Thermo Fisher Scientific announces FDA clearance of breakthrough immunoassays to aid in the risk assessment of preeclampsia
Thermo Fisher Scientific 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 for the risk assessment and clinical management of preeclampsia, a severe pregnancy complication.
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.
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.
These new assays are designed to run on the Thermo Scientific B·R·A·H·M·S KRYPTOR compact PLUS clinical chemistry analyzer. Using TRACE technology, based on Nobel Prize winning chemistry, the analyzer can deliver results in less than 30 minutes.
