Test to Detect Pregnancy-Related Complication Gets FDA Nod
(Reuters) -The U.S. Food and Drug Administration (FDA) has cleared Thermo Fisher Scientific Inc’s test, the first of its kind in the country, to detect women with risk of severe preeclampsia, the company said on Friday.
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.
(Reporting by Khushi Mandowara in Bengaluru; Editing by Shailesh Kuber)
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