PROGNOSIS study to determine whether serum test predicts preeclampsia

Rotkreuz/Switzerland, 25 November 2013

Positive results will help physicians identify patients at highest risk, improving clinical outcome and healthcare resource allocation

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PROGNOSIS1, a clinical study with more than 1200 subjects enrolled from 14 countries worldwide, is expected to mark a significant improvement in the short-term prediction of preeclampsia. Presented at the 18th World Congress on Controversies in Obstetrics, Gynecology & Infertility (COGI) held in Vienna in October, the study is investigating the correlation between the ratio of two proteins sFlt-1 (soluble fms-like tyrosine kinase-1) and PlGF (placental growth factor) in maternal blood and the risk of developing preeclampsia over the subsequent four weeks. Initial data from the interim analysis show promising results with the potential for clearly improving the conventional diagnostics of the disease, based on the clinical parameters hypertension and proteinuria.

In 2010 Roche introduced the Elecsys® preeclampsia test2, providing healthcare professionals with a reliable tool for the diagnosis of preeclampsia. Another very important benefit, if the study yields its anticipated results, is the possibility of using a fully automated test to predict the disease. Such a predictive test would enable healthcare professionals to focus on patients at highest need of appropriate and timely clinical intervention before the development of full-blown preeclampsia. Likewise, patients identified as unlikely to develop the disease can be safely discharged from hospital.

“The PROGNOSIS study will expand the use of these powerful markers for preeclampsia from the very good performance for aid in diagnosis towards the area of prediction and early risk stratification,” said Prof. Harald Zeisler, Professor of the Department of Obstetrics & Gynecology of the Medical University Vienna and site Principal Investigator for the PROGNOSIS study. "We hope that early identification of women at high risk of developing preeclampsia will allow healthcare professionals to prevent the most serious effects of the disease and avoid unnecessary expenditure by healthcare systems on excessive medical treatment or unnecessary hospital admission prompted by inadvertently positive diagnoses based on current standard of clinical practice.”

Preeclampsia affects about one in 20 pregnancies and is the second most common cause of maternal death. It can be life-threatening for mother and baby especially if diagnosed late and is an indication for immediate preterm delivery when acute. Based on the current guidelines that have remained unchanged for decades, the diagnosis of preeclampsia is based on the clinical parameters of hypertension and proteinuria that are neither specific nor sensitive. In addition, clinical criteria alone may be inadequate for predicting the disease and especially its adverse outcomes, hence the decision to run the PROGNOSIS study addressing the prediction of preeclampsia as an important unmet medical need.

More about PROGNOSIS

PROGNOSIS is a multicenter, prospective, double-blind and non-interventional trial evaluating the short-term prediction of preeclampsia, eclampsia and HELLP (hemolysis, elevated liver enzymes, low platelet count) syndrome in pregnant women with suspected preeclampsia. The study started enrolling in December 2010 at nine sites in Western Europe and was expanded to 31 sites worldwide across Australia, Canada, New Zealand and Latin America in 2012. Interim analysis of the data from the first 500 patients included in the study showed promising results with an approximately 20% prevalence of preeclampsia in the target population. Roche expects first study results to be reported in 2014.

Reference

1) in full: Prediction of short-term outcome in pregnant women with suspected preeclampsia study
2) not available in the U.S.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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