PROGNOSIS study published in the New England Journal of Medicine reveals innovative Roche blood test can be used as a predictive tool for preeclampsia
Study results validate the clinical value of measuring sFlt-1/PlGF ratios in women with suspected preeclampsia,1 accounting for more than 4 out of every 10 maternal deaths each year globally.2
- The PROGNOSIS study is the first multi-center, large-sample study to demonstrate the prognostic value of the Roche Elecsys preeclampsia test to predict the absence of preeclampsia for one week, and the development of preeclampsia within the subsequent four weeks in women with clinical suspicion of the syndrome.
- The addition of the sFlt-1/PlGF ratio measurement to proteinuria and blood pressure measures gives better prediction of preeclampsia, and can reduce hospitalization pre-diagnosis by 50%.3
- The PROGNOSIS study has highlighted the clinical value of measuring sFlt-1/PlGF ratios in women with suspected preeclampsia.
Roche today 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 preeclampsia,1 one of the leading causes of death and complications for mothers and their unborn babies.2
“The emotional benefits of the test are very important: preeclampsia can develop quickly and symptoms can develop even in women who so far have had a healthy pregnancy,” said Professor Harald Zeisler of the Department of Obstetrics and Gynecology at Medical University Vienna, Austria, and an investigator in the PROGNOSIS study. “If we can tell a patient with signs or symptoms that she has a low sFlt-1/PlGF value, and therefore a low risk of developing preeclampsia within short term, that’s a big advantage. On the other hand, women with high sFlt-1/PlGF values can be referred to hospitals with neonatal and adult intensive care units, where they can receive the specialist care they need.”
As well as potentially saving lives, the more accurate diagnosis of preeclampsia may also have positive economic impacts on healthcare systems. In 2005, the average cost of preeclampsia, excluding normal delivery costs, was an estimated GBP 9,009 per pregnancy. With an estimated 8.5 million women affected by preeclampsia every year, the annual cost of preeclampsia worldwide is estimated to be GBP 76.6 billion (based on the 2005 estimate), representing a major financial burden.4 Clinical use of the sFlt-1/PlGF ratio to predict and diagnose preeclampsia could help reduce the associated health care costs, by cutting both inappropriate discharges and unnecessary hospitalizations. Routine use of the Roche preeclampsia test could reduce by 50% the number of women hospitalized prior to preeclampsia diagnosis, leading to a cost savings of approximately 400GBP per patient.3
“The PROGNOSIS study is the first to demonstrate that the Elecsys sFlt-1/PlGF immunoassay ratio can reliably rule out preeclampsia for one week,” said Roland Diggelmann, Chief Operating Officer, Roche Diagnostics. “We’re delighted to see the results published in such a world-renowned journal as the New England Journal of Medicine, and confident the findings will have a positive impact on the prediction and clinical management of this serious medical condition. They also support our vision to bring medical value to patients, which will enable proactive disease management and better patient care.”
1Zeisler, H., Llurba, E., Chantraine, F., et al. (2016). NEJM .
2Verlohren, S., et al. (2010). Am J Obstet Gynecol 202 (161): e1-11
3Strunz-McKendry et al (2014). 20th COGI World Congress 2014
4Anderson, U.D., et al.. (2012) . Placenta. 33(suppl), S42-7