MALTA PRE-ECLAMPSIA EVENT

Malta, 9 October 2018; Around 26 specialists in Obstetrics and Gynaecology together with personnel from the Department of Pathology of Mater Dei Hospital and private hospitals gathered at the Malta Maritime Museum for an event to talk about better ways to diagnose pre-eclampsia; a condition in pregnant women that can be dangerous and, in extreme cases, fatal for mother and baby. The event was hosted by Vivian, one of Malta’s leading distributors, founded in 1952, was chaired by Prof. Yves Muscat Baron, the Director of the Department of Obstetrics and Gynaecology at Mater Dei Hospital and the key note speech was delivered by Dr. Manu Vatish, Senior Clinical Fellow and Consultant in Obstetrics at Nuffield Department of Obstetrics, Oxford University Hospitals NHS Foundation Trust.

There were 33 cases of pre-eclampsia in Malta in 2016, according to the DHIR.⁸ Typical signs of pre-eclampsia which support the diagnosis include high blood pressure along with protein in urine after 20 weeks of pregnancy. However, it is generally accepted that these clinical characteristics are not highly predictive of the women who will actually go on to develop pre-eclampsia.⁶

Approximately 6% of Maltese mothers develop high blood pressure each year ⁸ and preeclampsia is often suspected in this group of mothers to be. Current clinical management can lead to unnecessary hospital stays since the majority of women with suspected preeclampsia will not develop the condition.¹⁰ This is not an ideal situation for mothers, as prolonged hospitals stays can be both emotionally stressful and practically difficult for their families. Additionally, the inability to distinguish women with preeclampsia from those not at risk of the disease can impact hospital resources¹⁰, and has potential financial implications for both the hospital and the mother.

At this evening’s event, attendees were told about a blood test developed by Roche Diagnostics that can help predict the chances of an expectant mother developing pre-eclampsia within the next 7 days.⁴  This test is recommended by NICE (National Institute for Health and Care Excellence) in the UK in conjunction with standard clinical assessment and subsequent clinical follow-up to help rule-out pre-eclampsia in women presenting with suspected pre-eclampsia between 20 weeks and 34 weeks plus 6 days of gestation⁹ and can support help our healthcare providers to focus the right care on mothers who are more likely to be at risk, while discharging those who are not at risk with increased confidence.

Jeremy Moss, Head of UK Management Centre, Roche Diagnostics Limited said; “Roche is the leading investor in research and development in healthcare globally⁷. We developed the test for pre-eclampsia as we knew that it was an area of need, both for expectant mothers in ensuing they receive the most appropriate care, and for healthcare providers to ensure appropriate use of resources. No blood test, other than the traditional monitoring of blood pressure and proteins in the urine, existed to give both healthcare professionals and expectant mothers this peace of mind. The Elecsys® test is available for use in Malta through our distribution partner, Vivian.”

Joanna Gatt, Managing Director, Vivian Corporation said; ‘Vivian has just launched its new branding strategy which revolves around the concept of ‘together through life.’ The introduction of the innovative pre-eclampsia test from Roche Diagnostics is testimony of our commitment towards improving the quality of life of mothers and their babies. This pre-eclampsia test together with our work in the fields of vaccination and infant feeding, further enables Vivian to provide the best possible start to life for a healthy future of our little ones and their mothers.

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. 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 www.roche.com.

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%.⁴

All trademarks used or mentioned in this release are protected by law.

ELECSYS is a trademark of Roche.

1. Vatish, M Et al. ‘Interventional Study Evaluation the Short-Term Prediction of Pre-eclampsia / Eclampsia in Pregnant Women with Suspected Pre-eclampsia – INSPIRE Study’ Abstract presented at ISSHP Congress in Berlin, Germany. 7 September 2017.
2. Rana, S., Powe, C.E., Salahuddin, S., Verlohren, S., Perschel, F.H., et al (2012). Angiogenic factors and the risk of adverse outcomes in women with suspected pre-eclampsia. Circulation 125(7), 911-919
3. Verlohren S, Herraiz I, Lapaire O, et al (2014). New gestational phase-specific cutoff values for the use of the soluble fms-like tyrosine kinase-1/placental growth factor ratio as a diagnostic test for pre-eclampsia. Hypertension 63: 346-52.
4. Zeisler H, Llurba E, Chantraine F, et al (2016). Predictive value of the sFlt-1:PlGF ratio in women with suspected pre-eclampsia. N Engl J Med;374:13-22
5. Verlohren, S, Herraiz I, Lapaire O, et al (2012). The sFlt-1/PlGF ratio in different types of hypertensive pregnancy disorders and its prognostic potential in pre-eclamptic patients. Am J Obstet Gynecol 206, 58:e1-8
6. http://fortune.com/2014/11/17/top-10-research-development/
7. Gatt, M., Borg, M. (2017). NOIS Annual Report, 2016. National Obstetric Information System, Directorate for Health Information and Research. Available at: https://health.gov.mt/en/dhir/Pages/Registries/births.aspx
8. PlGF-based testing to help diagnose suspected pre-eclampsia (Triage PlGF test, Elecsys immunoassay sFlt-1/PlGF ratio, DELFIA Xpress PlGF 1-2-3 test, and BRAHMS sFlt-1 Kryptor/BRAHMS PlGF plus Kryptor PE ratio). NICE Diagnostics guidance [DG23] Published date: May 2016. Available from https://www.nice.org.uk/guidance/dg23/chapter/2-clinical-need-and-practice
9. Vatish et al. (2016). sFlt‐1/PlGF ratio test for pre‐eclampsia: an economic assessment for the UK. Ultrasound Obstet Gynecol. 2016 Dec; 48(6): 765–771.