METABOLOMIC DIAGNOSTICS HELPS LAUNCH IRISH NATIONAL PREECLAMPSIA AWARENESS DAY
Cork, Ireland, July 10th 2014 18:05 BST
Metabolomic Diagnostics welcomed Executive Director of the Preeclampsia Foundation, Eleni Tsigas to Ireland last week in a major effort to help raise awareness of Preeclampsia in Ireland. Speaking at an event at the Rotunda Hospital in Dublin where she met with Minister for Science and Innovation Sean Sherlock TD, and the Master of the Rotunda Dr. Sam Coulter-Smith, she said “I am delighted to be working with the Irish government and industry here, particularly the INFANT Research Centre and Metabolomic Diagnostics, to help raise symptom awareness and encourage more people, male and female, carers and friends, to recognise this potentially fatal illness.”
Our efforts to raise awareness resulted in national news coverage on press and national and local radio stations. Here is a link to a report from “The Journal,” Ireland’s leading online news source:
Help Raise Awareness: Watch and Share This Video
News Update- U.S Preventitive Services Task Force (USPSTF) Panel Urges Low-Dose Aspirin to Reduce Pre-eclampsia Risk
By CATHERINE SAINT LOUIS, APRIL 7, 2014, 5:24 PM
Pregnant women should take low-dose aspirin daily to reduce their chance of developing pre-eclampsia if they are at high risk for the life-threatening disorder, an influential government panel said on Monday.
The United States Preventive Services Task Force’s draft recommendation follows a growing scientific consensus that low doses may be beneficial to some high-risk women and their offspring. Low-dose aspirin reduced the risk of pre-eclampsia by 24 percent in clinical trials, according to a systematic review underpinning the new recommendation, which was published in Annals of Internal Medicine.
Low-dose aspirin also reduced the risk of premature birth by 14 percent and of intrauterine growth restriction — a condition in which the fetus doesn’t grow as fast as expected — by 20 percent.
“For every four women who would have gotten pre-eclampsia, one case is prevented,” said Dr. Ira M. Bernstein, the chair of department of obstetrics, gynecology and reproductive sciences at the University of Vermont. “The ability to prevent a quarter of disease is substantial.”
Pre-eclampsia is a condition usually occurring in the second half of pregnancy and characterized by high blood pressure, protein in the urine, liver disease and blood-clotting abnormalities.
It is a leading complication for expectant mothers and their infants, affecting roughly 4 percent of pregnancies nationwide. The only “cure” is delivery. When a pregnant women develops pre-eclampsia in the second trimester, her infant often must be delivered prematurely to avoid severe maternal complications, like stroke.
The task force recommended that women at high risk for pre-eclampsia take 81 milligrams of low-dose aspirin daily after 12 weeks of gestation. High-risk women include those who have had pre-eclampsia in a prior pregnancy, especially those who have had to deliver preterm; women carrying multiple fetuses; and women who had diabetes or high blood pressure at conception.
But the task force also advised that expectant women with multiple moderate-risk factors “may also benefit from low-dose aspirin.” These risks include obesity, a family history of pre-eclampsia, women older than 35, and African-American women.
A single high-risk factor merits low-dose aspirin use, but “it’s a judgment call between physicians and patients as to whether a combination of moderate-risk factors is enough to justify taking low-dose aspirin,” said Dr. Michael L. LeFevre, the chair of the task force and a professor of family medicine at the University of Missouri in Columbia.
Low-dose aspirin appears to cause no short-term harm during pregnancy, according to the new review of 19 clinical trials and two observational studies. However, potential rare or long-term harms could not be ruled out.
The largest trial followed infants 18 months after birth, and “found no differences in development outcomes,” said Jillian T. Henderson, the lead author of the review and an investigator at Kaiser Permanente Center for Health Research in Portland, Ore.
The researchers also found that use of low-dose aspirin doesn’t increase the risk of excessive bleeding after delivery, placental abruption (when the placenta detaches from the uterus before it should) or bleeding inside the baby’s cranial vault.
Dr. Phyllis August, a professor of medicine in obstetrics and gynecology at Weill Cornell Medical College, praised the careful appraisal of the potential risks of taking aspirin. “They critically reviewed the risks, and well,” said Dr. August, who for 20 years has had selected high-risk patients use low-dose aspirin.
In recent months, medical organizations like the American College of Obstetricians and Gynecologists and the American Heart Association also have advised that high-risk women use low-dose aspirin, with slight variations in who qualifies.
Still, “our general impression is it’s being used infrequently,” said Dr. LeFevre.
It’s not currently possible to predict which women will develop pre-eclampsia or its complications. Some women classified as low risk still get the syndrome out of the blue. Effective prevention of pre-eclampsia has been difficult to pinpoint, experts said, but a remedy that could prevent a quarter of the cases is a significant step forward.
“We’d like to be able to prevent four out of four cases, obviously,” Dr. Bernstein said. “There’s still a lot to learn about why the other three are still getting it, and how to prevent their disease.”
News Update– Metabolomic Diagnostics Secures $1.03 Million Venture Funding
Cork, Ireland, January 2014
Metabolomic Diagnostics, is pleased to announce that it has secured €750,000 ($1.03m) in venture funding through a syndicate of investors including SOS ventures Ireland Fund, AIB Seed Capital Fund and Enterprise Ireland.
“We are delighted to be backing Metabolomic diagnostics as they have a great team and a real shot at significant and speedy commercial success. Their product has a real chance of saving the lives of mothers and their babies which is pretty cool.” said Bill Liao, european venture partner, SOSventures International. The Irish Minister for Research and Innovation, Sean Sherlock TD, welcomed the investment stating “This is an important investment, given the potential significance of this metabolomic diagnostic test, the results of which include saving lives. I look forward to following the results of this innovative technology in the future.”
The company has been privately funded to date, following the licensing of its technology from University College Cork. This Series A round is the first external funding which the company has taken and will allow it to continue its work to validate and refine its PrePsia early pregnancy screening test for pre-eclampsia.
News Update–Participant recruitment commences in IMPROvED study- Press Release
IMPROvED an acronym for ‘IMproved PRegnancy Outcomes by Early Detection’ entails the use of novel metabolite and protein biomarkers to develop a non-invasive, sensitive, specific, and clinically robust blood-screening test for this common late-stage pregnancy complication. An international consortium of obstetric clinicians and scientists led by Louise Kenny, Professor of Obstetrics, University College Cork, Director of the Irish Centre for Foetal and Neonatal Translational Research (INFANT), Cork and Consultant Obstetrician and Gynaecologist, University Maternity Hospital launched a major EU funded programme where maternal and foetal health care stand to become revolutionised through a significantly more personalised approach.
The study will be conducted with the help and participation of first-time pregnant women recruited in major obstetric centres across five European countries, as well as €6m in funding from the European Union’s Seventh Framework Programme.
Pre-eclampsia is the current leading cause of maternal death in Europe and the cause of 70,000-80,000 maternal deaths worldwide annually (and more than 500,000 infant deaths). The objective of the IMPROvED project is to assess and refine two innovative screening tests for the early detection of this complex disorder. First-time pregnant women and women who have never before given birth are to be recruited in Ireland, the United Kingdom, Germany, Sweden and the Netherlands to take part in the study. Eligible women who meet the selection criteria – fewer than 16 weeks restriction (i.e., no high blood pressure, no diabetes, no kidney disease) – will be invited to undergo normal clinical evaluations, such as weight, height, blood pressure, and pulse readings, and also give urine, hair, and blood samples at the centres. Follow up post-natal visits will also be conducted.
Professor Louise Kenny said “our goal is to save the lives of affected mums and babies by reducing and eventually preventing the life-threatening complications associated with pre-eclampsia. Mums-to-be can be confident that they are in excellent hands as all participating obstetric recruitment centres (University College Cork, Erasmus University Rotterdam, Klinikum der Universitaet zu Koeln, University of Liverpool, Karolinska Institute of Sweden, University of Keele) have well-established track records and outstanding reputations for the research and management of pre-eclampsia”.
The help of first-time mothers is vital to the success of IMPROvED. Amanda McCarthy, the first patient recruited to the project added, “Pre-eclampsia can have a devastating outcome for both mums and babies. By joining IMPROvED I feel that I am contributing to a better and more personalised approach to understanding the cause of this disease”.
The team who make up the international consortium of IMPROvED want to hear from first-time-mothers who are interested in participating on the programme. Not only will this revolutionise the world of maternal health, there are other tangible benefits to be gained as well, such as:
- Reducing the overall disease burden on mums and babies
- Reducing healthcare costs
- Facilitating high-calibre research
- Increasing European competitiveness in this research field
News Update- Participant recruitment commences in IMPROvED study
The first participant for the IMPROvED study was recruited in Cork last Friday (29th November) and many more participants have enrolled since. The story was covered in national and local news.
Interviewed on the national TV station (RTE 1):
News Update– Metabolomic Diagnostics to attend the ninth annual Saving Grace- A Night of Hope in Iowa City
Diarmuid Cahalane will travel to Coralville, Iowa City to attend the ninth annual Saving Grace benefit that supports the Pre-eclampsia foundation. This year’s Saving Grace fundraising event, on October 18, from 6:00 to 10:00 pm, will occur immediately after this year’s regional and national Continuing Medical Education (CME) event in conjunction with the University of Iowa Hospitals and Clinics.
textAt this CME event, more than 200 of the nation’s top clinicians will convene under one roof to learn about preeclampsia. Presenters will include the headliners in hypertensive disorders of pregnancy (Dr. Ananth Karumanchi, Dr. James Martin, Dr. Thomas Easterling, and more). The day-long national symposium is titled: “Controversies in the Care of Women with Preeclampsia: A National Debate.”
News Update– Inventor of world’s first test for pre-eclampsia wins Enterprise Ireland award
Resulting new company plans to create 40 jobs
27 September 2013
Professor Louise Kenny has won the Enterprise Ireland Life Sciences & Food Commercialisation Award for developing and commercialising the first predictive diagnosis for pre-eclampsia in early pregnancy.
Louise is Director of the Irish Centre for Fetal and Neonatal Translational Research (Infant), Professor of Obstetrics at UCC and a Consultant Obstetrician and Gynaecologist at Cork University Maternity Hospital. INFANT is funded by Science Foundation Ireland and located at Cork University Maternity Hospital.
Pre-eclampsia is a very common condition affecting 5% of first time mothers. Currently, 70-80,000 mothers and over 500,000 infant deaths are attributed to pre-eclampsia each year and it is responsible for occupancy of approximately 20% of neonatal intensive care unit cots. If ‘at risk’ first time mothers could be identified in early pregnancy, steps could be taken to prevent almost a third of cases.
Professor Kenny received the award at the Enterprise Ireland Big Ideas Technology Showcase which took place in Dublin yesterday (25th September 2013).
Presenting Professor Kenny with her award, Seán Sherlock T.D Minister for Research & Innovation said; “Professor Kenny has accomplished a huge amount in her career to date so it is very fitting that this award from Enterprise Ireland recognises her contribution to society and the economy. Through the commercialisation of this technology Louise and her team will help women and their babies, deliver cost savings to hospitals and create employment”.
Gearóid Mooney, Manager of Research & Innovation at Enterprise Ireland congratulated Professor Kenny on her achievement and explained why she was selected for the award.
“Over the course of her career Professor Kenny could see the problems caused by being unable to predict which women would develop pre-eclampsia in pregnancy. So she decided to do something about it and using public funding provided by Science Foundation Ireland and the Health Research Board, she and her research team developed the world’s first predictive diagnostic blood test for pre-eclampsia”.
“With the help of Enterprise Ireland the test was put through a technical evaluation and brought to the point where it was ‘investor ready’. Enterprise Ireland, working with UCC’s technology transfer office, introduced Professor Kenny to a business partner, Charles Garvey and helped them to establish a new company called Metabolomics Diagnostics Ltd.” said Mooney.
Charles Garvey is now the CEO of the company which is an Enterprise Ireland high potential start-up with plans to create up to 40 new jobs.
Congratulating his colleague on her award, Mr. Garvey said; “Louise’s technology represents a game changing opportunity for perinatal care. I am looking forward to working with her to bring the test to the market to allow its full potential to be realised”. Minister Sherlock also presented Enterprise Ireland Commercialisation Awards to Tony O’Dowd and Dr. Mark Southern.
News Update– Metabolomic Diagnostics Receive Triple Quadropole Mass Spectrometer from Agilent Technologies
Metabolomic Diagnostics is delighted to confirm the arrival of a state of the art Triple Quad Mass Spectrometer from Agilent Technologies. This equipment will help us to analyse samples and develop methodologies which will ensure the success of its flagship product “Prepsia” once it is deployed on the market.
This collaboration with Agilent is further evidence of the strong potential of our product to transform prenatal care worldwide. Speaking following a recent meeting with Agilent Technologies in Santa Clara, California, Metabolomic Diagnostics Chief Executive Officer, Charles Garvey welcomed the support of Agilent Technologies in the ongoing development of Metabolomic Diagnostics. “This is further vindication of our technology, our science, and our team, and we greatly appreciate the assistance provided by Agilent Technologies. We look forward to working with Agilent over the coming months as we complete the development of “Prepsia.
News Update– Metabolomic Diagnostics Recruitment
Following Metabolomic Diagnostics recent move to larger facilities in Inchera Little Island, the company has expanded it’s team by recruiting Katy Hyland as regulatory scientist. Ms. Hyland, who is a qualified molecular scientist completed her masters in Molecular Cancer Research and will be a valuable asset to the Metabolmic Diagnostics team as the company ramps up its in house scientific and regulatory capabilities prior to the deployment of the revolutionary Prepsia predictive screening test for pre-eclampsia on the market.
News Update– New Facility
Metabolomic Diagnostics has moved into it’s new facility in Hoffman Park, Inchera, Little Island, Co. Cork. In the heart of Cork’s Pharmaceutical and Biotech Cluster, Metabolomic Diagnostics now has access to it’s own laboratory in addition to state of the art office facilities.
Speaking at the opening of the new facility, Metabolomic Diagnostics CEO, Charles Garvey, said: “These laboratories and offices will greatly enhance Metabolomic Diagnostics’ capacity to develop and commercialise innovative metabolomic screening diagnostic tests.”
Metabolomic Diagnostics will be locating their new Triple Quad Mass Spectrometer in the facility from April 24th.
News Update– Metabolomic Diagnostics Recruits Vice President Of Research & Development
Metabolomic Diagnostics is delighted to announce that Dr. Robin Tuytten has joined the company as VP of Research and Development. Robin joins us at an exciting time in our development of a revolutionary risk stratification predictive screening test for pre-eclampsia which will transform perinatal care. A recognised authority in mass spectrometry and research into womens health, Robin joins us from Pronota in Belgium. Robin’s appointment is further evidence of Metabolomic Diagnostics’ commitment to delivering world class research capabilities to ensure the prompt deployment of our flagship product, Prepsia, on the world market.
News Update– Metabolomic Diagnostics Meets with Pre-eclampsia Foundation, FDA, and Key Stakeholders
Diarmuid Cahalane, Head of Regulatory Affairs at Metabolomic Diagnostics recently attended a meeting in Washington DC, organised by the Pre-eclampsia Foundation. The meeting was organised by the Pre-eclampsia Foundation in an effort to accelerate the development and deployment of a predictive test for the disease. Head of the Office of IVD Evaluation and Safety at FDA, Alberto Gutierrez also attended.
Metabolomic Diagnostics looks forward to collaborative work with other like-minded companies, patient advocacy groups, research institutes and regulatory authorities as itworks to bring Prepsia to market.
News Update– Funding
November 7th 2012
CORK, Ireland & GHENT, Belgium–(BUSINESS WIRE)–The European Union has awarded €6 million ($8 Million) of research funding under the FP7-health framework to a consortium which is working to bring a predictive test for pre-eclampsia to market. The consortium is coordinated by Prof Louise Kenny at University College Cork, Ireland and driven by two companies, Metabolomic Diagnostics Ltd. of Ireland and a Belgian company, Pronota, both at the forefront in the discovery and development of novel blood-borne biomarkers for disease prediction. Speaking after the announcement of the award Charles Garvey, CEO of Metabolomic Diagnostics said:
“Metabolomic Diagnostics, is delighted to be involved in this innovative consortium. We believe that an early pregnancy-screening test can make a major contribution to maternal safety and this project, once completed, will help accelerate its adoption.”
The IMPROvED (IMproved PRegnancy Outcomes via Early Detection) project will establish a multicentre clinical study to assess and refine two innovative prototype screening tests for this common late pregnancy complication. These tests are based on proteomic and metabolomic profiles developed by the two companies.
Prof Louise Kenny, co-ordinating principal investigator of IMPROvED commented: “Pre-eclampsia is a very serious condition. It affects almost one in 20 first time mothers and globally causes approximately 70,000 maternal deaths each year. We were therefore extremely pleased to see that researchers from different fields, centres and countries were enthusiastic about the IMPROvED project. Our ultimate goal is to develop a robust predictive test for pre-eclampsia and to improve the outcome of pregnancy for both mothers and their babies.”
The four-year IMPROvED project will establish a high quality pregnancy biobank with blood samples collected from 5,000 first-time pregnant women recruited from at least five countries including Ireland, the United Kingdom, Germany, Sweden and the Netherlands. All recruitment centres involved (University College Cork, Erasmus University Rotterdam, Klinikum der Universität zu Köln, The University of Liverpool, Karolinska Institute, University of Keele) are major obstetric centres with a proven track record in the research and management of pre-eclampsia. The scientific value of the biobank will be enhanced by the collection and storage of comprehensive clinical data along with the samples (Medscinet AB, Sweden). Dedicated and independent teams of statisticians (Region Hovedstaden, Denmark) and economics (University of Groningen) will ascertain clinical and health economical validity of the developed proteomics and metabolomics tests.
Prof Phil Baker (Keele University), co-principal investigator, added: “An effective screening test will allow antenatal care to be tailored to an individual woman’s risk, such that at risk women receive the best possible care – so diminishing the burden of this potentially devastating disease. The approval of IMPROvED is a strong endorsement of European researchers and is recognising the importance of enhancing maternal and fetal health.”
For more details on this significant announcement please visit the IMPROvED website: