IMPROvED

IMproved Pregnancy Outcomes by Early Detection; personalized medicine for pregnant women: novel metabolomic and proteomic biomarkers to detect pre-eclampsia and improve the outcome

1 in 20 first time pregnancies are complicated by pre-eclampsia, the leading cause of maternal death in Europe. No clinically useful screening test exists; consequently, clinicians are unable to offer targeted surveillance or known/emerging preventative strategies. Consortium members have pioneered a personalised medicine approach to identifying blood-borne biomarkers through recent technological advancements, especially in the field of mass spectrometry and the comprehensive mapping of the blood metabolome and proteome.
The overall objective of the IMPROvED project is to develop a sensitive, specific, high-throughput and economically viable early pregnancy screening test for pre-eclampsia. This will involve a multicentre, phase IIa clinical study to assess and refine novel and innovative prototype tests based on emerging metabolomic and proteomic technologies developed by SMEs within the consortium. The study will i) recruit 5000 first time pregnant women; ii) establish a high calibre biobank, augmented by accurate clinical metadata; iii) determine whether prototype predictive assays and algorithms translate to the clinical environment; iv) assess potential synergy of a combined metabolomic and proteomic approach and v) progress regulatory approval and development of the selected test into the clinical arena.
The application of new technologies to identify ‘at risk’ patients in early pregnancy will allow stratified care with personalized fetal and maternal surveillance, early diagnosis and timely intervention. If an effective test halved antenatal visits and administration of therapies (such as aspirin) to those at risk reduced the incidence of disease by only 20%, potential savings would approximate to €4 billion of the estimated €9 billion/yr spent in Europe providing antenatal care for nulliparous women and treatment for pre-eclampsia. Moreover, an accurate predictive test would be a crucial step in reducing the life-threatening complications of the disease.

• accelopment Schweiz AG, CH
• Erasmus Universitair Medisch Centrum, NL
• Karolinska Institutet, SE
• MedSciNet AB, SE
• Metabolomic Diagnostics Ltd, IE
• Pronota NV, IE
• Region Hovedstaden, DK
• Rijksuniversiteit Groningen, NL
• The University of Liverpool, UK
• University College Cork, IE
• University of Keele, UK