Feasibility study for clinical validation of NTproCNP as a novel biomarker for pregnancy complications

Project Information

Safe Gestation

Grant agreement ID: 684335

DOI 10.3030/684335

Project closed

EC signature date 3 June 2015

Start date 1 July 2015

End date 31 October 2015

Funded under

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

Total cost € 71 429,00

EU contribution € 50 000,00

Coordinated by

THE ANTIBODY LAB GMBH
Austria

Objective

In Europe and US about 12 million women are pregnant every year. 2 % to 8 % are affected by pre-eclampsia and intra uterine growth restriction. And more dramatically worldwide more than 50,000 mothers and babies are dying yearly due to undetected pre-eclampsia. Accuracy and prognostic performance of the current “gold standard” diagnosis, relying on blood pressure and urinary protein measurement, are relatively poor. Thus a reliable test for the common causes of fetal and maternal morbidity is needed. BDF previously developed an improved research-use-only test system for measuring NTproCNP for prediction of severe events in pregnancy very early before month 16. This marker is superior to all other solutions on the market, and to coming up solutions. However, before entering of NTproCNP measurement into medical routine, the marker has to be validated in a large prospective clinical study and NTproCNP measurement has to be made available in an automated and most robust way to guarantee worldwide application and distribution.
Having this diagnostic tool in hand assuming 20,000 of severe cases in western countries could be prevented, saving lives and improving quality of life for women and families. Moreover, health care costs up to 1.3 billion Euro could be saved. The absolute market for the diagnostic tool is estimated to be nearly 290 million €, promising as well high economic prospects and growth for BDF GmbH.
In phase 1 of the project, information on potential clinical market in gynaecology as well as regulatory requirements in this segment will be collected and analysed, the clinical trial will be planned, and the elaborated business plan will be prepared.

Fields of science (EuroSciVoc)

CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: https://op.europa.eu/en/web/eu-vocabularies/euroscivoc.

• medical and health sciences › clinical medicine › obstetrics › fetal medicine
• medical and health sciences › clinical medicine › gynaecology

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Programme(s)

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

Topic(s)

• PHC-12-2015-1 - Clinical research for the validation of biomarkers and/or diagnostic medical devices

Call for proposal

H2020-SMEInst-2014-2015

See other projects for this call

Sub call

H2020-SMEINST-1-2015

Funding Scheme

SME-1 - SME instrument phase 1

Coordinator

THE ANTIBODY LAB GMBH

• Net EU contribution: € 50 000,00
• Address: DIVISCHGASSE 4 ; 1210 WIEN ; Austria
• SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes:
  Region
  Ostösterreich › Wien › Wien
• Region: Ostösterreich › Wien › Wien
• Activity type: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Total cost: € 71 429,00