A novel test trio to detect peptide biomarkers in saliva and blood for enhanced diagnosis and management of Alzheimer's Disease

Project Information

FluiDx-AD

Grant agreement ID: 101155955

DOI

10.3030/101155955

EC signature date 29 November 2024

Start date 1 November 2024

End date 30 April 2028

Funded under

• Health

Total cost

No data

EU contribution

€ 7 699 219,38

Coordinated by

OSLO UNIVERSITETSSYKEHUS HF
Norway

Periodic Reporting for period 1 - FluiDx-AD (A novel test trio to detect peptide biomarkers in saliva and blood for enhanced diagnosis and management of Alzheimer's Disease)

Reporting period: 2024-11-01 to 2026-01-31

Summary of the context and overall objectives of the project

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.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

FluiDx-AD is developing a complementary suite of three minimally invasive in vitro diagnostic tests for Alzheimer’s disease (AD) based on biomarkers measurable in saliva, plasma, and blood cells. Together, these assays are designed to support the full diagnostic pathway, from early population-level risk screening to confirmatory diagnosis and treatment-related risk stratification.

During the first project period, several technical and scientific progress has been achieved.
A secure central FluiDx-data infrastructure was established to integrate clinical information and biomarker measurements from multiple cohorts, resulting in a large multi-site dataset. This resource provides a robust foundation for biomarker discovery, assay optimisation, and validation studies.

Several advances were made in the development and optimisation of the three diagnostic systems.
- For SalivaDx-AD, protocols for saliva collection, biomarker extraction, and ultrasensitive detection of AD-related proteins were established, together with documented analytical performance, stability, and usability characteristics.
- For PlasmaDx-AD, assay sensitivity and robustness were substantially improved through optimisation of electrochemiluminescence-based immunoassays, enabling reliable detection of low-abundance biomarkers and evaluation of candidate diagnostic panels using large biobank datasets.
- For BloodCellDx-AD, protocols for assessing peripheral amyloid-β clearance capacity were refined, demonstrating reproducible performance and preparing the assay for evaluation as a stratification tool for treatment-related risk.

Across all platforms, standard operating procedures were defined, analytical characteristics documented, and protocols for proof-of-concept studies, reference range determination, and clinical validation were completed

Collectively, these achievements mark a transition from early research concepts toward clinically evaluable diagnostic tools. The project has established the necessary scientific foundations, technical methodologies, and data resources to support large-scale validation and future regulatory development of minimally invasive diagnostics for Alzheimer’s disease.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

At this early stage of the project period, FluiDx-AD has primarily produced foundational technical outputs rather than publishable scientific results. Activities have focused on establishing core data infrastructures, optimising assay methodologies, and preparing clinical study protocols for three complementary biomarker-based diagnostic systems targeting different stages of the Alzheimer’s disease (AD) diagnostic pathway. These efforts create the basis for future validation studies and are expected to enable earlier, less invasive, and more accessible detection and stratification of AD.

The potential impact includes improved early diagnosis, reduced reliance on costly or invasive procedures, and safer use of emerging immunotherapies through better patient selection. If successfully validated, the tests could support more timely clinical decision-making, improved patient outcomes, and more efficient use of healthcare resources.

To ensure further uptake and success, key needs include continued clinical validation in diverse populations, real-world demonstration studies, and alignment with regulatory requirements for in vitro diagnostics. Implementing late-stage development, strong intellectual property management, and engagement with regulators, standardisation bodies, and healthcare stakeholders will be essential to support market adoption and long-term impact.