"Screening of Type 1 Diabetes has become a hot topic and is discussed at every international diabetes meeting since a couple of years back", says Gun Forsander. "The vision is to diagnose persons already at an early stage and be able to offer a personalized follow-ups and treatment to prevent or at least delay the clinical onset. Research has proved that Type 1 Diabetes is not one single disease but rather a composite of subgroups that will respond differently to offered interventions. Precision medicine is therefore of utmost importance to achieve best possible impact of interventions and care for people at risk for Type 1 Diabetes".

A key highlight of the development work is the use of individual survival prediction (ISP) models, which move beyond traditional statistical strategies for risk determination by offering personalized insights into when a subject is likely to develop Type 1 Diabetes. The models have been trained and validated using data from The Environmental Determinants of Diabetes in the Young (TEDDY; https://teddy.epi.usf.edu/index.html) study and demonstrated the potential to optimize screening frequency and improve follow-up strategies. The predictor models have been developed for possible implementation on the MainlyAI platform, a one-stop-shop for secure and collaborative work with AI/ML (https://www.mainly.ai/).

• AI-based models leverage individual data, including genetics (such as HLA typing), autoantibody profiles and patient history to predict risk.
• Unlike traditional statistical approaches, which assess risk at the population level over standardized intervals, the novel ISP enhances predictive accuracy by estimating the likelihood of disease onset at an individual level.
• The models offer significant potential in clinical decision-making, allowing healthcare providers to customize screening schedules and follow-up frequency on an individual level. High-risk individuals may benefit from closer, more frequent monitoring, optimizing early detection and intervention strategies.

"The notion of a precision medicine ecosystem, where AI-powered screening and risk prediction seamlessly integrate with targeted interventions, is a game changer, says Ulf Hannelius, CEO of Diamyd Medical. "It has the potential to greatly improve patient outcomes and reshape pharma and biotech, leading to better treatments and more sustainable healthcare. By using AI for earlier diagnosis, personalized risk assessment, and tailored treatments, we are paving the way for meaningful improvements throughout the patient journey."

Using AI for early disease detection
The ASSET project, funded by the Swedish Innovation Agency (Vinnova) since 2021 and coordinated by Diamyd Medical, is focused on evaluating how AI can enhance Type 1 Diabetes screening strategies by integrating genetic data, clinical and digital biomarkers to predict disease onset with greater precision.

As AI-driven approaches continue to evolve, the ASSET consortium envisions a future where such strategies can also support the implementation of a precision medicine approach to Type 1 Diabetes, through personalized interventions and improved disease management. Further research will focus on refining predictive models and showcasing how AI could be used in facilitating earlier diagnosis and treatment selection within Type 1 Diabetes.

ASSET is a collaboration between Diamyd Medical, Mainly AI, Lund University, Sahlgrenska and Örebro University hospitals, the National Diabetes Registry and Leading Healthcare foundation.

About Diamyd Medical
Diamyd Medical develops precision medicine therapies to prevent and treat Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd^® is an investigational antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production specifically for individuals carrying a HLA DR3-DQ2 gene. Diamyd^® has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 3 (insulin requiring) Type 1 Diabetes. Diamyd^® has also been granted Fast Track Designation for the treatment of Stage 1 and 2 (not yet insulin requiring) Type 1 Diabetes. DIAGNODE-3, a confirmatory Phase III trial is actively recruiting patients with recent-onset (Stage 3) Type 1 Diabetes at 60 clinics in eight European countries and in the US. Significant results have previously been shown in a large genetically predefined patient group - in a large-scale meta-analysis as well as in the Company's prospective European Phase IIb trial, DIAGNODE-2. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of recombinant GAD65 protein, the active ingredient in the antigen-specific immunotherapy Diamyd^®. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB.

Diamyd Medical's B share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company's Certified Adviser.