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PerkinElmer Expands Prenatal Screening Test Offerings, Introducing First Early Onset Preeclampsia Screening Test in the U.S.

PerkinElmer, a global leader in human and environmental health and an innovator in the field of prenatal screening for more than thirty years, announced today the first available early onset preeclampsia screening test in the United States. The PreeclampsiaScreen™ | T1 serum screening test enables physicians to more precisely detect asymptomatic patients in the first trimester of pregnancy who are at high risk for developing the dangerous condition, allowing for earlier identification, management and intervention. Early onset preeclampsia is a potentially serious condition that affects 0.5% of all pregnancies, often contributing more to the pregnant mother’s and baby’s risks of morbidity and mortality than does the late form of the disorder.

“This first of its kind screen is our latest commitment to providing clinicians with new, innovative ways to address some of today’s most challenging prenatal clinical scenarios,” said Jim Corbett, Senior Vice President and President, Diagnostics and Life Sciences & Technology for PerkinElmer. “Together with our recent advances, including offering a non-invasive prenatal test based on cell-free fetal DNA, plus a wide range of prenatal testing from biochemical screening to SNP microarray testing to detect birth defects and chromosome abnormalities, we’re giving physicians effective new tools for patient management.”

According to Dr. Jiri Sonek, MD RDMS, President, Fetal Medicine Foundation USA, and Adjunct Professor, Department of Obstetrics and Gynecology from Wright State University, “Preeclampsia is one of the remaining great challenges in obstetrics. It is a major cause of maternal, fetal, and neonatal morbidity and mortality. Fortunately, some physicians may recommend a simple and inexpensive intervention to reduce the risk of preeclampsia which is available in the form of low-dose aspirin. However, this treatment is effective only if begun early in pregnancy. That is why first trimester screening is such a critical component of preeclampsia prevention.”

Early onset preeclampsia is defined as preeclampsia, a sudden increase in blood pressure and protein in the urine, which leads to delivery of the fetus prior to 34 weeks’ gestation. If found early, options such as increased monitoring, modified activity, bed rest and medication can help reduce or avoid complications related to early onset preeclampsia.

PreeclampsiaScreen™ | T1 is administered during the first trimester of pregnancy through a simple blood test to detect three biochemical markers in the mother’s blood: PAPP-A (pregnancy-associated plasma protein-A); PlGF (placental growth factor) and AFP (alpha fetoprotein) that, when evaluated collectively with personal demographic data, provide an individual risk of developing early onset preeclampsia. Physicians have the option to provide two additional biophysical measurements for their patients — mean arterial pressure (MAP) and uterine artery Doppler pulsatility index (UtAD-PI) – each increasing the sensitivity of the screen when included in the testing protocol.

Source: PerkinElmer

New Test Assesses Gestational Diabetes Risk Early in Pregnancy

Levels of a biomarker in a pregnant woman’s blood can help physicians gauge her risk of developing gestational diabetes during the first trimester, according to a recent study accepted for publication in The Endocrine Society’s Journal of Clinical Endocrinology & Metabolism (JCEM).

Gestational diabetes is a form of diabetes that can develop during pregnancy, often during the second trimester. The condition causes glucose levels in the bloodstream to be higher than normal. Early diagnosis and treatment can help the woman manage the condition. If left untreated, high blood glucose in the mother increases the risk of jaundice, breathing and hypoglycemia problems in the newborn. Uncontrolled gestational diabetes also can increase the risk of premature delivery and preeclampsia, or pregnancy-induced high blood pressure.

“Although it is important to quickly intervene in cases of gestational diabetes, often only women who have risk factors like a family history or obesity are screened early in pregnancy,” said one of the study’s authors, Atsuhiro Ichihara, MD, PhD, of Tokyo Women’s Medical University. “Women who don’t have the traditional risk factors may not be diagnosed until the second trimester. The method identified in this study offers every pregnant woman the opportunity to know her risk early on.”

The prospective cohort study tested the blood of 716 pregnant women during the first trimester to measure their levels of the soluble (pro)renin receptor, or s(P)RR. Of the participants, 44 women developed gestational diabetes.

Researchers found pregnant women with elevated s(P)RR levels were more likely to be diagnosed with gestational diabetes. Women who had the highest s(P)RR levels were 2.9 times more likely to develop gestational diabetes than women who had the lowest levels.

“In addition to gestational diabetes, recent studies have found elevated s(P)RR levels are associated with the birth of larger babies and high blood pressure in late pregnancy,” Ichihara said. “The evidence suggests the biomarker is important in the interaction between mother and fetus during pregnancy.”

Source: Prediction of Gestational Diabetes Mellitus by Soluble (Pro)Renin Receptor during the First Trimester

Source: EurekAlert!

Baby Knows Best: Fetuses Emit Hormone Crucial to Preventing Preeclampsia

In a study using mice, researchers from the University of North Carolina School of Medicine found that a hormone, adrenomedullin, plays a crucial role in preventing the pregnancy complication preeclampsia. Surprisingly, this hormone protects women from preeclampsia when emitted by the fetus, not the mother, during the most critical times in pregnancy.

“We’ve identified the fact that the baby is important in protecting the mom from preeclampsia,” said the study’s senior author, Kathleen M. Caron, PhD, assistant dean for research at the UNC School of Medicine and an associate professor in the Department of Cell Biology and Physiology. “If the baby’s cells are not secreting this hormone, the mother’s blood vessels don’t undergo the dilation that they should.”

Preeclampsia affects roughly one in fifteen pregnancies. An important characteristic of the condition is that blood vessels in the placenta fail to enlarge, or dilate, to accommodate increased blood flow to the fetus. Untreated, it can threaten the life of both mother and baby.

“We really don’t know that a pregnant woman is going to get preeclampsia until she has it,” said Caron. Because the condition has numerous risk factors and causes, it’s difficult for doctors to know which patients are at highest risk. “Identifying molecules that could predict preeclampsia would be really important.”

The researchers studied mice that were genetically programmed to produce either reduced or increased levels of adrenomedullin. The study revealed that in a normal pregnancy, the fetus secretes adrenomedullin into the placenta during the second trimester, signaling special cells called “natural killer cells” to help dilate the mother’s blood vessels and allow more blood to flow to the growing fetus.

The study is one of the first to identify an important chemical message sent from fetus to mother in the womb. Scientists understand more about the mom’s side of the ‘chemical conversation’ that goes on between mother and baby, but much of the hormonal signaling in the placenta remains a mystery.

By identifying the key role of adrenomedullin, the research could pave the way to new methods for detecting and preventing preeclampsia. For example, adrenomedullin levels could potentially be used as a biomarker, or early indicator, to identify which patients might be predisposed to the condition. “Having a biomarker would be wonderful—it could allow the physician to manage a woman differently in the early part of her pregnancy,” said Caron.

As a next step, the researchers plan to build upon their mouse studies to examine patterns of adrenomedullin levels and preeclampsia in pregnant women.

This paper was published online ahead of print on May 1, 2013 in the Journal of Clinical Investigation (JCI). The paper will appear in the June 2013 print edition.

The study’s co-authors include Manyu Li, Nicole M.J. Schwerbrock, Patricia M. Lenhart, Kimberly L. Fritz-Six, Mahita Kadmiel, Kathleen S. Christine, Scott T. Espenschied, Helen H. Willcockson and Christopher P. Mack of UNC and Daniel M. Kraus of Duke University Medical Center.

Study: Fetal-derived adrenomedullin mediates the innate immune milieu of the placenta

Source: University of North Carolina at Chapel Hill (UNC) Heath Care and University of North Carolina at Chapel Hill (UNC) School of Medicine

Miraculins to License Additional Preeclampsia Technology from Mount Sinai Hospital

Miraculins Inc. (TSX-V:MOM), a medical diagnostic company focused on acquiring, developing and commercializing diagnostic tests and risk assessment technologies for unmet clinical needs, announces today its plans to add to its suite of maternal health biomarkers under license from Mount Sinai Hospital’s Samuel Lunenfeld Research Institute by signing a term sheet to license methods and reagents for detecting hydroxylated Hypoxia Inducible Factor 1 alpha (“HIF-1aOH”), a promising biomarker with potential in differentiating high and low risk pregnancies, including risk of preeclampsia. The technology is part of the pioneering research on preeclampsia and placental development being conducted by Dr. Isabella Caniggia, Senior Investigator at the Samuel Lunenfeld Research Institute, in collaboration with Dr. Martin Post, a Senior Scientist at The Hospital for Sick Children. Dr.Caniggia is also a member of Miraculins’ Scientific Advisory Board and is cross-appointed at the University of Toronto as a Professor in Obstetrics and Gynecology as well as Physiology.

In addition to its promise in maternal health and preeclampsia, HIF-1aOH also presents an opportunity as a cancer biomarker and of further note, the license will include unique monoclonal antibodies highly sensitive to HIF-1aOH and the exclusive rights to manufacture reagents that measure the biomarker using materials developed by Dr. Caniggia. Miraculins is currently advancing a development plan for a kit to detect and measure HIF-1aOHin bodily fluid, which if successful could lead to a near term commercial research use product and allow for more widespread research into the utility of this novel biomarker. The ultimate goal for the biomarker development program would be worldwide sales of the biomarker technology, either alone or in combination with other markers, in a diagnostic kit for the early detection of preeclampsia or as a pregnancy risk assessment tool.

“Since HIF-1a is central to proper placental development, early detection of abnormal HIF-1a regulatory mechanisms could one day provide tools to physicians and caregivers to differentiate high and low risk pregnancies. Although HIF-1a itself is a very promising biomarker, the hydroxylated form may prove to be important to diagnosing the severity of preeclampsia and to better manage this disease throughout pregnancy,” stated Dr. Isabella Caniggia, the discoverer of the markers that comprise Miraculins’ preeclampsia biomarker suite and inventor of the HIF-1aOH technology. “I am very eager to expand our continued work with the Miraculins team to achieve the goal of better outcomes for mothers and babies.”

“We are very pleased to expand our maternal health program and partnership with Dr. Caniggia and Mount Sinai Hospital’s Samuel Lunenfeld Research Institute,” stated Christopher J. Moreau, President and Chief Executive Officer of Miraculins Inc. “This program has been very successful to date, and recently produced a license agreement for the biomarker Endoglin with a major global diagnostic company. We look forward to continuing research into this promising biological pathway with the goal of developing additional preeclampsia diagnostic tools for this devastating disease of growing incidence worldwide.”

Source: Miraculins

Thermo Fisher Scientific Acquires All Rights for Pre-eclampsia Biomarker from Nephromics

Thermo Fisher Scientific Inc., the world leader in serving science, today announced it has signed an asset purchase agreement with Nephromics LLC, which includes a patent license for exclusive rights to use PlGF (Placental Growth Factor) for the diagnosis of pre-eclampsia or eclampsia. Clinical trials have shown that PlGF supports the diagnosis and risk prediction for preeclampsia (PE). Thermo Fisher will develop PlGF as an immunoassay on its own KRYPTOR™ platform and, through management of several sublicenses under the acquired license, will strengthen its global position in prenatal screening by expanding the availability of the assay through license partners.

According to the World Health Organization (WHO), PE occurs in up to 8 percent of pregnancies worldwide and is a life-threatening disorder that occurs only during pregnancy and the postpartum period. Pre-eclampsia and related disorders such as HELLP syndrome and eclampsia are most often characterized by a rapid rise in blood pressure that can lead to seizure, stroke, multiple organ failure and death of the mother and/or baby. Global health care costs for pre-eclampsia are estimated to be $3 billion per year. Current methods for identification of pre-eclampsia – regular measurements of blood pressure and protein testing in the urine during routine prenatal visits – deliver PE diagnoses after the condition has reached an advanced status.

“The measurement of maternal serum PlGF at 11-13 weeks of gestation is essential in providing an excellent screening test both for chromosomal defects and for pre-eclampsia,” said Kypros Nicolaides, professor of Fetal Medicine at Harris Birthright Research Centre for Fetal Medicine, King’s College Hospital, London, UK, and Department of Fetal Medicine, University College Hospital, London, UK, and founder of Fetal Medicine Foundation (FMF). “Early identification of the pregnancies at high risk for PE gives the option for therapeutic interventions with such drugs as low-dose aspirin, which substantially reduces the prevalence of the disease.”

“Taking into account the fatal consequences of pre-eclampsia, an assay for testing PlGF may offer a much better outcome for patients with this disorder,” said Andy Thomson, president of the Thermo Fisher’s Specialty Diagnostics business. “Levels of PlGF in patients with PE are significantly lower than in non-preeclamptic pregnancies. This test is an additional tool in PE screening and will help identify women at risk earlier and, therefore, support therapy management.”

The addition of this PlGF assay is a complement to Thermo Fisher’s already existing prenatal screening portfolio (PAPP-A, Free βhCG, AFP, hCG+β, Fast Screen pre I plus software) and ongoing research and development activities in that field. Market entry for the new assay PlGF is planned for the first quarter of 2013.

Source: Thermo Fisher Scientific