Thermo Fisher Scientific acquires rights for pre-eclampsia biomarker from Nephromics

Thermo Fisher Scientific has signed an asset purchase agreement with Nephromics, which includes a patent licence for exclusive rights to use PlGF (Placental Growth Factor) for the diagnosis of pre-eclampsia (PE) or eclampsia. Clinical trials have shown that PlGF supports the diagnosis and risk prediction for pre-eclampsia. Thermo Fisher will develop PlGF as an immunoassay on its own KRYPTOR platform and expand the availability of the assay through licence partners.

According to the World Health Organization (WHO), PE occurs in up to 8% 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 characterised 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 healthcare costs for PE are estimated to be $3 billion per year. Current methods for identification of the disorder - regular measurements of blood pressure and protein testing in the urine during routine prenatal visits - deliver 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, and Department of Fetal Medicine, University College Hospital, London, 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 Thermo Fisher’s Specialty Diagnostics business. “Levels of PlGF in patients with PE are significantly lower than in non-pre-eclamptic 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.