Thermo Fisher Scientific Granted FDA Clearance for Groundbreaking Immunoassays Facilitating Preeclampsia Risk Assessment
Thermo Fisher Scientific, a leading global provider of scientific solutions, 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 immunoassays have been granted breakthrough designation and are the first of their kind to aid in the risk assessment and clinical management of preeclampsia, a severe pregnancy complication
Preeclampsia is a deadly blood pressure condition that can emerge during pregnancy and the postpartum period, causing significant maternal and fetal morbidity and mortality, with incidence rates climbing in the United States.
The newly cleared assays, when used alongside other laboratory tests and clinical assessments, help evaluate the risk of pregnant women hospitalized for hypertensive disorders of pregnancy. They specifically identify individuals at risk of developing preeclampsia with severe features within the next two weeks. This clearance marks a significant milestone in improving prognosis and treatment for thousands of at-risk women annually in the U.S.
The B·R·A·H·M·S sFlt-1 KRYPTOR and B·R·A·H·M·S PlGF plus KRYPTOR biomarkers have undergone rigorous testing, including the PRAECIS study involving over 700 pregnant women across 18 hospitals in the United States. These biomarkers have been validated to detect the development of severe preeclampsia. Pregnant women who test positive based on the risk stratification ratio of the two assays (sFlt-1/PlGF ratio ≥ 40) can receive enhanced surveillance and expedited care before severe symptoms emerge.
Thermo Fisher Scientific's B·R·A·H·M·S KRYPTOR compact PLUS clinical chemistry analyzer, equipped with TRACE technology, offers rapid results in under 30 minutes. This innovative analyzer enables healthcare professionals to efficiently assess and manage preeclampsia risk.
This achievement is a testament to Thermo Fisher Scientific's dedication to advancing clinical tools through collaboration with research and regulatory bodies like the FDA. It represents a significant step forward in improving the assessment and management of preeclampsia, benefiting the health and well-being of pregnant women and their babies.
