January 16, 2026, Copenhagen – In 2025, gMendel® made meaningful scientific and strategic progress despite facing financing and operational challenges.
At the heart of gMendel®’s mission is the reduction of infant mortality, one of the most powerful indicators of societal progress and well-being. We address this challenge by pioneering affordable, accurate, and scalable genetic screening solutions that enable early diagnosis in prenatal and newborn care. Our goal is to reduce the emotional and financial burden on families while delivering substantial, system-wide healthcare cost savings.
gMendel® is architected as a regulatory-grade screening platform rather than a single-use test. The system cleanly separates laboratory automation, bioinformatics, and clinical decision layers, enabling new disease panels to be designed, validated, and deployed in months rather than years, without revalidating the core platform. As the portfolio expands, marginal development and regulatory costs decrease while clinical and commercial reuse increases, creating compounding technical and regulatory advantages over point solutions and positioning gMendel® as scalable infrastructure for population-scale genetic screening.
At the beginning of 2025, we set four strategic commitments focused on identifying and preparing countries in the Global South for the launch of gMendel® technology. A key prerequisite for execution was securing sufficient financing.
Despite extensive efforts, we were unable to close the full financing round due to administrative and procedural delays. Limited funding was secured from iFutura and Quaternity, enabling only minimal operational activities. As a result, while we made substantial scientific and strategic progress, we were unable to localize the technology or initiate large-scale revenue generation in 2025. Our activities therefore focused on clinical validation, scientific dissemination, and engagement with key stakeholders, particularly Ministries of Health.
Key Achievements in 2025
1. Clinical validation: We finalized two high-impact studies with outstanding results:
– Aarhus University Hospital: Sensitivity 95%, Specificity 98%
– Paraguay Newborn Screening Program (Ministry of Health): Sensitivity 98%, Specificity 100%
These results strongly validate the robustness, accuracy, and scalability of our technology.
2. Scientific output: We published three peer-reviewed scientific papers and one white paper, strengthening our credibility and scientific leadership.
3. Intellectual property: Our core patent application progressed significantly and is expected to be granted in Q1 2026.
4. Commercial readiness: We structured our commercial strategy into three revenue tiers and finalized or are in the final stages of agreements covering nine countries.
5. External recognition: We received grants and awards, including the European Commission’s Seal of Excellence, reaffirming the innovation and impact of our work.
6. Global engagement: We participated in multiple international conferences and congresses, strengthening and expanding partnerships with public health systems, industry leaders, key opinion leaders (KOLs), and patient communities.
Looking ahead, we enter 2026 with clear priorities and renewed focus:
Commitment #1: Finalize due diligence with two strategic investors in Q1 2026.
Commitment #2: Launch gMendel®Test in selected countries in the Global South, with the objective of initiating revenue generation in 2026.
Thank you for your continued trust and support. Despite the challenges faced in 2025, we have built a strong scientific, regulatory, and strategic foundation. We enter the next phase with confidence, determination, and a clear path toward impact.
Together, we are advancing affordable and accurate mass screening technologies for early diagnosis in prenatal and newborn care, reducing the burden on families and delivering significant, long-term cost savings for healthcare systems worldwide.
gMendel® Executive Management
Read the full 2025 Year in Review – Building the Foundation for 2026 here.