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CORDIS

Advancing Affordable, Immune-Based Multi-Cancer Early Detection

Objective

Cancer is the second leading cause of death in Europe, and its burden is expected to rise sharply, with the World Health Organization projecting a 77% increase in cases by 2050. Despite commitments to expand population-based screening, 50% of cancers are still detected at advanced stages and 70% of cancer deaths arise from cancers without available screening. Current multicancer detection tests, largely based on circulating tumour DNA (ctDNA), remain too insensitive for early-stage disease and too expensive for widespread use (~€875 per patient), making them unsuitable for population-scale implementation.
Enlighten®, developed by Proteotype Diagnostics, introduces a new approach to multicancer early detection (MCED), by measuring the host’s immune-driven proteomic response rather than scarce tumour-derived material. Using a simple fluorescence-based kit and an AI classifier, Enlighten® quantifies Protein Cross Sections directly from neat plasma. Independent validation shows high stage I sensitivity, with 95% overall sensitivity and 100% specificity across multiple solid tumours, at a price point compatible with decentralised, population-level screening.
The Enlighten Pre-Accelerator project will advance Enlighten® from TRL 5 to TRL 6 and BRL 4 to BRL 6 through AI model optimisation, multi-geography data harmonisation, and development of a clinician-ready digital interface. Cloud security, interoperability and SaMD documentation will be strengthened to meet IVDR and ISO 13485/IEC 62304 requirements. These activities will deliver a clinically verified, regulatory-ready platform and establish a clear pathway toward pivotal validation studies and EIC Accelerator funding.
The Enlighten Pre-Accelerator will deliver a CE-ready TRL6/BRL6 platform for affordable MCED. Enlighten® has the potential to become Europe’s first scalable MCED solution, reducing late-stage diagnoses, lowering healthcare expenditure, and enabling more equitable access to cancer prevention.

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Programme(s)

Topic(s)

Funding Scheme

HORIZON-CSA - HORIZON Coordination and Support Actions

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Call for proposal

(opens in new window) HORIZON-WIDERA-2025-02

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Coordinator

PROTEOTYPE DIAGNOSTICS UNIPESSOAL LDA
Net EU contribution
€ 498 840,56
Address
RUA DR GOMES LEAL N3A
2560-331 TORRES VEDRAS
Portugal
SME
Yes
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Total cost
No data