FluiDx-AD aims to transform Alzheimer’s disease (AD) diagnosis and prepare the EU healthcare systems for the emergence of new AD therapies, with a 1st-in-class trio of In Vitro Diagnostics tests. FluiDx-AD tests detect a unique and proprietary suite of biomarkers in simple bodily fluids (saliva, plasma/blood), towards widespread, patient-empowering, and all-inclusive AD diagnosis, at least as accurate as the costly and invasive procedures currently in place. FluiDx-AD tests have the potential to shorten AD diagnosis by 7-15 years, by detecting biomarkers that mark the onset of AD years before the appearance of clinical symptoms. Earlier diagnosis means earlier access to preventive interventions, which are now more effective thanks to next-generation immunotherapies. The clinical use of these new drugs is not consensual though, because of the severe side-effects they inflict in some patients. FluiDx-AD tests offer a pioneering tool to stratify and monitor patients eligible for these drugs, towards reducing their associated risk and accelerating their regulatory clearance in the EU. FluiDx-AD tests are thus devised to work complementarily and sequentially, covering the full AD diagnostic journey (from population-wide screenings to confirmatory diagnosis, and downstream patient stratification and monitoring), tackling key challenges of early AD diagnosis and AD prevention with new drugs, while also paving the way for the development of new therapies by streamlining patient selection and appraisal in clinical trials. FluiDx-AD brings together a team of highly motivated, committed, and reputed entrepreneurs, clinicians, and scientists from biotechs, hospitals, academic centres, and patient organizations across the EU. Leveraging our unique blend of trans-disciplinary/-sectoral expertise and access to advanced technologies and infrastructures, we join forces to realize the vision of a new era of AD clinical management for the benefit of millions of patients globally.