Feb. 18, 2025—Roche announced that its Roche Elecsys sFlt-1/PlGF ratio for preeclampsia has received FDA 510(k) clearance. The preeclampsia ratio supports the management of pregnant patients who have a singleton pregnancy and is intended to help clinicians stratify hospitalized patients into low- and high-risk categories for developing severe preeclampsia within two weeks of presentation.
The Elecsys sFlt-1 and Elecsys PlGF assays are provided in separate kits. The ratio must be calculated using Elecsys sFlt 1 and Elecsys PlGF results obtained on the same patient sample and the same Cobas immunoassay analyzer per the intended use. The assay results should be used only in conjunction with information available from clinical evaluations and other standard-of-care procedures.