Thermo Fisher : FDA Clears Immunoassays To Aid In Risk Assessment Of Preeclampsia

(RTTNews) - The U.S. Food and Drug Administration has cleared the Thermo Scientific B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR novel biomarkers, the first and only immunoassays to receive breakthrough designation and clearance for the risk assessment and clinical management of preeclampsia, a severe pregnancy complication, Thermo Fisher Scientific Inc. (TMO) said in a statement on Friday.

Preeclampsia is a life-threatening blood pressure disorder that can occur during pregnancy and the postpartum period. Preeclampsia is the leading cause of maternal and fetal mortality and morbidity worldwide, with incident rates that have increased rapidly in the United States over the last decade.

The new assays are designed to be used along with other laboratory tests and clinical assessments to aid in the risk assessment of pregnant women who have been hospitalized for hypertensive disorders of pregnancy to determine if they are at risk of progressing to preeclampsia with severe features within the next two weeks.

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