PROGNOSIS study of Elecsys sFlt-1/PlGF immunoassay ratio test for pre-eclampsia published in NEJM- Roche
Roche has announced that the New England Journal of Medicine has published the results of PROGNOSIS, a groundbreaking clinical study demonstrating the prognostic value of the company’s Elecsys sFlt-1/PlGF immunoassay ratio test in predicting which pregnant women are at highest risk of developing pre-eclampsia, one of the leading causes of death and complications for mothers and their unborn babies.
The PROGNOSIS study has demonstrated that low ratios of the proteins sFlt-1 and PlGF in the blood of women showing the signs and symptoms of pre-eclampsia can predict the absence of the condition within a period of one week (the rule-out claim). The data published shows that an sFlt-1/PlGF ratio of 38 and below can rule out the development of pre-eclampsia within the next week with a very high confidence level of 99.3%. Identifying women who are unlikely to develop pre-eclampsia in the short term will save them from the stress of monitoring and the disruption to their home life caused by a stay in hospital. PROGNOSIS also demonstrated that an sFlt-1/PlGF ratio greater than 38 may help predict whether women with suspected pre-eclampsia will develop the condition within four weeks (the rule-in claim), allowing doctors to identify at-risk patients who need close monitoring.
These important new findings represent a step-change in the prediction of pre-eclampsia in the clinical setting, where the gold standard has traditionally relied on the measurement of proteinuria (protein in the urine) and blood pressure. Unfortunately, both are sub-optimal predictors of which women will develop pre-eclampsia and how the disease will progress. As a consequence, many women with signs and symptoms of the disease are unnecessarily admitted to hospital for intensive observation and monitoring, resulting in worry for them and their families, and additional costs to the health provider.
Comment: Elecsys sFlt-1/PlGF immunoassay ratio test has a CE Mark.
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