A new study published in the New England Journal of Medicine 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.3
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.