Siemens Healthcare Diagnostics has entered into a global licensing agreement with Nephromics LLC to develop two assays to be used as an aid in the diagnosis of preeclampsia. The assays are being developed for the detection of two biomarkers, soluble fms-like tyrosine-kinase-1 (SFLT-1) and placental growth factor (PLGF), which clinical studies have shown to provide early identification of patients with preeclampsia, a potentially life-threatening condition that occurs during pregnancy and affects both mothers and their unborn children.

Currently, the standard methodologies for screening at-risk women are routine blood pressure monitoring and testing for protein in the urine during prenatal visits. With these methods, preeclampsia is often diagnosed at an advanced stage when there are limited treatment options, according to Siemens.

A rapidly progressive condition characterized by high blood pressure and the presence of protein in the urine, preeclampsia affects at least five to eight percent of all pregnancies and is a leading cause of maternal and fetal mortality. Pregnant women with preeclampsia may experience swelling, sudden weight gain, headaches, and changes in vision; however, some women with rapidly advancing disease report few symptoms.

“Given the prevalence and associated mortality with preeclampsia, clinicians need better diagnostic tools to identify the condition before it becomes advanced,” said Dave Hickey, CEO, Chemistry, Immunoassay, Automation, and Diagnostics IT Business Unit, Siemens Healthcare Diagnostics. “The development of assays designed to detect preeclampsia earlier is an evolving area of diagnostic medicine, and we are excited to enter into the agreement with Nephromics to offer these diagnostic solutions to our customers, clinicians and patients.”

Under the terms of the agreement with Nephromics, Siemens Healthcare Diagnostics will obtain rights for the development of the SFLT-1 and PLFG assays to be used in conjunction with each other to aid in the diagnosis of preeclampsia. Siemens reports that clinical studies show that these assays, when used together, are better predictors of preeclampsia than either marker alone.

The addition of these assays would complement Siemens’ existing portfolio of integrated OB/GYN diagnostic solutions, which include both ultrasound imaging and reproductive endocrinology laboratory testing.