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Preeclampsia is a leading cause of mortality in pregnant women globally, where they could experience high blood pressure after 20 weeks of pregnancy and during the postpartum period.
The condition happens in about 1 in 25 pregnancies in the United States, according to the U.S. Centers for Disease Control and Prevention.
The FDA clearance is based on a study that examined data from over 700 pregnant women in 18 U.S. hospitals.
The regulatory nod for the biomarker test will have a significant impact on prognosis and treatment for thousands of women at risk for preeclampsia every year in the U.S, said Alan Sachs, chief medical officer at Thermo Fisher Scientific.
