FDA clearance of breakthrough immunoassays to aid in the risk assessment of preeclampsia

Thermo Fisher Scientific Inc. recently announced that the U.S. Food and Drug Administration (FDA) 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 immunoassays to receive breakthrough designation and clearance for the risk assessment and clinical management of preeclampsia, a severe pregnancy complication.

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 past decade.

These 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.

“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 Alan Sachs, chief medical officer at Thermo Fisher Scientific. “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 U.S.”

Testing of the blood-based biomarkers, B·R·A·H·M·S sFlt-1 KRYPTOR and B·R·A·H·M·S PlGF plus KRYPTOR, aids in the detection of the development of severe preeclampsia as validated by the PRAECIS study, which examined 18 U.S. hospitals, looking at more than 700 pregnant women across the country¹ . Women who test positive, based on the risk stratification ratio of the two assays (sFlt-1/PlGF ratio ≥ 40), could receive enhanced surveillance and accelerated care before severe features develop.

“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,” said Ravi Thadhani, MD, MPH, executive vice president of health affairs at Emory University and co-author of the PRAECIS study.

These new assays are designed to run on the Thermo Scientific™ B·R·A·H·M·S™ KRYPTOR™ compact PLUS clinical chemistry analyzer. Using time resolved amplified cryptate emission (TRACE) technology the analyzer can deliver results in less than 30 minutes.

References:

Thadhani R, Lemoine E, Rana S, et al. Circulating angiogenic factor levels in hypertensive disorders of pregnancy. NEJM Evid 2022; 1(12); DOI:10.1056/EVIDoa2200161.