FDA approves novel blood tests for preeclampsia

The US Food and Drug Administration (FDA) has approved a pair of blood tests to assess the risk of the deadly pregnancy complication preeclampsia.

The US biotech company Thermo Fisher Scientific has received both breakthrough designation and clearance for B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR biomarkers for the risk evaluation and clinical management of preeclampsia.

Designed for use with other laboratory tests and clinical assessments, the new assays, the company says, will enable the risk assessment of pregnant women who were hospitalised for hypertensive disorders of pregnancy.

Preeclampsia is a condition that affects some pregnant women, usually during the second half of pregnancy or soon after their baby is delivered.

In the United States, it affects between five to eight per cent of pregnancies and is the cause of about 15 per cent of premature deliveries. While many women with preeclampsia do not have any symptoms, early signs include high blood pressure, protein in the urine and retaining water.

The tests, developed by Thermo Fisher Scientific, can assist in assessing the likelihood of pregnant women developing severe preeclampsia in the coming two weeks.

The Thermo Scientific B·R·A·H·M·S KRYPTOR compact PLUS clinical chemistry analyser, which can offer results within half an hour, is used to run both assays.

“Thermo Fisher is committed to advancing diagnostic solutions for reproductive health as part of our broader mission to enable our customers to make the world healthier, cleaner and safer,” said Thermo Fisher Scientific chief medical officer, Alan Sachs.

“Today’s clearance of these breakthrough biomarkers will have a significant impact on prognosis and treatment for thousands of women at risk for preeclampsia every year in the US.”

The PRAECIS study, which was conducted across 18 hospitals in the US, analysed more than 700 pregnant women to validate the efficacy of blood-based biomarkers in detecting the onset of severe preeclampsia.

Emory University health affairs executive vice-president Dr Ravi Thadhani said: “FDA clearance and availability of these novel biomarker tests throughout the country will allow caregivers to better manage and potentially improve outcomes for both mothers and their newborns.”