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Respiratory-ImmunoDx SIGNED

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

Total Cost €

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EC-Contrib. €

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Partnership

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 Respiratory-ImmunoDx project word cloud

Explore the words cloud of the Respiratory-ImmunoDx project. It provides you a very rough idea of what is the project "Respiratory-ImmunoDx" about.

public    diagnosis    ageing    blood    physicians    lrti    diagnostic    tools    signature    worldwide    pon    viral    bacteria    gt    trail    infection    burden    incidents    memed    1100    significantly    infections    accelerated    validated    obtain    antibiotic    outpatient    adult    pioneering    clearance    health    annually    respiratory    innovative    versus    hours    strategy    guiding    host    disease    adults    treatment    globally    sme    distinguished    measured    lrtis    death    profoundly    million    point    3rd    older    immunodx    clinically    ce    subpopulation    impactful    emergence    adoption    comprising    tests    performed    trade    market    enrolling    outperforming    initially    light    drop    insufficient    prospective    give    bacterial    accurate    aligned    immunoxpert    setting    validating    46    biomarker    lower    accurately    clinical    validate    billion    managed    approved    lab    risk    regulatory    complications    instrument    device    goals    adverse    ivd    reducing    immunoxperttm    prohibit    actionable    population    slowing    overuse    protein    patients    tract    underuse    1000    mortality    resistant    quality    life   

Project "Respiratory-ImmunoDx" data sheet

The following table provides information about the project.

Coordinator
MEMED DIAGNOSTICS LTD 

Organization address
address: NAHUM HETH STREET 5
city: TIRAT CARMEL
postcode: 39120
website: www.me-med.com

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
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 Coordinator Country Israel [IL]
 Project website http://www.me-med.com/html5/
 Total cost 2˙935˙000 €
 EC max contribution 2˙935˙000 € (100%)
 Programme 1. H2020-EU.2.1.3. (INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Advanced materials)
2. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-SMEINST-2-2015
 Funding Scheme SME-2
 Starting year 2015
 Duration (year-month-day) from 2015-12-01   to  2018-11-30

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    MEMED DIAGNOSTICS LTD IL (TIRAT CARMEL) coordinator 2˙935˙000.00

Map

Leaflet | Map data © OpenStreetMap contributors, CC-BY-SA, Imagery © Mapbox

 Project 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

 Deliverables

List of deliverables.
A dedicated website for OBSERVER and ImmunoDxâ„¢ Websites, patent fillings, videos etc. 2019-05-31 17:19:04
Presenting at infectious disease conference Websites, patent fillings, videos etc. 2019-05-31 17:19:02

Take a look to the deliverables list in detail:  detailed list of Respiratory-ImmunoDx deliverables.

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The information about "RESPIRATORY-IMMUNODX" are provided by the European Opendata Portal: CORDIS opendata.

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