Thermo Fisher gets FDA clearance for first blood test of severe preeclampsia risk

Dive Brief:

Thermo Fisher Scientific received clearance from the Food and Drug Administration for the first blood test to predict the risk of severe preeclampsia, a life-threatening hypertensive disorder that occurs only during pregnancy and the postpartum period.
The test compares the ratio of two proteins to determine if pregnant women with hypertensive disorders are likely to develop the condition, which can only be treated with the immediate delivery of the baby.
Thermo Fisher has designed the assays to run on its B·R·A·H·M·S KRYPTOR compact PLUS clinical chemistry benchtop analyzer and to deliver results in 30 minutes.

Dive Insight:

Incidence of new‐onset hypertensive disorders of pregnancy doubled in the U.S. from 2007 to 2019. Some researchers link the trend, which accelerated after 2014, to changes in obesity, physical activity and diet. Some women with hypertensive disorders develop severe preeclampsia, while the methods for predicting who will develop a life-threatening case have limitations.

Lacking the means to predict who will progress, physicians may keep women in the hospital until they deliver the baby at 37 weeks to mitigate the risks of a condition that accounts for 17% of maternal deaths and 15% of premature birth in the U.S. In 2012, the cost of preeclampsia in the 12 months after delivery was $2.18 billion.

Thermo Fisher’s expectation that it can improve the management of the condition is underpinned by data from a study that evaluated 1,014 pregnant women. In the trial, the ratio of the two proteins, sFlt-1 and PlGF, was a better predictor of the risk of developing preeclampsia with severe features than standard clinical measures, the research found.

Eleni Tsigas, CEO at the Preeclampsia Foundation, welcomed the FDA clearance.

“Patients and providers will benefit from having better tests to predict progression to preeclampsia with severe features, especially for those patients at risk of severe, early-onset disease or for whom there is some diagnostic uncertainty,” Tsigas said in a statement distributed by Thermo Fisher.