. With no self-testing PKU products currently on the market, the system addresses a potential market of 75,000 people across the UK, EU, and Middle East, representing an immediate opportunity exceeding SEK 1 billion.

Professor MacDonald will present the study data at the European Society for PKU (ESPKU) annual meeting in September.