FDA OKs Thermo Fisher’s Breakthrough Preeclampsia Immunoassays

Thermo Fisher Scientific has received U.S. Food and Drug Administration (FDA) clearance for its B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR novel biomarkers, which, according to the company, are the first and only immunoassays to gain breakthrough designation and clearance for risk assessment and clinical management of preeclampsia.
 
The new assays are designed for use with other lab tests and clinical evaluations to aid in risk assessment of pregnant women who were hospitalized for hypertensive disorders of pregnancy to determine if they’re at risk of progression to preeclampsia with severe feature in 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,” Alan Sachs, chief medical officer at Thermo Fisher Scientific told the press. “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.”
 
B·R·A·H·M·S sFlt-1 KRYPTOR and B·R·A·H·M·S PlGF plus KRYPTOR, helps with detection of development of severe preeclampsia as validated by the PRAECIS study, which examined 18 U.S. hospitals, looking at over 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 VP of health affairs at Emory University and co-author of the PRAECIS study.
 
“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,” said Eleni Tsigas, CEO at the Preeclampsia Foundation. “Our organization celebrates this result after many years of advocacy with leaders in research and regulatory bodies, such as the FDA, to accelerate the development and adoption of better clinical tools.”
 
Reference
¹ Thadhani R, Lemoine E, Rana S, et al. Circulating angiogenic factor levels in hypertensive disorders of pregnancy. NEJM Evid 2022; 1:EVIDoa2200161.