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Unlocking the prediction of

preeclampsia, a widespread, life-


threatening pregnancy complication
Preeclampsia affects 8.5 million women every year.1 An innovative
test is the key to identifying women at risk

What is preeclampsia?
A disease occurring during pregnancy that impacts almost 1 in 20
women worldwide, preeclampsia represents a significant threat to
women’s health. The condition involves reduced blood flow through
the placenta and inadequate oxygen and nutrients for the foetus
which, if left undetected, can lead to serious health consequences
for both mother and baby. Globally, the condition causes 15% of all
premature births and 42% of all maternal deaths.2

The costs of poor prediction


Many of the early symptoms of preeclampsia resemble the normal
effects of pregnancy on the body and so are difficult to pinpoint.
Standard diagnosis involves detecting high blood pressure after 20
weeks and protein in the urine. Yet both indicators are poor
predictors of which women will develop adverse outcomes and
which will go on to have normal pregnancies.
Approximately 80% of pregnant women with signs of preeclampsia
do not develop the condition.3 Often, these women are
unnecessarily hospitalised, causing the mother anxiety and
increasing the overall cost of treatment.

An innovative new approach for triage of women with


suspected disease
Recognising that early detection and effective care can vastly
reduce the number of preeclampsia-related deaths, a novel
preeclampsia test has been developed that measures the two
proteins* found in the mother’s blood. The test can predict which
pregnant women with suspected preeclampsia will and will not
develop the condition with greater certainty than standard
diagnostics, giving doctors the confidence to send healthy women
home safely and to focus patient management on women who are
more likely to develop preeclampsia.

Enhanced predictions benefiting patients and care providers


A recent study looked at the impact of the new test on more than
1,200 pregnant women suspected of having preeclampsia in 30
sites in Europe, Canada, South America, Australia and New
Zealand. The PROGNOSIS study, published in the New England
Journal of Medicine, shows that the test predicts which women will
not develop preeclampsia in the next week with more than 99%
confidence.4 Additional benefits include:

 The predictive value for clinicians: By determining the absence of


preeclampsia for one week, and the development of preeclampsia
within the subsequent four weeks, the test gives doctors the insight
needed to predict or rule out preeclampsia early.
 The significant benefits to patients: The negative predictive value
saves women who are unlikely to develop the condition the stress of
close monitoring, the disruption of a hospital stay and the costs
associated with additional treatment, whilst at-risk patients can
receive specialised care.
 Reduced hospitalisation and greater cost savings: By using the new
test in clinical practice, the hospitalisation of women suspected of
having preeclampsia could be reduced by 50%, leading to cost
savings of 344 GBP per patient.5 Annual UK savings are projected
to be >£24 million.5

Roche recognises the enormous medical and economic value of


diagnostics for both patients and healthcare providers. By facilitating
proactive disease management, the new preeclampsia test enables
more efficient and effective care for women in need.
*sFlt-1/PlGF ratio: ratio between soluble fms-like thyrosine kinase 1 (sFlt-1) and Placental Growth
Factor (PlGF)

Potential for timely detection of complications

Dr. Maria Schödl, Study Manager


and Clinical Operations and Functional Representative Cardiac and Women's Health at Roche
Diagnostics

“Preeclampsia testing gives pregnant women more confidence,”


says Dr. Maria Schödl, Study Manager and Clinical Operations and
Functional Representative Cardiac and Women's Health at Roche
Diagnostics, who was in the team leading the PROGNOSIS study
that showed the relevance of the sFlt-1/PlGF ratio for predicting
impending preeclampsia.
“In the past, preeclampsia was also called the ‘disease of theories,’”
said Maria. “Even today, the causes are still not completely clear.
But we do know that in the course of the disease, the blood flow
through the placenta becomes abnormal. During the ongoing study,
I became pregnant with my first child. It was an irony of fate that I
developed preeclampsia myself, which the doctors did not diagnose
in time. The severe symptoms occurred directly after my daughter’s
birth, so she was fortunately not affected. I too came through the
disease without complications. If the results of the study had already
been available at the time, I could have benefited from that myself.
During my second pregnancy, I had my sFlt-1/PlGF value regularly
checked at a hospital so as to rule out the possible occurrence of
preeclampsia. Fortunately, everything went well.”
Since then, the sFlt-1/PlGF ratio has been introduced into clinical
guidelines in the UK which recognise its utility alongside standard
clinical assessment and follow-up to help to accurately and quickly
rule out the development of preeclampsia in patients with suspected
disease. This means patients can be discharged secure in the
knowledge that they are not at risk of developing preeclampsia over
the next seven days.
The sFlt-1/PlGF ratio could help reduce UK hospitalisations by
50%,5 resulting in significant savings for the National Health Service
and also freeing up hospital beds to allow clinicians and midwives to
care for those patients most in need.
“This certainty spares pregnant women an unnecessary hospital
stay, and also decreases the burden on the health system in the
long term,” concludes Maria.

References
1 Anderson, U.D., Olson, M.G., Kristensen, K.H., Åkerström, B., & Hansson, S.R. (2012) Review:
Biochemical markers to predict preeclampsia. Placenta. 33(suppl), S42-7.
2 Verlohren, S., Galindo, A., Schlembach, D., Zeisler, H., Herraiz, I., et al. (2010). An automated
method for the determination of the sFlt-1/PIGF ratio in the assessment of preeclampsia. Am J
Obstet Gynecol. 202(2), 161.e1-161.e11.
3 Klein, E., Schlembach, D., Ramoni, A., et al. (2016). Influence of the sFlt-1/PIGF ratio on
clinical decision-making in women with suspected preeclampsia. Plos ONE 11(5): e0156013.
doi:10.1371/journal.pone.0156013.

4 Zeisler, H., Llurba, E., Chantraine, F. et al. (2016). Predictive Value of the sFlt-1: PlGF Ratio in
Women with Suspected Preeclampsia. N Engl J Med. 374, 13-22.
5 Vatish, M., Strunz-McKendry, T., Hund, M., Allegranaz, D., Wolf, C., Smare, C. (2016).
sFIt/PIGF ratio test for pre-eclampsia: an economic assessment for the UK. Ultrasound in Obstet
Gynecol. 48(6):765-771

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