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Respiratory-ImmunoDx

Financiado

Cerrado

Clinical validation of host biomarker signature for distinguishing bacterial ver...

Clinical validation of host biomarker signature for distinguishing bacterial versus viral lower respiratory tract infections LRTI in adults at the point of need 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 the... ver más

30/11/2018

MeMed Diagnostics

3M€

Presupuesto del proyecto: 3M€

Líder del proyecto

MEMED DIAGNOSTICS LTD No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Fecha límite participación Sin fecha límite de participación.

Financiación concedida El organismo H2020 notifico la concesión del proyecto el día 2018-11-30

PHC-12-2015: Clinical research for the validatio...

I+D

Cerrada hace 9 años

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Información adicional privada

No hay información privada compartida para este proyecto. Habla con el coordinador.

1 Participantes

MeMed Diagnostics

2.94M€ | Lider

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Duración del proyecto: 36 meses Fecha Inicio: 2015-11-27
Fecha Fin: 2018-11-30

Líder del proyecto

MEMED DIAGNOSTICS LTD No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Presupuesto del proyecto 3M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto 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

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