TAmiRNA aims to commercialize an in-vitro diagnostic test that is intended to predict fracture-risk in case of osteoporosis. The OsteomiR-Test meets an urgent clinical need by combining superior diagnostic performance with a simple test principle, thus, ensuring cost competiveness, good scalability and commercial success. Osteoporosis is a chronic skeletal disease characterized by systemic loss of bone strength and consequently high incidence of bone fractures. Osteoporotic fractures constitute one of the most common and costly health problems in the European Union (EU): costs related directly to fractures were EUR 24.3 billion in 2004 and will rise to EUR 76.8 billion by 2050 due to increasing life expectancy. Effective fracture prevention can be achieved through exercise, diet and drug treatment, but depends on reliable early prognosis of fracture risk. Currently, bone mineral density and clinical factors are the basis for prognosis of fracture risk. However, the low specificity of these tests limits efficient fracture prevention and creates an urgent clinical need for novel and better tests. The OsteomiR-Test measures a proprietary combination of circulating microRNAs from standard blood samples. The analyzed microRNAs provide a direct readout of bone metabolism, stress and biological age, and have been demonstrated to have a strong association with fracture-risk. It is a robust, easy-to-use test with good scalability. In order to commercialize the OsteomiR-Test, a detailed assessment of a market entry strategy is required. Therefore, TAmiRNA will i) develop health economic models to prioritize EU-countries for market launch, (ii) identify suitable manufacturing and distribution partners, (iii) define a strategy for IVD regulatory approval and, (iv) conduct a freedom-to-operate analysis. The results of this feasibility study will help to select target markets and define the cost structure of the test, and are therefore essential to successful commercialization.

Diabetes mellitus has emerged as a novel risk factor for fragility fractures. While in type 1 diabetes the 3-fold overall relative risk for fractures may mostly derive from low bone mineral density (BMD) likely due to the lack of the bone-anabolic hormones, in type 2 diabetes, the fracture risk is increased about 2-fold, despite a normal or even higher BMD. This suggests that bone fragility in each form of diabetes develops by distinct mechanisms that to date remain largely unknown and may require an individualized approach for effective treatment. As the diabetes epidemic is increasing worldwide with aging, and the fractures that are associated with diabetes cause an increase in morbidity, mortality, and healthcare costs, diabetes-induced osteoporosis imposes a significant burden on our society and our healthcare system. FIDELIO offers a comprehensive, multidisciplinary training program for Early Stage Researchers (ESRs) in this emerging field, unravelling i) the biological mechanisms that contribute to altered bone quality parameters with subsequent bone fragility in diabetes, ii) identify predictive markers for patient stratification and individualized interventions, and iii) develop novel imaging techniques to determine bone quality aspects. The research will employ well-defined patient cohorts, preclinical models of diabetic bone disease, in vitro studies, genetic databases, artificial intelligence, and cutting-edge imaging technologies in a highly collaborative and interdisciplinary environment. ESRs will be trained through individual research projects, secondments, residential courses, and webinars provided by a broad range of experts, including bone biologists, clinicians, epidemiologists, geneticists, engineers and entrepreneurs, as well as companies supporting this important area of research. The joint training programme will also develop transferable and entrepreneurial skills to help the ESRs succeed in their choice of professional future.

Total joint arthroplasties (TJA), such as hip and joint replacements, are among the most common surgical procedures worldwide, with over 4,3 million performed annually in OECD countries. This number is expected to increase by 12-50% by 2050. The growing prevalence of TJA has led to a rise in complications (~12% of all surgeries), particularly periprosthetic joint infections (PJI), which occur in 1-2% of patients and is a major cause of surgery revisions. PJI results not only in morbidity and prolonged hospital stays but also a substantial financial burden on healthcare systems. Nevertheless, there is an unmet need for a solution that specifically diagnoses PJI in a timely and cost-effective manner. Current diagnostic methods for PJI are inadequate due to low sensitivity, specificity, long turnaround times, restriction to specific bacterial strains, and high costs. TAmiRNA has developed promiR, the first-in-class microRNA-based biomarker test, which offers near 100% accuracy in diagnosing PJI. promiR stands out by its unique integration of biological and technological innovations. It combines the detection of microRNAs, which are released during the response to infection from the joint tissue as well as immune cells, into a one-stop, streamlined solution, thereby ensuring a precise and reliable diagnosis of PJI. TAmiRNA’s B2B framework plans to introduce promiR in 15 countries from 2027 to 2028, outsourcing manufacturing and distribution. This presents a multimillion market opportunity, with a TAM of €645 million and an initial SAM of €77,5 million. Moreover, assuming a 2032 average market share of 35% in the 15 countries, the SOM will be €28,3 million. EIC funding is crucial for accelerating innovation by closing technological gaps, facilitating regulatory compliance, and successful commercialization of promiR, ultimately revolutionizing PJI diagnostics and improving patient outcomes.

Qualified biomarkers help to optimize drug development and patient safety, yet for the regulatory acceptance of safety biomarkers substantial sample sizes are needed to ensure adequate case and control numbers, and robust evidence sufficient for qualification. To address this challenge, a consortium of leading European research institutions and SMEs has been established. The consortium will generate exploratory and confirmatory data enabling regulatory qualification of new safety biomarkers for application in drug development; establish robust datasets on the DILI, DIKI, DIPI, DIVI and DINI biomarkers to enhance diagnosis of disease; develop and validate assays for new safety biomarkers; implement profiles of circulating miRNAs as tissue and mechanism specific diagnostic tool; have key safety biomarkers accepted as qualified drug development tools by EMA, FDA, and PMDA. Given the significant expertise available across the consortium, the group will be able to tackle the key challenges related to successful biomarker qualification. A key driving principle of the consortium is cross-linking via existing networks of top profile research institutions, as well as capitalizing on existing data and resources. The Consortium is embedded into a network of international research collaborations such as the Pro-Euro-DILI-registry, TransQST, eTRANSAFE, the i2b2 tranSMART Foundation, the CIOMS DILI working group, EPoS, LITMUS, and BBMRI. To optimize regulatory interaction, we intend to continue our successful collaboration with non-European consortia such as PSTC, the FNIH Biomarkers Consortium, and US DILIN. A key expected result of the consortium will be a “Safety Biomarker Factory”, regularly qualifying new markers, with an associated “Safety Biomarker Warehouse”, providing to the scientific community, industry, and patients detailed data and information, and knowledge across a large spectrum of advanced safety biomarkers.