Pronota, a company dedicated to the development of best-in-class diagnostics for early detection of life-threatening conditions, has announced that it has successfully validated its mid-gestation pre-eclampsia screening test.
The 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.
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.
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.”