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Safe Gestation

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Feasibility study for clinical validation of NTproCNP as a novel biomarker for p...

Feasibility study for clinical validation of NTproCNP as a novel biomarker for pregnancy complications 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 d... ver más

31/10/2015

BDF

71K€

Presupuesto del proyecto: 71K€

Líder del proyecto

THE ANTIBODY LAB GMBH 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 2015-10-31

PHC-12-2015-1: 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

BDF

50.00K€ | Lider

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Duración del proyecto: 4 meses Fecha Inicio: 2015-06-03
Fecha Fin: 2015-10-31

Líder del proyecto

THE ANTIBODY LAB GMBH No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Presupuesto del proyecto 71K€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto 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.

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