Ghent, Belgium, July 9, 2012. Pronota NV, a company dedicated to the development of best-in-class diagnostics for early detection of life-threatening conditions, announced today that it has successfully validated its mid-gestation pre-eclampsia screening test. This test correctly identifies 80% of women at risk for the development of pre-term pre-eclampsia according to a study in collaboration with the SCreening fOr Pregnancy Endpoints (SCOPE) Consortium, one of the largest international research efforts dedicated to the prediction of late pregnancy diseases.
Pre-eclampsia is responsible for 50,000 maternal deaths annually and is a major cause of premature and still births. This potentially devastating condition is unique to pregnancy and primarily affects women who are pregnant for the first time. Between 4 and 7% of healthy women have their first pregnancy complicated with pre-eclampsia with no prior predisposition or warning signs. Pronota’s assay, which combines five protein biomarkers and blood pressure, offers an improvement to existing tests.
Dr. Philip Baker, Professor of Obstetrics and Gynaecology at the University of Alberta, commented: “A test that correctly identifies women at risk of pre-eclampsia could allow physicians to adapt prenatal care and lead to improved outcomes for both mothers and infants.”
Pronota used its proprietary proteomics platforms to identify, verify and validate a panel of novel blood biomarkers which are predictive of pre-eclampsia at the mid-gestation time point. An unbiased large scale proteomics biomarker discovery experiment was followed by verification of the results in 300 women who either subsequently developed pre-eclampsia or did not. The predictive merit of the biomarker panel was subsequently confirmed in another study of 300 women from a different population. In this validation study, the screening test identified 80% of the women who developed pre-eclampsia that resulted in birth of a premature baby (preterm pre-eclampsia). These MS based results were successfully translated to an ELISA type read out. This important milestone was achieved through a longstanding scientific collaboration with Professor Baker from the University of Alberta, Professor North from King’s College, London and Dr. Myers from Manchester Maternal & Fetal Health Research Centre, UK.
Professor North from King’s College, London commented: “The prediction model developed in this study represents a rare example of a rigorously validated proteomic biomarker study, the findings of which have the potential to be translated into a clinical prediction tool.”
The cohort used for the study was compiled by the SCOPE Consortium who collected blood samples and gathered medical and lifestyle information from 5,600 women in six centres across Australia, New Zealand, the UK and the Republic of Ireland over eight years. This controlled prospective study using high quality plasma samples and clinical data allowed for the rigorous and stepwise validation of Pronota’s test.
Dr. Jenny Myers, Clinical Senior Lecturer, Manchester Maternal & Fetal Health Research Centre, UK, will present a discussion of the Pronota-SCOPE study at the International Society for the Study of Hypertension in Pregnancy meeting in Geneva in July.
Katleen Verleysen, CEO of Pronota, said: “We are very pleased to bring forward a novel combination of biomarkers predictive for pre-eclampsia, which will provide physicians with the best tools to ensure the highest quality of care for patients. This study also validates Pronota’s approach towards biomarker discovery and validation, a company capable of taking unbiased discovery results through to validation.”
Dr Katleen Verleysen, CEO
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Pronota is developing and commercialising first-in-class diagnostics for early detection of life-threatening conditions and unmet medical needs including pre-eclampsia, ovarian cancer and sepsis. Our non-invasive, validated, diagnostics are proprietary and focused on improving quality of care for patients. Backed by a solid base of investors including GIMV, LSP, KBC Private Equity and JJDC, and a wide network of renowned key opinion leaders, Pronota is committed to making a difference in diagnosis and personalized healthcare.
Pre-eclampsia is a medical condition where hypertension arises in pregnancy, in association with protein leakage into the urine. It is the leading causes of maternal deaths in the US and Europe. With over 4m pregnancies a year in the US alone, there is a compelling health economic argument for the needs for an effective, early, pre-eclampsia prediction test. Pronota has a validated test for risk-stratification of pre-eclampsia at 20 weeks of gestation, using the company’s proprietary mass-spectrometry based platform for detection and validation of low abundance protein biomarkers.
About SCOPE Consortium
The SCOPE study arises from the knowledge that there are a number of potential clinical and molecular markers (certain proteins, fats and small molecules in blood) for these complications. None of these candidate markers are useful as individual predictive tests, but combinations of markers are likely to result in clinically useful screening tests. Further, recent advances in proteomic and metabolomic technologies and bioinformatics (advanced mathematics) allow us to discover and map differences in molecules circulating in the blood of women who later develop these conditions. This has created the opportunity to develop effective methods of predicting these diseases, with the potential to dramatically improve maternal and infant health worldwide.