New FDA-approved Biomarker Test System: The Thermo Scientific PlGF and sFlt-1 Test System.

On May 19, 2023, the U.S. Food and Drug Administration (FDA) announced the FDA approval granting marketing of Thermo Fisher Scientific's BRAHMS sFlt-1/PlGF ratio KRYPTOR test system to aid in the risk assessment of certain pregnant women hospitalized for hypertensive disorders such as preeclampsia or chronic hypertension or gestational hypertension likely to progress to PE with severe features.

The test system is an automated immunofluorescent assay that uses Time-Resolved Amplified Cryptate Emission (TRACE) technology for the quantitative detection of placental biomarkers, Placental Growth Factor (PlGF) and Soluble Fms-like tyrosine kinase-1 (sFlt-1) in human serum and plasma. The BRAHMS sFlt-1/ PlGF KRYPTOR Test System is the first device to receive FDA approval to aid in the prognosis of PE with severe features in pregnant women. 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, the test system can deliver results in less than 30 minutes.

The test system measures the serum or plasma levels of the two biomarkers, PlGF and sFlt-1 and the results are expressed as the sFlt-1/PlGF ratio or referred to as the risk stratification ratio. A positive result for the test is a ratio equal or greater than 40. Women who test positive based on the risk stratification ratio of > 40 would be considered as candidates to benefit from enhanced surveillance and accelerated care before severe PE features develop.