New Biomarker to Detect Major Prenatal Disorder

A prospective biomarker show promise of identifying patients at risk for preeclampsia, a threatening disorder that affects 5-7% of all pregnant women and can result in premature birth as well as death.

Unlike other potential biomarkers, the placental protein 13 (PP13) marker appears to be manifested earlier in the pregnancy. The data from preliminary research show that measuring PP13 in a blood sample during routine prenatal testing in the first trimester might identify as many as 90% of women at risk. Moreover, the new marker apparently identifies patients who are at risk for both forms of the disorder, restricted fetal growth preeclampsia and normal fetal growth preeclampsia.

Preeclampsia can also cause blindness, motor and mental disorders, hypertension, and malfunction of the kidneys, liver, and heart. In the United States alone, an estimated U.S.$30 billion is spent to treat newborns and their mothers with preeclampsia.

PerkinElmer, Inc. (Boston, MA, USA), has secured exclusive global rights to the PP13 marker, initially developed by Diagnostics Technologies Ltd. (DTL, Yokneam, Israel), a developer of diagnostic kits and devices for monitoring pregnancies at risk. The two companies are collaborating on further validation of PP13.

"This new partnership with Diagnostic Technologies holds the promise to provide early identification of patients at risk for preeclampsia and facilitate the adoption of protective measures before complications develop,” said Robert F. Friel, president of PerkinElmer Life and Analytical Sciences.

"According to the CDC [U.S. Centers of Disease Control and Prevention] national birth statistics, preeclampsia is the second-most-frequent cause of maternal death during pregnancy,” observed Dr. Hamutal Mein, CEO of Diagnostic Technologies.

Further testing of PP13 is needed determine whether the marker can detect the predisposition for preeclampsia. Currently, there is no effective way to prevent preeclampsia, although the prophylactic use of low-dose aspirin has shown some evidence of reducing the disease's prevalence, according to Professor Kypros Nicolaides, director of the Fetal Medicine Foundation (London, UK).

"The preliminary data on PP13 is encouraging. It is now necessary to validate that data and undertake a large screening study of maternal serum PP13 and uterine artery Doppler, and randomize women in the high-risk group to determine if early intervention can truly reduce the prevalence of the disease,” said Prof. Nicolaides.


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