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New Test May Uncover Deadly Hypertension Disease in Pregnancy

Collaborators at Cottage Health System and University of California, Santa Barbara (UCSB) have identified biomarkers that may yield a revolutionary diagnostic test for pre-eclampsia, a complex and potentially life-threatening hypertensive condition affecting 5% of pregnancies worldwide.

Pronota’s Risk Stratification Test Breaks New Ground in the Early Detection of Pre-term Pre-eclampsia Cases in SCOPE Consortium Study

Pronota NV, a company dedicated to the development of best-in-class diagnostics for early detection of life-threatening conditions, announced today that it has successfully validated its mid-gestation pre-eclampsia screening test. This test correctly identifies 80% of women at risk for the development of pre-term pre-eclampsia according to a study in collaboration with the SCreening fOr Pregnancy Endpoints (SCOPE) Consortium, one of the largest international research efforts dedicated to the prediction of late pregnancy diseases.

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