Qlife Holding AB ("Qlife" or the "Company") a first mover in clinical-grade home diagnostics, announces publication of the clinical study for PKU children and adolescents under 18 years of age. The study, led by Professor Anita MacDonald at Birmingham Women's and Children's NHS Foundation Trust, demonstrated solid validation of the Egoo system for home testing in this setting. The outcome represents a significant milestone as Qlife prepares for its upcoming CE-IVDR submission and subsequent market launch. The Egoo PHE System, the first application of the Egoo Health platform, enables essential laboratory blood testing for this rare condition to be performed in patients' homes. This innovation will simplify disease management and enhance quality of life for affected individuals.
The Company considers the now clinically validated Egoo PHE System to be a proof of concept for the broader Egoo Health platform and is pursuing similar opportunities in large markets such as heart failure and kidney failure, where key biomarker tests can likewise be transitioned from the laboratory to the home.
"The publication is a significant step for us. The positive outcome and publication of this clinical trial allow us to finalize our CE-mark filing, representing a major milestone for the Company. We are preparing our submission dossier accordingly and plan to submit it to the authorities in the near future," says Thomas Warthoe, CEO of Qlife.
"In addition to being an important milestone for the Company, I am extremely pleased to see a lifelong effort to provide people living with this chronic condition a better tool for daily blood management come to fruition," adds Peter Warthoe, CSO of Qlife.
The article can be found here: https://www.mdpi.com/2072-6643/17/23/3800
About PKU
Currently, there is no self-testing phenylalanine product available on the market. The UK PKU population is estimated at 5,000 individuals, the EU population at 50,000, and the Middle East population at 20,000. With an average usage of one Egoo Phe Test per person per week, the immediate total addressable market for the UK/EU/Middle East region is estimated to exceed SEK 1 billion.
For more information, please contact:
Thomas Warthoe
Chief Executive Officer (CEO)
Phn: +45 21 63 35 34
E-mail: tw@egoo.health
This disclosure contains information that Qlife Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 05-12-2025 11:13 CET
Qlife is a Swedish company based in Göteborg, which develops and markets an innovative medical technology platform, Egoo.Health ("Egoo"), with the goal of giving people access to clinical biomarker data when testing at home. The company is listed on the Nasdaq First North Growth Market (ticker: QLIFE). G&W Fondkommission is the Company's Certified Adviser. For additional information, please visit www.qlifeholding.com.