The US Food and Drug Administration (FDA) has granted clearance for Thermo Fisher Scientific’s novel immunoassays to support the risk evaluation of a severe pregnancy complication called preeclampsia.
The company 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 will enable the risk assessment of pregnant women who were hospitalised for hypertensive disorders of pregnancy.
The tests 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 30 minutes, is used to run both assays.
Thermo Fisher Scientific chief medical officer Alan Sachs said: “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.
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“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.”