7th January 2016
New Study Shows How Pregnant Women Can Rule Out Pre-eclampsia With One Simple Blood Test
Clinical study shows Roche pre-eclampsia test can better predict which women will, and will not, develop pre-eclampsia
Could reduce hospitalisation by up to 50%, saving healthcare systems millions
- Pre-eclampsia is one of the biggest health threats to pregnant women globally
- Pre-eclampsia affects about 8.5 million women a year worldwide, causes 15% of all premature births and 42% of maternal deaths.2
- The new PROGNOSIS study from the New England Journal of Medicine shows the Roche pre-eclampsia blood test can predict with much higher confidence than current methods which women will, and will not, develop pre-eclampsia.
- There are currently no tests which can be used to confidently rule-out the presence of pre-eclampsia. This results in the unnecessary hospitalisation of many women.
- Adding the test to the standard clinical assessment in the UK could reduce hospitalisation by 50%,10 saving the NHS approximately GBP 28 million annually13 according to an economic analysis based on the results of the PROGNOSIS study.
- The Roche pre-eclampsia blood test is available globally except in the United States and Japan
BASEL, Switzerland (7 January 2016) – A new study published in the New England Journal of Medicine today shows that Roche’s Pre-eclampsia Elecsys® blood test can predict which pregnant women will, and will not, develop pre-eclampsia,1 one of the leading causes of death and complications for mothers and their unborn babies.2
Celebrity mothers who have suffered from pre-eclampsia include Kim Kardashian and Mariah Carey. Pre-eclampsia is one of the biggest health threats to pregnant women and their babies, affecting 8.5 million2 women a year and accounting for 15% of preterm deliveries and 42% of maternal deaths globally.2
Pre-eclampsia is difficult to diagnose and manage. Physicians estimate that around 80% of pregnant women suspected of having pre-eclampsia don’t go on to develop it.1 Many of those women are unnecessarily hospitalised while other pre-eclamptic patients are only detected at a very late stage, endangering both them and their babies.
The PROGNOSIS study showed that the Roche pre-eclampsia test can predict with 99.3% confidence which women WILL NOT develop pre-eclampsia in the next week. There are currently no other tests that can be used to confidently rule-out the presence of pre-eclampsia. The test also predicts which patients WILL develop pre-eclampsia in the next four weeks almost twice as accurately as current prediction methods (33.7% confidence).
Pre-eclampsia places a major financial burden on health care systems. An economic analysis, based on the PROGNOSIS results, showed that introducing the test into clinical practice in the UK could reduce the number of women hospitalised prior to pre-eclampsia diagnosis by 50%,10 saving the NHS approximately GBP 28 million annually.13
The UK’s National Institute for Health and Care Excellence, is currently in a consultation process to issue guidance on pre-eclampsia tests. The final recommendations will not be available until May 2016 but the latest public document provisionally recommends that Roche’s test is used to help rule out pre-eclampsia.
Paul Skingley, Director of Centralised Solutions, Roche Diagnostics UK and Ireland, said: “It is vital that women are given the best care for their baby and themselves. The NHS needs to provide women with appropriate advice on all pregnancy related conditions including pre-eclampsia as well as fast access to diagnostics and treatment if required.”
Dr Manu Vatish, Consultant Obstetrician at John Radcliffe, Oxford University Hospital, said:
“A pre-eclampsia diagnosis can be extremely frightening for women and their families. The condition can be life-threatening and affects around five per cent of all pregnancies. Pre-eclampsia symptoms are often non-specific and, without a reliable test to diagnose the condition, many women are admitted to hospital unnecessarily. Not only does this result in additional stress for the women involved, but it also costs the NHS in unnecessary tests and extra inpatient bed days.
“Today’s study shows that a new era has arrived in the management of this disease. The research demonstrates that the new test from Roche Diagnostics, which can give a result in 18 minutes, is exceptionally good at ruling out the presence of the disease. Effectively ruling out the disease means reducing unnecessary admissions. Allowing women who are not at risk to go home safely enables the NHS to focus attention on women who have the greatest need.”
Ann Marie Barnard, CEO, Action on Pre-eclampsia, said:
“Thousands of expectant mothers are hospitalised with suspected pre-eclampsia in England each year. Fortunately only a small number of these admissions actually result in a diagnosis of pre-eclampsia. However, many mothers tell us of the stress and anxiety caused at this time both for themselves and their families.
“Being able to rule out if a mother is at risk of developing pre-eclampsia is a huge leap forward for antenatal care. The results of the PROGNOSIS study give hope that unnecessary hospitalisation of expectant mums may be avoided in the future, reducing stress and anxiety for them and allowing clinicians to utilise resources more effectively.”
The Roche pre-eclampsia blood test is available globally, except in the United States and Japan.
Roche Diagnostics Press Office – 020 7054 9974 / firstname.lastname@example.org
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Pre-eclampsia is a serious pregnancy complication which is a leading cause of maternal deaths during pregnancy, preterm birth and consequent death or ill health of newborns.
Who is at risk?
Typically, pre-eclampsia occurs after 20 weeks of pregnancy. Several factors increase the chances of a woman developing pre-eclampsia including:
- A first time pregnancy
- Pre-eclampsia was diagnosed in a previous pregnancy
- A family history of pre-eclampsia
- Pregnancy in early teens or past the age of 40
- A pregnancy of multiple babies (twins or triplets)
- The woman has kidney disease or high blood pressure
- The woman is obese
What are the symptoms?
The symptoms of pre-eclampsia can be difficult to detect because they resemble the “normal” effects of pregnancy on the body. (e.g. nausea, lower back pain, weight gain and swelling of limbs). Many women will experience no symptoms at all.
What are the treatment options?
Pre-eclampsia is a progressive and unpredictable disease that cannot be treated. The only cure is delivery of the baby. A woman found to be at risk of pre-eclampsia will be closely monitored via regular blood pressure tests, urine samples and ultrasound scans and may also receive medication to lower her blood pressure and enable the pregnancy to continue safely for as long as possible.
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, immunology, infectious diseases, ophthalmology 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 diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy. In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 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
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About the pre-eclampsia test
The pre-eclampsia test, called Elecsys® sFlt-1/PlGF immunoassay ratio, assesses the ratio of two proteins sFlt-1 (soluble fms-like tyrosine kinase-1) and PlGF (placental growth factor) found in the mother’s blood. An sFlt-1/PlGF ratio of 38 and below can rule out the development of pre-eclampsia within the next week with a negative predictive value of 99.3%, whilst a ratio above this cut off value predicts the development of pre-eclampsia within four weeks with a positive predictive value of 36.7%.1 The ratio had previously already been used as an aid in the diagnosis of pre-eclampsia and it is associated with adverse outcomes for mother and baby.7,8,9
About the PROGNOSIS study
PROGNOSIS was a multi-centre, prospective, double-blind, non-interventional trial evaluating the short-term prediction of pre-eclampsia, eclampsia and HELLP (haemolysis, elevated liver enzymes, low platelet count) syndrome in pregnant women with suspected pre-eclampsia. Sponsored by Roche, the PROGNOSIS study aimed to address the limitations of the traditional clinical parameters used to predict pre-eclampsia, and to demonstrate the utility of the Elecsys® pre-eclampsia ratio test in this context.1 Between December 2010 and January 2014, more than 1,270 pregnant women were enrolled at 30 sites in 14 countries. Results of the PROGNOSIS study were published in the New England Journal of Medicine in 2015.1 They demonstrated that a ratio of the proteins sFlt-1/PlGF of 38 and below predicts an absence of pre-eclampsia, eclampsia and HELLP syndrome for one week, whilst an sFlt-1/PlGF ratio above 38 predicts onset of pre-eclampsia, eclampsia and HELLP syndrome within four weeks.
1. Zeisler, H., Llurba, E., Chantraine, F., et al. (2016). N Engl J Med.
2. Verlohren, S., et al. (2010). Am J Obstet Gynecol 202 (161): e1-11
3. Verlohren, S., Stepan, H., & Dechend, R. (2012). Clin Sci 122(2): 43-52
4. Williams, D., Craft, N. (2012) BMJ 345:e4437
5. Chaiworapongsa, T., et al. (2014). Nat Rev Nephrol 10, 466–480
6. Preeclampsia Foundation FAQs – who gets preeclampsia. Available at http://www.preeclampsia.org/health-information/faqs#gets-preeclampsia. [Accessed October 2015].
7. Rana, S., Powe, C.E., Salahuddin, S., Verlohren, S., Perschel, F.H., et al. (2012). Circulation 125(7), 911-919
8. Verlohren, S., et al. (2012). Am J Obstet Gynecol 206, 58:e1-8
9. Verlohren, S, et al (2014) Hypertension 63, 346-352
10. Strunz-McKendry et al (2014). 20th COGI World Congress 2014
11. NICE. NICE clinical guideline 107: Hypertension in Pregnancy. 2011.
12. Office for National Statistics. Births in England and Wales, 2014. http://www.ons.gov.uk/ons/dcp171778_410897.pdf [accessed October 2015]
13. The expected annual cost savings for the UK National Health Service of using Roche’s test with standard clinical assessment of pre-eclampsia, is approximately £28 million annually, based on a cohort of 68,900 women presenting annually with clinical signs of pre-eclampsia (10% prevalence of hypertensive disorders amongst pregnant women11) applied to a population of 695,233 pregnant women in the UK per annum 12 and cost savings of £399 per patient 10 suspected of having pre-eclampsia.