Thermo Fisher Scientific has announced that its novel immunoassays, the Thermo Scientific B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR biomarkers, have received clearance from the U.S. Food and Drug Administration (FDA). These breakthrough biomarkers are the first and only immunoassays to be cleared for the risk assessment and clinical management of preeclampsia, a severe complication during pregnancy.
Preeclampsia is a dangerous blood pressure disorder that can occur during pregnancy and in the postpartum period. It is a leading cause of maternal and fetal mortality and morbidity worldwide, and its incidence rates have been rapidly increasing in the United States over the past decade.
The newly cleared assays, B·R·A·H·M·S sFlt-1 KRYPTOR and B·R·A·H·M·S PlGF plus KRYPTOR, are designed to be used in conjunction with other laboratory tests and clinical evaluations. They aid in the risk assessment of pregnant women who have been hospitalized for hypertensive disorders of pregnancy, helping to determine if they are at risk of developing 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.”
The efficacy of the blood-based biomarkers, B·R·A·H·M·S sFlt-1 KRYPTOR and B·R·A·H·M·S PlGF plus KRYPTOR, was validated by the PRAECIS study, which involved the examination of over 700 pregnant women across 18 hospitals in the United States. The study demonstrated that women who tested positive for the risk stratification ratio of the two assays (sFlt-1/PlGF ratio ≥ 40) were more likely to develop severe preeclampsia. Early detection allows for enhanced surveillance and accelerated care to be provided 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.
“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, chief executive officer 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.”
The Thermo Scientific B·R·A·H·M·S KRYPTOR compact PLUS clinical chemistry analyzer is designed to run these new assays. The analyzer utilizes TRACE technology, based on Nobel Prize-winning chemistry, to deliver results in less than 30 minutes.