Qlife Holding AB ("Qlife" or the "Company"), a pioneer in clinical-grade home diagnostics, together with its partner Hipro Biotechnology Co., Ltd. ("Hipro"), announces a major milestone: 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 optimally for partnering and commercialisation potentially, the first home-use HbA1c test to meet the same stringent clinical and regulatory standards as central laboratory testing.
Managing diabetes at home requires solutions that are accurate, convenient, and cost-effective. HbA1c testing remains the gold standard for long-term glucose control, providing a clear picture of average blood sugar levels over the past 2-3 months. Unlike continuous glucose monitors (CGMs), which offer real-time data for short-term adjustments, HbA1c delivers simplicity and reliability in a single finger-prick sample for long-term diabetes management.
Achieving high precision in HbA1c testing is notoriously challenging. Regulatory requirements for in vitro diagnostics typically demand CV-values between 3% and 6%. Existing home-use HbA1c tests have struggled to meet these standards, often showing poor precision. Egoo's breakthrough (CV values below 3%) sets a new benchmark offering both clinical relevance and regulatory compliance. This positions Egoo uniquely in the global diabetes management market.
The diabetes diagnostics market, including home-use products such as glucose meters, CGMs, and HbA1c kits, is projected to grow from $35.3?billion in 2025 to over $70?billion by 2034 (CAGR ~8%), driven by rising prevalence, aging populations, and the shift toward home-based care (refs. 1, 2)
The milestone has generated significant interest from major global players in the diabetes diagnostics fields and partnering discussions are ongoing. In addition, the clinical diabetes validation studies currently underway at Beijing Tsinghua Changgung Hospital will benefit significantly from the improved sensitivity in this optimized version of the Egoo platform.
"The demonstrated unique precision of the Egoo system may be seen as a game-changer for diabetes care at home. By achieving precision levels comparable to central laboratories, Egoo brings true clinical quality into the hands of patients. Our vision is to empower people with reliable tools for managing chronic conditions without compromising accuracy. Together with Hipro and potential global commercialisation partners we are committed to accelerating regulatory approval and making this innovation widely accessible", 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
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.
References:
- Diabetic Care Devices Market Report 2025 - Global Diabetes
- Continuous Glucose Monitoring Device Market Size to Hit USD 10.65 Bn by 2034
