SYNDECAN-3 BASED BLOOD TEST FOR EARLY ALZHEIMER’S DIAGNOSIS

Obiettivo

SYNEAD aims to transform Alzheimer’s disease (AD) diagnostics by validating the world’s first syndecan-3 (SDC3)-based blood-test for early, affordable, and accessible detection. AD is typically diagnosed at late stages, as current tests rely on costly or invasive cerebrospinal fluid and PET procedures. More than 80 % of early-stage patients remain undiagnosed until irreversible neurodegeneration occurs. As the first disease-modifying treatments are becoming available, and are only effective at the earliest stage of disease, there is an urgent need and large potential market, for a novel method for early detection of AD.

Building on Pharmacoidea’s patented technologies (EP4185874B1, US20230296629A1) and existing laboratory proof-of-concept (TRL 4), SYNEAD will advance the SDC3 diagnostic workflow to a validated, regulatory-ready level (TRL 6) through systematic analytical optimisation and biobank-based validation. SDC3 detection standardised and tested across monocyte, PBMC, and plasma matrices using quality-management principles consistent with ISO 13485 and aligned with EU IVDR analytical-performance requirements. Validation on 200 biobank samples will confirm diagnostic sensitivity ≥ 80 % and specificity ≥ 75 %, establishing SDC3 as an upstream, disease-causative biomarker.

In parallel, SYNEAD will generate CE-IVD-aligned technical documentation, a regulatory roadmap, and an investment-ready business plan supported by market, IP, and reimbursement analyses. Its exploitation strategy combines direct deployment in EU diagnostic laboratories with strategic licensing to industrial partners, enabling rapid market uptake while maintaining European production sovereignty. The project supports the EU’s goals in neurodegenerative-disease prevention, health-system resilience, and biomedical strategic autonomy, generating tangible economic and societal benefits through earlier AD detection and improved quality of life for patients and caregivers.