Preeclampsia is a pregnancy complication which affects approximately 8.5 million women a year worldwide.1 It is one of the leading causes of death and complications for mothers and their unborn babies. The statistics are sobering - it affects one in 20 pregnancies, is the direct cause of 1 in 7 premature births and accounts for more than 4 out of every 10 maternal deaths each year around the world.2
Despite the impact it has, preeclampsia is still something of a mystery - in fact, its causes are to this day still not well understood. And the medical gold standard for diagnosis hasn't changed significantly since the 1960s: urine protein tests and blood pressure measurement, neither of which are very accurate in predicting the disease and its complications.
Paradoxically, preeclampsia is consistently both over- and under-diagnosed. Because of the potential danger, many women with signs and symptoms of the disease are unnecessarily admitted to hospital for intensive observation and monitoring. However, approximately 80 per cent of pregnant women with preeclamptic symptoms do not develop the condition.3 At the same time, because many of the early symptoms of preeclampsia resemble the normal effects of pregnancy on the body, many women who actually will develop the condition go undetected. As a result, healthcare providers spend an estimated US$120 billion every year managing preeclampsia.1,4
In this context, a test that can accurately and reliably predict which at-risk women are likely to get preeclampsia is a game-changer. Roche Diagnostics has developed a novel preeclampsia test called the Roche Elecsys® sFlt-1/PlGF immunoassay ratio test - a groundbreaking way to accurately predict the onset of preeclampsia. This simple and quick blood test can rule out preeclampsia within one week with over 99% accuracy, giving doctors the confidence to send healthy women home safely.
The introduction of the Roche test in to clinical practice could reduce hospitalization by 50 per cent in the UK alone5, while also freeing up hospital beds to allow clinicians and midwives to care for patients most in need. Recently, the UK National Institute for Health and Care Excellence (NICE) has advised midwives and doctors in the National Health Service (NHS) to use the Elecsys® sFlt-1/PlGF test to rule out the life threatening condition of preeclampsia in pregnant women. With potential annual savings of more than £16 million in the UK, NICE has recommended the test in its newly published guidelines on the management of suspected preeclampsia.6
The new guidance shows that a new era has arrived in the management of this disease, says Dr Manu Vatish, Consultant Obstetrician at John Radcliffe, Oxford University Hospital.
Effectively ruling out the disease means reducing unnecessary admissions. Allowing women who are not at risk to go home safely means that the NHS can focus attention on women who have the greatest need.
This recommendation is built on compelling data that was published about the Elecsys® sFlt-1/PlGF test in the New England Journal of Medicine in January 2016. The results of PROGNOSIS, a ground-breaking clinical study involving 1270 pregnant women, showed that not only can the Elecsys® sFlt-1/PlGF immunoassay ratio test predict with a confidence level of 99.3% which women will not develop preeclampsia in the next week, but also that it can predict which patients will develop preeclampsia in the next four weeks almost twice as accurately as current tests.3
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.
- Anderson, U.D., Olson, M.G., et al. (2012) Placenta 33(A-26): S42-S47 DALY: Disability-adjusted life years.
- Verlohren, S., et al. (2010). Am J Obstet Gynecol 202 (161): e1-11.3.
- Zeisler H, Llurba E, Chantraine F, et al (2016). N Engl J Med;374:13-22
- Meads, C.A., et al. (2008). Health Technol Assess 12(6).
- Strunz-McKendry, T., et al. (2014) Poster presented at 20th World Congress on Controversies in Obstetrics, Gynecology & Infertility (COGI) 4th – 7th December 2014, Paris, France.
- National Institute for Health and Care Excellence (2016). NICE Guideline DG23. Retrieved from https://www.nice.org.uk/guidance/dg23