At the European Association for the Study of Diabetes (EASD) 2024 conference, a pioneering study, named the DiaUnion Project, was presented, showcasing advances in early screening for type 1 diabetes (T1D) and associated autoimmune diseases. This research addresses the early identification of T1D, celiac disease (CD), and autoimmune thyroid disease (AITD)—known collectively as the TRIAD diseases—using innovative antibody detection technologies. This represents a major step forward in the implementation of large-scale, presymptomatic screening programs that could transform the way these conditions are identified.
The study involved over 3,600 participants, including first-degree relatives (FDR) of newly diagnosed T1D patients in Denmark and children from the general population in Skåne, Sweden. It evaluated the feasibility of at-home capillary blood sampling, the effectiveness of the antibody detection by agglutination-PCR (ADAP) multiplex technology, and its comparison with the gold-standard radio binding assay (RBA) for detecting autoantibodies (AAB) related to T1D, CD, and AITD.
The results confirmed the high prevalence of autoimmune markers in FDRs, with 13.5% of the Danish cohort testing positive for a TRIAD-related AAB and 7.5% for a T1D-specific AAB. Similar findings were observed in the general Swedish population, with 9.3% testing positive for TRIAD autoantibodies and 2.6% for T1D-specific markers. Importantly, the ADAP technology showed excellent agreement with the RBA, demonstrating a 97.1–99.3% match, validating it as a viable, less invasive, and scalable method for large-scale screening.
This research underscores the critical importance of presymptomatic screening for T1D and other autoimmune conditions. Early detection through AAB screening allows for the identification of high-risk individuals before clinical symptoms emerge, offering a window of opportunity for early intervention strategies. As the incidence of T1D continues to rise globally, the ability to detect individuals at risk could shift the focus from reactive treatment to proactive disease management.
The DiaUnion Project further highlights the feasibility of at-home screening programmes, with participants successfully collecting and submitting their own blood samples via mail. This model could significantly reduce the burden on healthcare systems while increasing accessibility to screening for autoimmune diseases. The study’s success in establishing a large-scale recruitment and sampling process demonstrates the potential for such programs to be expanded, targeting high-risk populations and general public cohorts alike.
For pharmaceutical companies, the implications of the DiaUnion Project are far-reaching. As presymptomatic screening becomes more widespread, there will be growing demand for therapies that can delay or even prevent the progression of T1D in individuals identified as high-risk. This opens the door for companies to invest in disease-modifying therapies, particularly those targeting immune modulation in the early stages of autoimmunity.
The demonstrated success of ADAP as a reliable and scalable method for AAB detection could also reduce the costs associated with early-stage clinical trials, as large numbers of at-risk individuals can be identified more efficiently. This may streamline trial recruitment, accelerating the pace of research and innovation in autoimmune therapies.
Moreover, the TRIAD concept outlined in the study supports a broader approach to autoimmune disease management, where screening and treatment strategies may be integrated across T1D, CD, and AITD. This multi-disease focus could lead to the development of combination therapies or preventive approaches that address overlapping autoimmune pathways.
The DiaUnion Project’s findings signal a major advancement in presymptomatic screening for T1D and related autoimmune diseases. With the potential to implement widespread screening programs and the validation of diagnostic technologies like ADAP, this research paves the way for earlier detection, a significant unmet need in the T1D landscape. For pharmaceutical companies, the opportunity to develop disease-modifying treatments presents a significant frontier in T1D management, ultimately transforming the landscape of autoimmune disease care.
