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A next-generation PCR tool for rapid and early diagnosis of sepsis aetiology

Objective

Sepsis is a life-threatening condition caused by a dysregulated immune response to infection, responsible for over 11M deaths annually. Rapid identification of the causative pathogen is essential, as each hour of delay in targeted treatment increases mortality by ~8%. Current diagnostics, such as blood culture, are slow (up to five days) and frequently yield false negatives, while existing PCR-based tools remain limited by narrow pathogen panels, low sensitivity in whole blood, and dependence on complex, costly instrumentation.

The SURPASS project, led by DIANA Biotechnologies, will advance SepsiSense, a next-generation molecular diagnostic tool enabling rapid, ultra-sensitive detection of sepsis-causing pathogens directly from whole blood. SepsiSense integrates proprietary PCR enzymes, inhibitor-resistant chemistry, and a novel deep multiplex design capable of detecting ~30 bacterial and fungal pathogens, and antibiotic resistance genes in a single reaction. Its unique RNA–DNA co-detection approach provides superior sensitivity and enables assessment of pathogen viability and resistance activity, delivering clinically actionable results within 2 hours.

Through SURPASS, DIANA will mature SepsiSense from early TRL 4 to TRL 6, expanding the pathogen panel, validating the assay across commercial PCR platforms, and aligning performance with IVDR standards. In parallel, the project will strengthen DIANA’s business and investor readiness through development of a market-validated business plan, IP and regulatory strategy, and partnerships with hospitals, KOLs, and diagnostic companies.

Offering high performance, affordability (~€25/test), and compatibility with existing PCR systems, SepsiSense will enable faster, more accurate diagnostics, support antibiotic stewardship, and reinforce Europe’s leadership and autonomy in advanced molecular healthcare technologies.

Fields of science (EuroSciVoc)

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Keywords

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Programme(s)

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Topic(s)

Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.

Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

HORIZON-CSA - HORIZON Coordination and Support Actions

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

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

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Coordinator

DIANA Biotechnologies, a.s.
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 498 969,10
Address
Prumyslova 596
252 50 Vestec
Czechia

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Česko Střední Čechy Středočeský kraj
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

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