Qlife Holding AB

Qlife provides end-year operational update on key issues

Källa: Cision
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Sammanfattning

QLife rapporterar operationella framsteg under året, inklusive genombrott inom diabetesdiagnostik med Egoo HbA1c-testet som uppnått klinisk precision. Bolaget har också inlett en regulatorisk process för sin PKU-testning och betonar sin kostnadseffektiva modell genom strategiska partnerskap.

Analys

Egoo Healths HbA1c-test för diabeteshantering har uppnått en precision (CV < 3%) som potentiellt möter kliniska och regulatoriska standarder för hemmabruk. Detta är en viktig milstolpe som kan öppna dörrar för partnerskap inom den växande marknaden för diabetesdiagnostik i hemmet. Bolaget har också inlett en regulatorisk process för sin PKU-testning (Egoo Phe System) under den nya IVDR-förordningen, vilket är ett steg för att validera Egoo Health-plattformens regulatoriska ramverk. Ett icke-bindande Letter of Intent (LOI) med ett "Top-20" läkemedelsbolag har ingåtts, och dialogen fortsätter. Bolaget framhåller sin kostnadsmodell där resurskrävande funktioner hanteras av strategiska partnern Hipro Biotechnology, vilket ger lägre overheadkostnader. VD:n betonar att grunden för Egoo Health-plattformen är lagd för att attrahera partnerskap inom diagnostik och läkemedel för 2026.

Qlife Holding AB (“Qlife” or the “Company”), a pioneer in clinical-grade home diagnostics, provides a year-end operational update on key issues.

Diabetes data

Egoo Health has achieved breakthrough precision in key diabetes biomarker test. The Egoo HbA1c blood test for diabetes management has achieved best-in-class precision with a coefficient of variation (CV) below 3%. This achievement positions Egoo as potentially the first home-use HbA1c test to meet the same stringent clinical and regulatory standards. The diabetes diagnostics market, with a focus on moving clinical diabetes management into home-use products represents a significant partnering opportunity.

Partnerships

The Company continues to prioritize strategic partnerships. During 2025, the Company entered into a non-binding Letter of Intent with a Top-20 pharmaceutical company and has since maintained an active dialogue, progressing in line with the agreed roadmap. In parallel, Qlife is experiencing growing interest from global in vitro diagnostics (IVD) companies, driven by the positive outcome of the Birmingham clinical study and the demonstrated best-in-class precision of the Egoo HbA1c blood test.

Submission EGOO PHE proof-of-concept product

The Company has started to upload the technical files for the Egoo Phe System for PKU-management to a Notified Body (authority). This process is expected to be finalized by mid-January, at which point the Company will have submitted its first application under the new In Vitro Diagnostics Regulation (IVDR). This represents a major milestone, not only for the specific test, but also in validating the regulatory framework of the Egoo Health platform, which is an important step in the Company’s partnerships strategy.

Cost reduction model

The Company will continue to maintain a lean cost structure by having typically resource-intensive functions done by strategic partner, Hipro Biotechnology. This close collaboration provides Qlife with a significant advantage: the ability to operate with lower overhead compared to traditional IVD companies. By having Hipro manage most of the costs associated with development, regulatory and compliance processes, production, and sales & marketing, Qlife can sustain an efficient organisation and a highly competitive cost model.

CEO year-end statement

”During 2025, we have established the fundamentals for the Egoo Health product platform that needs to be in place to become an attractive partnering opportunity for major diagnostics and pharmaceutical companies. As we enter 2026, I believe we are now well positioned to break into the new personalized Dx/Rx paradigm and to partner with industry leaders that can take our innovative Egoo Health platform to the next level across multiple applications”, says Thomas Warthoe, CEO Qlife.

For more information, please contact: 

Thomas Warthoe, Chief Executive Officer (CEO)

Phn: +45 21 63 35 34

E-mail: tw@egoo.health