5 March 2025, Oslo, Norway – The FluiDx-AD project, funded by the European Union’s Horizon Europe programme with a budget of EUR 7,699,219.38 for three and a half years, aims to improve the early diagnosis and management of Alzheimer’s disease (AD). The project is scientifically led by Dr Erik Christensen MD PhD, Co-founder and CMO at Pre Diagnostics AS.

Coordinated by Oslo University Hospital, represented by Dr Ira Ronit Hebold Haraldsen MD PhD, the project brings together a consortium of ten partners across Europe.

AD affects over 10 million people in the EU, a number expected to triple by 2050. Current diagnostic tools, such as brain imaging and cerebrospinal fluid tests, are partially invasive, costly and often only used in already advanced disease stages.

FluiDx-AD addresses these limitations by developing minimally invasive, cost-effective in vitro diagnostic (IVD) tests using saliva and blood samples. “Currently, people with Alzheimer’s disease can wait for over a year until they are diagnosed, which means they might miss a crucial window of opportunity for treatment with novel disease-modifying therapies,” Ira Haraldsen explained. “FluiDx-AD aims to make the diagnostic process faster and more accessible, by developing a suite of cutting-edge clinical tests that use minimally-invasive techniques.”

FluiDx-AD seeks to develop a trio of complementary tests:

• SalivaDx-AD: An easy-to-use, at-home saliva test for population-wide detection of individuals at risk of developing AD in its prodromal stages.
• PlasmaDx-AD: A minimally invasive and cost-effective blood test for high-precision confirmatory diagnosis for individuals with suspected AD.
• BloodCellDx-AD: A minimally invasive, whole blood ex vivo test system to evaluate the risk of amyloid-related imaging abnormalities (ARIA), to support patient eligibility assessments and ARIA monitoring for anti-amyloid therapies 

These tests aim to enable earlier detection, better patient stratification and improved monitoring during treatment, enhancing quality of life for millions affected by AD. The project also seeks to expedite the development and acceptance of new disease-modifying therapies by addressing safety concerns and supporting clinical trial recruitment.

Statement from Professor Ole Petter Ottersen, Executive Chairman of Pre Diagnostics AS:

“The new antibody-based AD drugs have serious side effects in a substantial proportion of the patients receiving them. The latest recommendations are calling for biomarkers that can help us distinguish between those patients that stand to benefit from the treatment and those patients that are at risk for serious side effects. Such a biomarker can safely be said to be a medical holy grail in this transformative moment of Alzheimer’s therapy as they would be critical for market penetration of the new drugs. Pre Diagnostics’ unique proprietary blood-based biomarkers hold a strong potential in this regard and the EU grant provides the funding for further development and clinical validation.”

The FluiDx-AD consortium includes:

• Pre Diagnostics and its affiliated entity Pre Neurolab: Scientific Coordinator and developers of patent-protected blood-based biomarkers for amyloid clearance.
• HemoDx: offers a device for saliva collection and biomarker extraction.
• Oslo University Hospital: Project Coordinator and data manager, leveraging expertise from the AI-Mind study.
• Hospitals in Oslo (Oslo universitetssykehus), Helsinki (HUS-yhtymä) and Rome(Università Cattolica del Sacro Cuore & Policlinico Universitario Fondazione Agostino Gemelli): supplying tested samples from an established cohort.
• Fundación Centro de Investigación de Enfermedades Neurológicas (Madrid): providing a biobank and clinical samples.
• Alzheimer Europe: responsible for communication, Public Involvement and ethical considerations.
• Medip Analytics: will develop Health Technology Assessment tools to assess financial implications for healthcare systems and engage with regulatory bodies.

With recent regulatory approvals of disease-modifying therapies and the advent of blood-based biomarkers for early diagnosis, the need for robust, accessible diagnostic solutions for Alzheimer’s disease has never been greater. “This Horizon Europe project unites leading hospitals, academic institutions, SMEs, patient organisations, and health technology assessment experts.” explained Erik Christensen, Scientific Lead of FluiDx-AD. “Together, we are working to bridge the gap between research and clinical practice, accelerating the delivery of innovative diagnostic tools that can transform patient outcomes and enhance Alzheimer’s treatment and care.”

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For further information, contact: 

Scientific Coordinator

Dr Erik Christensen MD PhD: erik@pre-diagnostics.com

Project Coordinator

Dr Ira Ronit Hebold Haraldsen MD PhD: ira.haraldsen@icloud.com

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Stay up-to-date on our activities: https://linktr.ee/FluiDx_AD

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