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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


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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Net EU contribution
€ 2 935 000,00
Nahum Heth Street 5
39120 Tirat Carmel

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00