Qlife Holding AB ("Qlife" or the "Company"), a pioneer in clinical-grade home diagnostics, today announces that the Company has formally submitted its Egoo PHE home-testing system for regulatory approval to the relevant Notified Body and authorities. This marks a major milestone in Qlife's mission to make high-quality, decentralized testing for Phenylalanine (PHE) available for patients living with Phenylketonuria (PKU).
The submission follows the recently published clinical trial results from Birmingham Women's and Children's NHS Foundation Trust, which demonstrated strong performance in children and adolescents under 18. These data validate the accuracy, usability, and reliability of the Egoo PHE self-testing solution in real-world home settings-a key requirement for market authorization.
With the technical documentation, clinical evidence package, and quality management documentation now delivered, Qlife is awaiting the authorities' review and decision. Approval will allow the Company to begin commercialization in selected EU and UK markets, representing an important step in scaling access to at-home monitoring for people living with PKU.
"Submitting Egoo PHE for approval is a defining moment for Qlife. This is the culmination of years of development, close collaboration with leading clinical partners, and the strong clinical results recently published in the UK. People living with PKU, especially children, deserve easier access to high-frequency testing, and we are proud to be one step closer to offering that solution. We now look forward to the authorities' review and will continue preparing our commercial launch together with our strategic partners." says Thomas Warthoe, CEO, Qlife
The Egoo PHE submission is part of Qlife's broader strategy to expand its decentralized diagnostics platform, with additional biomarkers in clinical development and a growing commercial partnership footprint, including the recently announced agreements with Hipro Biotechnology.
About PKU
Phenylketonuria (PKU) is a rare genetic disorder that prevents the body from breaking down an amino acid called phenylalanine, leading to its buildup, which can cause serious health issues if untreated. 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
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.
