Validation of a point-of-care H-FABP test for a rapid exclusion of Acute Myocardial Infarction in patients with cardiac complaints.

Projektinformationen

RapidEx

ID Finanzhilfevereinbarung: 666666

DOI 10.3030/666666

Abgeschlossenes Projekt

EK-Unterschriftsdatum 27 Juni 2015

Startdatum 1 April 2015

Enddatum 31 Oktober 2017

Finanziert unter

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Gesamtkosten € 1 633 750,00

EU-Beitrag € 1 633 750,00

Koordiniert durch

FABPULOUS BV
Netherlands

Ziel

There is a pressing need for improvement of the diagnosis of acute myocardial infarction (AMI) for healthcare professionals (HCP). 1–1,5% of the population consult a physician each year with chest pain complaints. While the majority (60–80%) of these patients are sent to a hospital for further inspection, eventually AMI is diagnosed in only 8–18% of these cases. Consequently, a rapid, objective test that helps to better select patients suspected of AMI by HCPs would reduce the number of unnecessary hospital referrals and admissions, thereby saving costs and contributing to a more sustainable healthcare.

FABPulous (SME) is a medical device company spun out of Maastricht University in 2008. The core of the company is its innovative proprietary technology that allows a simple, robust and ultra-rapid diluted plasma preparation from a drop of blood. This offers great advantages over current technologies in point-of-care and home testing.

The CE-marked H-FABP True Rapid Test (H-FABP TRT) developed by FABPulous aids the HCP in ruling out AMI with a very high level of confidence. It is based on the heart-type fatty acid binding protein (H-FABP), which can be used as biomarker for AMI. With H-FABP TRT a physician is able to rule out the occurrence of an AMI for a large proportion of patients suspected of AMI. It is intended for use in both primary and emergency care.

In this project FABPulous seeks to medico-economically validate H-FABP TRT in primary (Netherlands+Belgium) and emergency care (UK) by performing two clinical trials. Outcomes of these studies lead to adoption of H-FABP TRT in medical guidelines and form the basis of a request for reimbursement towards health insurers. In this project FABPulous will improve the production process as well in order to decrease the cost price to €5 per test.

The addressable market in NW Europe alone amounts to at least 2 mln tests. The phased introduction plan leads to €8.6 mln revenue with a gross margin of €6.5 mln in 2018.

Wissenschaftliches Gebiet

• medical and health sciences › clinical medicine › surgery
• medical and health sciences › clinical medicine › emergency medicine
• natural sciences › biological sciences › biochemistry › biomolecules › lipids
• medical and health sciences › health sciences › infectious diseases › RNA viruses › HIV
• medical and health sciences › clinical medicine › cardiology › cardiovascular diseases

Programm/Programme

• H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme
• H2020-EU.3.1.3. - Treating and managing disease

Thema/Themen

• PHC-12-2014 - Clinical research for the validation of biomarkers and/or diagnostic medical devices

Aufforderung zur Vorschlagseinreichung

H2020-SMEInst-2014-2015

Andere Projekte für diesen Aufruf anzeigen

Unterauftrag

H2020-SMEINST-2-2014

Finanzierungsplan

SME-2 - SME instrument phase 2

Koordinator

FABPULOUS BV

• Netto-EU-Beitrag: € 1 633 750,00
• Adresse: OXFORDLAAN 55 ; 6229 EV MAASTRICHT ; Niederlande
• KMU Die Organisation definierte sich zum Zeitpunkt der Unterzeichnung der Finanzhilfevereinbarung selbst als KMU (Kleine und mittlere Unternehmen). Ja:
  Region
  Zuid-Nederland › Limburg (NL) › Zuid-Limburg
• Region: Zuid-Nederland › Limburg (NL) › Zuid-Limburg
• Aktivitätstyp: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Gesamtkosten: € 1 633 750,00