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Clinical validation of host biomarker signature for distinguishing bacterial versus viral lower respiratory tract infections (LRTI) in adults at the point-of-need

Objective

Lower respiratory tract infection (LRTI) is the 3rd leading cause of death worldwide. In the EU 30 million incidents occur annually, with associated costs of €46 billion. Older adults are at higher risk of developing LRTI, and therefore, in light of Europe's ageing population, the disease burden will increase. Since most adult LRTIs are managed in the outpatient setting, innovative diagnostic tools for guiding treatment at the point-of-need (PON), would be impactful.
MeMed identified a host-biomarker signature comprising a novel viral induced protein called TRAIL. Based on this signature, MeMed developed a test called ImmunoXpertTM (CE-IVD approved). In a prospective study with >1000 patients, ImmunoXpert™ accurately distinguished viral versus bacterial infections, significantly outperforming traditional tests. Two factors prohibit wide adoption of ImmunoXpert for managing LRTI adult patients: i) insufficient clinical evidence validating the signature in this subpopulation and ii) ImmunoXpert™ is performed in a lab and requires 2 hours. To address this we propose:

• To clinically validate the biomarker signature for accurate diagnosis of viral versus bacterial LRTI, in a prospective study enrolling 1100 adult EU patients at the PON

• To develop, validate and obtain EU regulatory clearance for a new PON device (to be called ImmunoDx™) that rapidly measures the signature from a drop of blood

These objectives are highly aligned with the SME instrument goals and MeMed’s strategy. They will allow a pioneering test to achieve accelerated market adoption, initially in Europe and then globally. The validated signature, measured using ImmunoDx™, will give physicians, accurate and actionable information at the PON. This test has potential to profoundly impact patients' quality of life by reducing adverse effects due to antibiotic overuse; reducing complications and mortality due to underuse; and slowing the emergence of antibiotic resistant bacteria, a major public health

Fields of science (EuroSciVoc)

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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.

SME-2 - SME instrument phase 2

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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) H2020-SMEInst-2014-2015

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Coordinator

MEMED DIAGNOSTICS LTD
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.

€ 2 935 000,00
Address
NAHUM HETH STREET 5
39120 TIRAT CARMEL
Israel

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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
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
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.

€ 2 935 000,00
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